{"id":2838,"date":"2018-10-14T12:23:07","date_gmt":"2018-10-14T16:23:07","guid":{"rendered":"http:\/\/journals.law.harvard.edu\/jol\/?p=2838"},"modified":"2021-12-03T18:29:06","modified_gmt":"2021-12-03T23:29:06","slug":"food-product-disclosure","status":"publish","type":"post","link":"https:\/\/journals.law.harvard.edu\/jol\/2018\/10\/14\/food-product-disclosure\/","title":{"rendered":"Be Warned: A Proposal to Reform Food Product Disclosure Statements"},"content":{"rendered":"

Be Warned: A Proposal to Reform Food Product Disclosure Statements<\/strong><\/p>\n

By Gideon Zvi Palte, J.D. \u201918[*]<\/a><\/p>\n

I. Introduction<\/strong><\/p>\n

Dietary choices can have a significant effect on health.[1]<\/a> Moderate reduction in salt consumption can reduce the risk of cardiovascular disease, stroke, and coronary heart attack.[2]<\/a> High cholesterol has been identified as a major contributor to coronary heart disease, heart attacks, and strokes.[3]<\/a> Reducing fat intake can contribute to weight loss.[4]<\/a><\/p>\n

The societal prevalence of health conditions can have sizeable economic effects. The World Health Organization has identified a push to reduce salt intake as one of the most cost-effective population health measures that countries can implement.[5]<\/a> Obesity costs the United States health care system $147 billion annually.[6]<\/a><\/p>\n

The impact of dietary choices on health and the costs of chronic health conditions have led other countries to implement front-of-package food labeling requirements to warn consumers of high levels of specific nutrients in food products. Ecuador requires food products to display red, yellow, and green warning icons to indicate sugar, fat, and sodium contents.[7]<\/a> Chile has implemented aggressive food labeling reforms to combat national obesity rates that are lower than such rates in the United States.[8]<\/a><\/p>\n

The United States does not require comparable warnings of the risk of high contents of specific nutrients in food products. Although federal regulations identify fat, saturated fat, cholesterol, and sodium as nutrients that have the potential to increase the risk of a diet-related disease or health condition,[9]<\/a> food products that contain these \u201chealth-risk nutrients\u201d[10]<\/a> in potentially dangerous quantities are not required to provide consistent or clear warning to consumers.<\/p>\n

Food products are required to display disclosure statements to warn consumers of potentially dangerous health-risk nutrient contents only when those food products make a nutrient content claim[11]<\/a> that characterizes the level of a nutrient in the food (e.g., \u201chigh in fiber\u201d).[12]<\/a> Because nutrient content claims are voluntarily included on food products,[13]<\/a> food manufacturers can easily avoid the requirement to include a disclosure statement to warn of potentially dangerous health-risk nutrient contents by choosing not to display nutrient content claims on their packaging. Consumers therefore receive inconsistent notice of potentially dangerous health-risk nutrient contents in food products. Moreover, consumers do not receive clear notice of potentially dangerous health-risk nutrient contents because disclosure statements do not explicitly state that the food product poses a health risk due to its content of the health-risk nutrient.[14]<\/a><\/p>\n

The shortcoming of the disclosure statement in providing consistent and clear notice of potentially dangerous health-risk nutrient contents in foods stems from its initial enactment alongside referral statements, which were intended to refer consumers to the Nutrition Facts label whenever a food product made a nutrient content claim.[15]<\/a> The referral statement and disclosure statement requirements were enacted together as part of the Nutrition Labeling and Education Act of 1990 (\u201cNLEA\u201d),[16]<\/a> which required standardized nutrition information on food product packaging for the first time.[17]<\/a> Referral statements served to remind consumers to consult the newly required comprehensive nutrition information, instead of nutrient content claims that food manufacturers voluntarily included on food packaging, to learn about the nutrient contents of foods.[18]<\/a> However, this requirement was abrogated with the passage of the Food and Drug Administration Modernization Act of 1997 (\u201cFDAMA\u201d),[19]<\/a> leaving only disclosure statements, which are required to accompany nutrient content claims when food products contain health-risk nutrients at potentially dangerous levels.[20]<\/a><\/p>\n

This Article proposes reforming disclosure statements to provide consistent and clear notice of potentially dangerous levels of health-risk nutrients in foods. The proposal would make disclosure statements (1) mandatory irrespective of the presence or absence of nutrient content claims and (2) explicit in indicating that the food products to which they apply contain health-risk nutrients in a quantity that poses a health risk.<\/p>\n

The Article will first review the history of the legal requirement of disclosure statements in the United States and describe the current requirement and its shortcomings. Next, the Article will explore a private sector food labeling initiative in the United States and the regulatory approaches adopted by Chile and Ecuador to warn consumers of high contents of specific nutrients in foods. It will then discuss the importance of mandatory clear and accurate food labeling in addressing diet-related diseases and facilitating informed consumer decisions. Finally, the Article will propose a statutory reformation of disclosure statements in order to give consumers consistent and clear notice of contents of health-risk nutrients in food products that pose a health risk, followed by an analysis of the constitutional permissibility of the proposal.<\/p>\n

<\/p>\n

II. A brief legislative history of the legally required disclosure statement<\/strong><\/p>\n

In the 1980s, nutrition information on food labels in the United States was largely unregulated. Displaying such information was optional, and when displayed, it was often misleading or of dubious accuracy.[21]<\/a> For instance, nutrient claims used terminology such as \u201clow\u201d and \u201clight\u201d inconsistently.[22]<\/a> Likewise, some food manufacturers made questionable claims that their products could reduce the risk of disease.[23]<\/a> Kellogg\u2019s, for example, claimed in 1984 that its All Bran and Cracklin\u2019 Oat Bran cereals could reduce the risk of certain types of cancer due to high fiber and low fat content.[24]<\/a><\/p>\n

Congress passed the Nutrition Labeling and Education Act of 1990 (\u201cNLEA\u201d)[25]<\/a> to require comprehensive nutrition information on food packaging in a standardized format.[26]<\/a> The NLEA also required voluntary claims regarding a food product\u2019s nutrient content to use descriptive terms such as \u201clow\u201d and \u201clight\u201d in a manner consistent with definitions that the Food and Drug Administration (\u201cFDA\u201d) developed.[27]<\/a> In addition, the NLEA prohibited health claims linking food products to disease prevention unless such claims were supported by FDA-recognized scientific findings.[28]<\/a> When passing the NLEA, members of Congress recognized the link between diet and overall health, as well as the importance of providing consumers with accurate nutrition information so that they could make informed dietary choices.[29]<\/a><\/p>\n

Congress included a requirement in the NLEA that food products displaying a nutrient content claim must also display \u201cprominently and in immediate proximity to such claim\u201d the accompanying message, \u201cSee [appropriate panel] for nutrition information.\u201d[30]<\/a> This text was called a referral statement.[31]<\/a> In addition, if the food product contained a nutrient at a level that the Secretary of Health and Human Services (\u201cthe Secretary\u201d) through the FDA[32]<\/a> determined would \u201cincrease[] to persons in the general population the risk of a disease or health-related condition which is diet related,\u201d the statement would also be required to identify that nutrient.[33]<\/a> This additional requirement was called a disclosure statement.[34]<\/a> The purpose of these statements was thus twofold for food products displaying nutrient content claims: first, to refer consumers to the newly required Nutrition Facts label to find nutrition information (through the referral statement), and second, to warn consumers of the presence of specific nutrients in quantities that could pose a health risk (through the disclosure statement). Notably, disclosure statements were merely an appendage of referral statements; the text of the disclosure statement was required to be added to referral statements in food products with potentially dangerous quantities of health-risk nutrient contents.[35]<\/a> Under the NLEA, a disclosure statement could never appear without a referral statement.[36]<\/a><\/p>\n

By 1997, the Nutrition Facts label (and not nutrient content claims) had become the preferred tool to learn about the nutrition information of food products.[37]<\/a> Republican Senator Mitch McConnell of Kentucky observed in 1997 that the vast majority of consumers were familiar with the Nutrition Facts label and consulted it for nutrition information.[38]<\/a><\/p>\n

As consultation of the Nutrition Facts label for nutrition information became more prevalent even in the absence of nutrient content claims, lawmakers questioned whether it was necessary to require a referral statement to refer consumers to the Nutrition Facts label whenever such claims were made. Instead, they considered whether the disclosure statement might be more effective as a standalone requirement. Senator McConnell proposed a statutory amendment as part of the Food and Drug Administration Modernization Act of 1997 (\u201cFDAMA\u201d)[39]<\/a> to \u201cimprove the effectiveness of [consumer] notice by requiring a referral statement only in those instances where the FDA identifies that a food contains a nutrient at a level that could increase the risk of a health condition for vulnerable persons.\u201d[40]<\/a> In essence, this alteration eliminated the referral statement requirement and left disclosure statements as the only required statement to accompany nutrient content claims. Senator McConnell\u2019s proposal was passed by Congress and codified in 21 U.S.C. \u00a7 343(r)(2)(B).[41]<\/a><\/p>\n

 <\/p>\n

III. Disclosure statements according to current legal requirements<\/strong><\/p>\n

Since the passage of FDAMA, federal law has required prominent disclosure statements for food products that make nutrient content claims only if those food products contain health-risk nutrients in a quantity that poses a health risk.[42]<\/a> If a food product makes a nutrient content claim and exceeds specified quantities per serving of fat, saturated fat, cholesterol, or sodium, the product must prominently display the statement, \u201cSee nutrition information for __ content,\u201d with the blank space replaced by any health-risk nutrient or nutrients in the food product that exceed the specified quantity.[43]<\/a><\/p>\n

21 U.S.C. \u00a7 343(r)(2)(B) specifies the required text of the disclosure statement and mandates its presence for any food product that (1) makes a nutrient content claim and (2) has a quantity of a nutrient that the Secretary has determined \u201cincreases to persons in the general population the risk of a disease or health-related condition that is diet related.\u201d[44]<\/a> 21 U.S.C. \u00a7 343(r)(2)(B) also requires that the statement be displayed \u201cprominently and in immediate proximity to\u201d the product\u2019s nutrient content claim.[45]<\/a> The FDA assumes the responsibility of regulating disclosure statements on behalf of the Secretary.[46]<\/a> 21 C.F.R. \u00a7 101.13(h) specifies quantities of fat, saturated fat, cholesterol, and sodium per serving that require a prominent disclosure statement on food product packaging.[47]<\/a> The quantities vary depending on whether the food product is a meal product, a main dish product, or neither, as displayed in the table below.[48]<\/a><\/p>\n\n\n\n\n\n\n\n
Nutrient<\/strong><\/td>\nDefault Quantity*<\/strong><\/p>\n

(21 C.F.R. \u00a7 101.13(h)(1))<\/strong><\/td>\n

Meal Product Quantity<\/strong><\/p>\n

(21 C.F.R. \u00a7 101.13(h)(2))<\/strong><\/td>\n

Main Dish Product Quantity <\/strong><\/p>\n

(21 C.F.R. \u00a7 101.13(h)(3))<\/strong><\/td>\n<\/tr>\n

Fat<\/td>\n13.0 g<\/td>\n26 g<\/td>\n19.5 g<\/td>\n<\/tr>\n
Saturated Fat<\/td>\n4.0 g<\/td>\n8.0 g<\/td>\n6.0 g<\/td>\n<\/tr>\n
Cholesterol<\/td>\n60 mg<\/td>\n120 mg<\/td>\n90 mg<\/td>\n<\/tr>\n
Sodium<\/td>\n480 mg<\/td>\n960 mg<\/td>\n720 mg<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

*Food \u201cintended specifically for use by infants and children less than 2 years of age\u201d is exempted from the requirements of 21 C.F.R. \u00a7 101.13(h).[49]<\/a><\/p>\n

 <\/p>\n

IV. Shortcomings of the current disclosure statement requirement<\/strong><\/p>\n

FDAMA abrogated referral statements and instead repurposed 21 U.S.C. \u00a7 343(r)(2)(B) to focus exclusively on warning consumers of potentially dangerous health-risk nutrient contents of food products making nutrient content claims. The original referral statement and disclosure statement requirements included in the NLEA were intended to ensure that nutrient content claims would not mislead consumers.[50]<\/a> Congress instituted these requirements as part of a broader effort to require food products to display uniform nutrition information for the first time.[51]<\/a> The disclosure statement requirement was dependent on and largely inseparable from the referral statement requirement.[52]<\/a> Indeed, when Senator McConnell proposed eliminating the referral statement requirement, he still used the term \u201creferral statement\u201d to refer to his proposed requirement of a standalone disclosure statement.[53]<\/a> Considered in this context, the NLEA referral statement and disclosure statement requirements are best understood together as a reminder to consumers to consult the Nutrition Facts label, and not voluntary nutrient content claims, for comprehensive and accurate nutrition information.[54]<\/a> Although the disclosure statement served to warn consumers of potentially dangerous levels of specific nutrients in certain food products, its function was part of a broader purpose to combat consumer deception by referring consumers to the Nutrition Facts label to obtain complete nutrition information.[55]<\/a><\/p>\n

The abrogation of referral statements as part of FDAMA fundamentally changed the nature and purpose of 21 U.S.C. \u00a7 343(r)(2)(B). Instead of always reminding consumers who might be misled by nutrient content claims to consult the Nutrition Facts label for detailed nutrition information, statements required by that section would now only signal the presence of specific health-risk nutrients at potentially dangerous levels when such claims were made.[56]<\/a> The requirement to display the statement was now dependent on the content of nutrients not mentioned in the claims. Under the new provision, consumers could mistakenly rely on a claim that a food product was \u201chigh in fiber\u201d as long as that product did not exceed specified content thresholds for fat, saturated fat, cholesterol, and sodium.[57]<\/a><\/p>\n

The statutory change is puzzling. It was based on a belief that consumers don\u2019t rely on nutrient content claims for nutrition information and that they instead commonly consult the Nutrition Facts panel for this information.[58]<\/a> In other words, there was no need to refer consumers to the Nutrition Facts panel because they already knew it was there.[59]<\/a> Yet, if that was the case, then why leave any statement alongside claims at all? If, in Senator McConnell\u2019s words, \u201cmost individuals look immediately to the mandatory Nutrition Facts panel to receive nutrition information,\u201d[60]<\/a> why should Congress mandate a prominent disclosure statement referring consumers to the Nutrition Facts panel when food products contain levels of health-risk nutrients that pose a health risk?<\/p>\n

The answer must be that despite determining that it was unnecessary to refer consumers to the Nutrition Facts label for complete and accurate nutrition information, Congress still deemed it important to prominently warn consumers of the potential dangers of levels of health-risk nutrients in food products that posed a health risk. The disclosure statement that survives today is purely a warning mechanism to alert consumers to potentially dangerous health-risk nutrient contents. Yet the statutorily mandated language of the disclosure statement and the requirement\u2019s dependence on the presence of voluntary nutrient content claims significantly undermine the warning\u2019s effectiveness.<\/p>\n

Requiring disclosure statements only in the presence of nutrient content claims can mislead consumers regarding the relative health risks presented by similar products. For example, Philadelphia Original Cream Cheese Spread and Kroger Original Cream Cheese Spread both contain 4.5 grams of saturated fat per serving, as shown in Exhibit A.[61]<\/a> The Secretary has determined that this quantity of saturated fat per serving \u201cincreases to persons in the general population the risk of a disease or health-related condition that is diet related.\u201d[62]<\/a> While the saturated fat content in each product is identical and poses the same health risk, only the Philadelphia Original Cream Cheese Spread carries a disclosure statement.[63]<\/a> Why? The Philadelphia Original Cream Cheese Spread makes a nutrient content claim that it has eighty calories per two tablespoons.[64]<\/a> No disclosure statement is required for the Kroger Original Cream Cheese Spread because it does not make such a nutrient content claim.[65]<\/a> Consumers therefore have inconsistent notice regarding the health risk posed by the saturated fat content of these two products and may mistakenly assume that the saturated fat content of the Kroger product poses less of a health risk. Requiring disclosure statements only when food products make nutrient content claims is incompatible with providing consumers effective and transparent warning of the health risks of their food. In the case of similar products, the current disclosure statement requirement itself can be a source of consumer deception.<\/p>\n

Moreover, the currently mandated language of the disclosure statement does not give consumers clear warning that a food product has a potentially harmful quantity of health-risk nutrients. By law, the disclosure statement states only \u201cSee nutrition information for __ content\u201d and does not explicitly signal that the food product has content of the health-risk nutrient that poses a health risk.[66]<\/a> A consumer who sees this statement may not infer that the food product contains a nutrient at a level that the Secretary has determined increases the likelihood of a health-related disease or health condition. Furthermore, consulting the Nutrition Facts label would reveal only the quantity of the health-risk nutrient per serving and the percentage of the FDA\u2019s recommended daily value of the nutrient.[67]<\/a> In other words, nowhere on the food product would the consumer explicitly see an indication that it contains a level of the health-risk nutrient that poses a health risk. The absence of such an indication undermines the legislative intent behind the requirement to improve consumer notice regarding the health risk posed by the food product\u2019s health-risk nutrient content.<\/p>\n

The required presence of disclosure statements in \u201cimmediate proximity\u201d[68]<\/a> to nutrient content claims magnifies the detrimental effect of the unclear language on effective consumer notice of potentially dangerous health-risk nutrient contents. For example, the MorningStar Farms Hickory BBQ Riblets shown in Exhibit B display the disclosure statement \u201cSee nutrition information for sodium content,\u201d but this text appears among numerous nutrient content claims and does not unambiguously alert the consumer to the risk posed by the food product\u2019s sodium content.[69]<\/a> Further obscuring the disclosure statement\u2019s indication of the risk presented by the product\u2019s sodium content is the appearance alongside the disclosure statement of a statement that the Riblets have 3.5 grams of total fat per serving.[70]<\/a> This \u201ctotal fat\u201d statement is permissible under 21 C.F.R. \u00a7 101.13(i).[71]<\/a> Both the language of the disclosure statement and its location among many claims and statements pertaining to the nutrient contents of the product hinder the effectiveness of warning to consumers that the product has a quantity of sodium per serving that the Secretary has deemed a potential health risk.<\/p>\n

 <\/p>\n

V. Alternative approaches to food labeling<\/strong><\/p>\n

There are certainly other ways to inform consumers consistently and clearly about the contents of specific nutrients in food products. Both private industry and foreign governments have made efforts to improve consumer notice regarding nutrient contents of foods. This section discusses a voluntary private sector initiative and regulatory approaches adopted by Chile and Ecuador and how they might (or might not) address the two principal shortcomings of federally required disclosure statements.<\/p>\n

A. The Facts Up Front Initiative<\/u><\/p>\n

Facts Up Front (formerly called Nutrition Keys) is a voluntary program in which participating food manufacturers include basic icons on the front of food packaging that provide calorie, saturated fat, sodium, and sugar information for their products.[72]<\/a> For saturated fat and sodium, the icons display the percentage daily values per serving.[73]<\/a> The FDA has expressed tacit approval of Facts Up Front if implemented across a food manufacturer\u2019s entire product line.[74]<\/a><\/p>\n

Nevertheless, the Facts Up Front Initiative does not address the two principal flaws of disclosure statements. As a voluntary program, it is not universally required (or required at all) of food manufacturers. For example, Kroger Original Cream Cheese Spread displays Facts Up Front icons[75]<\/a> while Philadelphia Original Cream Cheese Spread does not,[76]<\/a> as shown in Exhibit C. Furthermore, although the Facts Up Front icons display the nutrients\u2019 quantities, they do not inform consumers whether such quantities exceed levels that the Secretary has identified as creating a potential health risk. Neither do they include information on fat and cholesterol, which the Secretary has identified as health-risk nutrients.[77]<\/a> Research confirms that even highly educated consumers tend to find the format of the Facts Up Front icons misleading.[78]<\/a><\/p>\n

MorningStar Farms Hickory BBQ Riblets[79]<\/a> and Kroger Original Cream Cheese Spread[80]<\/a> display Facts Up Front icons, as shown in Exhibit C. While the Facts Up Front icons display the sodium and saturated fat content per serving of the food products and indicate the percentage of the recommended daily value that the quantities represent, the icons do not explicitly inform the consumer that the Secretary has determined that the products\u2019 respective quantities of sodium and saturated fat \u201cincrease[] to persons in the general population the risk of a disease or health-related condition that is diet related.\u201d[81]<\/a> This deficiency means that consumers may not be aware of the potential health risk presented by the products\u2019 respective quantities of sodium and saturated fat per serving.<\/p>\n

B. Chile\u2019s new nutritional labeling regulation<\/u><\/p>\n

Whereas a voluntary private sector initiative may fail in requiring food products to provide clear warning of potentially dangerous quantities of health-risk nutrients, a regulatory approach could succeed. Chile provides an illustrative example. In order to combat the increasing prevalence of obesity among its citizens,[82]<\/a> Chile published a regulation on June 26, 2015, that instituted new labeling requirements for packaged food products with high contents of sugar, calories, saturated fat, and sodium.[83]<\/a> Food products exceeding specified quantities of these nutrients must display an octagonal warning icon that explicitly states that the product has a high level of the nutrient.[84]<\/a> Food products may be required to display between zero and four such icons (shown in Exhibit D) depending on the quantities of sugar, calories, saturated fat, and sodium they contain.[85]<\/a> These nutrient quantity thresholds went into effect on June 26, 2016, with a schedule of increased stringency to culminate in the final requirements taking effect after June 26, 2018.[86]<\/a> As a result of this graduated enforcement schedule, food products will gradually be subjected to more stringent nutrient quantity thresholds that would legally require the warning icons to be displayed.[87]<\/a><\/p>\n

Chile\u2019s regulation addresses the two principal flaws of disclosure statements in the United States. The Chilean icons are universally applicable to packaged food products that exceed threshold levels of regulated nutrients, and they clearly indicate to consumers that the products have a high content of the nutrients. They achieve Senator McConnell\u2019s goal of clear consumer notice better than the current federal statutory requirement.<\/p>\n

C. Ecuador\u2019s \u201ctraffic light\u201d labeling requirements<\/u><\/p>\n

Ecuador provides another example of a regulatory requirement providing effective notice to consumers of the potential health risks presented by nutrient quantities in food products. Since November 2014, Ecuador has required food products to display red, yellow, and green icons (shown in Exhibit E) that correspond to their sugar, fat, and sodium contents.[88]<\/a> Under the Ecuadorian regulation, red signals high content, yellow signals average content, and green signals low content.[89]<\/a><\/p>\n

Although implementation of the requirement has been inconsistent and has resulted in some food products displaying the icons less prominently than others,[90]<\/a> consumers recognize and understand the icons. The bright colors of the icons and their similarity to red, yellow, and green traffic lights have played a substantial role in making them easy to interpret.[91]<\/a> Red icons leave a particularly strong impression on consumers, who associate the color with a warning of potential danger.[92]<\/a> Still, other factors such as flavor, brand, and price also play a role in shaping consumers\u2019 choices as to whether to buy products with red icons.[93]<\/a> For consumers, red does not necessarily mean that they should not purchase a food product, but it does serve as a warning to consider the potential health risks that the product poses.[94]<\/a> Whether as a result of Ecuadorian consumers pausing to think about health concerns or food producers selling fewer products high in sugar, fat, and sodium, sales of products high in these nutrients dropped by thirty-five percent by May 2016.[95]<\/a><\/p>\n

 <\/p>\n

VI. The need for disclosure statement reform<\/strong><\/p>\n

As the regulatory approaches of Chile and Ecuador demonstrate, food labeling can play an important role in addressing the public health concerns presented by diet-related health conditions and diseases. Research from around the world suggests that nutrition labels can help consumers make healthier consumption choices.[96]<\/a> In the United States, the FDA has traditionally sought to ensure that nutrition labeling requirements \u201chelp people make better informed food choices that support a healthy diet.\u201d[97]<\/a><\/p>\n

As early as 1990, health promotion efforts such as food labeling reforms were recognized as one of the least expensive ways to improve health and reduce health care costs in the United States.[98]<\/a> Today, there is great need for such efforts, with 70.1 percent of Americans overweight or obese[99]<\/a> and a national obesity rate of 37.7%.[100]<\/a> Moreover, obesity is associated with some of the top causes of preventable death, including heart disease, stroke, type 2 diabetes, and certain types of cancer.[101]<\/a> It costs the United States health care system $147 billion annually.[102]<\/a> There is bipartisan consensus that obesity is a major national public health issue,[103]<\/a> and the United States cannot afford to further delay in addressing it.<\/p>\n

Providing consumers with more effective notice of the health risk posed by health-risk nutrient contents in food products would be a simple step in the right direction. Considering that many food manufacturers have voluntarily elected to change the labels of their products as part of the Facts Up Front Initiative, as well as the fact that Chile has successfully implemented a warning icon requirement in conjunction with other aggressive reforms,[104]<\/a> the cost of changing the content of disclosure statements should be one that the industry can afford.[105]<\/a><\/p>\n

Even if providing consumers with consistent and clear notice that food products contain potentially dangerous levels of health-risk nutrients will not quickly or even necessarily change consumption patterns,[106]<\/a> reforming disclosure statements nonetheless serves an important public need for consumer access to relevant nutrition information. In urging his colleagues to vote for the NLEA in 1990, Republican Senator Orrin Hatch of Utah asserted the importance of providing consumers with access to nutrition information so that they could \u201cmake a judgment whether or not to buy a product.\u201d[107]<\/a> He continued, \u201cConsumers should not be denied information they want in the form they want it\u2014on product labels on supermarket shelves.\u201d[108]<\/a>\u00a0 Research shows that consumers want clear, easily comprehensible nutrition information.[109]<\/a> Color-coded icons, such as those adopted in Ecuador, on the front of food packages are most effective in meeting these expectations.[110]<\/a><\/p>\n

While the actual effect of information about potentially dangerous health-risk nutrient levels will likely vary by individual, consumers must have consistent and clear access to this information in order to make informed decisions about their diet. The current disclosure statement requirement provides neither consistent nor clear information regarding potentially dangerous levels of health-risk nutrients in food products. Consumers therefore cannot make informed choices about whether to consume foods that pose a health risk due to their health-risk nutrient contents.<\/p>\n

 <\/p>\n

VII. Policy proposal and First Amendment analysis<\/strong><\/p>\n

Disclosure statements in the United States should be reformed to embrace their current purpose of warning consumers of potentially dangerous levels of health-risk nutrients in food products. They should resemble the language of the warning icons adopted by Chile, display a recognizable red symbol like food products with high contents of specific nutrients in Ecuador, and appear regardless of whether a nutrient content claim is present. This reform would improve the efficacy and transparency of consumer notice regarding potentially dangerous health-risk nutrient levels by consistently and clearly informing consumers when food products contain health-risk nutrients in quantities that the Secretary has deemed potentially harmful to consumer health.<\/p>\n

This section will provide a proposed amendment of 21 U.S.C. \u00a7 343(r)(2)(B), followed by a constitutional analysis of the proposal under First Amendment jurisprudence.<\/p>\n

A. Policy proposal<\/u><\/p>\n

My proposal would require reforming disclosure statements so that they (1) are required for food products that contain potentially dangerous levels of health-risk nutrients whether or not those products make a nutrient content claim, and (2) indicate unambiguously that the food product\u2019s health-risk nutrient poses a risk through both text (e.g., \u201csodium risk\u201d) and overall visual appearance (through a red icon). Exhibit F displays sample food products with the proposed disclosure statement.<\/p>\n

Because 21 U.S.C. \u00a7 343(r)(2)(B) limits the applicability of disclosure statements to food products that make nutrient content claims and specifies the required text of disclosure statements, implementation of this proposal would require federal legislation. The statutory text could be amended as follows (deletions stricken out, additions underlined):<\/p>\n

If a claim described in subparagraph (1)(A) [e.g., a nutrient content claim] is made with respect to a nutrient in a food and<\/span> the Secretary makes a determination that a food contains a nutrient at a level that increases to persons in the general population the risk of a disease or health-related condition that is diet related, the label or labeling of such food shall contain, prominently and in immediate proximity to such claim<\/span> a red rectangular icon<\/u>, the following statement: \u201cSee nutrition information for ___ content.\u201d <\/span>\u201cFederal Food and Drug Administration: ___ HEALTH RISK.\u201d<\/u> The blank shall identify the nutrient associated with the increased disease or health-related condition risk. In making the determination described in this clause, the Secretary shall take into account the significance of the food in the total daily diet.<\/em><\/p>\n

The Secretary could then amend 21 C.F.R. \u00a7 101.13 in accordance with the new statutory language and designate a future effective date for the new regulation in order to afford affected food manufacturers the opportunity to update the packaging of their products.<\/p>\n

The current legal framework already contains the other elements necessary to support universally applicable and explicit disclosure statements. Federal statutory law delegates to the Secretary the authority to identify nutrients that \u201cincrease[] to persons in the general population the risk of a disease or health-related condition that is diet related.\u201d[111]<\/a> The Secretary has identified fat, saturated fat, cholesterol, and sodium as nutrients that carry this risk when present in large quantities.[112]<\/a> Current nutrition labeling requirements already require measurement of the quantities of these nutrients in food products and a prominent disclosure statement when food products exceed specified quantities of health-risk nutrients and make nutrient content claims.[113]<\/a><\/p>\n

B. First Amendment analysis<\/u><\/p>\n

Both the current and proposed disclosure statements would likely be considered a form of compelled commercial speech, much like other nutrition information required to be displayed on food product packaging.[114]<\/a> Because commercial speech is constitutionally protected,[115]<\/a> the requirements would need to be constitutionally permissible in order to be legally imposed on food manufacturers.<\/p>\n

1. Applicable standards: Zauderer<\/em> and Central Hudson<\/em><\/u><\/p>\n

Although government-compelled political or religious speech often receives the greatest of constitutional protections under a strict scrutiny analysis,[116]<\/a> compelled commercial speech is subject to a less rigorous standard. In Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio<\/em>,[117]<\/a> the Supreme Court of the United States concluded that an Ohio law requiring attorneys hired on a contingency basis to disclose that clients would still have to pay costs even if their lawsuits were unsuccessful was \u201creasonably related to the state\u2019s interest in preventing the deception of consumers\u201d[118]<\/a> and not \u201cunjustified or unduly burdensome.\u201d[119]<\/a> In upholding the requirement, the Court emphasized that Ohio\u2019s compelled disclosure pertained to \u201cpurely factual and uncontroversial information.\u201d[120]<\/a><\/p>\n

The Zauderer<\/em> standard is less rigorous than the traditional intermediate scrutiny standard applied to commercial speech articulated in Central Hudson Gas & Electric Corp. v. Public Service Commission of New York<\/em>,[121]<\/a> in which the Supreme Court held that commercial speech regarding lawful activity that is not false or misleading may be restricted to serve a substantial government interest if the regulation directly advances that interest, and the regulation is not more extensive than is necessary.[122]<\/a> In its application of a different standard, the Zauderer<\/em> court noted that required disclosures \u201ctrench much more narrowly . . . than do flat prohibitions on speech.\u201d[123]<\/a><\/p>\n

While the proposed statement is best analyzed under Zauderer<\/em>, there is also a strong argument that it would pass Central Hudson<\/em> scrutiny as well.<\/p>\n

2. The proposed disclosure statement is purely factual and uncontroversial, as required by Zauderer<\/em>.<\/u><\/p>\n

The proposed disclosure statement is a disclosure requirement that represents an undisputed fact: that the FDA has determined that the food product\u2019s health-risk nutrient content poses a health risk. The characterization of a quantity of the nutrient that, to quote the statute, \u201cincreases to persons in the general population the risk of a disease or health-related condition that is diet related\u201d[124]<\/a> as a \u201chealth risk\u201d could hardly be considered controversial.[125]<\/a> The quantity thresholds for the currently required disclosure statement effectively indicate levels of health-risk nutrients in food products that the FDA regards as posing a health risk. Characterizing the thresholds as quantities that pose a \u201chealth risk\u201d does not change what the agency is already doing when it determines health-risk nutrient thresholds for different types of foods.[126]<\/a><\/p>\n

The fact that the FDA already specifies quantities of health-risk nutrients that \u201cincrease[] to persons in the general population the risk of a disease or health-related condition that is diet related\u201d[127]<\/a> differentiates the proposed disclosure statement from other disclosure requirements based on statutory terminology that have been struck down in the federal courts of appeals. Those cases\u2014which concluded that the statutory definition of \u201csexually explicit\u201d in characterizing video games[128]<\/a> and a statutory term referring to minerals that were \u201cDRC-conflict free\u201d (referring to the conflict in the Democratic Republic of the Congo)[129]<\/a> were not purely factual and uncontroversial\u2014considered new, never-before-enforced disclosure requirements. By contrast, the health-risk nutrient quantity thresholds that require a disclosure statement have remained unchanged since 1993, when the FDA issued regulations implementing the NLEA\u2019s referral statement and disclosure statement requirements.[130]<\/a> Food manufacturers have never before challenged the disclosure statement requirement, which was promulgated through notice-and-comment rulemaking procedures and which has been consistently enforced according to the same health-risk nutrient content thresholds since 1993[131]<\/a> (and in its current form since 1998).[132]<\/a> They have complied with the requirement in some form according to the same thresholds for the past twenty-five years.[133]<\/a> The introduction of an intuitive rephrasing to make the meaning of the requirement clear to consumers does not render the long-existing thresholds for a required disclosure statement controversial.[134]<\/a><\/p>\n

The proposal\u2019s red rectangular icon does not alter the factual and uncontroversial nature of the statement. It does call attention to the text, but its emotional impact on the consumer and potential for misinterpretation are considerably less severe than the graphic photographs illustrating the potential devastating health effects of cigarette smoking[135]<\/a> that were determined not to be purely factual in R.J. Reynolds Tobacco Co. v. FDA<\/em>.[136]<\/a> Other courts considering cigarette labeling requirements have determined that as a conceptual matter, warning images could be considered factual for the purposes of Zauderer<\/em> even if the images evoke an emotional response.[137]<\/a> If images can be purely factual, then a red rectangle should be as well. Moreover, the proposed disclosure statement requirement does not advocate a particular course of action from consumers, such as urging consumers to quit smoking[138]<\/a> or providing advice on what to do to avoid radio frequency energy emissions from cell phones.[139]<\/a> The red icon calls the consumer\u2019s attention to the statement, but it does not advise the consumer whether or not to purchase the product or have another meaning independent of the text displayed within it. The red icon should therefore not alter the factual and uncontroversial nature of the statement.<\/p>\n

It is interesting to consider that the current disclosure statement requirement, just like the referral statement and disclosure statement required by the NLEA, is not factual; rather it is imperative. It commands the consumer, \u201cSee<\/em> nutrition information for __ content.\u201d[140]<\/a> I am unaware of any federal court cases analyzing the constitutional permissibility of an imperative disclosure requirement such as the one currently in effect for food products that have potentially dangerous health-risk nutrient contents and that display nutrient content claims. Whether courts would apply Zauderer <\/em>to such a claim is an open question. In this sense, the proposed disclosure statement, \u201cFederal Food and Drug Administration: ___ health risk\u201d is more factual, and thus more suitable for Zauderer <\/em>scrutiny, than the current disclosure statement requirement.<\/p>\n

3. The proposed statement directly serves interests that are sufficiently substantial for both Zauderer<\/em> and Central Hudson<\/em>.<\/u><\/p>\n

The original NLEA referral statement and disclosure statement requirements fit squarely within the consumer deception interest addressed in Zauderer<\/em>.[141]<\/a> The NLEA requirements ensured that consumers would not be deceived by nutrient content claims and that they would instead consult the new Nutrition Facts panel for nutrition information.[142]<\/a><\/p>\n

The current disclosure statement requirement, which has been in effect since the enactment of FDAMA in 1997, does not serve the interest of consumer deception and can itself be a source of such deception for similar food products.[143]<\/a> Although it functions to warn consumers of potentially dangerous health-risk nutrient contents, its limitation to products making nutrient content claims undermines its capacity to serve the government\u2019s public health or consumer awareness interests.[144]<\/a><\/p>\n

On the other hand, the proposed disclosure statement serves the interests of public health and consumer awareness by consistently and clearly warning consumers of the health risk posed by health-risk nutrient contents of food products. These interests are likely sufficient to warrant Zauderer <\/em>scrutiny. In New York State Restaurant Association v. New York City Board of Public Health<\/em>,[145]<\/a> the Second Circuit cited \u201cNew York\u2019s interest in preventing obesity\u201d when applying Zauderer <\/em>to uphold New York\u2019s requirement for food labels to display calorie information.[146]<\/a> The Ninth Circuit has explicitly characterized an interest in the health of citizens as \u201ca substantial government interest.\u201d[147]<\/a> In American Meat Institute v. U.S. Department of Agriculture<\/em>, the D.C. Circuit upheld country-of-origin labeling requirements and explicitly overruled its prior case law implying that Zauderer<\/em> was limited to cases where the government had an interest in preventing consumer deception.[148]<\/a> The court characterized as \u201csubstantial\u201d the government\u2019s combined interest in continuing the longstanding practice of informing consumers when products are American-made, in giving consumers information that they want, and in addressing potential health concerns in the event of a foodborne illness outbreak.[149]<\/a> The proposed disclosure statement is similar in that it represents thresholds that have been in effect for twenty-five years, gives consumers information that can inform their purchasing decisions, and serves the government\u2019s interest in public health. The interests that the proposed disclosure statement serves are most likely sufficiently substantial to merit analysis under Zauderer<\/em>.<\/p>\n

The Supreme Court has characterized the government\u2019s interest in \u201cpromoting the health, safety, and welfare of its citizens\u201d as a substantial interest under Central Hudson<\/em>.[150]<\/a> The proposed disclosure statement promotes citizen health, safety, and welfare by consistently and clearly warning consumers of potentially dangerous health-risk nutrient contents. The interests it serves should therefore be sufficiently substantial to pass Central Hudson<\/em> scrutiny as well.<\/p>\n

4. The proposed statement is not unjustified or unduly burdensome, nor is it more extensive than necessary.<\/u><\/p>\n

The proposed disclosure statement is not \u201cunjustified or unduly burdensome.\u201d[151]<\/a> It clearly indicates that the compelled speech is from the government and not from the food manufacturer.[152]<\/a> The size of the statement, however, need not change according to the proposal. A recently enjoined San Francisco ordinance requiring fixed advertisements for sugar-sweetened beverages to display a warning message that drinking such beverages contributes to obesity, diabetes, and tooth decay also attributed the required disclosure to the government authority requiring the message\u2014the City and County of San Francisco.[153]<\/a> While the affected beverage companies argued that the warning unduly burdened their commercial speech because it was required to cover twenty percent of their advertisements and because it forced them to display a message from the San Francisco government with which they disagreed, the Ninth Circuit relied only on the size of the advertisement, and not the fact that the requirement required the companies to carry the government\u2019s message, in finding an undue burden.[154]<\/a> In January 2018, the Ninth Circuit announced its decision to rehear the case en banc and disclaimed the prior case as binding precedent.[155]<\/a> It will be interesting to see how the Ninth Circuit\u2019s reconsideration of the San Francisco requirement may affect how courts and scholars regard the permissible burden of commercial disclosure requirements under Zauderer<\/em>.<\/p>\n

If the size of the current disclosure statement requirement is not unjustified or unduly burdensome, then the proposed disclosure statement, which can be the same size, is not problematic either. However, there is case law that suggests that any front-of-package disclosure requirement, even if limited to food products making voluntary claims, may not be constitutionally permissible. International Dairy Foods Association v. Boggs<\/em>[156]<\/a> considered an Ohio requirement for dairy products claiming to be from milk that is free from recombinant bovine somatotropin (rbST) to display the accompanying statement, \u201cThe FDA has determined that no significant difference has been shown between milk derived from rbST-supplemented and non-rbST-supplemented cows.\u201d[157]<\/a> Applying Zauderer<\/em>,[158]<\/a> the court determined that despite the reasonable relationship between the required disclosure and the state\u2019s interest in preventing consumer deception, there was no rational basis for the requirement that the disclosure be displayed alongside the claim because the state\u2019s purpose could be served by an asterisk referring the consumer to an explanation on another display panel.[159]<\/a> This conclusion calls into question the reasonableness of the current disclosure statement requirement, which must appear \u201cprominently and in immediate proximity to\u201d nutrient content claims.[160]<\/a>And, as discussed in Part IV, the dependence of the current disclosure statement requirement on the presence of nutrient content claims does not serve the interest of consumer deception or of informing consumers of the health risks posed by their foods.[161]<\/a> The Boggs<\/em> rationale seriously undermines the reasonableness of the current disclosure statement requirement.<\/p>\n

Unlike the current disclosure statement, the proposed disclosure statement\u2019s requirement that it must be \u201cprominently\u201d displayed reasonably relates to the government\u2019s interests in public health and facilitating consumer awareness of the health risks of their foods. It is also no more extensive than necessary because it must appear prominently on all regulated foods with potentially dangerous health-risk nutrient contents in order to consistently and clearly inform consumers and promote public health. Today\u2019s food labeling landscape features an abundance of nutrition information that is not presented clearly and that confuses many consumers.[162]<\/a> The current disclosure statement requirement, which does not clearly state that a food product\u2019s content of health-risk nutrients poses a health risk, is a perfect example of the lack of clarity in current requirements. In today\u2019s age of confusion, a prominent and clearly worded disclosure statement is necessary for the government to serve its interests in promoting public health and consumer awareness of the health risks of food products.<\/p>\n

Finally, a consideration of whether the proposed requirement is unduly burdensome could address its potential costs. While those costs are difficult to estimate in the abstract, May 2016 final rules[163]<\/a> updating the requirements for the Nutrition Facts label could serve as a helpful proxy. Those rules estimated that the changes they required would have annualized benefits ranging from $0.2 to $5 billion and annualized costs ranging from $0.2 to $0.8 billion over twenty years, although they noted the \u201csubstantial uncertainty\u201d regarding the actual effects.[164]<\/a> Labeling costs and the costs food manufacturers might incur to reformulate their products in order to avoid some of the new requirements account for the bulk of these projected annualized costs, potentially up to $668 million per year over twenty years.[165]<\/a> The proposed disclosure statement could arguably be considered to present similar labeling and reformulation costs. And the benefits of the proposal could exceed the projected benefits of the changes to the Nutrition Facts label given that the disclosure statement will be in color and on the front of the package. Furthermore, the cost of changing front-of-package displays is likely not prohibitive for manufacturers, as they voluntarily change their labels very frequently.[166]<\/a> Given the projected cost effectiveness of the changes to the Nutrition Facts label, it seems unlikely that the proposed disclosure statement would not be cost effective.<\/p>\n

A recently enacted federal law requiring food manufacturers to disclose when their products contain genetically modified organisms (GMOs)[167]<\/a> also suggests that the proposed disclosure statement\u2019s cost would not be considered unduly burdensome. That legislation was enacted to preempt states from imposing their own GMO labeling requirements after Vermont enacted a law with such requirements.[168]<\/a> Under the new federal requirement, food products with GMO ingredients can either include a disclosure statement or a QR code that consumers can scan to find the GMO information of the food.[169]<\/a> Crucially for the analysis here, it was enacted despite the lack of scientific evidence that GMOs pose a health risk.[170]<\/a><\/p>\n

Despite the lack of the GMO labeling law\u2019s relationship to the government\u2019s interest in public health and improving consumer awareness of the health risks of their food, the law could prove very costly to implement. The United States Department of Agriculture estimates a projected implementation cost for the law of $0.598 to $3.5 billion for the first year alone, with subsequent future costs between $0.132 and $0.471 billion.[171]<\/a> It is important to emphasize that the proposed disclosure statement serves much more substantial government interests than does the GMO labeling law. While evidence does not suggest that GMOs have any adverse health effects, the proposed disclosure requirement mandates disclosure of nutrients that the FDA has determined pose a health risk. In other words, the reason for the disclosure is that the nutrients serve the substantial interests of public health promotion and consumer awareness of pertinent health information.[172]<\/a> These interests are more substantial than what could be articulated as a \u201cconsumer curiosity\u201d interest[173]<\/a> in the case of the federal GMO labeling law. If the cost of the GMO labeling law is not unduly burdensome relative to the interests it serves, then the projected lower cost of the proposed disclosure statement[174]<\/a> should not be unduly burdensome in addressing the government\u2019s more substantial interests in promoting public health consumer awareness of the health risks of food products.<\/p>\n

For these reasons, the proposed disclosure statement requirement should pass both Zauderer<\/em> and Central Hudson<\/em> scrutiny.<\/p>\n

 <\/p>\n

VIII. Conclusion<\/strong><\/p>\n

This Article\u2019s proposal would give consumers the information required to make informed dietary decisions. It does not represent a new regulatory agenda; rather, it would align the text of 21 U.S.C. \u00a7 343(r)(2)(B) with its current purpose of warning consumers of potentially dangerous levels of health-risk nutrients in food products. The need for this alignment is long overdue, with 21 U.S.C. \u00a7 343(r)(2)(B) having been employed exclusively to warn consumers for over two decades. Disclosure statements provide ineffective warning of potentially dangerous levels of specific health-risk nutrients in foods because they are required only in the presence of nutrient content claims and because their text does not clearly state that the food product contains health-risk nutrients in potentially dangerous quantities. More fundamentally, however, their shortcomings result from the abrogation of the referral statement requirement with the passage of FDAMA in 1997. Congress should reform disclosure statements to more effectively provide notice to consumers of the potentially dangerous health-risk nutrient contents of food products. Consumers deserve to be warned when their food poses a health risk.<\/p>\n

 <\/p>\n

Exhibits<\/strong><\/p>\n

A. Philadelphia Original Cream Cheese Spread (with disclosure statement identified by the red arrow) and Kroger Original Cream Cheese Spread with their nutrition information<\/p>\n

 <\/p>\n

\"\"<\/a><\/p>\n

\"\"<\/a><\/p>\n

Sources: For the image of the Philadelphia Original Cream Cheese Spread, see Philadelphia Original Cream Cheese Spread<\/em>, Kroger, https:\/\/www.kroger.com\/p\/philadelphia-original-cream-cheese-spread\/0002100000014 (last visited Feb. 19, 2018). For the image of the Kroger Original Cream Cheese Spread, see Kroger Cream Cheese Spread \u2013 Original<\/em>, Kroger, https:\/\/www.kroger.com\/p\/kroger-cream-cheese-spread-original\/0001111088222 (last visited Feb. 19, 2018).<\/p>\n

\"\"<\/a><\/p>\n

\"\"<\/a><\/p>\n

Sources: For the nutrition information of the Philadelphia Original Cream Cheese Spread, see Philadelphia Original Cream Cheese Spread<\/em>, Fatsecret, https:\/\/www.fatsecret.com\/calories-nutrition\/philadelphia\/original-cream-cheese-spread?frc=True [https:\/\/perma.cc\/8TSP-ULX6]. For the nutrition information of the Kroger Original Cream Cheese Spread, see Kroger Original Cream Cheese Spread<\/em>, Fatsecret, https:\/\/www.fatsecret.com\/calories-nutrition\/kroger\/original-cream-cheese-spread [https:\/\/perma.cc\/XS5L-728W].<\/p>\n

B. MorningStar Farms Hickory BBQ Riblets with disclosure statement outlined in red<\/p>\n

\"\"<\/a><\/p>\n

Source: Morningstar Farms,<\/em> Meal Starters Hickory BBQ Riblets, 10 oz (Frozen)<\/em>, Amazon, https:\/\/www.amazon.com\/Morningstar-Farms-Starters-Hickory-Riblets\/dp\/B0036C7O5S [https:\/\/perma.cc\/55U2-8A9A].<\/p>\n

C. Food products with Facts Up Front icons outlined in red<\/p>\n

 <\/p>\n

\"\"<\/a><\/p>\n

\"\"<\/a><\/p>\n

\"\"<\/a><\/p>\n

For sources, see Exhibits A and B.<\/p>\n

D. Chilean icons for food products high in sugar, calories, saturated fat, and sodium<\/p>\n

\"\"<\/a><\/p>\n

Source: Rodrigo Ram\u00edrez, Nicole Sternsdorff & Carolina Pastor, Llorente & Cuenca Special Report: Chile\u2019s Law on Food Labelling and Advertising: A Replicable Model for Latin America? 5 (2016), http:\/\/www.desarrollando-ideas.com\/wp-content\/uploads\/sites\/5\/2016\/05\/160504_DI_report_food_chile_ENG.pdf [https:\/\/perma.cc\/6XH3-6NKG].<\/p>\n

E. Ecuadorian red, yellow, and green icons for quantities of sugar, fat, and sodium<\/p>\n

\"\"<\/a><\/p>\n

\"\"<\/a><\/p>\n

Source for Ecuadorian Labels (Spanish): Instituto Nacional de Salud P\u00fablica de M\u00e9xico, Review of current labelling regulations and practices for food and beverage targeting children and adolescents in Latin America countries (Mexico, Chile, Costa Rica and Argentina) and recommendations for facilitating consumer information 8 (2016), https:\/\/www.unicef.org\/ecuador\/english\/20161122_UNICEF_LACRO_Labeling_Report_LR(3).pdf [https:\/\/perma.cc\/5HPT-DPGX].<\/p>\n

Source for Ecuadorian Labels (English): Wilma B. Freire et al., A qualitative study of consumer perceptions and use of traffic light food labelling in Ecuador<\/em>, 20 Pub. Health Nutrition 805, 806 (2016), https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/73D51ECDC1F9C1B6E2147C68261F1019\/S1368980016002457a.pdf\/qualitative_study_of_consumer_perceptions_and_use_of_traffic_light_food_labelling_in_ecuador.pdf [https:\/\/perma.cc\/S86U-TAR3].<\/p>\n

F. Products with proposed warning statement signaling health risk due to health-risk nutrient contents<\/p>\n

\"\"<\/a><\/p>\n

*Click to enlarge<\/p>\n

\"\"<\/a><\/p>\n

*Click to enlarge<\/p>\n

\"\"<\/a><\/p>\n

*Click to enlarge<\/p>\n

______________________________________________________________<\/p>\n

*<\/a> B.A.\u00a0summa cum laude<\/em>\u00a02013, Washington University in St. Louis; J.D. cum laude<\/em> 2018, Harvard Law School. The author would like to thank Nicole Negowetti, Lecturer on Law at Harvard Law School, and the Harvard Journal on Legislation Online staff for helpful comments on this Article.<\/p>\n

[1]<\/a> See <\/em>U.S. Food and Drug Admin., Regulatory Impact Analysis For Final Rules On: \u201cFood Labeling: Revision of the Nutrition and Supplemental Facts Labels\u201d and \u201cFood Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size For Breath Mints; and Technical Amendments,\u201d Docket Nos. FDA-2012-N-1210 & FDA-2004-N-0258 73 (2016) [hereinafter 2016 Nutrition Facts Amendments Regulatory Impact Analysis].<\/p>\n

[2]<\/a> See Salt Reduction<\/em>, World Health Org. (June 30, 2016), http:\/\/www.who.int\/mediacentre\/factsheets\/fs393\/en\/ [https:\/\/perma.cc\/G5YJ-P3W5].<\/p>\n

[3]<\/a> See <\/em>Am. Heart Ass\u2019n, About Cholesterol<\/em>, Heart.org, http:\/\/www.heart.org\/HEARTORG\/Conditions\/Cholesterol\/AboutCholesterol\/About-Cholesterol_UCM_001220_Article.jsp#.WraY1Yjwbcs [https:\/\/perma.cc\/9WZD-PYNC] (last updated Jan. 11, 2018).<\/p>\n

[4]<\/a> See <\/em>Lee Hooper et al., Effect of Reducing Total Fat Intake on Body Weight: Systematic Review and Meta-analysis of Randomized Controlled Trials and Cohort Studies<\/em>, 2012 BMJ 1, 7 (2012), http:\/\/www.bmj.com\/content\/345\/bmj.e7666 [https:\/\/perma.cc\/6FBT-BXM2].<\/p>\n

[5]<\/a> See <\/em>World Health Org., supra <\/em>note 2.<\/p>\n

[6]<\/a> Adult Obesity Facts<\/em>, Ctrs. for Disease Control and Prevention, https:\/\/www.cdc.gov\/obesity\/data\/adult.html [https:\/\/perma.cc\/JT9T-YUXC] (last updated Aug. 13, 2018) [hereinafter Adult Obesity Facts<\/em>].<\/p>\n

[7]<\/a> See <\/em>Rodrigo Ram\u00edrez, Nicole Sternsdorff & Carolina Pastor, Llorente & Cuenca Special Report: Chile\u2019s Law on Food Labelling and Advertising: A Replicable Model for Latin America? 11 (2016), http:\/\/www.desarrollando-ideas.com\/wp-content\/uploads\/sites\/5\/2016\/05\/160504_DI_report_food_chile_ENG.pdf [https:\/\/perma.cc\/49SW-YJ6W].<\/p>\n

[8]<\/a> See, e.g.<\/em>, Andrew Jacobs, In Sweeping War on Obesity, Chile Slays Tony the Tiger<\/em>, N.Y. Times (Feb. 7, 2018), https:\/\/www.nytimes.com\/2018\/02\/07\/health\/obesity-chile-sugar-regulations.html [https:\/\/perma.cc\/8UR5-86Y4].<\/p>\n

In 2009, the obesity rates in the United States of America and Chile were 35% and 25% respectively. OECD, Health Policy in Chile<\/em> 2 (Feb. 2016), http:\/\/www.oecd.org\/chile\/Health-Policy-in-Chile-February-2016.pdf [https:\/\/perma.cc\/LE4B-CSNY].<\/p>\n

[10]<\/a> This term is used in the Article to refer to the nutrients specified in 21 C.F.R. \u00a7 101.13(h), namely fat, saturated fat, cholesterol, and sodium. It has not been adopted by the FDA or industry stakeholders.<\/p>\n

[11]<\/a> A nutrient content claim \u201cis a claim on a food product that directly or by implication characterizes the level of a nutrient in the food (e.g., \u2018low fat,\u2019 \u2018high in oat bran,\u2019 or \u2018contains 100 calories\u2019).\u201d U.S. Food and Drug Admin., Guidance for Industry: A Food Labeling Guide 72 (2013), https:\/\/www.fda.gov\/downloads\/Food\/GuidanceRegulation\/GuidanceDocumentsRegulatoryInformation\/UCM265446.pdf [https:\/\/perma.cc\/U6YR-EX25] [hereinafter FDA Food Labeling Guide]; see also<\/em> 21 C.F.R. \u00a7 101.13(b) (2017) (defining expressed and implied nutrient content claims).<\/p>\n

[12]<\/a> See <\/em>21 U.S.C. \u00a7 343(r)(2)(B) (limiting the disclosure statement requirement to food products that make a claim described in 21 U.S.C. \u00a7 343(r)(1)(A)); 21 C.F.R. \u00a7 101.13(b) (stating that a nutrient content claim \u201cmay not be made on the label or in labeling of foods unless the claim is made in accordance with this regulation and with the applicable regulations in subpart D of this part or in part 105 or part 107 of this chapter\u201d).<\/p>\n

[13]<\/a> See<\/em> 21 C.F.R. \u00a7 101.13(b) (stipulating that a nutrient content claim \u201cmay not be made\u201d unless it complies with applicable regulations). These claims are made voluntarily by food manufacturers but must abide by federal requirements.<\/p>\n

[14]<\/a> See <\/em>21 U.S.C. \u00a7 343(r)(2)(B) (specifying the required text of the disclosure statement); 21 C.F.R. \u00a7 101.13(h) (adopting the disclosure statement text from 21 U.S.C. \u00a7 343(r)(2)(B)).<\/p>\n

[15]<\/a> See <\/em>Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535 \u00a7 3(a), 104 Stat. 2353, 2358 (1990); see also <\/em>143 Cong. Rec. 19836, 19849 (1997) (statement of Sen. McConnell); Nutritional Labeling and Education Act (NLEA) Requirements (8\/94 – 2\/95)<\/em>, U.S. Food and Drug Admin. 11\u201312 (Aug. 1994), https:\/\/www.fda.gov\/ICECI\/Inspections\/InspectionGuides\/ucm074948.htm#Referral%20Statement [https:\/\/perma.cc\/Z8AW-PXEP] (last updated Nov. 25, 2014) [hereinafter NLEA Requirements<\/em>].<\/p>\n

[16]<\/a> Pub. L. No. 101-535, 104 Stat. 2353.<\/p>\n

[17]<\/a> See <\/em>136 Cong. Rec. 35,093, 35,094 (1990) (statement of Rep. Waxman) (\u201cThe bill will require all manufacturers of packaged foods to provide complete nutrition information about their products. Information about calories, fat, salt and other important ingredients will be mandated by law. . . . Consumers have long demanded this information, but under current law it is optional. Under the bill it will be mandatory.\u201d); id.<\/em> at 35,095 (statement of Rep. Madigan) (\u201cThe main features of the bill requires [sic] food products\u2014except meat, poultry, and eggs\u2014to disclose their nutritional content. Every food would have a uniform label that would disclose the amount of [fat], calories, salt, and other nutrients.\u201d); id.<\/em> at 35,096 (statement of Rep. Moakley) (\u201cWith the enactment of this bill, consumers will, for the first time, be able to purchase foods with nutrition content labeling on all packages. Currently only about half of the food products found on grocers\u2019 shelves contain any nutrition information on the label. And of those with labels, only the ones making specific health, diet, or nutrition claims are required by law to list nutrition contents.\u201d); 136 Cong. Rec. 33,425, 33,427 (1990) (statement of Sen. Mitchell) (\u201cThe elements of this bill will help all consumers to better understand and improve their eating habits by providing uniform nutritional information in a coherent and understandable format.\u201d); id.<\/em> at 33,428 (statement of Sen. Hatch) (\u201cOur effort to educate consumers on dietary practices has been less than adequate. It is now time that we have legislation requiring accurate and uniform nutrition labeling on all processed packaged foods.\u201d).<\/p>\n

[18]<\/a> See <\/em>143 Cong. Rec. 19,836, supra<\/em> note 15, at 19,849 (statement of Sen. McConnell) (\u201cThe original intent of this provision was to help educate consumers about the presence and location of nutrition information on food products.\u201d).<\/p>\n

[19]<\/a> Pub. L. No. 105-115, 111 Stat. 2296 (1997).<\/p>\n

[20]<\/a> See<\/em> Food and Drug Administration Modernization Act of 1997 \u00a7 305; 21 U.S.C. \u00a7 343(r)(2)(B) (2012).<\/p>\n

[21]<\/a> See <\/em>136 Cong. Rec. 35,093, supra<\/em> note 17, at 35,094\u201395 (statement of Rep. Waxman) (\u201cHealth claims were not permitted on foods until the 1980\u2019s. But when the FDA relaxed enforcement of regulations during the early years of the Reagan administration, it lost control of the marketplace, and many unfounded claims began being used of [sic] foods. [The NLEA] will recognize the marketplace so that only truthful claims may be made on foods.\u201d).<\/p>\n

[22]<\/a> See id.<\/em> at 35094 (statement of Rep. Waxman) (\u201cThe bill will prohibit manufacturers from using terms like \u2018light,\u2019 \u2018high,\u2019 and \u2018low\u2019 unless they have been defined.\u201d); id.<\/em> at 35,095 (statement of Rep. Madigan) (\u201cRegarding nutrition claims on foods, the bill requires that content claims such as light, low, et cetera, would have to be consistent with terms defined by the FDA.\u201d); id. <\/em>at 35,096 (statement of Rep. Moakley) (\u201cThe current format for nutrition labeling on foods is often inadequate for today\u2019s consumer needs. In many cases the information is confusing and, in some cases, very misleading. Terms such as lite, high fiber, and low cholesterol, which now have little or no guidelines, will be defined and their use restricted to the FDA definition.\u201d); 136 Cong. Rec. 33,425, supra<\/em> note 17, at 33,428 (statement of Sen. Hatch) (\u201cToday, there is confusion about terms that are used when products are advertised as being \u2018light,\u2019 or \u2018free,\u2019 or \u2018high[.]\u2019\u201d).<\/p>\n

[23]<\/a> See FDA\u2019s Continuing Failure to Regulate Health Claims for Foods<\/em>: Hearing Before the Intergovernmental Relations Subcomm. of the H. Comm. on Government Operations<\/em>, 101st Cong. 6\u20139 (1989) (statement of Bruce A. Silverglade, Director of Legal Affairs, Center for Science in the Public Interest).<\/p>\n

[24]<\/a> See id.<\/em> at 6; see also<\/em> 136 Cong. Rec. 35,093, supra<\/em> note 17, at 35,094 (statement of Rep. Waxman) (explaining that the Nutrition Labeling and Education Act of 1990 would \u201cprohibit disease claims\u2014such as fiber prevents cancer\u2014unless the Food and Drug Administration has found that the claim is supported by science.\u201d).<\/p>\n

[25]<\/a> Pub. L. No. 101-535, 104 Stat. 2353 (1990).<\/p>\n

[26]<\/a> See<\/em> supra<\/em> note 17.<\/p>\n

[27]<\/a> See <\/em>136 Cong. Rec. 35,093, supra<\/em> note 17, at 35,094 (statement of Rep. Waxman) (\u201cThe bill will prohibit manufacturers from using terms like \u2018light,\u2019 \u2018high,\u2019 and \u2018low\u2019 unless they have been defined.\u201d); id.<\/em> at 35,095 (statement of Rep. Madigan) (\u201cRegarding nutrition claims on foods, the bill requires that content claims such as light, low, et cetera, would have to be consistent with terms defined by the FDA.\u201d); id. <\/em>at 35,096 (statement of Rep. Moakley) (\u201cThe current format for nutrition labeling on foods is often inadequate for today\u2019s consumer needs. In many cases the information is confusing and, in some cases, very misleading. Terms such as lite, high fiber, and low cholesterol, which now have little or no guidelines, will be defined and their use restricted to the FDA definition. This bill will help curb misleading claims and will direct the Food and Drug Administration to present information in a more understandable and usable format to help consumers better understand and utilize this information in the context of the total daily diet.\u201d); 136 Cong. Rec. 33,425, supra<\/em> note 17, at 33,428 (statement of Sen. Hatch) (\u201cToday, there is confusion about terms that are used when products are advertised as being \u2018light,\u2019 or \u2018free,\u2019 or \u2018high[.]\u2019 . . . Consumers will benefit because of this legislative change.\u201d).<\/p>\n

[28]<\/a> See <\/em>136 Cong. Rec. 35,093, supra<\/em> note 17, at 35,094 (statement of Rep. Waxman) (explaining that the NLEA would \u201cprohibit disease claims\u2014such as fiber prevents cancer\u2014unless the Food and Drug Administration has found that the claim is supported by science.\u201d); id.<\/em> at 35,095 (statement of Rep. Madigan) (\u201cThe bill would also require that disease claims, such as bran prevents cancer, would have to be substantiated by the FDA. Once the FDA decides that a specific claim is valid, then any company could make a claim that was consistent with the FDA\u2019s findings.\u201d); 136 Cong. Rec. 33,425, supra<\/em> note 17, at 33,428 (statement of Sen. Hatch) (\u201cIn order to get approval for a claim, there must be publicly available scientific evidence and significant scientific agreement that the claim is accurate while reviewed with the totality of publicly available scientific evidence.\u201d).<\/p>\n

[29]<\/a> See <\/em>136 Cong. Rec. 35,093, supra<\/em> note 17, at 35,095 (statement of Rep. Madigan) (\u201cIn the past few years, important scientific evidence has been repeatedly reported that clearly links dietary habits to good health. For this reason, the need to provide consumers with better information about the foods they eat is important.\u201d); id.<\/em> at 35,096 (statement of Rep. Moakley) (\u201cMore and more the evidence is clear that diet is a major component in our overall good health. Healthy eating can enhance our quality of life and significantly lower our risk for certain illnesses. Countless studies and research findings clearly indicate that the two leading killers in our Nation, heart disease and cancer, are influenced by the foods we eat, particularly by those foods high in saturated fats. Yet current labels do not give information on saturated fat or on the percentage of fat, both of which are major dietary factors. This bill will give us that information as well as other vital facts about the foods we consume.\u201d); 136 Cong. Rec. 33,425, supra<\/em> note 17, at 33,427 (1990) (statement of Sen. Metzenbaum) (noting \u201c[t]he rapid pace of scientific advances linking nutritional substances to the maintenance of long-term human health and the prevention of long-term disease\u201d); id.<\/em> at 33,428 (statement of Sen. Hatch) (\u201cHeart disease, cancer, and stroke\u2014our No. 1, 2, and 3 causes of death\u2014still take an incredible toll in our society. . . . Diet has been implicated as a factor in all three of these diseases as well as [a] large number of others. . . . Our effort to educate consumers on dietary practices has been less than adequate. It is now time that we have legislation requiring accurate and uniform nutrition labeling on all processed packaged foods.\u201d).<\/p>\n

[30]<\/a> See <\/em>Nutrition Labeling and Education Act of 1990 \u00a7 3(a); see also NLEA Requirements<\/em>, supra<\/em> note 15, at 11\u201312; 143 Cong. Rec. 19,836, supra<\/em> note 15, at 19,849 (statement of Sen. McConnell).<\/p>\n

[31]<\/a> See <\/em>143 Cong. Rec. 19,836, supra<\/em> note 15, at 19,849 (statement of Sen. McConnell); NLEA Requirements<\/em>, supra <\/em>note 15, at 12.<\/p>\n

[32]<\/a> See NLEA Requirements<\/em>, supra<\/em> note 15, at 11\u201312.<\/p>\n

[33]<\/a> See<\/em> Nutrition Labeling and Education Act of 1990 \u00a7 3(a).<\/p>\n

[34]<\/a> See NLEA Requirements<\/em>, supra <\/em>note 15, at 11\u201312.<\/p>\n

[35]<\/a> See <\/em>Nutrition Labeling and Education Act of 1990 \u00a7 3(a).<\/p>\n

[36]<\/a> See id.<\/em><\/p>\n

[37]<\/a> See<\/em> Scott B. Keller et al., The Effects of Nutrition Package Claims, Nutrition Facts Panels, and Motivation to Process Nutrition Information on Consumer Product Evaluations<\/em>, 16 J. Pub. Pol\u2019y & Marketing 256, 265\u201366 (1997) (\u201cIn summary, results from this study indicate that when evaluating a food product, consumers tend to rely more on information in the Nutrition Facts panel than on nutrition claims. . . . These findings for claims and Nutrition Facts labels are consistent with those of recent FDA focus groups in which consumers report that . . . [i]nformation from the Nutrition Facts panel . . . is viewed as more credible [than nutrient content claims]\u201d).<\/p>\n

[38]<\/a> See <\/em>143 Cong. Rec. 19,836, supra<\/em> note 15, at 19,849 (statement of Sen. McConnell) (\u201cBased on the NLEA\u2019s success, today few consumers even notice th[e] generic referral statement because most individuals look immediately to the mandatory Nutrition Facts panel to receive nutrition information.\u201d).<\/p>\n

[39]<\/a> Pub. L. No. 105-115, 111 Stat. 2296 (1997).<\/p>\n

[40]<\/a> 143 Cong. Rec. 19,836, supra<\/em> note 15, at 19,849 (statement of Sen. McConnell).<\/p>\n

[41]<\/a> See<\/em> Food and Drug Administration Modernization Act of 1997 \u00a7 305; 21 U.S.C. \u00a7 343(r)(2)(B) (2012).<\/p>\n

[42]<\/a> See <\/em>FDA Food Labeling Guide, supra<\/em> note 12, at 72.<\/p>\n

[43]<\/a> 21 C.F.R. \u00a7 101.13(h) (2017); see also<\/em> 21 U.S.C. \u00a7 343(r)(2)(B).<\/p>\n

[44]<\/a> 21 U.S.C. \u00a7 343(r)(2)(B).<\/p>\n

[45]<\/a> Id.<\/em>; see also <\/em>21 C.F.R. \u00a7 101.13(h)(4) (implementing this requirement).<\/p>\n

[46]<\/a> See <\/em>FDA Food Labeling Guide, supra<\/em> note 12, at 72.<\/p>\n

[47]<\/a> See <\/em>21 C.F.R. \u00a7 101.13(h).<\/p>\n

[48]<\/a> See<\/em> id.<\/em><\/p>\n

[49]<\/a> See <\/em>21 C.F.R. \u00a7 101.13(h)(1).<\/p>\n

[50]<\/a> See <\/em>143 Cong. Rec. 19,836, supra<\/em> note 15, at 19,849 (statement of Sen. McConnell) (\u201cThe original intent of this provision was to help educate consumers about the presence and location of nutrition information on food products.\u201d).<\/p>\n

[51]<\/a> See<\/em> supra<\/em> note 17.<\/p>\n

[52]<\/a> See <\/em>Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535 \u00a7 3(a), 104 Stat. 2353, 2358 (1990).<\/p>\n

[53]<\/a> See <\/em>143 Cong. Rec. 19,836, supra<\/em> note 15, at 19,849 (statement of Sen. McConnell) (\u201cMy proposal seeks to improve the effectiveness of [consumer] notice by requiring a disclosure statement only in those instances where the FDA identifies that a food contains a nutrient at a level that could increase the risk of a health condition for vulnerable persons.\u201d).<\/p>\n

[54]<\/a> See id.<\/em> (\u201cThe original intent of this provision was to help educate consumers about the presence and location of nutrition information on food products.\u201d).<\/p>\n

[55]<\/a> See id.<\/em><\/p>\n

[56]<\/a> See id.<\/em> (\u201cMy proposal seeks to improve the effectiveness of [consumer] notice by requiring a disclosure statement only in those instances where the FDA identifies that a food contains a nutrient at a level that could increase the risk of a health condition for vulnerable persons.\u201d).<\/p>\n

[57]<\/a> See <\/em>21 C.F.R. \u00a7 101.13(h) (2017) (identifying these nutrients as health-risk nutrients); see also<\/em> 21 U.S.C. \u00a7 343(r)(2)(B) (2012) (authorizing the Secretary of Health and Human Services to impose the requirements specified in 21 C.F.R. \u00a7 101.13(h) on any food product that makes a nutrient content claim and that \u201ccontains a nutrient at a level that increases to persons in the general population the risk of a disease or health-related condition that is diet related\u201d).<\/p>\n

[58]<\/a> See <\/em>143 Cong. Rec. 19,836, supra<\/em> note 15, at 19,849 (statement of Sen. McConnell) (\u201cBased on the NLEA\u2019s success, today few consumers even notice th[e] generic referral statement because most individuals look immediately to the mandatory Nutrition Facts panel to receive nutrition information.\u201d).<\/p>\n

[59]<\/a> See id. <\/em>(\u201cThe original intent of this provision was to help educate consumers about the presence and location of nutrition information on food products. Based on the NLEA\u2019s success, today few consumers even notice th[e] generic referral statement because most individuals look immediately to the mandatory Nutrition Facts panel to receive nutrition information.\u201d).<\/p>\n

[60]<\/a> Id.<\/em><\/p>\n

[61]<\/a> For the nutrition information of the Philadelphia Original Cream Cheese Spread, see Philadelphia Original Cream Cheese Spread<\/em>, Fatsecret, https:\/\/www.fatsecret.com\/calories-nutrition\/philadelphia\/original-cream-cheese-spread?frc=True [https:\/\/perma.cc\/7S2T-JQQ5]<\/strong> (last updated Nov. 2, 2014). For the nutrition information of the Kroger Original Cream Cheese Spread, see Kroger Original Cream Cheese Spread<\/em>, Fatsecret, https:\/\/www.fatsecret.com\/calories-nutrition\/kroger\/original-cream-cheese-spread [https:\/\/perma.cc\/28NY-JDGT]<\/strong> (last updated Feb. 7, 2017).<\/p>\n

[62]<\/a> 21 U.S.C. \u00a7 343(r)(2)(B); see<\/em> also <\/em>21 C.F.R. \u00a7 101.13(h)(1) (specifying that food products containing more than 4.0 grams of saturated fat per serving must display a disclosure statement in the presence of nutrient content claim for food products that are not meal products, main dish products, or food intended specifically for infants and children younger than two years of age).<\/p>\n

[63]<\/a> For an image of the Philadelphia Original Cream Cheese Spread, see Philadelphia Original Cream Cheese Spread<\/em>, Kroger, https:\/\/www.kroger.com\/p\/philadelphia-original-cream-cheese-spread\/0002100000014 (last visited Feb. 19, 2018) [hereinafter Image of Philadelphia Original Cream Cheese Spread<\/em>]. For an image of the Kroger Original Cream Cheese Spread, see Kroger Cream Cheese Spread \u2013 Original<\/em>, Kroger, https:\/\/www.kroger.com\/p\/kroger-cream-cheese-spread-original\/0001111088222 (last visited Feb. 19, 2018) [hereinafter Image of Kroger Original Cream Cheese Spread<\/em>].<\/p>\n

[65]<\/a> See <\/em>21 U.S.C. \u00a7 343(r)(2)(B) (limiting the disclosure statement requirement to food products that make a claim described in 21 U.S.C. \u00a7 343(r)(1)(A)); 21 C.F.R. \u00a7 101.13(b) (\u201c[A] nutrient content claim . . . may not be made on the label or in labeling of foods unless the claim is made in accordance with this regulation and with the applicable regulations in subpart D of this part or in part 105 or part 107 of this chapter.\u201d). The Kroger Original Cream Cheese Spread does display Facts Up Front icons, see Image of Kroger Original Cream Cheese Spread<\/em>, supra <\/em>note 63, which are discussed later. See<\/em> infra<\/em> Part V.A. Although the Facts Up Front icons are considered to be nutrient content claims by the FDA, the agency has indicated that it will exercise enforcement discretion and not enforce nutrient content claim requirements as they relate to Facts Up Front icons implemented across a producer\u2019s entire product line. See Letter of Enforcement Discretion to GMA\/FMI re \u201cFacts Up Front\u201d<\/em>, U.S. Food and Drug Admin. (Dec. 13, 2011), https:\/\/www.fda.gov\/Food\/IngredientsPackagingLabeling\/ucm302720.htm [https:\/\/perma.cc\/D8VL-LLZ2<\/strong>] [hereinafter FDA Letter of Enforcement Discretion<\/em>].<\/p>\n

[66]<\/a> See <\/em>21 U.S.C. \u00a7 343(r)(2)(B) (specifying the required text of the disclosure statement); 21 C.F.R. \u00a7 101.13(h) (adopting the disclosure statement text from 21 U.S.C. \u00a7 343(r)(2)(B)).<\/p>\n

[67]<\/a> See How to Understand and Use the Nutrition Facts Label<\/em>, U.S. Food And Drug Admin., https:\/\/www.fda.gov\/Food\/LabelingNutrition\/ucm274593.htm [https:\/\/perma.cc\/VQ7Q-X5WN] (last updated Jan. 3, 2018)<\/strong>.<\/p>\n

[68]<\/a> See <\/em>21 U.S.C. \u00a7 343(r)(2)(B); see also <\/em>21 C.F.R. \u00a7 101.13(h)(4) (implementing this requirement).<\/p>\n

The requirement for disclosure statements to be present in \u201cimmediate proximity\u201d to nutrient content claims was part of the original disclosure statement requirement in the NLEA. See <\/em>Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353 \u00a7 3(a) (1990).<\/p>\n

[69]<\/a> See Morningstar Farms, Meal Starters Hickory BBQ Riblets, 10 oz (Frozen)<\/em>, Amazon, https:\/\/www.amazon.com\/Morningstar-Farms-Starters-Hickory-Riblets\/dp\/B0036C7O5S [https:\/\/perma.cc\/2WVD-CHTF]<\/strong> [hereinafter Hickory BBQ Riblets<\/em>]. The riblets\u2019 620 milligrams of sodium per serving exceeds the minimum quantity of 480 milligrams that would require a disclosure statement. See <\/em>21 C.F.R. \u00a7 101.13(h)(1) (specifying that food products containing more than 480 milligrams of sodium per serving must display a disclosure statement in the presence of nutrient content claim for food products that are not meal products, main dish products, or food intended specifically for infants and children younger than two years of age).<\/p>\n

[70]<\/a> See Hickory BBQ Riblets<\/em>, supra<\/em> note 69.<\/p>\n

[71]<\/a> See<\/em> 21 C.F.R. \u00a7 101.13(i).<\/p>\n

[72]<\/a> See Facts Up Front Front-of-Pack Labeling Initiative<\/em>, Grocery Mfrs.\u2019 Ass\u2019n, https:\/\/www.gmaonline.org\/issues-policy\/health-nutrition\/facts-up-front-front-of-pack-labeling-initiative\/ [https:\/\/perma.cc\/R7YK-NCQX][hereinafter Facts Up Front<\/em>]; see also<\/em> GMA Board of Directors, Food and Beverage Industry Launches Nutrition Keys Front-of-Pack Nutrition Labeling Initiative to Inform Consumers and Combat Obesity<\/em>, Grocery Manufacturers\u2019 Association (Jan. 24, 2011), http:\/\/www.gmaonline.org\/news-events\/newsroom\/food-and-beverage-industry-launches-nutrition-keys-front-of-pack-nutrition-\/.<\/p>\n

[73]<\/a> See Facts Up Front<\/em>, supra <\/em>note 72 (displaying an image of the icons for saturated fat and sodium that contain percentage daily values per serving).<\/p>\n

[74]<\/a> See FDA Letter of Enforcement Discretion<\/em>, supra<\/em> note 65 (\u201cWe recognize . . . that standardized, non-selective presentation of the four Basic Icons on a company’s product line would alleviate some of FDA\u2019s concern regarding the potential for product labeling to mislead consumers by presenting only \u2018good news\u2019 about nutrient content on the front of the package, which is the concern that the regulations governing nutrient content claims were intended to address. We also recognize that the standardized, non-selective presentation of the four Basic Icons on a company\u2019s entire product line, if widely adopted by the food industry in a uniform manner, may contribute to FDA’s public health goals by fostering awareness of the nutrient content of foods in the marketplace and assisting consumers in making quick, informed, and healthy food choices.\u201d).<\/p>\n

[75]<\/a> See Image of Kroger Original Cream Cheese Spread<\/em>, supra <\/em>note 63.<\/p>\n

[76]<\/a> See Image of Philadelphia Original Cream Cheese Spread<\/em>, supra<\/em> note 63.<\/p>\n

[77]<\/a> See<\/em> 21 C.F.R. \u00a7 101.13(h) (2017).<\/p>\n

[78]<\/a> See <\/em>Instituto Nacional de Salud P\u00fablica de M\u00e9xico, Review of current labelling regulations and practices for food and beverage targeting children and adolescents in Latin America countries (Mexico, Chile, Costa Rica and Argentina) and recommendations for facilitating consumer information 3 (2016), https:\/\/www.unicef.org\/ecuador\/english\/20161122_UNICEF_LACRO_Labeling_Report_LR(3).pdf [https:\/\/perma.cc\/692G-WYRV].<\/p>\n

[79]<\/a> See Hickory BBQ Riblets<\/em>, supra<\/em> note 69.<\/p>\n

[80]<\/a> See Image of Kroger Original Cream Cheese Spread<\/em>, supra <\/em>note 63.<\/p>\n

[81]<\/a> 21 U.S.C. \u00a7 343(r)(2)(B) (2012).<\/p>\n

[82]<\/a> See <\/em>Jacobs, supra <\/em>note 8.<\/p>\n

[83]<\/a> See <\/em>Ram\u00edrez et al., supra<\/em> note 7, at 6. Chile has also taken other measures to regulate the marketing of unhealthy food products, particularly to children. See<\/em> Jacobs, supra<\/em> note 8.<\/p>\n

[84]<\/a> See<\/em> Nelson Ramirez, U.S. Dep\u2019t of Agric., Foreign Agric. Serv., Chile: New Nutritional Labeling Regulation (2015), http:\/\/gain.fas.usda.gov\/Recent%20GAIN%20Publications\/New%20Nutritional%20Labeling%20Regulation_Santiago_Chile_4-22-2015.pdf [https:\/\/perma.cc\/K9EJ-9DW5] [hereinafter New Nutritional Labeling Regulation].<\/p>\n

[85]<\/a> See id.<\/em> at 4\u20135.<\/p>\n

[86]<\/a> See id.<\/em><\/p>\n

[87]<\/a> See id.<\/em><\/p>\n

[88]<\/a> See <\/em>Ram\u00edrez et al., supra<\/em> note 7, at 11.<\/p>\n

[89]<\/a> See id.<\/em><\/p>\n

[90]<\/a> See <\/em>Wilma B. Freire et al., A qualitative study of consumer perceptions and use of traffic light\u00a0<\/em>food labelling in Ecuador<\/em>, 20 Pub. Health Nutrition 805, 811 (2016), https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/73D51ECDC1F9C1B6E2147C68261F1019\/S1368980016002457a.pdf\/qualitative_study_of_consumer_perceptions_and_use_of_traffic_light_food_labelling_in_ecuador.pdf [https:\/\/perma.cc\/7L78-AP5E].<\/p>\n

[91]<\/a> See id.<\/em> at 808.<\/p>\n

[92]<\/a> See id.<\/em><\/p>\n

[93]<\/a> See id.<\/em> at 809\u201311.<\/p>\n

[94]<\/a> See id.<\/em> at 808.<\/p>\n

[95]<\/a> See <\/em>Ram\u00edrez et al., supra<\/em> note 7, at 11\u201312.<\/p>\n

[96]<\/a> See <\/em>Freire et al., supra <\/em>note 90, at 805.<\/p>\n

[97]<\/a> Robert M. Califf, M.D. & Susan Mayne, Ph.D., Unveiling the New Nutrition Facts Label<\/em>, U.S. Food and Drug Admin. (May 20, 2016), http:\/\/blogs.fda.gov\/fdavoice\/index.php\/2016\/05\/unveiling-the-new-nutrition-facts-label\/ [https:\/\/perma.cc\/VL65-X9GR].<\/p>\n

[98]<\/a> See <\/em>136 Cong. Rec. 33,425, supra<\/em> note 17, at 33,428 (statement of Sen. Hatch) (\u201cOne of the least expensive changes we could make in this country to reduce our health care costs would be to increase our efforts in the area of health promotion and disease prevention.\u201d).<\/p>\n

[99]<\/a> See <\/em>OECD, United States<\/em>, OECD Data, https:\/\/data.oecd.org\/united-states.htm#profile-health [https:\/\/perma.cc\/N79D-RNNT].<\/p>\n

[100]<\/a> See <\/em>Nat\u2019l Inst. of Diabetes and Digestive and Kidney Diseases, Overweight & Obesity Statistics<\/em>, Nat\u2019l Insts. of Health (Aug. 2017), https:\/\/www.niddk.nih.gov\/health-information\/health-statistics\/overweight-obesity [https:\/\/perma.cc\/6C7F-B3HP].<\/p>\n

[101]<\/a> See Adult Obesity Facts<\/em>, supra <\/em>note 6.<\/p>\n

[102]<\/a> See id.<\/em><\/p>\n

[103]<\/a> See <\/em>Pew Research Center, Public Agrees on Obesity\u2019s Impact, Not Government\u2019s Role: Yes to Calories on Menus, No to Soda Limits<\/em> (Nov. 12, 2013), http:\/\/www.people-press.org\/2013\/11\/12\/public-agrees-on-obesitys-impact-not-governments-role\/ [https:\/\/perma.cc\/KQR3-ZP7P] (stating that 77% of Democrats and 61% of Republicans regard obesity as a very serious public health problem).<\/p>\n

[104]<\/a> See<\/em> Jacobs, supra<\/em> note 8.<\/p>\n

[105]<\/a> Potential costs of a proposal to reform disclosure statements in accordance with the recommendations of this Article will be explored later. See<\/em> infra<\/em> Part VIII.iv.<\/p>\n

[106]<\/a> See <\/em>Freire et al., supra <\/em>note 90, at 811.<\/p>\n

[107]<\/a> 136 Cong. Rec. 33,425, supra<\/em> note 17, at 33,428 (statement of Sen. Hatch).<\/p>\n

[108]<\/a> Id.<\/em><\/p>\n

[109]<\/a> See<\/em> Freire et al., supra <\/em>note 90, at 805.<\/p>\n

[110]<\/a> See id.<\/em><\/p>\n

[111]<\/a> 21 U.S.C. \u00a7 343(r)(2)(B) (2012).<\/p>\n

[113]<\/a> See id.<\/em><\/p>\n

[114]<\/a> See <\/em>Nigel Barrella, First Amendment Limits on Compulsory Labeling<\/em>, 71 Food & Drug L.J. 519, 526 (2016) (\u201c[C]ourts have readily concluded that an item\u2019s packaging (its label) is<\/em> commercial speech . . . A product label\u00a0sitting on a store shelf, in a very real sense, proposes a commercial transaction by saying, \u2018Here is what is in this box. Please buy it.\u2019\u201d) (emphasis in original).<\/p>\n

[115]<\/a> See <\/em>Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748, 762 (1976).<\/p>\n

[116]<\/a> See <\/em>West Virginia Bd. of Educ. v. Barnette, 319 U.S. 624, 642 (1943); Wooley v. Maynard, 430 U.S. 705, 713 (1977).<\/p>\n

[117]<\/a> 471 U.S. 626 (1985).<\/p>\n

[118]<\/a> Id. <\/em>at 651\u201352.<\/p>\n

[119]<\/a> Id.<\/em><\/p>\n

[120]<\/a> Id.<\/em><\/p>\n

[121]<\/a> 447 U.S. 557 (1980).<\/p>\n

[122]<\/a> See id. <\/em>at 566.<\/p>\n

[123]<\/a> Zauderer<\/em>, 471 U.S. at 651.<\/p>\n

[124]<\/a> 21 U.S.C. \u00a7 343(r)(2)(B) (2012).<\/p>\n

[125]<\/a> Notably, no court has relied on the \u201cuncontroversial\u201d prong of the Zauderer <\/em>test in reaching a decision on a compelled disclosure. See <\/em>Barrella, supra<\/em> note 116, at 532 (noting that \u201cno such cases are apparent to date, which provides some support for the notion that the phrase \u2018purely factual and uncontroversial information\u2019 must be read as a whole, rather than separated into two independent elements.\u201d).<\/p>\n

[126]<\/a> See <\/em>21 C.F.R. \u00a7 101.13(h) (2017).<\/p>\n

[127]<\/a> 21 U.S.C. \u00a7 343(r)(2)(B).<\/p>\n

[128]<\/a> Entm\u2019t Software Ass\u2019n v. Blagojevich, 469 F.3d 641, 652 (7th Cir. 2006).<\/p>\n

[129]<\/a> Nat\u2019l Ass\u2019n of Mfrs. v. Sec. & Exch. Comm\u2019n, 800 F.3d 518, 530 (D.C. Cir. 2015).<\/p>\n

[130]<\/a> Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food, 58 Fed. Reg. 2302, 2308 (Jan. 6, 1993) (codified at 21 C.F.R. pts. 5 & 101).<\/p>\n

[131]<\/a> See id.<\/em><\/p>\n

[132]<\/a> See <\/em>Food Labeling; Nutrient Content Claims\u2014General Provisions, 63 Fed. Reg. 26,978, 26,980 (May 15, 1998) (codified at 21 C.F.R. pt. 101.13(h)).<\/p>\n

[133]<\/a> Cf. <\/em>Am. Meat Institute v. U.S. Dep\u2019t of Agric., 760 F.3d 18, 23 (D.C. Cir. 2014) (citing the government\u2019s interest in continuing the longstanding practice of informing consumers which products are American-made as significant in determining whether there was a sufficient interest to compel country of origin labels for produce).<\/p>\n

[134]<\/a> This argument applies to manufacturers of foods that do not display nutrient content claims, as well as manufacturers of foods that display such claims. While it is true that food products that have health-risk nutrient contents in excess of the regulatory thresholds can avoid displaying the current disclosure statement requirement by not making nutrient content claims, the commercial speech of the manufacturers of those products is still burdened by the current disclosure statement requirement because the requirement limits their expression of potential nutrient content claims on their food products. Although such manufacturers could challenge the current disclosure statement requirement as inhibiting their decision as to whether to display nutrient content claims on their products, none have done so.<\/p>\n

[135]<\/a> For photographs of the warning images at issue in the case, see Bill Mears, Federal appeals court strikes down FDA tobacco warning label law<\/em>, CNN (Aug. 25, 2012), https:\/\/www.cnn.com\/2012\/08\/24\/justice\/tobacco-warning-label-law\/index.html [https:\/\/perma.cc\/6FHQ-HUZ9].<\/p>\n

[136]<\/a> 845 F. Supp. 2d 266, 273 (D.C. Cir. 2012).<\/p>\n

[137]<\/a> See <\/em>Disc. Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509, 559 (6th Cir. 2012) (concluding that the argument that graphics can never be factually accurate \u201cstands at odds with reason . . . . We can envision many graphic warnings that would constitute factual disclosures under Zauderer<\/em>.\u201d); id. <\/em>at 569 (\u201c[W]e vigorously disagree with the underlying premise that a disclosure that provokes a visceral response must fall outside Zauderer<\/em>\u2019s ambit. Facts can disconcert, displease, provoke an emotional response, spark controversy, and even overwhelm reason, but that does not magically turn such facts into opinions.\u201d).<\/p>\n

[138]<\/a> See R.J. Reynolds Tobacco Co.<\/em>, 845 F. Supp. 2d at 273 (\u201cThe images, coupled with the placement of the toll free number, do not \u2018promote informed choice\u2019 but instead advocate to consumers that they should \u2018QUIT NOW.\u2019 A telling example is the image depicting a man wearing a t-shirt that features a \u2018no smoking\u2019 symbol and the words \u2018I QUIT\u2019 next to the \u20181\u2013800\u2013QUIT\u2013NOW\u2019 phone number.\u201d).<\/p>\n

[139]<\/a> See <\/em>CTIA-Wireless Ass\u2019n v. City & Cty. of San Francisco, 494 F. App\u2019x 752, 753 (9th Cir. 2012).<\/p>\n

[140]<\/a> See <\/em>21 U.S.C. \u00a7 343(r)(2)(B) (2012) (emphasis added) (specifying the required text of the disclosure statement); 21 C.F.R. \u00a7 101.13(h) (2017) (emphasis added) (adopting the disclosure statement text from 21 U.S.C. \u00a7 343(r)(2)(B)).<\/p>\n

[141]<\/a> See Zauderer<\/em>, 471 U.S. at 651 (\u201c[W]e hold that an advertiser\u2019s rights are adequately protected as long as disclosure requirements are reasonably related to the State\u2019s interest in preventing deception of consumers.\u201d).<\/p>\n

[142]<\/a> See <\/em>143 Cong. Rec. 9811, supra <\/em>note 15, at 9824 (statement of Sen. McConnell) (\u201cThe original intent of this provision was to help educate consumers about the presence and location of nutrition information on food products.\u201d).<\/p>\n

[143]<\/a> See supra<\/em> Part IV.<\/p>\n

[144]<\/a> See id.<\/em><\/p>\n

[145]<\/a> 556 F.3d 114 (2d Cir. 2009).<\/p>\n

[146]<\/a> Id.<\/em> at 134.<\/p>\n

[147]<\/a> Am. Beverage Ass\u2019n v. City and Cty. of San Francisco, 871 F.3d 884, 898 (9th Cir. 2017). It should be noted that the Ninth Circuit later decided to rehear this case and declared that this judgment should not be binding precedent in the circuit. Am. Beverage Ass\u2019n v. City and Cty. of San Francisco, 880 F.3d 1019, 1020 (9th Cir. 2018) (\u201cThe three-judge panel disposition in these cases shall not be cited as precedent by or to any court of the Ninth Circuit.\u201d). However, the statement still reveals the judges\u2019 belief in the importance of the government\u2019s interest in protecting the health of its citizens.<\/p>\n

[148]<\/a> 760 F.3d at 27.<\/p>\n

[149]<\/a> Id. <\/em>at 23.<\/p>\n

[150]<\/a> Rubin v. Coors Brewing Co., 514 U.S. 476, 485 (1995) (\u201c[T]he Government here has a significant interest in protecting the health, safety, and welfare of its citizens . . . . Both panels of the Court of Appeals that heard this case concluded that the goal of suppressing strength wars constituted a substantial interest, and we cannot say that their conclusion is erroneous.\u201d).<\/p>\n

[151]<\/a> Zauderer<\/em> 471 U.S. at 651.<\/p>\n

[152]<\/a> See supra<\/em> Part VII; cf. <\/em>Johanns v. Livestock Mktg. Ass\u2019n, 544 U.S. 550, 559 (2005) (suggesting that compelled support of a government message is fundamentally different from compelled support of the message of a private entity); Walker v. Texas Div., Sons of Confederate Veterans, Inc., 135 S. Ct. 2239, 2245\u20132246 (2015) (treating government speech as distinct from private speech in the context of the First Amendment. Unlike a private individual or entity, \u201c[w]hen government speaks, it is not barred by the Free Speech Clause from determining the content of what it says.\u201d).<\/p>\n

[153]<\/a> See <\/em>Am. Beverage Ass\u2019n v. City and Cty. of San Francisco, 871 F.3d 884, 888 (9th Cir. 2017).<\/p>\n

[154]<\/a> See id.<\/em> at 896\u201397 (\u201cThe Associations argue that the warning unduly burdens their protected commercial speech because a warning that satisfies the ordinance\u2014a black box, bold warning that covers 20 percent of their advertisements\u2014effectively takes over their message. Moreover, the Associations argue that the ordinance forces them to carry San Francisco\u2019s message about the health effects of sugar-sweetened beverages, which the Associations claim is misleading and one-sided. . . . We agree with the Associations that the warning requirement in this case unduly burdens and chills protected commercial speech. As the sample advertisements show, the black box warning overwhelms other visual elements in the advertisement.\u201d).<\/p>\n

[155]<\/a> Am. Beverage Ass\u2019n v. City and Cty. of San Francisco, 880 F.3d 1019, 1020 (9th Cir. 2018) (\u201cThe three-judge panel disposition in these cases shall not be cited as precedent by or to any court of the Ninth Circuit.\u201d).<\/p>\n

[156]<\/a> 622 F.3d 628 (6th Cir. 2010).<\/p>\n

[157]<\/a> Id.<\/em> at 634\u201335.<\/p>\n

[158]<\/a> See id.<\/em> at 642 (\u201cWe therefore conclude that the less-burdensome analytical framework of Zauderer<\/em> should apply.\u201d).<\/p>\n

[159]<\/a> See id.<\/em> at 643 (\u201cNotwithstanding our conclusion that the Rule\u2019s disclosure requirement is reasonably related to the State\u2019s interest in preventing consumer deception, we find there to be no rational basis between this concern and the \u2018contiguous\u2019 requirement of such a disclosure.\u201d).<\/p>\n

[160]<\/a> 21 U.S.C. \u00a7 343(r)(2)(B) (2012).<\/p>\n

[161]<\/a> In fact, as the cream cheese example demonstrates, the dependence of the current disclosure statement requirement on the presence of nutrient content claims can be a source of consumer deception itself.<\/p>\n

[162]<\/a> See<\/em> Reuters Staff, Clearer food labels might help with healthy food choice: study<\/em>, Reuters (Jan. 23, 2013), https:\/\/www.reuters.com\/article\/us-food-labels\/clearer-food-labels-might-help-with-healthy-food-choice-study-idUSBRE90M1GB20130124 [https:\/\/perma.cc\/CH4Z-HBSC] (referring to Amy M. Lando & Serena C. Lo, Single-Larger-Portion-Size and Dual-Column Nutrition Labeling May Help Consumers Make More Healthful Food Choices<\/em>, 113 J. Acad. Nutrition & Dietetics 241 (2013)); Shereen Lehman, \u2018Low content\u2019 claims on food labels may confuse consumers<\/em>, Reuters (Mar. 24, 2017), https:\/\/www.reuters.com\/article\/health-groceries-labels\/low-content-claims-on-food-labels-may-confuse-consumers-idUSKBN16V2ID [https:\/\/perma.cc\/2P5U-Y49X]; see also<\/em> Betsy A. Hornick et al., Is it Time to Rethink Nutrition Communications? A 5-Year Retrospective of Americans\u2019 Attitudes toward Food, Nutrition, and Health<\/em>, 113 J. Acad. Nutrition & Dietetics 14, 22 (2013) (\u201cDuring the 5 years of the survey, there has been an explosion in access to technology and information, including food, nutrition, and health counsel, yet this has not appeared to facilitate greater consumer understanding or action. These data raise the question of whether traditional nutrition communications may have contributed to consumer confusion and perhaps, the lack of motivation expressed by many Americans.\u201d).<\/p>\n

[163]<\/a> Food Labeling: Revision of the Nutrition and Supplement Facts Labels, 81 Fed. Reg. 33,742 (May 27, 2016) (codified at 21 C.F.R. pt. 101); Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments, 81 Fed. Reg. 34,000 (May 27, 2016) (codified at 21 C.F.R. pt. 101). In 2017, the Trump administration delayed the implementation of these changes to give food manufacturers more time to comply with the requirements. See<\/em> Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Proposed Extension of Compliance Dates, 82 Fed. Reg. 45,753, 45,753 (Oct. 2, 2017) (codified at 21 C.F.R. pt. 101); see also<\/em> Caitlin Dewey, Trump\u2019s FDA just took another swipe at Michelle Obama\u2019s food legacy<\/em>, Wash. Post (June 13, 2017), https:\/\/www.washingtonpost.com\/news\/wonk\/wp\/2017\/06\/13\/trumps-fda-just-took-another-swipe-at-michelle-obamas-food-legacy\/?utm_term=.5170151bb32d [https:\/\/perma.cc\/4VQ9-ZDAX].<\/p>\n

[164]<\/a> 81 Fed. Reg. 33,742, 33,744; 81 Fed. Reg. 34,000, 34,001).<\/p>\n

[165]<\/a> 2016 Nutrition Facts Amendments Regulatory Impact Analysis, supra<\/em> note 1, at 57, 72 (displaying the projected annualized costs for relabeling in Table 4 on page 57 and the projected annualized costs for reformulation in Table 10 on page 72).<\/p>\n

[166]<\/a> For example, many manufacturers add color symbols to the front of their products every spring before the Jewish holiday of Passover, during which many Jews eat only food designated as suitable for consumption during the holiday. See, e.g.<\/em>, Dannon re-launches Kosher for Passover Yogurt<\/em>, Refrigerated & Frozen Foods (March 28, 2018), https:\/\/www.refrigeratedfrozenfood.com\/articles\/94407-dannon-re-launches-kosher-for-passover-yogurt [https:\/\/perma.cc\/9J7B-2PM2].<\/p>\n

[167]<\/a> National Bioengineered Food Disclosure Standard, Pub. L. No. 114-216, \u00a7 293, 130 Stat. 834, 835 (2016).<\/p>\n

[168]<\/a> See <\/em>Brad Plumer, The controversial GMO labeling bill that just passed Congress, explained<\/em>, Vox (July 14, 2016), https:\/\/www.vox.com\/2016\/7\/7\/12111346\/gmo-labeling-bill-congress [https:\/\/perma.cc\/V87N-SV7V].<\/p>\n

[169]<\/a> See id.<\/em><\/p>\n

[170]<\/a> See, e.g.<\/em>, nat\u2019l Acads. of scis., eng\u2019g., & med., Genetically Engineered Crops: Experiences and Prospects 1 (2016), https:\/\/www.nap.edu\/resource\/23395\/GE-crops-report-brief.pdf [https:\/\/perma.cc\/J9B9-8RAF] (\u201c[W]hile recognizing the inherent difficulty of detecting subtle or long-term effects in health or the environment, the study committee found no substantiated evidence of a difference in risks to human health between currently commercialized genetically engineered (GE) crops and conventionally bred crops, nor did it find conclusive cause-and-effect evidence of environmental problems from the GE crops.\u201d); Brad Plumer, 5 big takeaways from the most thorough review of GMOs yet<\/em>, Vox (May 18, 2016), https:\/\/www.vox.com\/2016\/5\/18\/11690992\/gmos-review-evidence-safety-health [https:\/\/perma.cc\/LNQ9-3QB5] (\u201cThe best evidence suggests current GM crops are just as safe to eat as regular crops.\u201d).<\/p>\n

[171]<\/a> See <\/em>National Bioengineered Food Disclosure Standard, 83 Fed. Reg. 19860, 19881 (proposed May 4, 2018) (to be codified at 7 C.F.R. pt. 66).<\/p>\n

[172]<\/a> See Rubin<\/em>, 514 U.S. at 485.<\/p>\n

[173]<\/a> When considering Vermont\u2019s mandatory disclosure of the use of rBST in dairy products in International Dairy Foods Association v. Amestoy<\/em>, 92 F.3d 67 (2d Cir. 1996), the Second Circuit concluded that consumer interest\u00a0 was not a strong enough interest to compel even an accurate, factual statement. Id. <\/em>at 74. It also stated, \u201cAbsent . . . some indication that this information bears on a reasonable concern for human health or safety or some other sufficiently substantial governmental concern, the manufacturers cannot be compelled to disclose it.\u201d Id. <\/em>The government might find it difficult to justify the permissibility of its GMO labeling requirement under the International Dairy Foods Association<\/em> standard. But see<\/em> Grocery Mfrs. Ass\u2019n v. Sorrell, 102 F. Supp. 3d 583, 630\u201332 (D. Vt. 2015) (determining that Vermont had articulated sufficiently substantial interests in enacting its GMO labeling law notwithstanding the International Dairy Foods Association<\/em> decision). By contrast, the government would find it far easier to argue that this Article\u2019s proposed disclosure statement satisfies the International Dairy Foods Association<\/em> test. Public health promotion and consumer awareness of pertinent health information are stronger interests than mere consumer curiosity. See, e.g.<\/em>, Coors Brewing Co.<\/em>, 514 U.S. at 485 (\u201c[T]he Government here has a significant interest in protecting the health, safety, and welfare of its citizens . . . . Both panels of the Court of Appeals that heard this case concluded that the goal of suppressing strength wars constituted a substantial interest, and we cannot say that their conclusion is erroneous.\u201d).<\/p>\n

[174]<\/a> This is assuming that its costs would be similar, or at least comparable, to the 2016 Nutrition Facts changes, which has a maximum projected cost of $0.8 billion over twenty years. See <\/em>81 Fed. Reg. 33,742, 33,744; 81 Fed. Reg. 34,000, 34,001.<\/p>\n","protected":false},"excerpt":{"rendered":"

Be Warned: A Proposal to Reform Food Product Disclosure Statements By Gideon Zvi Palte, J.D. \u201918[*] I. Introduction Dietary choices […]<\/p>\n","protected":false},"author":101984,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[28,30,3],"tags":[],"class_list":["post-2838","post","type-post","status-publish","format-standard","hentry","category-jol-online","category-jol-online-article","category-jol-online-notes"],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/peZQ7o-JM","jetpack_sharing_enabled":true,"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/journals.law.harvard.edu\/jol\/wp-json\/wp\/v2\/posts\/2838","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/journals.law.harvard.edu\/jol\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/journals.law.harvard.edu\/jol\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/journals.law.harvard.edu\/jol\/wp-json\/wp\/v2\/users\/101984"}],"replies":[{"embeddable":true,"href":"https:\/\/journals.law.harvard.edu\/jol\/wp-json\/wp\/v2\/comments?post=2838"}],"version-history":[{"count":0,"href":"https:\/\/journals.law.harvard.edu\/jol\/wp-json\/wp\/v2\/posts\/2838\/revisions"}],"wp:attachment":[{"href":"https:\/\/journals.law.harvard.edu\/jol\/wp-json\/wp\/v2\/media?parent=2838"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/journals.law.harvard.edu\/jol\/wp-json\/wp\/v2\/categories?post=2838"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/journals.law.harvard.edu\/jol\/wp-json\/wp\/v2\/tags?post=2838"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}