Are The FDA’s New Definitions And Labeling Requirements Good For Us, Or Just Empty Calories?

By Diana R. H. Winters

[Crossposted from the Health Affairs Blog]

The Food and Drug Administration (FDA) has recently taken three steps toward providing consumers with more and better information about food products that the agency regulates. First, in response to several citizen petitions, the agency requested comments on the use of the term “natural” on food labeling. Second, the agency issued a statement in early May indicating that “in the near future” it planned to solicit comments reevaluating how nutrient content claims are regulated — including the term “healthy.” And third, the agency issued a final rule on an updated Nutrition Facts label, with which large companies must comply by July 2018.

With each of these actions the FDA is attempting to ensure that information provided to consumers by food manufacturers comports with the latest scientific understanding about food components. Indeed, the updated nutrition facts label will provide important information and potentially allow consumers to make more informed choices about what they eat. The agency, however, has set itself a far trickier task in defining words such as “natural” and “healthy.”

Act Naturally

In the past, the FDA has repeatedly declined to define the term “natural.” The Nutrition Labeling and Education Act (NLEA) of 1990 required the FDA to standardize definitions for nutrient content claims, like “fat free” or “high in fiber,” and to limit the use of health claims, like “heart healthy” (21 U.S.C. §§ 343(r)(1)(A), (B)). The word “natural,” however, does not fit into either of these categories.

In 1991, the agency requested public comment on a definition, stating that “if the term ‘natural’ is adequately defined, the ambiguity surrounding use of this term that results in misleading claims could be abated.” But nothing came of the comments and in 1993, the FDA declined to define the term, citing “resource limitations and other agency priorities” (58 Fed. Reg. 2302, 2407 (Jan.6, 1993)).

Beginning in 2013, plaintiffs filed a large number of suits against food manufacturers, alleging that the use of the term “natural” was misleading under various state laws. And in late 2013, three courts in Northern California stayed several of these cases pending the FDA’s determination of the issue. (I’ve written about this use of the primary jurisdiction doctrine here.) In January 2014, in a letter to these courts, the agency again declined to define the term, citing resource limitations. However, after receiving several citizen petitions on the issue in late 2015, the FDA once again requested public comment on whether it should define “natural,” and if so, how. When the comment period for this request closed on May 10, 2016, the agency had received 7,690 comments.

Implying Health

Although it did not define “natural” after the 1990 passage of the NLEA, the FDA did define the term “healthy.” The agency explained that some claims made on food labels suggest “that the food, because of its nutrient content, may be useful in maintaining healthy dietary practices.” This, the agency said, implied nutrient content claims (21 C.F.R. § 101.13(b)(2)(ii)). And according to a regulation finalized in the early 1990s, the term “healthy” cannot be used in such a claim if the relevant food contained more than a certain amount of fat or sodium (21 C.F.R. § 101.65).

In March of 2015, the FDA sent a letter to the Chief Executive Officer of Kind, LLC, a company that manufactures protein bars, explaining that the product’s labels violated the agency’s regulations in several respects, most notably by the use of the term “healthy.” The bars contained too much saturated fat to be labeled healthy, according to the agency.

The company responded that the fat in its bars was derived from nuts, which are “generally considered to be good for you.” The extensive media coverage of the dispute focused on recent research showing that saturated fats, especially from foods such as nuts, may actually be healthy. The FDA and Kind reached a resolution in May of this year, and the FDA explained in a statement that the company could “use ‘healthy and tasty’ as part of its corporate philosophy, as opposed to using ‘healthy’ in the context of a nutrient content claim.” Moreover, the agency announced plans to ask for public comment on the redefinition of the term “healthy” soon.

Nutrition Facts 2.0

A prohibition on misbranding is one of the main tenets of the Food, Drug, and Cosmetic Act first enacted in 1938. Since then, the federal government has made the provision of accurate information a cornerstone of its food regulatory scheme.

In early 2014, the FDA published its proposed rule to update the Nutrition Facts label on most packaged foods listing the amount of calories and nutrients. In October of 2015, the then-Commissioner of the FDA, Dr. Margaret Hamburg, confirmed the agency’s commitment to providing consumers with accurate information, stating in a letter that “[t]oday, ready access to reliable information about the calorie and nutrient content of food is even more important, given the prevalence of obesity and diet-related diseases in the United States.”

The Nutrition Facts label, finalized in May 2016, is an important part of this strategy. Large manufacturers will have to begin using the new label by July 26, 2018, while those with annual sales under $10 million have another year to comply the rule. Studies have shown that consumers actually use the Nutrition Facts label to make decisions about what to purchase and to eat. Forty two percent of respondents to the National Health and Nutrition Examination Survey in 2009-2010 used the Nutrition Facts label “always or most of the time,” compared to 34 percent in 2007-2008. The updated Nutrition Facts label is thus important and past due.

The new label updates serving sizes, which haven’t been changed since 1993. And although there is the possibility that some people may think the FDA now sanctions larger servings, serving sizes are, by law (21 C.F.R. § 101.9(b)(1)), supposed to reflect what people actually eat, not what they should be eating. For better or for worse (probably worse), people eat more than they used to, and the new serving size requirements should help them understand the calories, fat, and nutrients in an average portion.

The FDA is also requiring manufacturers to begin listing some nutrients that we now know are important such as Vitamin D and potassium. The update also eliminates the required inclusion of other nutrients such as Vitamins A and C, which Americans now get enough of, and updates some daily values. Requiring manufacturers to list added sugars on the label is significant, because, as the agency explains in its highlights of the new label fact sheet, “[s]cientific data shows that it is difficult to meet nutrient needs while staying within calorie limits if you consume more than 10 percent of your total daily calories from added sugar.” The design of the label will also change, to make the information more accessible to consumers. You can see the original and the updated labels here.

The Aura Of Truth

The benefits of the agency acting to define “natural” and redefine “healthy” are less clear. Any consideration of the thousands of comments the agency received regarding whether and how it should define natural shows that such a definition would be more philosophy than science, and would represent a compromise among stakeholders. Questions of whether the term “natural” should encompass methods of production as well as ingredients, and whether genetically engineered ingredients can ever be considered natural, are only two of many on which much investment rests and about which interested parties may hold many different positions.

As far as deciding the meaning of “healthy,” a term that may seem more concrete than “natural,” the current debate illustrates how nutrition science is unsettled, and how quickly wisdom about certain nutrients can change. The ponderous regulatory process cannot keep up with the pace of changing scientific understanding. In addition, adding the FDA’s imprimatur to these terms fosters consumers’ overreliance on words, the specific content of which they may be unaware of or misunderstand. It is easier to buy food labeled “natural” or “healthy” than to take the time necessary to understand what kinds of products and ingredients are actually best for one’s body.

In short, the Nutrition Facts labels correct an information imbalance, providing consumers with otherwise unavailable data, and allowing them to better assess their choices — definitions of terms such as “healthy” and “natural” do not. Any such definition will be a negotiated and artificial construct, imbued by the FDA with an aura of truth. The agency should spend its scarce resources elsewhere.