FDA to Reevaluate ‘Healthy’ Food Claims

Currently, if a food company wants to include certain types of “healthy” claims on a product label, FDA’s regulations stipulate that, among other things, the food must be both “low fat” and “low saturated fat.” This means that, because of their fat content, certain nutrient-rich foods like nuts, avocados, olives, and salmon are precluded from using the term “healthy” as a nutrient content claim.

Last year, FDA issued to KIND LLC a Warning Letter alleging various violations of the food labeling requirements of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. While many of the alleged violations were minor technical errors, the letter raised a larger issue regarding the appropriate use of the term “healthy.” More specifically, FDA asserted in the Warning Letter that the use of the claim “[h]ealthy and tasty, convenient and wholesome” was an implied nutrient content claim because it was made in connection with statements including “good source of fiber,” “no trans fats,” and “7g protein.” FDA took the position that the use of the term “healthy” in this context was improper because the KIND products are not low in saturated fat. In response, and as further described below, KIND petitioned FDA to take certain steps to bring its regulations and enforcement policy in line with the current federal dietary recommendations, which have changed significantly since the “healthy” regulation was published over twenty years ago.

When FDA finalized its current regulations on nutrient content claims, it relied heavily on the recommendations set forth in the federal Dietary Guidelines for Americans that were in place at that time. Based upon those recommendations (published by the U.S. Department of Agriculture), as well as on dietary recommendations from the Surgeon General and the Institute of Medicine’s Food and Nutrition Board that Americans reduce dietary intake of total and saturated fats, the FDA required that a food comply with specified limits or thresholds on fats, cholesterol, and certain other nutrients in order to be eligible for a “healthy” nutrient content claim. Among other things, FDA concluded that it would be inappropriate for a food to bear a “healthy” nutrient content claim if the food is not low in both fat and saturated fat. For these reasons, FDA’s regulations preclude the use of the term “healthy” and its derivatives in a nutrient content claim unless the food contains three grams or less total fat and one gram or less of saturated fat per serving. See 21 C.F.R. § 101.65(d)(2).

The USDA Guidelines have been updated several times since FDA’s nutrient content regulations were published in 1994. Although previous editions of the Guidelines focused primarily on individual dietary components such as food groups and nutrients, as we noted here, the latest edition of the Guidelines shifts the focus away from individual nutrients and instead encourages healthy eating patterns. The current Guidelines specifically recommend that individuals consume nutrient-dense foods and beverages, such as a variety of vegetables and fruits, whole grains, fat-free or low-fat milk and milk products, seafood, lean meats and poultry, eggs, beans and peas, and nuts and seeds. The Guidelines now encourage consumption of certain oils — fats naturally present in nuts, seeds, seafood, olives and avocados. FDA’s regulation of nutrient content claims are intended to help consumers make healthy eating choices by ensuring that labels provide accurate and reliable information. To the extent that these regulations emphasize avoiding all types of fat intake—including the type of fats derived from nuts and seeds—they are arguably outdated and no longer reflective of sound nutritional science.

In response to the Warning Letter, on December 1, 2015, KIND submitted to FDA a Citizen Petition requesting that the Agency reevaluate its nutrient content claim regulations and amend them as necessary to ensure consistency with the 2010 Dietary Guidelines for Americans and the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (used to form the scientific basis for the 2015 Dietary Guidelines for Americans, which had not been issued at the time the Petition was filed). KIND also proposed a number of specific policy changes, including that certain fats be excluded from the calculation of disqualifying fat content levels and that “healthy” claims be deemed nutrient content claims only if they directly characterize the level of a nutrient.

In its announcement this week, the Agency noted that it had closed out the KIND Warning Letter and does not object to KIND using the phrase “healthy and tasty” on product labels as part of its corporate philosophy. The Agency also stated that “[i]n light of evolving nutrition research, forthcoming Nutrition Facts Labeling final rules, and a citizen petition, we believe now is an opportune time to reevaluate regulations concerning nutrient content claims, generally, including the term ‘healthy.’”