The FDA issued a draft guidance document to clarify the administration’s policy on the declaration of small and trace amounts of nutrients on manufacturers’ nutrition labels. Released as a notice in Federal Register, the draft guidance, when finalized, will “...explain to manufacturers of conventional foods and dietary supplements [the FDA’s] policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount.”
Issuing the draft guidance was determined necessary by the emergence of a potential conflict of interest between specific stipulations of the Code of Federal Relations (CFR). In the agency’s own words, “...declaring small amounts of nutrients and dietary ingredients in the nutrition labeling may result in a conflict between 21 CFR 101.9(c)(1) through (8) and 21 CFR 101.9(g)(4)(ii) and 21 CFR 101.9(g)(5). In such cases, we are recommending manufacturers declare nutrients and dietary ingredients in accordance with Sec. 101.9(c)(1) through (8).”
The FDA’s announcement will render food labels with declarations of nutritional content “misbranded” should they fall outside a standard deviation of 20% from the suggested amount of a given nutrient or caloric metric. In other words, a nutrition label claiming 8 grams of saturated fat per serving but in fact featuring 10 grams would be “misbranded.” Likewise, a product that claims to feature 50% of one’s daily recommended value (DRV) of Vitamin A that actually offers only 39% of one’s DRV would be subject to departmental recourse.
The draft guidance document is mostly directed at clarifying the nuances of American labeling laws for food manufacturers and purveyors. In the words of the bureau, “the draft guidance represents the current thinking of FDA on our policy on declaring small amounts of nutrients and dietary ingredients on nutrition labels. It does not establish any rights for any person and is not binding on FDA or the public.” Furthermore, the FDA is accepting public comments on the draft guidance up until September 28, 2015.
The U.S. Department of Agriculture’s Food and Nutrition Service (FNS) is requesting food nutrition information available to schools that participate in the National School Lunch Program and the School Breakfast Program (“SMPs”). According to the Federal Register dated 8/19/2011, “FNS is interested in examining what nutrition information and ingredient lists are made available to schools, the manner and scope of the information’s accessibility, and how that information and accessibility compare with the information schools may be seeking” in hopes to better understand how schools are currently deciding how to plan their menus and buy their foods.
The FDA notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act.
The violations cited in the Warning Letters include unauthorized health claims, unauthorized nutrient content claims, and the unauthorized use of terms such as “healthy,” and others that have strict, regulatory definitions. Companies have 15 business days to reply to the FDA regarding corrective steps.
Nutrition labeling is a major priority for the FDA. Br uce A. Silverglade, director of legal affairs of the Center for Science in the Public Interest stated in a NY Times article. “The F.D.A. is not merely firing a shot across the bow; it is declaring war on misleading food labeling.” CSPI is a leading advocacy group that had pushed for stricter rules.
You can view these warning letters on the FDA’s site.