The FDA issued a draft guidance document to clarify the administration’s policy on the declaration of small and trace amounts of nutrients on manufacturers’ nutrition labels. Released as a notice in Federal Register, the draft guidance, when finalized, will “...explain to manufacturers of conventional foods and dietary supplements [the FDA’s] policy on determining the amount to declare on the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Issuing the draft guidance was determined necessary by the emergence of a potential conflict of interest between specific stipulations of the Code of Federal Relations (CFR).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The draft guidance document is mostly directed at clarifying the nuances of American labeling laws for food manufacturers and purveyors. In the words of the bureau, “the draft guidance represents the current thinking of FDA on our policy on declaring small amounts of nutrients and dietary ingredients on nutrition labels.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 Furthermore, the FDA is accepting public comments on the draft guidance up until September 28, 2015.
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Last modified on Tuesday, 25 August 2015 11:53