As of the beginning of July 2016, the FDA has finalized the draft guidance document (originally drafted and released for consultation at the end of July 2015) on its policy about Nutrition Labels and how small quantities of nutrients and dietary ingredients should be declared by food and dietary supplement manufacturers.
The finalized guidance document acknowledges the conflict that sometimes may arise when being in compliance with two distinct sections of regulations and which regulation takes precedence in the discretion of the FDA. The two sections of FDA regulations (both from Title 21 of the Code of Federal Regulations [21 CFR] 101.9) where compliance could potentially be mutually exclusive are:
The conflicting values for a nutrient can arise when small quantities of nutrients have to be declared. The rounding requirements under 101.9(c)(1)-(8) may result in a value being declared that exceeds the 20% deviation permitted in 101.9(g)(4)(ii) and (5). An example would be a food containing 0.70 g of saturated fat per serving. The quantity that should be declared according to 101.9(c)(2)(i) would be 0.5 g. However this declaration would not comply with § 101.9(g)(5) because 0.70 g is more than 20 percent in excess of 0.5 g.
The FDA’s resolution (“to be applied to all products in a consistent way” ) is based on the rationale that as the FDA’s nutrition labelling requirements in 21 CFR 101.9(c)(1)-(8) specifies the increments and units of measure for declaring nutrient values while 21 CFR 101.9(g)(4)(ii) and (5) does not, the “FDA considers it more practical and consistent” for manufacturers to follow paragraph (c)(1)-(8) when a conflict occurs between 21 CFR 101.9(c)(1)-(8) and 21 CFR 101.9(g)(4)(ii) and (5).
dicentra is well-versed in interpreting the oft-confusing FDA regulations for both food and dietary supplements in the United States, even when they appear conflicting. Our breadth of experience has provided us considerable understanding in how dietary supplements and nutrition labels are not only viewed by enforcement agencies such as the FDA and FTC, but also by consumers and what appeals in today’s marketplace. dicentra can assist with the regulatory compliance of your existing labels or can even help you prepare a complete label from scratch. We can be reached at 1-866-647-3279 or at email@example.com