When Regulations Collide: FDA Addresses Nutrition Label Issue for Small Amounts of Nutrients and Dietary Ingredients in Finalized Guidance Document

July 25, 2016 By

When Regulations Collide: FDA Addresses Nutrition Label Issue for Small Amounts of Nutrients and Dietary Ingredients in Finalized Guidance Document

As of the beginning of July 2016, the FDA has finalized the draft guidance document (originally drafted and released for consultation at the end of July 2015) on its policy about Nutrition Labels and how small quantities of nutrients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:

  • 21 CFR 101.9(c)(1)-(8): These regulations describe the nutrition-labelling requirements in declaring the nutrient values in a serving of conventional food. It specifies that in declaring nutrients, specific “rounding” rules have to be applied, where the stated value has to be to a distinct increment (ex. the quantitative amount of total fat present at 5 g or less must be rounded to the nearest 0.5 increment).  This regulation also specifies how the FDA tests for compliance to these values.
  • 21 CFR 101.9(g)(4)(ii) and (5): These regulations describe the compliance requirements for declaring dietary ingredients and nutrients in nutrition labelling.  These compliance provisions (sometimes referred to as the “20-20” rule) describes a product to be misbranded under the following two conditions:
    1. The amount of a naturally present vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated fat, monounsaturated fat or potassium is less than 80% of the value for that nutrient declared on the label (21 CFR 101.9(g)(4)(ii)).
    2. The amount of calories, sugars, total fat, saturated fat, trans fat, cholesterol, or sodium is more than 120% of the declared value for that nutrient (21 CFR 101.9(g)(5).

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 info@dicentra.com