FDA Releases Draft Guidance on Declaration of Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels

FDA has issued a Draft Guidance document stating the Agency's policy on the declaration of small amounts of nutrients and dietary ingredients on nutrition labels. Specifically, the Draft Guidance provides FDA's recommendations on how to comply with nutrition labeling requirements in cases where the presence of small amounts of nutrients or dietary ingredients creates a conflict between applicable regulatory provisions. 

FDA's regulations in 21 C.F.R. § 101.9(c)(1)-(8) describe requirements for nutrition labeling for conventional foods and also apply to dietary supplements when certain dietary ingredients - i.e., those with a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) - are present. 

FDA's regulations in 21 C.F.R. § 101.9(g)(4) and (5) describe compliance requirements applicable to the declaration of nutrients and dietary ingredients in nutrition labeling.  A product is misbranded where:

• The nutrient content of the composite of a naturally occurring (indigenous) vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium is below 80 percent of the value for that nutrient declared on the label (21 C.F.R. § 101.9(g)(4)(ii)) (Note:  For foods with added vitamins, minerals, protein, dietary fiber, or potassium, the nutrient composite must be at least equal to the value for that nutrient declared on the label.)  
• The nutrient content of the composite of calories, sugars, total fat, saturated fat, trans fat, cholesterol, or sodium (whether indigenous or added) is greater than 20 percent in excess for the value of that nutrient declared on the label (21 C.F.R. § 101.9(g)(5))

Typically, the declaration of nutrients and dietary ingredients in accordance with 21 C.F.R. § 101.9(c)(1)-(8) does not conflict with the compliance requirements above.  However, certain small amounts of nutrients or dietary ingredients cannot be declared in a manner that complies with both sets of provisions.  FDA's Draft Guidance provides specific examples of such conflicts.  One example is reproduced below:

Under 21 C.F.R. § 101.9(c)(2)(iv), monounsaturated fat content is expressed to the nearest 0.5 g increment at amounts below 5 g.  If a product contains 0.75 to 1.00 g of monounsaturated fat, the amount is declared as 1.00 g on the nutrition label.  This situation creates the following conflict under existing regulations:

In the Draft Guidance, FDA indicates that where the presence of small amounts of nutrients generates a conflict between the requirements in 21 C.F.R. § 101.9(c)(1)-(8) and the compliance requirements, the Agency intends to consider the use of its enforcement discretion with respect to the compliance requirements.  FDA thus recommends that manufacturers declare nutrients and dietary ingredients in accordance with 21 C.F.R. § 101.9(c)(1)-(8). 

FDA's notice announcing the availability of the Draft Guidance appeared in the Federal Register on July 30, 2015 (80 Fed. Reg. 45465):  The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Draft Guidance for Industry; Availability

The Draft Guidance itself is available on FDA's website:  FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels, "Draft Guidance" (July 2015)