Icon: RSS Icon: Email Icon: Twitter Icon: Facebook Icon: Linked In Icon: YouTube Icon: Leaf

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

Posted on October 27 2016 | Author: Admin

As of the beginning of July 2016, the FDA has finalized the draft guidance document (originally drafted and released for consultation at the end of July 2015) on its policy about Nutrition Labels and how small quantities of nutrients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

 

Article provided by dicentra

About dicentra
dicentra provides sought-after food safety guidance, compliance consulting services and scientific guidance for food and health-related products sold in North American marketplaces. Since 2002, dicentra has been helping clients resolve complex scientific and safety issues, develop safe and effective market-leading products and facilitate timely regulatory approvals. To learn more about dicentra, please visit www.dicentra.com

Click here to view the original article. 






Email this page to a friend
Comment

Main Body Footer

Sponsors                                          
 

Our Commitment to Accessibility for those with Disabilities
© Bioenterprise Corporation. All rights reserved.