CFSAN/FDA has made available a guidance document and a small entity compliance guide to assist industry in complying with its revised nutrition labeling requirements for conventional foods and dietary supplements:
- Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category (Feb. 2018) [hereinafter “RACC Guide”]; and
- Guidance for Industry: Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Small Entity Compliance Guide (Feb. 2018) [hereinafter “Serving Size Guide”].
The RACC Guide provides examples of products that belong in each of the Product Categories included in the two tables of RACCs codified in 21 C.F.R. § 101.12(b). CFSAN/FDA made available similar information when it promulgated its rules for mandatory nutrition labeling back in 1993.
Table 1 in § 101.12(b) provides RACCS for foods intended for infants and young children 1 through 3 years of age, and Table 2 provides RACCS for foods intended for individuals 4 years of age and older. The tables in the RACC Guide essentially mirror these regulatory tables, but add a column that contains examples of food products that fall within each Product Category.
The RACC Guide is intended to help industry identify the Product Category to which specific food products belong. However, it is not meant to provide an all-inclusive list of food products that are available on the market for each Product Category.
Serving Size Guide
The Serving Size Guide is intended to restate, in plain language, the legal requirements set forth in FDA’s May 27, 2016, final rule, which essentially amended the definition of a single-serving container, required dual-column labeling for certain containers, updated the tables of RACCs, and amended the Serving Size for breath mints.
The Serving Size Guide provides advice on the following topics:
- Who is subject to the rule?
- What foods are covered by the rule?
- What foods are not covered by the rule?
- How does a person comply with the label serving size requirements?
- How does a person determine the appropriate serving size for a product?
- By when must a person comply with the rule?
- What happens if a person does not comply with the rule?
Comments on the RACC Guide and the Serving Size Guide may be submitted to FDA at any time after March 2, 2018.