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Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition
In the Federal Register of May 27, 2016 (81 FR 34000), we published a final rule pertaining to serving sizes for food. The final rule amends the definition of a single-serving container, requires dual-column labeling for certain containers, updates the tables of Reference Amounts Customarily Consumed (reference amounts, or RACCs), and amends the serving size for breath mints. The rule became effective on July 26, 2016. We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document restates in plain language the legal requirements set forth in the rule, and is intended to help small entities comply with the rule established in 21 CFR 101.9 and 101.12.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in our guidances means that something is suggested or recommended, but not required.
In the remainder of this guidance, “you” and “I” refer to food manufacturers that are subject to the rule. Many answers in this guidance are followed by citations to show where a specific requirement can be found in either the Federal Food, Drug, and Cosmetic Act (FD&C Act) or Title 21 of the Code of Federal Regulations.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2004-N-0258.