Draft FDA Guidance Documents on the Nutrition Facts Label

The FDA has sent out the following e-mail this morning.  Note that these are nonbinding regulations.

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The U.S. Food and Drug Administration today issued two draft guidance documents related to the final rules on Nutrition Facts labeling and Serving Sizes to help industry comply with those rules.

The first draft guidance answers questions related to compliance, labeling of added sugars, rounding as it relates to the declaration of quantitative amounts of vitamins and minerals, and label format (thickness of lines and space between lines).

The second draft guidance provides examples of food products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion that are established in FDA’s serving size regulations. These examples will help industry identify the appropriate food categories for their products and, in turn, determine the serving size on a product’s Nutrition Facts label.

The final rules on the Nutrition Facts label and serving sizes published May 27, 2016. The compliance date is July 26, 2018, but smaller businesses with annual food sales that are less than $10 million have until July 26, 2019 to comply.

The FDA is accepting comments on the draft guidance documents and is requesting them within 60 days of publication in the Federal Register to have them before it begins work on the final documents. Instructions for submitting comments can be found in the notices of availability at the links below:

Nutrition Labels - Draft 1

• Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals
• Federal Register Notice for the Draft Guidance on Questions and Answers

Racc - Draft 2

• Draft Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category
• Federal Register Notice for the Draft Guidance on Reference Amounts

Changes to the Nutrition Facts Label