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GUIDANCE DOCUMENT

Guidance for Industry: Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels August 2019

Final Level 2 Guidance
Docket Number:
FDA-2016-D-4484
Issued by:
Guidance Issuing Office
Office of Nutrition and Food Labeling

August 2019

This guidance document provides step-by-step instructions to manufacturers of retail food products marketed in the United States on how they may convert the previous units of measure for certain nutrients to the new units in the updated Nutrition Facts label (81 FR 33742 at 33906-33916 and § 101.9 (21 CFR 101.9)). This guidance document also provides conversion factors that can be used for each of these nutrients and example  calculations for converting to the new units of measure for conventional foods and dietary supplements. Lastly, this guidance document provides information that can help manufacturers understand and comply with relevant labeling requirements.

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 guidance documents means that something is suggested or recommended, but not required.

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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:

Dockets Management
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-2016-D-4484.