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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled “A Dietary Supplement Labeling Guide: Chapter II. Identity Statement.” This guidance is part of a longer guidance entitled “A Dietary Supplement Labeling Guide,” which covers the most frequently raised questions about the labeling of dietary supplements using a question and answer format and is intended to help ensure that the dietary supplements sold in the United States are properly labeled. We are revising the guidance to correct an inaccurate statement.
Submit either electronic or written comments on FDA guidances at any time.
You may submit comments as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2004-D-0544 (formerly 2004D-0487) for “A Dietary Supplement Labeling Guide: Chapter II. Identity Statement: Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the guidance to the Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.
Cara Welch, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2375.
We are announcing the availability of a revised guidance for industry entitled “A Dietary Supplement Labeling Guide: Chapter II. Identity Statement.” We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 CFR 10.115). As with all FDA guidance, the guidance represents our current thinking on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
In April 2005, we issued a guidance for industry entitled “A Dietary Supplement Labeling Guide.” The guidance covers the most frequently raised questions about the labeling of dietary supplements using a question and answer format and is intended to help ensure that the dietary supplements sold in the United States are properly labeled. We recently were made aware that the guidance was inaccurate in one detail. Specifically, in Chapter II, entitled “Identity Statement,” question 3 asked “Can the term ‘dietary supplement’ by itself be considered the statement of identity?” The response to the question said that it could not, but this response was not consistent with section 403(s)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(s)(2)(B)) and our regulations at 21 CFR 101.3(g). Thus, we are revising the guidance to state that the term “dietary supplement” may be used as the entire statement of identity for a dietary supplement and to explain the basis for that conclusion. We are also revising questions 1, 2, and 3 for clarity and consistency with 21 CFR 101.3(g) and FDA's guidance on statements of identity for conventional foods in “A Food Labeling Guide: Guidance for Industry” (available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm). The guidance announced in this notice revises the guidance dated April 2005.
This guidance is being implemented without prior public comment because the Agency has determined that such prior public participation is not feasible or appropriate (§ 10.115(g)(2)). The Agency made this determination because this guidance's primary revision of the existing guidance merely corrects an inaccurate statement to make the guidance consistent with the FD&C Act and FDA's regulations, and it would be inappropriate to solicit comment on whether or not a guidance should be consistent with requirements set forth in the statute and regulations. The guidance also contains other clarifying edits to existing guidance that do not set forth initial or changed interpretations of statutory or regulatory requirements. Although this guidance document is being implemented immediately, it remains subject to comment in accordance with the Agency's GGP regulation (§ 10.115(g)).
Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04948 Filed 3-4-16; 8:45 am]
BILLING CODE 4164-01-P