
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11813-11814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04948]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0544 (formerly 2004D-0487)]


A Dietary Supplement Labeling Guide: Chapter II. Identity 
Statement; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: 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.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.

[[Page 11814]]

     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    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.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION:

I. Background

    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 (Sec.  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 (Sec.  
10.115(g)).

II. Electronic Access

    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


