[Federal Register Volume 79, Number 9 (Tuesday, January 14, 2014)]
[Notices]
[Pages 2450-2451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00500]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0542]
Guidance for Industry: Considerations Regarding Substances Added
to Foods, Including Beverages and Dietary Supplements; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry entitled ``Guidance for
Industry: Considerations Regarding Substances Added to Foods, Including
Beverages and Dietary Supplements.'' This guidance is intended to
remind manufacturers and distributors of conventional foods about the
requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
regarding substances added to
[[Page 2451]]
conventional foods, including beverages. This guidance also is intended
to remind dietary supplement manufacturers and distributors that the
same requirements apply to certain substances that are added to dietary
supplements; namely, those that are not dietary ingredients as defined
in the FD&C Act.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Food Additive Safety, Center for Food Safety and Applied
Nutrition (HFS-200), 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.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Negash Belay, Center for Food Safety
and Applied Nutrition (HFS-255), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-1200.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance entitled
``Guidance for Industry: Considerations Regarding Substances Added to
Foods, Including Beverages and Dietary Supplements.'' This guidance is
being issued consistent with our good guidance practices regulation (21
CFR 10.115). The guidance represents our current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternate approach may
be used if such approach satisfies the requirements of the applicable
statutes and regulations.
In the Federal Register of December 4, 2009 (74 FR 63759), we made
available a draft guidance entitled ``Draft Guidance for Industry:
Factors That Distinguish Liquid Dietary Supplements From Beverages,
Considerations Regarding Novel Ingredients, and Labeling for Beverages
and Other Conventional Foods'' (draft guidance) and gave interested
parties an opportunity to submit comments by February 2, 2010, for us
to consider before beginning work on the final version of the guidance.
Elsewhere in this issue of the Federal Register, we announce the
availability of the final guidance, now entitled ``Guidance for
Industry: Distinguishing Liquid Dietary Supplements From Beverages.''
The draft guidance included a section entitled ``Ingredients in
Beverages and Other Conventional Foods are Subject to the Federal Food,
Drug, and Cosmetic Act's Requirements for Substances Added to Food''
(ingredients section). The ingredients section of the draft guidance
described the general requirements of the FD&C Act regarding substances
added to beverages and other conventional foods. We received several
comments on the draft guidance and have modified the final guidance
entitled ``Guidance for Industry: Distinguishing Liquid Dietary
Supplements From Beverages'' where appropriate. The modifications to
the final guidance entitled ``Guidance for Industry: Distinguishing
Liquid Dietary Supplements From Beverages'' include a modified version
of the ingredients section, which refers to the separate guidance that
is the subject of this document.
The guidance that is the subject of this document derives from the
ingredients section of the draft guidance. It is intended to remind
manufacturers and distributors of conventional foods about the
requirements of the FD&C Act regarding substances added to conventional
foods, including beverages. This guidance also is intended to remind
dietary supplement manufacturers and distributors that the same
requirements apply to certain substances that are added to dietary
supplements; namely, those that are not dietary ingredients as defined
in section 201(ff)(1) of the FD&C Act (21 U.S.C. 321(ff)(1)). We are
issuing this separate guidance, in addition to referring to it within
the guidance entitled ``Guidance for Industry: Distinguishing Liquid
Dietary Supplements From Beverages,'' to make it more prominent and
improve its accessibility to manufacturers and distributors who look
for guidance on the requirements of the FD&C Act regarding substances
added to conventional foods, including beverages. Although we met the
procedural requirements for issuing Level 1 final guidance by making
the draft guidance available for comment, we are issuing this final
guidance as Level 2 guidance under 21 CFR 10.115(g)(4) because it
merely summarizes long-established requirements in the FD&C Act and
regulations without setting forth any new interpretations of those
requirements (see 21 CFR 10.115(c)(1) to (c)(2)).
II. Comments
Interested persons may submit either electronic comments regarding
the guidance to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/FoodGuidances 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: January 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00500 Filed 1-13-14; 8:45 am]
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