[Federal Register Volume 74, Number 232 (Friday, December 4, 2009)]
[Notices]
[Page 63759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28926]
[[Page 63759]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0542]
Draft Guidance for Industry: Factors That Distinguish Liquid
Dietary Supplements From Beverages, Considerations Regarding Novel
Ingredients, and Labeling for Beverages and Other Conventional Foods;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Factors that Distinguish Liquid Dietary Supplements from Beverages,
Considerations Regarding Novel Ingredients, and Labeling for Beverages
and Other Conventional Foods.'' The draft guidance describes factors
that can be used to identify liquid products that are excluded from
being dietary supplements because they are represented as conventional
foods. Further, the draft guidance reminds manufacturers and
distributors of beverages and other conventional foods, particularly
those that contain novel ingredients, about the requirements of the
Federal Food, Drug, and Cosmetic Act (the act) regarding ingredients
and labeling.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
the draft guidance before it begins work on the final version of the
guidance, submit electronic or written comments on the draft guidance
by February 2, 2010.
ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to the
Office of Nutrition, Labeling, and Dietary Supplements, Center for Food
Safety and Applied Nutrition (HFS-800), 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: Robert Moore, Center for Food Safety
and Applied Nutrition (HFS-810), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-2375.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Guidance for Industry: Factors that Distinguish Liquid Dietary
Supplements from Beverages, Considerations Regarding Novel Ingredients,
and Labeling for Beverages and Other Conventional Foods.'' The draft
guidance is intended to assist dietary supplement and beverage
manufacturers and distributors in reaching a determination as to
whether a liquid product may be labeled and marketed as a dietary
supplement. The draft guidance describes factors that manufacturers and
distributors can use to identify liquid products that are excluded from
being dietary supplements because they are represented as conventional
foods. Further, the draft guidance reminds manufacturers and
distributors of beverages and other conventional foods, particularly
those that contain novel ingredients, about the requirements of the act
regarding ingredients and labeling.
FDA is issuing this draft guidance as Level 1 guidance consistent
with FDA's good guidance practices regulation (21 CFR 10.115). The
draft guidance, when finalized, will represent the agency's current
thinking on the topics discussed. 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.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding the draft
guidance. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified 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.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at http://www.fda.gov/FoodGuidances or http://www.regulations.gov.
Dated: November 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28926 Filed 12-3-09; 8:45 am]
BILLING CODE 4160-01-S