[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Draft Guidance for Industry: Factors That Distinguish Liquid 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availability of a draft guidance entitled ``Guidance for Industry: 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 The draft guidance describes factors 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 Further, the draft guidance reminds manufacturers and 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the draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 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ADDRESSES:  Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 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Submit written requests for single copies of the draft guidance to the 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