[Federal Register Volume 79, Number 9 (Tuesday, January 14, 2014)]
[Notices]
[Pages 2451-2452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00498]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0542]


Guidance for Industry: Distinguishing Liquid Dietary Supplements 
From Beverages; 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 ``Distinguishing 
Liquid Dietary Supplements From Beverages.'' This guidance is intended 
to help dietary supplement and beverage manufacturers and distributors 
determine whether a product in liquid form is properly classified as a 
dietary supplement or as a beverage. This guidance describes the 
factors that distinguish liquid products that are dietary supplements 
from those that are conventional foods. Further, this guidance reminds 
manufacturers and distributors of dietary supplements and beverages 
about the requirements of the Federal Food, Drug, and Cosmetic

[[Page 2452]]

Act (the FD&C Act) regarding ingredients and labeling.

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 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, or 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 those offices 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: Corey J. Hilmas, 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 guidance entitled 
``Guidance for Industry: Distinguishing Liquid Dietary Supplements From 
Beverages.'' 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'' 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. The 
guidance is intended to help dietary supplement and beverage 
manufacturers and distributors determine whether a product in liquid 
form is properly classified as a dietary supplement or as a beverage.
    We have observed an increase in the marketing of liquid products 
with a wide array of ingredients and intended uses. Some of these 
products are marketed as dietary supplements, and others as 
conventional foods. In some instances, products may be misbranded 
because their labeling or other representations made about them are 
inconsistent with the product category under which they are being 
marketed. In addition, products may be excluded from the dietary 
supplement category because of representations that they are for use as 
conventional foods. The guidance is intended to describe the factors 
that dietary supplement and beverage manufacturers and distributors 
should consider when deciding whether to market a liquid product as a 
dietary supplement or a conventional food. Further, this guidance 
reminds manufacturers and distributors of dietary supplements and 
beverages about the requirements of the FD&C Act regarding ingredients 
and labeling.
    We received several comments on the draft guidance and have 
modified the final guidance where appropriate. In addition, we made 
editorial changes to improve clarity. The guidance announced in this 
notice finalizes the draft guidance dated December 2009.

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. 2014-00498 Filed 1-13-14; 8:45 am]
BILLING CODE 4160-01-P