[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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