[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-P