[Federal Register Volume 72, Number 38 (Tuesday, February 27, 2007)]
[Notices]
[Pages 8756-8757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3259]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0480]


Draft Guidance for Industry on Complementary and Alternative 
Medicine Products and Their Regulation by the Food and Drug 
Administration; 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availability of a draft guidance for industry entitled ``Complementary 
and Alternative Medicine Products and Their Regulation by the Food and 
Drug Administration.'' In recent years, the practice of complementary 
and alternative medicine (CAM) has increased in the United States, and 
we have seen increased confusion as to whether certain products used in 
CAM are subject to regulation under the Federal Food, Drug, and 
Cosmetic Act (the act) or Public Health Service Act (PHS Act). We have 
also seen an increase in the number of CAM products imported into the 
United States. Therefore, the draft guidance discusses when a CAM 
product is subject to the act or the PHS Act.

DATES: Submit written or electronic comments on the draft guidance by 
April 30, 2007. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research, Food 
and Drug Administration, 1401 Rockville Pike, suite 200N Rockville, MD 
20852-1448. Send one self-addressed adhesive label to assist that 
office in processing your requests. 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draft guidance to the Division of Dockets Management (HFA-305), Food 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 electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy and 
Planning (HF-23), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0587.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Complementary and Alternative Medicine Products and Their 
Regulation by the Food and Drug Administration.'' The term 
``complementary and alternative medicine'' (CAM) encompasses a wide 
array of health care practices, products, and therapies that are 
distinct from practices, products, and therapies used in 
``conventional'' or ``allopathic'' medicine.
    In the United States, the practice of CAM has risen dramatically in 
recent years. In 1992, Congress established the Office of 
Unconventional Therapies, which later became the Office of Alternative 
Medicine (OAM), to explore ``unconventional medical practices.'' In 
1998, OAM became the National Center for Complementary and Alternative 
Medicine (NCCAM). NCCAM is a center within the National Institutes of 
Health. The Institute of Medicine, in its book entitled, Complementary 
and Alternative Medicine in the United States, stated that more than 
one-third of American adults reported using some form of CAM and that 
visits to CAM providers each year exceed those to primary care 
physicians (see Institute of Medicine, Complementary and Alternative 
Medicine in the United States, pages 34 through 35 (2005)).
    As the practice of CAM has increased in the United States, we have 
seen increased confusion as to whether certain products used in CAM 
(which, for convenience, we will refer to as ``CAM products'') are 
subject to regulation under the act or the PHS Act. We have also seen 
an increase in the number of CAM products imported into the United 
States. Therefore, the draft guidance discusses when a CAM product is 
subject to the act or the PHS Act. (When the draft guidance mentions a 
particular CAM therapy, practice, or product, it does so in order to 
provide background information or to serve as an example or 
illustration; any mention of a particular CAM therapy, practice, or 
product should not be construed as expressing FDA's support for or 
endorsement of that particular CAM therapy, practice, or product or, 
unless specified otherwise, as an agency determination that a 
particular product

[[Page 8757]]

is safe and effective for its intended uses or is safe for use.) The 
draft guidance makes the following two fundamental points:
    <bullet> First, depending on the CAM therapy or practice, a product 
used in a CAM therapy or practice may be subject to regulation as a 
biological product, cosmetic, drug, device, or food (including food 
additives and dietary supplements) under the act or the PHS Act.
    <bullet> Second, neither the act nor the PHS Act exempts CAM 
products from regulation.
    This draft guidance is being issued 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 
regulation of complementary and alternative medicine products by FDA. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative 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) written or electronic comments regarding this document. 
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 document at 
http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: December 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3259 Filed 2-26-07; 8:45 am]
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