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http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm
From the Federal Register Online via GPO Access
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry on Complementary and Alternative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availability of a draft guidance for industry entitled ``Complementary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 Therefore, the draft guidance discusses when a CAM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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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draft guidance to the Division of Dockets Management (HFA-305), Food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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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access to the draft guidance document.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FDA is announcing the availability of a draft guidance for industry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:
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.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
Dated: December 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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