Tuesday, April 17, 2007

Food and Drug Administration
[Docket No. 2006D-0480]

[Federal Register: February 27, 2007 (Volume 72, Number 38)]
[Notices]
[Page 8756-8757]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe07-95]
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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Draft Guidance for Industry on Complementary and Alternative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availability of a draft guidance for industry entitled ``Complementary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 Therefore, the draft guidance discusses when a CAM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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft guidance to the: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draft guidance to the: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://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access to the draft guidance document.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,

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

Source: FDA WEBSITE http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm

1 comment:

Research Group said...

Advanced Health Focuses on Scientific Health

FOR IMMEDIATE RELEASE:
Source: Vickie Barker
April 17, 2007

(PR) – ASH, an acronym for Advanced Scientific Health, researches
studies of Nobel prize winning scientists. It focuses on research that is
hidden in labs and scientific journals. ASH was started as the search of
one man who was slated for his fourth heart bypass. He decided to walk
out the doctor's office in spite of dire warnings that he would not survive.
He began to research studies from Nobel Prize winning scientists such
as Linus Pauling. The research developed into an understanding of what
makes the body tick and what was required as a foundation for the
body to survive and thrive. Others joined him. Some joined due to
challenges with cancer. Others joined due to challenges with fibromyalgia,
headaches, allergies, or diabetes.

The unique factor about ASH and its army of researchers is that they
have learned to become their own food and drug inspectors. The group
has also developed a simple and basic education program that allows
both health care professionals and families learn how the body works
at the cellular level. Based on the indisputable facts coming from the
scientific health care community they provide an education vehicle that
has never before been available.

The ASH program includes twice weekly Live Lecture calls that are open
to anyone desiring to learn more. Researchers can e-mail their questions
to be answered on the next available Live Lecture. Each researcher
receives a personal research website with access to the protocols
recommended by the Nobelists at Lab Cost to further their independent
research. These formulations are high quality, and the individual
components work together. The sum of the whole is greater than
that of the individual parts.

With today's costs of Cancer, Diabetes, Heart Disease and other
so called "incurable disease" research reaching the BILLIONS
of dollars, this group has found a way to research, apply and enjoy
good health for a minimal monthly cost. The big difference is, they have
found the natural cure for all "disease" and it is the human body itself.

"We just found out how the body works at the molecular level, applied the
knowledge from the insider doctors and scientists and are here to share it
with you and to make it available for the generations to come" says Barney
Folger, a founder of ASH.

To provide more information on health at the cellular level and an option for
others, a group of independent researchers are making available a Free
Elemental Health Research Guide at http://www.AdvancedHealthPlan.com .

Anyone suffering with illness and disease would be wise to look at all
options available. You can prevent needless pain, suffering and great
expense by becoming your own independent researcher. The days of
high cost medical bills, dangerous chemical drugs and invasive and
irreversible surgeries are over for those that are willing to learn Autology
(Study Thyself).

To find out more about ASH, how your body works at the molecular level and to join this group of researchers, simply visit the research site at: ADVANCED HEALTH PLAN http://www.ashnow.com/healthplan