Note: FDA's proposal here is dangerous and outrageous! This is part of the
ongoing effort to turn Foods into "Drugs". Beginning next week when FDA
publishes their proposed rule in the Federal Register, we will have 120
days to submit comments opposing this proposed rule which threatens to
usher in an unlevel playing field that will wipe out small companies. If a
claim is TRUE about a product ALL companies should have the right to say
so, not just the pharmaceutical companies that are members of the European
American Phytomedicines Coalition: Bioforce,(Netherlands, Swizerland, USA),
Boerhinger Ingleheim,(Germany), Indena,(Italy), Institut Henry Beaufour
(France),Lichtwer Pharma (Germany, USA), Murdock-Madaus-Schwabe
(Germany-US),Pharmaton (Switzerland), R.P.Sherer(UK), Sunsource Health
Products (USA). Ron Birckhead reports from Norway that this is the same
pattern used in Norway to destroy health freedom there.

Downloaded from http://www.fda.gov/bbs/topics/NEWS/NEW00637.html
 

HHS NEWS

U.S. Department of Health and Human Services
 

P98-15                        FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE         Print Media:       301-827-6242
April 24, 1998                Broadcast Media:   301-827-3434
                              Consumer Inquires: 800-532-4440

     FDA PROPOSES RULES TO MAKE CLAIMS FOR DIETARY SUPPLEMENTS MORE
                               INFORMATIVE, RELIABLE AND UNIFORM

In response to recommendations made by the Commission on Dietary Supplement
Labels, the Food and Drug Administration today proposed rules to give
consumers better information about dietary supplements by making the
labeling of these products more reliable and uniform. The proposal, which
defines certain permitted and prohibited types of labeling claims for
dietary supplements, will not affect the availability of these products or
consumers' access to them.

In addition to the new proposal, the FDA today is also responding to the
report of the Commission on Dietary Supplement Labels. (Separate fact
sheets on the new proposal and the response to the Commission report are
attached.) The Commission was an independent panel of experts mandated by
the Dietary Supplement Health and Education Act of 1994 (DSHEA) and
appointed by President Clinton to study and make recommendations on the
regulation of label claims and statements for dietary supplements,
including procedures for evaluation of such claims.

Under DSHEA, dietary supplements may carry "structure/function" claims --
claims that a product may affect the structure or functioning of the body
-- but not claims that they can treat, diagnose, cure or prevent a disease.

Today's proposal defines the criteria for the structure/function claims
that DSHEA permits and the disease claims that it prohibits, and provides
examples for both categories.

The law allows, without FDA's authorization, claims that are truthful and
not misleading about the effect of a dietary supplement on the structure or
function of the body for maintenance of good health and nutrition. Under
the proposal, such permissible structure/function claims can state, for
example, that the product "promotes regularity," "helps maintain
cardiovascular health," or "supports the immune system."

The proposal also identifies many types of so-called "disease claims" that
are prohibited under DSHEA. In general, these claims state or imply
benefits for a disease, which the proposal in part defines as any deviation
from, impairment of, or interruption of the normal structure or function of
any part, organ, or system of the body that is manifested by a
characteristic set of signs or symptoms. Under the proposal, dietary
supplements that expressly or implicitly claim to diagnose, treat, prevent
or cure a disease continue to be regarded as drugs, and have to meet the
safety and effectiveness standards for drugs under the Food Drug and
Cosmetic Act(FDCA). Examples of such prohibited disease claims for a
dietary supplement include "protects against cancer," "treats hot flashes,"
and "reduces nausea associated with chemotherapy."

The proposal also describes various means -- such as product names,
vignettes, graphics and citations -- by which a dietary supplement could
make or imply a disease claim prohibited under DSHEA.

"Consumers want access to dietary supplements, but also need reliable
information about the products they are consuming," said William Schultz,
FDA's Deputy Commissioner for Policy. "By clarifying for manufactures what
types of claims can and cannot be made on a dietary supplement label, this
new proposal helps consumers make more informed and wiser choices."

Today's proposal and FDA's response to the Commission's report will be
published next week in the Federal Register. The agency welcomes written
comments and recommendations on the proposed criteria and other aspects of
the proposal, and will accept such communication for the next 120 days. The
agency willalso accept written comments on its response to the Commission
on Dietary Supplement Labels. All comments should be addressed to:

   Dockets Management Branch (HFS-456)
   Food and Drug Administration
   12420 Parklawn Dr., Room 1-23
   Rockville, MD 20857

####
 
 
 

******************************************
Donations Needed- Need Help to Keep Helper On
International Advocates for Health Freedom
John C. Hammell, Legislative Advocate
2411 Monroe St. Hollywood, FL 33020 USA
800-333-2553, 954-929-2905, FAX 954-929-0507,
jham@iahf.com    http://www.iahf.com
HERBS ARE _NOT_ DRUGS! HELP PASS HR 2868
THE CONSUMER HEALTH FREE SPEECH ACT!!!