Edited: June 02, 2004 07:11
Legal Health Claims
The statement of denial that occurs on every page of supplement advertising is
the disclaimer. It is now required and will soon be on every supplement label.
The required FDA disclaimer:
"The statements herein have not been evaluated by the
Food and Drug Administration. These
products are not
intended to diagnose, treat, cure or prevent disease."
THINK on this last sentence -- so what exactly are health
food supplements intended for when you take them?
Only in America could there be a huge segment of industry making and selling
products that most everyone wants (and NEEDS) yet, by law, they really can have little to
say about those products. Of course, only in America can there be open discussion
and debate about how the people are regulated and, we believe, the only place where change
can come "quickly" enough to benefit healthy change in time for one to realize a
longer and healthier lifestyle.
The Nutrition FarmŽ manufactures and sells its own brands as well as doing private label manufacturing for other companies. As the
originator and responsible designer of all labels and product information, we have to be
very careful to not represent any product illegally by making or implying disallowed health claims.
Both the United States Food and Drug Administration (FDA) and
Federal Trade Commission (FTC) regulate all product labeling content of supplements.
The Dietary Supplement Health and
Education Act of 1994 (DSHEA) made it is the responsibility of the manufacturer (or
private label product distributor) to carry the burden of proof for any health
claims. However, the only health
claims that are allowed have already been designated by the FDA and are very few in
number. If a supplement should be proven to have a health claim, then FDA attempts
to make it a drug which necessitates requirements that the supplement now go through the
FDA drug regulatory procedures -- a very expensive and lengthy process.
Supplement labeling content is the regulated medium. Labeling refers to ALL
material that is written on the supplement, including bottle label, advertising,
pamphlets, fliers, internet web pages and even verbal discussion between us and the
customer. NO UN-ALLOWED HEALTH
CLAIM can be made at any time.
Therefore, we can make no health claims even though we have numerous case
histories for beneficial health effects for prevention and/or treatment of various
diseases. This places us in a an awkward position -- we need to educate the
consumers as much as possible about the products they are taking, yet we cannot give them
the information that they really require. Also, we believe that the lack of
providing truthful information is a miscarriage of justice when related to decreasing the
ability of the health-conscious consumer to obtain useful treatment or prevention of
disease.
We know of no nutritional supplement company (not to say that the
unscrupulous are not out there) that intentionally sells a health product
that does not benefit the consumers health or well-being. That is why we call them
"health food supplements" -- because they affect your health. Yet, FDA
wants them regulated (by themselves) and FTC wants truthful advertising. We agree on
truthful advertising and safety, and we welcome the upcoming FDA jurisdiction over
manufacturing (cGMPs).
The Nutrition FarmŽ stands behind all of its products (see our guarantee) and we try very hard to inform the public about
supplements and their use without making specific health claims. We let others make
the claims and hope you will then come to us to buy your products at the best quality and
price.
We encourage you to communicate with your congress people and let them know how
important it is that you have the freedom of choice when it comes to
deciding your own disease treatment and prevention mechanisms. This freedom of
choice has to be accompanied with truthful and not misleading information about the
supplements (or mechanisms) that you have chosen to help you live better and longer.
FDA-allowed health claims:
Folic Acid -- prevents birth defects, primarily spina bifida.
Calcium -- treats and prevents osteoporosis.
What about vitamin C?
Well, the orange juice trade association can make some claim to
cancer (as long as it is taken with the proper diet of mass quantities of fruits,
vegetables and fiber). Their association has, so far, taken the expensive steps to
petition the FDA and make a claim that FDA has, so far, chosen not to fight -- probably
because orange juice has so little vitamin C in it when compared to a dietary supplement.
Besides, pharmaceutical companies are not threatened by the orange juice makers.
And, FDA can not argue very well against fruits, vegetables and fiber being
healthy.
You have heard or read others. Do not think that they get away with it
just because you read or hear it. FDA and FTC are very busy trying to keep up with
the mass amount of misinformation in advertising (labeling). Naturally they spend
their valuable time and resources on those that make the really unhealthy and detrimental
claims.
It is all a matter of science and FDA (and FTC backed by FDA) debating health
through nutrition and statistics. This is such a mind-boggling issue and, if you pay
attention to the news, filled with contradictory studies. Whenever you hear of a
study "conclusion", think about the investigating team's agenda. Are they
pharmaceutical-funded scientists, nutrition-oriented doctors, or someone just wanting to
refresh their research grant budget. Have you ever heard any investigator NOT
say at the conclusion of their research paper "but this subject still needs further
investigation, research and study"? And the debate (and taxpayer funding) goes
on and on and on . . .
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