Or maybe this should
be titled, “The FTC goes where the FDA cannot.”
This month the Federal Trade Commission announced
penalties and refunds levied against several companies selling diet aids for
false advertising. They claimed that
there was insufficient scientific proof that these products, including Sensa,
L’Occitane skin cream and HCG Diet Direct actually benefited consumers in terms
of weight loss. The implication is that in order to advertise health benefits
for “supplements” or any other commodity, the sponsor would have to demonstrate
“scientific proof” of efficacy. The question
is, what constitutes scientific proof?
Does it have to be randomized double blind trials as the FDA
requires. The answer may be a resounding
“yes!”
If all of this is true, then how come these products are not
regulated by the FDA who actually have the expertise to evaluate whether or not
they have achieved proof of efficacy or not?
Well, because these products are not considered drugs and therefore,
according to congress and the laws of the land, do not fall under the aegis of
the FDA even if they claim drug like properties or effects from such
products. Personally, I think any
product making a health claim should fall under the FDA for approval to market
based on such claims. Under the Dietary Supplement Health and Education Act
(DSHEA) of 1994, the
sponsor is responsible for ensuring that the product is safe prior to
marketing. Apparently, there is no
requirement that the product actually provide any benefit whatsoever. The FDA
can only intervene if there is reason to believe that the product is unsafe
after it has been placed on the market. Does anyone (besides supplement
manufacturers) believe that this makes any sense at all? It is clear that the majority of the time
being spent by the FDA office of investigation is focused on bogus and unsafe
supplements with undeclared additives, unlabeled ingredients and other problems
all putting the health of Americans at risk.
Why do I, an
infectious diseases physician, care about this topic? Just do a Google search on the term
antibacterial supplements and you will see.
There are myriad products out there from garlic to grape seeds to St.
John’s Wort that are claimed to provide beneficial effects for infections
sometimes when applied topically – but more importantly, when ingested. The data to support these claims, for the
most part, do not come up to any standard of proof recognized by any
sophisticated physician or scientist. For bacterial infections in particular,
the ingestion of these so called cures could delay appropriate antibiotic
therapy and lead to more severe illness and even death. But these claims are
being allowed to stand as is on the internet, in newspapers and in health food
stores.
It is time for
congress either to give the FDA the power to protect us from these patently
false claims of effectiveness or for the FTC to come to our rescue and prevent
these manufacturers from continuing to bamboozle the American public. This is a potentially dangerous practice that
should be stopped immediately.
What is wrong with
us?
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