[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]
Considering the U.S. Food and Drug Administration’s (FDA) record
as a flibbertigibbet on weight-loss product enforcement (dragging its feet on
ephedrine for years while green-lighting dangerous weight-loss drugs on a
dime) — and in light of the FTC’s record of multimillion dollar fines and orders
against makers of supplement weight-loss products — for any company to enter
this arena, either with a proprietary slimming ingredient or with a finished
product, it is a minefield out there. Witness warning letters sent by the FDA to makers of HCG diet products.
Despite (or due to) the
aforementioned spotty record, it is hard to fathom an FDA agency advisory
committee’s recent green light for a combo of phentermine and topiramate
(Qnexa), a diet pill that has, according to the Alliance for Natural Health,
“documented risks of causing birth defects and heart problems.”
Abdominal
Cramps Anyone?
On January 24, 1996, the FDA
approved the synthetic fat-substitute, olestra, for use in snacks. But would
you want a product with this warning? “This Product Contains Olestra. Olestra
may cause abdominal cramping and loose stools. Olestra inhibits the absorption
of some vitamins and other nutrients.”
Anal leakage is most certainly
not on my “hit parade” of things I am looking for in a snack beverage, or any
product for that matter!
According to an update by
Center for Science in the Public Interest (CSPI), “Olestra is a moribund, if
not totally dead, product.” No surprise there.
A few years later, in March
1999, consumer and industry advocates successfully testified on Capitol Hill to
oppose the FDA’s proposal to redefine disease to include life stages and normal
discomforts, such as pregnancy, aging, menopause and headache.
The FTC
Steps Into the Breach
On November 9, 2004, the
Federal Trade Commission (FTC) launched “Operation Big Fat Lie,” what it billed
as “a nation-wide law enforcement sweep against […] companies making false
weight-loss claims in national advertisements.”
According to the FTC at the
time: “Operation Big Fat Lie is the latest in the Commission’s efforts to: stop
deceptive advertising and provide refunds to consumers harmed by unscrupulous
weight-loss advertisers; encourage media outlets not to carry advertisements
containing bogus weight-loss claims; and educate consumers to be on their guard
against companies promising miraculous weight loss without diet or exercise.”
Agreed, although the FDA’s
track record on weight-loss products in all categories has not helped American
consumers very much, either.
Alley-oop!
In 2006, GSK applied to get its
drug (orlistat) — which was said, at the time, by the group Public Citizen, to
have a history of side effects and gastrointestinal problems — re-classified as
an OTC weight loss drug called alli™.
Shades of olestra, Public
Citizen’s objections cited such embarrassing product usage problems as anal
leakage and such serious problems as pre-cancerous lesions. On February 7,
2007, the FDA dismissed the group’s well -argued petition, saying that the
product label already warns people about the messy bowel problems.
As to those pesky pre-cancerous
cellular changes allegedly caused by the drug (called “aberrant crypt foci”),
the FDA said they aren’t of “clinical significance.”
Interesting, because according
to the NIH National Cancer Institute, aberrant crypt foci represent “one of the
earliest changes that can be seen in the colon that may lead to cancer.”
But, then again, FDA’s
approvals were being called into question — institutional arrogance can’t allow
that — and a powerful drug maker’s products were also being questioned.
Still dead set on the
weight-loss market, on April 17, 2008, GSK and groups it funds submitted a
Citizen Petition (FDA-2008-P-0248-0001) calling for the FDA to reclassify all
weight loss support claims for dietary supplements as disease claims.
GSK was joined in this petition
by the American Dietetic Association, the Obesity Society, and Shaping
America’s Health. The organizations’ signatories included a lobbyist, a person
who helped get obesity classified as a disease and a fundraising guru.
In the petition’s summary, GSK
and its co-petitioners stated: “Moreover, the actions requested in this
petition would help address concerns about the safety of weight loss
supplements” and “By requiring weight-loss supplements to undergo pre-market
review, FDA would shift the burden to manufacturers to show that their products
are safe.”
What about the potential safety
problems related to GSK’s alli? This product went through both a prescription
drug and (an albeit cursory) OTC safety review process and it still has a
number of reported concerns associated with it.
Takeaway: Allowing questionable
weight-loss drugs and prohibiting legitimate claims for dietary supplements
that assist people in achieving body composition and weight-loss goals provides
Big Pharma an El Dorado, like the legendary lost city of gold, and cheats
consumers out of safe, effective products while exposing them to unwarranted
risk.
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