Congressional Committee on Energy and Commerce comes out swinging against
Diet Drugs targeted to Children, FDA Loopholes used to market Illegal
Steroids
STRAFFORD [drugINTEL] - 3 Apr 2003 - The Committee on Energy and Commerce
showed no signs of political stupor or regulatory catharsis as it stepped up
to take on some of the endemic problems that FTC and FDA have been helpless
to deal with. Targeting nutraceuticals touted as Diet Drugs, the Committee
on Energy and Commerce has demanded documentation of ingredients and
clinical demonstration of safety and efficacy that vendors breezily contend
is overwhelming but is never cited.
Members of the Committee on Energy and Commerce requested FDA Commissioner
Mark McClellan and the Drug Enforcement Agency to investigate and close
loopholes allowing banned steroids to get on the market without needing to
obtain FDA approval. Steroid precursors and pro-drugs that will form
testosterone-related Illegal Steroids in the body are being sold by
companies that were not named in the letters for obvious reasons.
Skinny Pill flouts Congressional Committee on Energy and Commerce Requests
Skinny Pill (see Website) is a name of a company (possibly identical to the
Fountain of Youth Group LLC) in Ponte Vedra Beach, Florida, whose president
is Edita Kaye. This pill contains a number of mostly diuretic herbal
components including Uva ursi, juniper berry, and buchu leaf. Uva ursi is
contraindicated in the PDR for children under 12. All cause the body to
lose water. Dr. Alison Hoppin, chief of the pediatric obesity clinic at
Massachusetts General Hospital, said "Diuretics in children can cause kidney
problems and electrolyte imbalances if taken long term." Diuretics are
likely to show an artefactual weight loss due to decrease in the amount of
water in the body, thus showing immediate changes on the bathroom scale.
"It's absolutely outrageous; "It's not going to help people lose weight.
It's junk science," added Keith Ayoob, a pediatric nutritionist and an
American Dietetic Association spokesman.
Daniel Mowrey, affiliated with competitor Klein-Becker (possibly identical
to Basic Research, both of Provo, Utah - a question Congress wants
clarified) makers/distributors of diet drug Anorex (See drugINTEL News 27
Jan 2003) states "On her website Kaye claims that her 'Skinny Pill for Kids'
is a 'safe, effective weight loss formula for children ages 6 -12'.
However, a review of the National Institutes of Health (NIH) / National
Library of Medicine database (PubMed) reveals not one single published
clinical trial that has been conducted with anything called the 'Skinny Pill
for Kids' or the combination and amount of active ingredients that make up
the formula related to weight loss in children ages 6 to 12."
Klein-Becker receives Congressional Request to put cards on the table
The Klein-Becker / Basic Research criticism is apparently a case of the
kettle calling the pot black, perhaps because of its competing product,
PediaLean, containing an unidentified product "Pediatropin" derived from the
P. rivieri root - all shrouded in mystery and scientific-sounding hype. A
letter from the Committee on Energy and Commerce points out the deceptive
nature of PediaLean advertising and notes the lack of safety or efficacy
data. We found no genus to correlate with "P." rivieri, but the plant in
question may be Amorphophallus rivieri also known as Konjac Root.
One of the supporters of PediaLean is Nathalie Chevreau, member of the
Scientific Advisory Board of Supplement Watch. Opinion: Caution is
necessary in weighing the endorsements of "Supplement Watch". A random
sampling of the reviews on Nutraceuticals revealed that some valid
criticisms were given where appropriate, although it is far from rigorous or
comprehensive - for instance, the very important induction of cytochrome
oxidases by St. John's wort is not noted, and warnings concerning Ripped
Fuel and Ephedra are understated. Despite the HON affiliation, source
literature is rarely cited. At least one member of Supplement Watch is
listed with a university affiliation, but it turns out that he was only a
postdoctoral student at the university. Many of the members do not hold
doctorates. Supplement Watch is "internally financed".
You can make a complaint to the FDA regarding Supplements at the link below
www.fda.gov/oc/buyonline/buyonlineform.htm
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