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 http://www.fda.gov/oc/buyonline/buyonlineform.htm
