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Lack of Oversight Blamed for Hydroxycut, StarCaps Debacles

May 6, 2009 | Parker Waichman LLP

Last week's massive Hydroxycut recall has raised further concerns about the safety of dietary supplements.  According to an editorial in the FASEB Journal, concerns over the safety of such diet aids have prompted recalls and lawsuits in the past.  Unfortunately, current laws prevent the Food & Drug Administration  (FDA) from effectively regulating dietary supplements like Hydroxycut.

According to an FDA safety alert issued last Friday, there have been 23 reports of serious liver problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant, linked to use of Hydroxycut products. In one case, a 19-year-old died as a result of Hydroxycut-associated liver damage. That death occurred in 2007, but was only reported to the agency in March.

The incidents prompted the FDA to order a recall of 14 Hydroxycut supplements, and the agency also warned consumers to stop using them immediately.  

According to the FASEB Journal, the Hydroxycut recall is similar to another issued for StarCaps supplements.    Before they were recalled, StarCaps were advertised as containing a "mix of the digestive enzyme in the papaya and the diuretic qualities in the garlic [that] result in weight loss for users." Advertisements for StarCaps also touted the herbal ingredient,  valerian, as a stress reliever and diuretic.

The StarCaps supplements are the subject of a false advertising class action lawsuit filed by an NFL  football player.  Last year, several NFL players blamed StarCaps supplements when they failed urinary steroid tests and faced four-game suspensions.  According to the players,  the maker  of StarCaps deceptively laced the product with  bumetanide, a diuretic banned by the NFL. According to the FASEB editorial, bumetanide will produce false positives in urine steroid tests.

In addition to failing to mention that StarCaps contained bumetanide, labeling for the supplements  "failed to note that papain is an effective protease that can be absorbed topically, that valerian has proven soporific effects in humans, and that the magnesium salts contained in the capsule affect the gut," the FASEB editorial said.

A month after the StarCaps lawsuit was filed, the FDA ordered the supplements recalled. According to the agency, bumetanide was found in the supplements at levels of 0.8 mg/capsule.  Shortly thereafter, the FDA ordered a recall of 60 weight-loss supplements that were found to contain sibutramine (a centrally acting, serotonin-norepinephrine reuptake inhibitor), rimonabant (a cannabinoid receptor antagonist), phenytoin (better known as dilantin), and phenolphthalein (a pH indicator and laxative, banned in the United States as a carcinogen).

Supplements like Hydroxycut and StarCaps are allowed to endanger the public because the FDA has no authority to order premarket testing of such products.  In fact, according to the FASEB editorial, since 1994,the FDA  has had no effective regulatory authority over dietary supplements, unless they cause harm or are doped with prescription drugs.  Thus, as in the case of Hydroxycut, such products can harm dozens of people before they are removed from the market.

"You don't need to be a pharmacologist to suspect that almost anything that really affects the structure or function of the human body might have an unwanted side effect (a.k.a., toxicity)," the editorial writer  states. "Indeed, a search in PubMed for 'herbal drugs/toxic effects' finds such 460 articles...These range from hepatotoxicity from herbals and weight-loss supplements in the United States to kidney failure as a result of aristolochia, a Chinese herb used worldwide."

The editorial makes a compelling case for more rigorous oversight of dietary supplements, pointing out that "unregulated drugs that have tangible personal and professional consequences that go well beyond anything described on their labels."


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