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FDA must continue crack-down on unapproved drugs being marketed as “dietary supplements”

Just a few months after the New York Times surprised many Americans with a report on dangerous, unapproved heart medications being prescribed and sold to patients by the million right here in the United States, additional safety issues have surfaced in publications like the Chicago Tribune and the Sun Sentinel concerning other unapproved drugs that are currently being sold to Americans.

The reports are on a children’s autism drug which, according to the FDA, lacks proper warnings to alert parents to potential side effects including “abnormalities of the pancreas,” and an array of supplements manufactured by “Atlas Operations,” which the FDA says make “misleading claims” and are produced under unsanitary conditions.

Boyd Haley, the maker of OSR#1, is trying to sell his autism therapy product as a dietary supplement, a categorization that would not legally obligate Haley to subject his product to the FDA’s rigorous testing process. But the FDA said in their warning letter sent to Haley that OSR#1 “does does not qualify as a dietary supplement” and therefore must undergo FDA approval. In addition, the FDA says OSR#1’s labeling “lacks adequate warnings for the protection of users” and lists a bevy of potential adverse side effects that could be experienced by patients as a result of the drug’s use.

Atlas Operations is also attempting to pass off their unapproved drugs as dietary supplements. These include sexual aids, sleeping pills and body building products. But according to the FDA’s warning letter sent to the company, some of those products pose “serious health risks” and contain “false and misleading labels.” Not only that, these products were “prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations for dietary supplements,” problems that the manufacturer had already been alerted to by the FDA in 2009.

The examples of OSR#1 and Atlas Operations’ unapproved products go a long way to show the substandard conditions under which many unapproved drugs are made, and the woefully insufficient testing that they often undergo before being sold to patients—if tested at all.  There is simply no reason why patients should be put at risk of suffering adverse reactions to unapproved drugs when approved drugs are available.

Hopefully the publication of stories like these will remind the FDA and others of the dangers often posed by unapproved drugs, which make up over 2% of prescription drugs on the marketplace today and have been associated with hundreds of deaths.  We must encourage the FDA to continue acting on its Unapproved Drugs Initiative, which was announced in 2006 and calls for the removal of unapproved drugs from the market.  Only then will the patients of America be able to visit their pharmacies knowing that FDA has done all it can do to make America’s pharmacies as safe as possible for consumers.


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