FDA keeps heat on adulterated supplements

FDA keeps heat on adulterated supplements

Even without Joshua Sharfstein as its deputy commissioner, the agency remains focused on the consumer safety threat created by adulterated weight-loss, bodybuilding and sexual enhancement products.

In an apparent effort to keep the issue of undeclared pharmaceutical ingredients in some “dietary supplements” on the front burner, the U.S. Food and Drug Administration (FDA) issued another consumer warning about adulterated products masquerading as supplements on March 15. The warning linked to FDA’s website, which details the potential dangers of adulterated products in the weight loss, bodybuilding and sexual enhancement categories.

“I don’t know if there’s anything new there. I know it’s an ongoing concern,” said John Endres, chief scientific officer of Seattle-based scientific and regulatory consultancy AIBMR.

Under former FDA Deputy Commissioner Joshua Sharfstein, MD, the agency—working with the leading U.S. supplement trade associations—stepped up its efforts to remove adulterated supplements from the market. But Sharfstein’s departure from the FDA earlier this year had some in the industry wondering whether the agency would turn its attention away from this issue, which threatens consumer safety and the credibility of the many legitimate companies selling dietary supplements in the United States.

This latest warning to consumers demonstrates that the issue remains on the FDA’s radar. The agency’s website says it has found nearly 300 fraudulent products—promoted mainly for weight loss, sexual enhancement, and bodybuilding—that contain hidden or deceptively labeled ingredients.

Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance, is quoted on the site as saying, “These products are masquerading as dietary supplements—they may look like dietary supplements but they are not legal dietary supplements. Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous.”

Adulterant list keeps growing

The main hidden pharmaceutical ingredients are analog versions of sildenafil (Viagra) in the sexual enhancement products, versions of diet drug sibutramine in the weight loss category, and various steroids and versions of prescription stimulants in the bodybuilding category.

These are merely the best-known adulterants, however. Many others may exist, and until odd spikes show up on test readouts and the substances corresponding to those spikes are identified, it’s hard to say what the new adulterants might be.

“The list keeps growing,” Endres said. “Some of the companies I’m aware of test for more than 200 pharmaceutical ingredients.”

Some of these drugs, in particular the Viagra knockoffs, can have serious interactions with other pharmaceuticals a consumer might be taking, such as blood pressure medications.  Without knowing the ingredient is in a given adulterated product in the first place and with no information about dosage level, it is impossible to use these products with a margin of safety.  It’s also hard to know how many users might have been harmed by these products, nor what the size of the market is.  How many men, for example, would want it publicly known that they are using a product called Stiff Nights?

Industry delves into adulteration issue

Two education sessions held at last week’s Natural Products Expo West/Engredea tradeshow focused on the issue of supplement adulteration.  One panel session looked at what responsibility retailers have to protect consumers from these products, while the second session looked at the issue from the suppliers’ point of view.

One of the panelists’ recommendations for retailers applies equally to consumers: Buy your products from “normal” distribution channels. For retailers, that would translate to dealing only with trusted distributors. For consumers: A brick-and-mortar store, one of the major MLM distributors, or a trusted online seller with a history of transparency and good performance.

The Internet has unfortunately become the favored sales channel for fly-by-night criminals.  E-commerce companies have taken the old world of mail order scams and infused it with a new level of speed and stealth, making it ever easier for these shysters to stay one step ahead of regulators.  A website, a warehouse and a relationship with a shipper are all that is needed to flood the market with adulterated products.

Such was the case with a company called International Pharmaceuticals (IP), busted by German authorities on Sept. 29, 2010.  IP produced steroids and other banned substances in India, stored them in a warehouse in a sleepy village in the German state of Hesse and from there distributed them to athletes all over the world. 

For more than twenty years IP had been a legendary brand on chat sites for strength athletes and others seeking that “extra boost;” but until the bust, no one knew where IP was located nor who was behind the operation.  In the bust, authorities seized more than 5 million pills, ampules and capsules worth an estimated $13.6 million, and that was just the stock on hand.  It’s a fair bet that hundreds of millions of dollars worth of illegal substances passed through the village of Nidda-Wallernhausen, which until now had been known only for its puppet theater.

The marketers of illegal drugs masquerading as dietary supplements can operate with similar chutzpah. Some of the adulterated products are coming out of China, but it’s only the easy answer to put up Chinese manufacturers as the bogeymen.  Industry sources indicate that many of the steroids being added to bodybuilding products appear to be of U.S. manufacture, but as the IP case shows, they can come from anywhere.  More so than ever, for consumers purchasing products in one of these categories it’s a case of caveat emptor – buyer beware. 

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