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FDA warns dietary supplement makers to police themselves on drugs in products

By David Brown
Washington Post Staff Writer
Wednesday, December 15, 2010; 11:17 PM

The Food and Drug Administration warned makers and distributors of dietary supplements Wednesday that it is coming after hundreds of products that contain drugs, or compounds acting as drugs.

The illegal supplements generally fall into three categories - weight-loss agents, bodybuilding products and "sexual enhancers." Many contain known pharmaceuticals or similar chemicals whose precise effects in human beings have not yet been studied.

In a media briefing, the FDA's principal deputy commissioner, Joshua M. Sharfstein, said that since 2007 the agency has identified about 300 pharmaceutical products "masquerading as dietary supplements." It has also investigated reports of "adverse events," including deaths, linked to products in all three categories.

Although FDA actions have included recall of supplements and referral of companies for criminal prosecution, "we do not think that the problem is solved," Sharfstein said. The latest strategy is a letter dated Dec. 15 warning makers of dietary supplements to police themselves, and their suppliers and distributors, to ensure that nobody is slipping drugs into their products. The agency enrolled five trade organizations to do the same.

"We share the concern of the FDA over the proliferation of these adulterated products," Scott M. Melville, president of the Consumer Healthcare Products Association, told reporters.

"The spiking of supplements with drugs is a crime," said John F. Gay, head of the Natural Products Association. "It endangers the public and undermines our efforts."

"We want to drive these pirates out of our industry," said Loren Israelsen, head of the United Natural Products Alliance.

The letter, signed by FDA Commissioner Margaret A. Hamburg, said that "responsible individuals and companies should be aware that the government may initiate criminal investigations" when drug-laced supplements are found.

Dietary supplements are regulated much less rigorously than drugs, which must undergo extensive testing before they are allowed to go on the market.

Federal law requires that supplement makers be "responsible for marketing a safe product," but they don't have to actually prove the safety or effectiveness of their products. There are limits, however, to claims they can make about a supplement's physiological action.

Most of the "sexual enhancers" contain sildenafil, the compound in Viagra, or other members of that chemical family. They are sold under names such as Mr. Male Magic Enhancer and Ejaculoid XXTreme. Many of the weight-loss supplements (Solo Slim, Joyful Slim Herb Supplement) contain sibutramine, an FDA-approved drug. The bodybuilding supplements (Clomed, Off Cycle II Hardcore) contain anabolic steroids or a class of compounds called "aromatase inhibitors" that increase testosterone production.

Steroid hormones have extremely complex structures, and chemists can synthesize compounds that differ only slightly from natural ones. Many "analogues" retain the original effects, or in some cases magnify them.

Speaking about the bodybuilding supplements, Michael Levy, director of FDA's division of new drugs and labeling compliance, said: "For the most part, they contain steroids that we have not encountered before."

Brad Pace, an FDA lawyer, said the agency's investigators "see an almost uniform lack of quality control with these products," with the undeclared active ingredients varying from batch to batch.

While the FDA refers to the supplements as "tainted" or "adulterated," the pharmaceutical components are clearly added by intent. Without them, most of the supplements - although not all - would be inert and ineffectual. In some cases, the drug's concentration is three or four times that taken in prescription form.

"These really are not at trace levels," Levy said.

The origin of the questionable supplements usually isn't known, but many of the products come with Chinese writing, suggesting that they are made in China. Some of the weight-loss supplements appear to be made in Brazil, Levy said.

The Council for Responsible Nutrition is a trade association representing about 75 dietary supplement manufacturers and ingredient suppliers. Asked how many of its members might be making substances that illegally contain drugs, Steve Mister, the group's president, said: "That's easy. None of them. Legitimate industry is not making these products. That is why we are so eager to work with FDA on this problem."

He said true dietary supplements "act gradually over time, with effects that are more subtle and more modest." They usually work only when paired with "lifestyle interventions," such as more exercise or a change in diet. Supplements sold with promises that they act quickly - weight loss in a month, an erection within minutes - are hints that they contain pharmaceutical compounds.

Mister said most of the questionable supplements are sold over the Internet. While he is confident in his members' integrity, he said, "legitimate industry is not totally protected from these kinds of things, because sometimes they show up in the ingredients. Manufacturers need to be very vigilant in their supply chain."

Hamburg's letter said the complications caused by the drug-containing supplements have included stroke, liver injury, kidney failure, blood clots in the lungs and death. FDA officials could not provide numbers or details about those incidents.

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