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FDA Issues Staunch Warning on Adulterated Products

WASHINGTON—FDA Commissioner Margaret Hamburg, M.D., reached out to the dietary supplement industry via a letter detailing the agency’s position on products adulterated with drug or drug-like compounds and sold as dietary supplements. The agency very clearly stated such products are illegal and those involved in the manufacturing, distribution and sale of such products can face criminal penalties. The agency is encouraging the responsible members of the supplement industry to step up their vigilance in this area and report products and companies they suspect of such back-alley behavior.

FDA said these products are not only deceptive in their marketing but dangerous in their adulteration, as a large number of such products have generated numerous serious adverse events over the past few years. In fact, on a conference call to media, FDA Principal Deputy Commissioner Joshua Sharfstein noted the agency has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products, which can cause strokes, organ failure and death.

The letter to industry also clearly reminds manufacturers and distributors they are solely responsible for ensuring their products comply with the law. Sharfstein said the agency has been discussing this problem for a while and worked with several supplement industry trade groups to extend the effort industry-wide and encourage the reporting of suspicious products and companies. These industry partners include the Council for Responsible Nutrition (CRN), Natural Products Association (NPA), United Natural Products Alliance (UPA), Consumer Healthcare Products Association (CHPA) and American Herbal Products Association (AHPA). Leaders from each group expressed their appreciation for FDA’s stepped up enforcement and attention to this matter, and pledged their support of continuing efforts, including disseminating the letter to member companies and working on ways to educate the industry at large on this issue of adulterated products masquerading as supplements.

FDA reported the majority of offending products they’ve found fall into one of three products categories: weight control, bodybuilding and sex function. In the weight arena, the agency has found the pharmaceutical compound sibutramine, which was pulled from the drug market due to increased risk of heart attack and stroke, has surfaced in a number of products marketed as supplements. In bodybuilding products, steroid or steroid analogs are the problem, increasing the risk of acute liver injury and increase the risk for heart attack, stroke and death. Similarly, several sex enhacement products masked as supplements contain the active ingredients in several FDA-approved sex drugs such as Cialis and Viagra.

Sharfstein provided some red flags to consider about suspicious products:

  1. Any labeling about being an alternative  or similar toFDA-approved drugs;
  2. Any mention of being a legal steroid;
  3. Marketing primarily in a foreign language;
  4.  Products marketed via mass emails;
  5.  Sexual enhancement products promising rapid or long-lasting effects; and
  6. Any warnings about the risk of testing positive in drug tests from consuming the product.

"The manufacturers selling these tainted products are operating outside the law,” Hamburg said, in a release. Companies operating in this illegal manner face not just warning letters but enforcement actions such as product seizures, injunctions, and criminal prosecution. Further, individuals involved in the illegal operation can also face criminal prosecution.

She said the agency is soliciting input from industry on ways to educate companies and devise new strategies to counter the problem. In addition to providing tools for companies to report possible offenders, FDA has created a new RSS feed to warn consumers more quickly about tainted products marketed as dietary supplements.

Steve Mister, CEO and president of CRN, said the trade group appreciates FDA’s willingness to distinguish between good and bad companies. “There are legitimate companies in all three of these categories,” he noted.

Tony Young, general counsel for AHPA, thanked FDA for recognizing the value of partnering with the associations to get the word out. “More eyes and ears on a problem like this always helps,” he said, adding, “This is the strongest [warning] letter I’ve seen in 35 years of law practice.”

“We have to drive these pirates out of our industry,” said Loren Israelsen, executive director of UPA, said he has been astonished by the growth of this particular class of products that are intentionally spiked. “We commit to find them, drive them out of industry and the United States, and  ensure our customers have full confidence in our industry and products.”

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