Dec. 15, 2010 — The FDA today announced new steps to target harmful products marketed as dietary supplements, including the possibility of launching criminal investigations against companies endangering public health.
”The FDA is stepping up our efforts,” Joshua Sharfstein, MD, principal deputy commissioner of the FDA, said during a news conference announcing the new steps.
At issue are products marketed as dietary supplements that contain hidden or deceptively labeled ingredients, such as the active ingredients in FDA-approved drugs or closely related drugs, as well as other compounds, such as synthetic steroids that don’t qualify as dietary supplement ingredients.
Since December 2007, Sharfstein says, the FDA has alerted consumers to about 300 products marketed as dietary supplements that were tainted in some way. Serious adverse reports associated with the products include strokes, artery blockage in the lungs, kidney failure, acute liver injury, and death, although the FDA couldn’t provide exact numbers of adverse events or deaths.
Dietary supplements are regulated by the FDA under a different set of regulations than are foods and drugs. Dietary supplement manufacturers are responsible for ensuring that their products are safe before marketing them, and the FDA is responsible for taking action against any unsafe dietary supplement on the market.
Tainted Dietary Supplements: New Targeting Efforts
The new steps taken by the FDA include:
- A letter from FDA Commissioner Margaret A. Hamburg to the dietary supplement industry, stressing its legal obligation to prevent tainted products from reaching the market. Hamburg emphasizes in the letter the possibility of criminal investigations against those who endanger public health by their involvement in tainted products.
- A new, rapid notification system for the public on the FDA web site to alert the public quickly to tainted products marketed as dietary supplements.
- A mechanism for industry to alert the FDA about the tainted products and the firms involved.
Industry Support for New Effort
At the conference, representatives of five dietary supplement industry organizations pledged to give their support to the new effort.
Among the speakers was Loren Israelsen, executive director of the United Natural Products Alliance. “We are committed to joining the FDA to find them,” he said of the tainted product makers, “and drive them out of our industry and out of the U.S.”
Another industry representative, Anthony Young, general counsel for the American Herbal Products Association, pledged support and commented on the commissioner’s letter. “It is the strongest letter I’ve seen in 35 years of law practice,” he says.
Recent FDA Actions Against Tainted Dietary Supplements
Among the warnings and alerts recently issued, the FDA today warned people to stop using Man Up Now, a product marketed for sexual enhancement, as it contains a variation of a drug ingredient found in Viagra that can lower blood pressure to a dangerous level.
In October, the FDA warned people not to use Slimming Beauty Bitter Orange Slimming Capsules, as they contain sibutramine, the active ingredient in a weight loss drug no longer available in the U.S. because of increased risk of heart attack and stroke.
In 2009, the FDA warned consumers against dietary supplements promoted as body-building products that contain synthetic steroids or other harmful ingredients, such as Tren Xtreme and Mass Xtreme. The products could cause serious liver injury, stroke, and other problems.
More Advice for Consumers
“We want consumers to be aware there are products masquerading as dietary supplements that can pose significant dangers,” Sharfstein says.
Among the tip-offs that a product may be tainted, he said, are claims of being an alternative to FDA-approved drugs or of being legal alternatives to anabolic steroids. Products that promise fast or long-lasting sexual enhancement results are also suspect, he said, as are products marketed via mass email.
Consumers should also be wary of products that give warnings about testing positive in performance-enhancing drug tests, he says.
Consumers Union, the publisher of Consumer Reports magazine, issued a statement, applauding the FDA actions. “Tainted dietary supplements can send you to the hospital or kill you,” Ellen Bloom, a spokeswoman, says in the statement.
”The FDA should be commended for prioritizing this issue and alerting consumers about dangerous supplements. Unfortunately, the challenge is that more dangerous products keep popping up.”
Consumers Union is urging the FDA to go further and vigorously oversee the dietary supplements marketplace through random spot checks and testing of products in the high-risk categories, Bloom says.