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FDA Warns Supplement Industry, Launches New System to Notify Consumers

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.

Most commonly, Sharfstein says, the tainted products marketed as dietary supplements are for weight loss, sexual enhancement, or body building.

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.

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