FDA Targets Tainted Dietary Supplements

December 20, 2011 By

By Arwen Brooks
Quality Assurance and Regulatory Affairs Assistant, dicentra

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 focus of these new procedures will be products that are openly marketed as dietary supplements, but contain hidden or deceptively labeled ingredients, or ingredients that constitute the active components in a variety of FDA-approved or closely related drugs. Among these adulterants are found other compounds, such as synthetic steroids that do not meet the definition of dietary supplement ingredients.

Since December 2007, the FDA has informed consumers of around 300 products that have been marketed as dietary supplements, but contain some form of contamination. Many of these contaminants have provoked serious adverse reactions, including strokes, artery blockage in the lungs, kidney failure, acute liver injury, and death.

The most commonly tainted products marketed as dietary supplements are for weight loss, sexual enhancement, or body building.

Some of 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.

The industry is in support of the new measures taken by the FDA. At the conference, representatives of five dietary supplement industry organizations pledged to give their support to the new effort, including representatives from the Council for Responsible Nutrition, the Natural Products Association, and the Consumer Healthcare Products Association.

The FDA has also made the effort to help consumers to identify products that may be among the tainted merchandise. Some of the key indications to question a product’s quality or authenticity 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, or products marketed via mass email should also be red-flagged as potentially hazardous.

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.


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