FDA Targets Tainted Dietary Supplements

Dec 20, 2010   
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Last week, the U.S. Food and Drug Administration (FDA) issued a letter to the dietary supplement industry, notifying companies of increased enforcement efforts and seeking cooperation from within the industry. The Letter, released on December 15, warns of products being marketed as dietary supplements that contain materials not qualified as dietary ingredients. The letter notes that, “FDA is very concerned about products marketed as dietary supplements that contain the same active ingredients as FDA-approved drugs, analogs of the active ingredients in FDA-approved drugs, or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.”

With this focus, the FDA indicated three distinct categories of products that the Agency believes are often marketed as dietary supplements but contain undeclared ingredients. These products include those that are marketed for: weight loss, sexual enhancement, and body building. Although these categories of products will receive “extra attention and scrutiny” from the Agency, all products will be subject to the increased enforcement measures. Finally, the letter makes it clear that enforcement will not only be focused on manufacturers and distributors of products but that parties at any stage in the supply chain may be liable for violations, as all are responsible for ensuring compliance with applicable law.

According to the letter, the FDA fears that tainted products may impact consumer safety in addition to undermining public confidence in products that are legitimately marketed as dietary supplements. To this end, the Agency outlined several measures to step up enforcement. For instance, noting that these ingredients often go undeclared in labeling, the Agency announced its intention to increase testing of dietary supplements. In addition to the FDAs traditional approach when violations are discovered, such as the issuance of warning letters, seizures and voluntary recalls, the FDA has established a RSS feed on its website. This new measure will be utilized by the FDA to alert consumers more quickly about dietary supplements that the Agency deems tainted. The FDA has also created a means for the industry to report suspected violations either via email or by anonymously reporting this information on the Agencys website.

For more information on FDA enforcement measures or regulatory compliance, please contact us at contact@fidjlaw.com.