FDA signals stricter DSHEA enforcement

Industry has responded positively to the Food and Drug Administration?s declaration that it will more assiduously police the US food supplements market via the Dietary Supplements and Health Education Act of 1994.

?The FDA announcement is basically good news,? said Mark Blumenthal, founder and executive director of the American Botanical Council. ?It is a sign that the agency appears to want to ensure that it fully enforces the terms of the DSHEA. This is a sign that the FDA?s future enforcement of the safety and claims regulations for dietary supplements will be more consistent and scientifically based.?

President of the US Council for Responsible Nutrition, Annette Dickinson, said: ?For the 150 million Americans who choose to use dietary supplements, the FDA?s actions signal the agency?s confidence in a regulatory framework that ensures consumers affordable access to a wide variety of safe dietary supplements. These actions also demonstrate that under the 1994 law, there are many regulatory approaches available to the FDA for effective enforcement.?

The FDA?s initiatives include guidance for industry on substantiation for structure function claims, warning and advisory letters to distributors and marketers of products making unsubstantiated claims, closer scrutiny of new dietary ingredients and adverse events, speedier and more punitive treatment of unsafe products, implementation of long-awaited GMPs and random supplement-content testing.

The FDA release can be found at www.fda.gov/bbs/topics/news/2004/NEW01130.html
Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.