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GAO Requests Input from ANA, Industry and Research Community Regarding Extent of use, Evidence for Safety and Efficacy, and Regulation of Dietary Weight-loss Supplements

The GAO (General Accounting Office) asked by Congress, has requested that ANA provide input on the safety, efficacy, regulation of dietary supplements used for weight loss in preparation for a July hearing and to include in the official record. Dr. Bernd Wollschlaeger, MD, co-chair of the ANA Medical Advisory Council is drafting a response to the questions submitted by GAO. Input from companies and researchers will be considered for inclusion in the ANA response, targeted for submission at the end of the week.

Extract of email received on June 24 from the General Accounting Office (GAO):

"The U.S. General Accounting Office has been asked by Congress to look into the extent of use, evidence for safety and efficacy, and regulation of dietary weight-loss supplements. We are not reviewing OTC (for example dexatrim or accutrim) products, prescription drugs, or products that are used strictly for performance enhancement. Our analysis looks at ingredients, not specific products or brands. In the course of our investigation we are speaking with federal agencies, consumer, industry, and professional groups.

We would like to get the ANA's perspective (whatever information you have on hand--please feel free to skip any questions for which you don't have information) on these issues. As we have a very short turn around time (we would like this information within the week if possible), we have put together a list of 10 questions for you.

  1. What kind of information might you have about the extent to which dietary supplements are being used for weight-loss in the U.S. by adults, children, adolescents, and teenagers? Source?
  2. To what extent are ephedra-containing supplements being used for weight-loss? Breakdown by gender, age? Source?
  3. Is there evidence for the safety or efficacy of weight-loss supplements? If so, what? Which supplements/ingredients?
  4. Are you aware of research underway to look at the safety or efficacy of multi-ingredient dietary supplements? If so, which multi-ingredient dietary supplements are being investigated? If not, what are the barriers to carrying out such research?
  5. Are there particular weight-loss supplements, ingredients, or combinations of ingredients that present greater concern in terms of adverse events, contraindications, or side effects?
  6. What is being done to protect consumers from questionable weight-loss supplements? Are you aware of any initiatives being undertaken by organizations such as yours to track reports of adverse events related to supplement use for weight loss?
  7. What are your thoughts on mandatory adverse event reporting? Good Manufacturing Practice (GMP) guidelines mandated by the FDA? Self-regulation initiatives by industry?
  8. Are you aware of any state legislation limiting the sale or labeling of dietary supplements for weight loss? If so, in which states? Which supplements?
  9. Do you or have you done work in the past with any federal agencies with respect to the weight-loss supplements? If so, which agencies? What was the nature of the work?
  10. Are you aware of other non-OTC, non-prescription supplements (not on the list below) being used for weight-loss? Have we listed some that should not be included, and if so, why? "

    Companies wishing to particpate or provide input into the ANA response should e-mail comments to:
    Attention: Bernd Wollschlaeger,M.D.

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