AHPA Asks FDA to Correct Public Information about Dietary Supplements

In a letter addressed to Sheila Walcoff, FDA’s newly appointed Associate Commissioner for External Affairs, AHPA has identified several errors related to herbs and other dietary supplements that the agency has posted on its website.

“AHPA’s hope and intention in pointing out these errors is that FDA will move quickly to correct these,” said AHPA President Michael McGuffin. “Consumers rely on FDA to provide truthful information about all classes of regulated products.”

The letter to Walcoff was delivered on September 8 and focused primarily on three documents on the FDA website. Identified inaccuracies include:

  • An erroneous statement that manufacturers do not need to register with FDA;
  • An unreferenced statement that implies that as little as 50 mg of the herb lobelia (Lobelia inflata) can cause death;
  • Identification of the herbs stephania (Stephania tetrandra) and magnolia (Magnolia spp.) as implicated in severe kidney injury, even though no such association exists;
  • Misleading information on the premarket safety requirements for all new ingredients in dietary supplements;
  • An article from the current issue of the FDA Consumer which erroneously states that kava (Piper methysticum) “has caused liver failure,” contrary to FDA’s prior published position that the herb presents a “potential risk.”

“To FDA’s credit, their most recent website postings are more accurate than some of the older documents that are still accessible at fda.gov,” McGuffin said. “Nevertheless, any errors of facts and statements that are misleading to the public and that are available today on FDA’s website need to be removed or corrected.”

AHPA’s letter to FDA can be found on AHPA’s website at the following URL: www.ahpa.org/members/04_0908_ahpa_fda_website.pdf


Karen Robin
Director of Communications
[email protected]
Telephone: 301-588-1171 x107
Fax: 301-588-1174

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