AHPA Requests FDA Correct Dietary Supplement Information

November 8, 2004

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AHPA Requests FDA Correct Dietary Supplement Information

SILVER SPRING, Md.TheAmerican Herbal Products Association (AHPA) sent a letter to the Food and DrugAdministration (FDA) requesting several inaccuracies posted on FDAs Web siterelated to herbs and other dietary supplements be corrected.

The letter, delivered Sept. 8 to Shelia Walcoff, FDAs newlyappointed associate commissioner for External Affairs, identified the followinginaccuracies:

  • An erroneous statement that manufacturers do not need toregister with FDA;

  • An unreferenced statement that implies as little as 50 mgof the herb lobelia (Lobelia inflate)can cause death;

  • Identification of the herbs stephania (Stephaniatetrandra) and magnolia (Magnoliaspp.) as implicated in severe kidney injury, eventhough no such association exists;

  • Misleading information on the premarket safetyrequirements for all new ingredients in dietary supplements; and An articlefrom the current issue of FDA Consumer whichstates that kava (Piper methysticum)has caused liver failure, contrary to FDAs prior published positionstating the herb presents a potential risk.

AHPAs hope and intention in pointing out these errors isthat FDA will move quickly to correct these, said Michael McGuffin, AHPApresident. Consumers rely on FDA to provide truthful information aboutall classes of regulated products.

The letter sent by AHPA is available online(www.ahpa.org/members/04_0908_ahpa_fda_website.pdf).

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