American Herbal Products Association Supports Serious Adverse Event Reporting for Dietary Supplements

SILVER SPRING, MD (JUNE 7, 2004) — Anthony Young, General Counsel to the American Herbal Products Association (AHPA), the recognized leader for promoting the responsible manufacture and sale of herbal products, testifies tomorrow before the Senate Governmental Affairs Subcommittee on Oversight of Government Management, the Federal Workforce and the District of Columbia. The hearing is entitled, “Dietary Supplement Safety Act: How is FDA Doing 10 Years Later?”

Mr. Young’s testimony will specifically address AHPA’s long-standing support for a mandatory system for serious adverse event reports (AERs) for dietary supplements. Below is a chronology of the Association’s efforts to encourage the establishment an AER system:

Oct. 2, 2002 — AHPA’s Board of Directors formally recommends that the U.S. Food and Drug Administration (FDA) establish, by rulemaking, a requirement for marketers of dietary supplements to communicate to FDA reports of serious adverse events.

Oct. 7, 2002 — AHPA President Michael McGuffin communicates its position for an AER system to the U.S. Department of Health and Human Services Secretary Tommy Thompson, and FDA staff.

Nov. 21, 2002 — FDA Deputy Commissioner Lester Crawford notes that AHPA’s recommendation would require a change in the current law.

Mar. 20, 2003 — AHPA files a Citizen Petition with FDA to request FDA create regulations that mandate serious adverse event reporting for dietary supplements, noting that FDA has in numerous instances utilized its current rulemaking authority to establish requirements that advance its public health mission even where specific statutory direction did not exist. AHPA notes that FDA’s current authority could be similarly applied to mandate serious adverse event reporting for dietary supplements.

AHPA’s March 2003 Citizen Petition to FDA adopts the definition and process for reporting serious adverse experience for prescription drugs. The drug AER system currently provides certain protections with the respect to the privacy of AER reporters and subjects that AHPA believes should be extended to serious adverse event reports for dietary supplements. These are:

• Patient privacy (i.e., protecting the privacy of individual consumers filing the AER)

• Non-disclosure of associated persons (e.g., healthcare professionals and facilities)

• Submission does not constitute admission (i.e., an AER does not lead to causal conclusions)

• Federal rule is preemptive on identity privacy (to preclude conflicting federal, state, local rules)

In the Senate testimony, AHPA continues its support the creation of a fair requirement for reporting serious adverse events associated with dietary supplements. A copy of Mr. Young’s written testimony may be accessed at tomorrow.


The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry. Founded in 1983, AHPA is the recognized leader in representing the responsible core of the botanical products industry, and is comprised of the finest growers, processors, manufacturers, and marketers of herbal products.

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