AER Amendment Dropped from Senate Defense Bill

(Silver Spring, MD, October 14, 2005) -- Following discussion on the Senate floor last week, Senator Richard Durbin (D-IL) won a commitment from the chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee to prioritize efforts to pass legislation requiring supplement manufacturers to submit serious adverse event reports (AERs) to the Food and Drug Administration (FDA).

Senator Durbin forced the issue, as he did last year, by proposing an amendment to the Senate Department of Defense appropriations bill that would have withheld funding from any store on a military installation that sells dietary supplements containing a stimulant unless the supplement manufacturers submit AERs associated with the supplement.

Senator Durbin withdrew the amendment after receiving assurances from the chairman of the HELP Committee, Senator Michael Enzi (R-WY), that the Committee would address the issue.

Last year Senator Durbin withdrew a similar amendment after Senator Orrin Hatch (R-UT) asked him to join efforts with Senator Tom Harkin (D-IA) to craft legislation to address the issue of mandatory submission of serious AERs. Senator Durbin said, “Here we are again, a year later, and nothing has happened.”

A transcript in the Congressional Record quotes the senators’ exchange on October 7, in which Senator Enzi noted, “It is important that we maintain the safety of dietary supplements that benefit so many Americans.” He also pointed out, “I think it is very important for us to come up with a piece of legislation that does that on and off military bases, so there is a reporting of adverse events so that FDA can take action when it is affecting people, and have enough information to be able to tell whether they are acting properly or not.”

The American Herbal Products Association has long supported a mandatory reporting system for dietary supplements, one that would provide the same protections currently in place for pharmaceutical drugs.


The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website:

Karen Robin, Director of Communications
Telephone: (301) 588-1171, x-107
Email: [email protected]

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