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New AER Bill for Supplements and OTC DRUGS
New AER Bill for Supplements and OTC DRUGS

The maturation of the modern herb and dietary supplement (DS) movement is evidenced by the introduction in June of a bill in the United States Senate, the Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3546). The new bill, if passed into law, would require manufacturers of DS and nonprescription (over-the-counter, OTC) drugs to include contact information on their products' labels for consumers to use in reporting serious adverse events (AEs). Also, companies would be required to report all serious adverse event reports (AERs) to the Food and Drug Administration (FDA) within 15 days.

The bill's terms also provide that any AERs submitted to the FDA would not be construed as an admission of liability that a company's product caused or contributed to the reported event. The bill also provides for protection of the identity of individuals reporting adverse events.

Support of the bill comes from both sides of the aisle and both sides of the dietary supplement debate: Senators Orrin Hatch (R-UT), Tom Harkin (D-IA), Dick Durbin (D-IL), Ted Kennedy (D-MA), and Mike Enzi (R-WY), Chairman of the Senate HELP committee.

It appears that most of the DS industry has lined up in support of the bill, as has the Consumer Healthcare Products Association, the organization representing the OTC industry, as well as the Center for Science in the Public Interest, a large consumer group that has historically taken adversarial positions against the DS industry.

One key industry figure, Loren Israelsen, founder and executive director of the Utah-based United Natural Products Alliance and one of the primary architects of the Dietary Supplement Health and Education Act of 1994, summed up his group's position: "We believe dietary supplements are exceptionally safe products and that this legislation will in future years confirm this fact. We also recognize that should a safety problem arise, we as an industry have a responsibility to quickly identify and resolve such situations and to do so in cooperation with FDA in those cases where the adverse event is serious." He also noted that, "It will also be incumbent on FDA to administer this legislation in such a way that all parties have full confidence that the intent and spirit of this bill is fully respected, which is to work with industry to resolve serious adverse events reports, rare as they may be, quickly and judiciously." 

Past concerns voiced by critics of the DS industry were that the industry was being either irresponsible by not reporting serious AERs or it was perceived that the industry was not adequately regulated by virtue of its not having to report AERs. The makers of OTC drugs have not had such a requirement, so it was a good move politically, and a reasonable proposal, to include serious AERs for OTC drugs in this bill. It helps to level the playing field for all consumer-selected health products (prescription drugs have had this responsibility for many years).

The genesis of this new bill goes back several years to the public debate on the safety of the controversial herb ephedra (Ephedra sinica), when media and legislators were highly vocal about their criticisms that the DS industry was not required to report AERs related to the controversial herb. This issue was particularly exacerbated after revelations that a major ephedra supplement manufacturer, Metabolife International, had withheld from the FDA the thousands of reports from consumers (the company called them mere "incident reports," but they were perceived as potentially adverse by regulator critics and the media); eventually a much smaller number of reports were deemed "serious."

If this bill becomes law, the major challenge will be setting up a reporting system for serious AERs—one properly designed to ensure adequate and accurate collection of information with the ability to determine potential associations between the events and the dietary supplement ingredients or the OTC drugs.

As Prof. Rick Kingston and I wrote in our HerbalGram 60 article on the deficiencies of the American Association of Poison Control Centers Toxic Event Surveillance System, "Collection of spontaneously reported botanical AERs in a systematic and consistent manner is a vital part of product stewardship and safety assurance. Defining and monitoring the safety of dietary supplements is a dynamic process, and cooperation among multiple stakeholders using reliable methods of surveillance and analyzing collected data in proper context will aid in this process." [For more information, see the July issue of HerbalEGram at]