June 2006

Adverse Event Reporting Act introduced into Congress

Legislation (S.3546) has been introduced into Congress that would require companies that sell dietary supplements and over-the-counter drugs to submit serious adverse event reports they receive from their customers to the Food and Drug Administration (FDA).

The Dietary Supplement and Nonprescription Drug Consumer Protection Act (or Adverse Event Report Act — AER) will require companies to include on their products’ labels an address or phone number through which consumers can report adverse events associated wit the use of the product. Companies will be required to inform the FDA of any serious adverse event reports within 15 business days.

The bill is supported by several groups, including the National Nutritional Foods Association (NNFA), the American Herbal Products Association (AHPA), and the Council for Responsible Nutrition (CRN).

“The bill will benefit the industry in the long run — first by helping to change the perception by critics of the dietary supplement industry that it is not well regulated. Second, over time, the recordkeeping and reporting requirements will substantiate what many in the industry have been saying for some time — that the safety record of dietary supplements is exemplary.”

CRN says it has long supported the concept of mandatory reporting for serious adverse events, calling it “the right thing for a responsible industry to do.”

Likewise, the board of AHPA adopted a position in October 2002 that called for a regulatory change to mandate adverse-event reporting, says Michael McGuffin, AHPA president.

AHPA says that the legislation as introduced will assure companies that file reports that any submissions they make to the FDA will not constitute an admission that their products caused or contributed to the reported event.

According to the NNFA, the bill contains several provisions to note:

Ann Holden, vice president of quality control at Standard Process, Inc., commented from the manufacturer’s point of view. “Standard Process supports the [ACT] and applauds the efforts of all of the dietary supplement industry groups who worked to advance this responsible legislation. An effective AER system will help the dietary supplement industry demonstrate the limited number of adverse events caused by dietary supplements.”

The bill is expected to be reviewed the Health, Education, Labor, and Pensions Committee before the end of June.

Sources: American Herbal Products Association, www.ahpa.org; Council for Responsible Nutrition, www.crnusa.org; National Nutritional Foods Association, www.nnfa.org; Standard Process Inc., www.standardprocess.com