AER Requirements Show Why Self-Regulation Works

It is rare for any industry to ask the federal government to impose more or stricter regulations, but this was the case when the American Herbal Products Association (AHPA) advocated for a law requiring dietary supplement manufacturers to submit serious adverse event reports (SAERs) to the U.S. Food and Drug Administration (FDA).

In 2002, AHPA requested FDA use its rulemaking powers to require dietary supplements marketers to submit any SAERs they received. And in March 2003, AHPA filed a Citizen’s Petition, requesting FDA to establish a mandatory adverse event report system for dietary supplements. FDA took the position that it did not have the authority to impose this requirement and so AHPA and the supplement industry initiated efforts to get the law changed.
 
AHPA worked with other organizations to encourage lawmakers, including Sen. Orrin Hatch (R-UT), a long-time advocate for responsible access to dietary supplements, Sen. Richard Durbin (D-IL), a consistent critic of current supplement law, and Sen. Tom Harkin (D-IA, retired) to develop a broad-based law that handles the adverse event reporting matter.

The result was the introduction and passage of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which became law in 2006 and came into effect at the end of 2007. This bipartisan legislation was strongly supported by consumer groups and the supplement industry.

The Senate Committee on Health, Education, Labor and Pensions noted in a report on this legislation that the SAER submission requirement should be limited to the information FDA really needs: reports of death; a life-threatening experience; hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect.

“In limiting the reporting system to serious events only, the committee recognizes that any broader reporting system could overburden manufacturers, consumers and the agency alike, generating information that may not be useful to the public health system at tremendous cost to all involved,” the committee’s report stated.

The herbal products industry advocated for this legislation for several reasons. Despite a long-established track record of safety, there was broad industry support for a system to inform the public and health care professionals of the rare cases when a dietary supplement may be associated with a possible health risk. In addition, some industry critics employed alarming rhetoric to warn about undocumented dangers of dietary supplements and the industry was confident that an SAER system would debunk their critics by demonstrating the safety of this class of goods.

Since the implementation of the SAER law, the data produced has confirmed the industry’s reasons for implementing this additional reporting requirement. The system shows relatively few incidents of serious adverse events are associated with dietary supplements. As the system matures it will continue to provide useful information about the safety of supplements, which will help inform consumers, the industry, and regulators.