New Congressional Attempt to Alter DSHEA

New Congressional Attempt to Alter DSHEA

WASHINGTONRep. Susan Davis(D-Calif.) introduced the Dietary Supplement Access and Awareness Act (H.R.3156), proposing revision of a key clause in the Dietary Supplement Health andEducation Act (DSHEA) that would lower the burden of proof required of the Foodand Drug Administration (FDA) in banning dietary supplements for safety reasons.Co-sponsored by industry critics Henry Waxman (D-Calif.) and John Dingell(D-Mich.), the bill is nearly identical to a bill these three representativesintroduced in 2003 (H.R. 3377), except for a section in the current bill thatwould allow the use of risk-benefit analysis in a non-dose-dependent manner toevaluate an ingredients unreasonable risk.

A risk analysis that does not consider the amount of theingredient stands several hundreds of years of science on its head, saidMichael McGuffin, president of the American Herbal Products Association (AHPA).Ignoring the amount of an ingredient by legislative fiat makes for badscience and for bad law.

Waxman and Dingell have long tried to distinguishsingle-vitamin supplements from combination botanical products. They have alsopromoted mandatory adverse reporting and premarket approval. As H.R. 3377proposed, the new bill would require supplement companies to submit seriousadverse event reports to FDA, as well as submit a product list, labels and aningredient list to the agency every six months.

AHPA has long stated its belief that submission of adverseevent reports should be mandatory for supplements, McGuffin noted. Butthis bill again fails to provide the protections to industry that areestablished by law for adverse event submissions by drug companies.

The bill has been sent to the House Committee on Energy andCommerce, on which Dingell sits as a ranking member.Waxman, Frank Pallone(D-N.J.) and Greg Walden (R-Ore.) are other key committee members.

A copy of the bill can be found on the AHPA Web site, www.ahpa.org/05_0630_HR3156.pdf.