WASHINGTON--Rep. 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 and Education Act (DSHEA) that would lower the burden of proof required of the Food and 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 representatives introduced in 2003 (H.R. 3377), except for a section in the current bill that would allow the use of risk-benefit analysis in a non-dose-dependent manner to evaluate an ingredient’s unreasonable risk.
“A risk analysis that does not consider the amount of the ingredient stands several hundreds of years of science on its head,” said Michael McGuffin, president of the American Herbal Products Association (AHPA) “Ignoring the amount of an ingredient by legislative fiat makes for bad science and for bad law.”
Waxman and Dingell have long tried to distinguish single-vitamin supplements from combination botanical products. They have also promoted mandatory adverse reporting and pre-market approval. As H.R. 3377 proposed a year ago, the new bill would require supplement companies to submit serious adverse event reports to FDA, as well as submit a product list, labels and an ingredient list to the agency every six months.
“AHPA has long stated its belief that submission of adverse even reports should be mandatory for supplements,” McGuffin noted. “But this bill again fails to provide the protections to industry that are established by law for adverse even submissions by drug companies.”
The bill has been sent to the House Committee on Energy and Commerce, on which Dingell sits as a ranking member. Waxman, Frank Pallone (D-N.J.) and Greg Walden (R-Ore.) are other key committee members.
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