According to the American Herbal Products Association (AHPA), Silver Spring, MD, U.S. Representative Susan Davis (D-CA) has introduced a bill that proposes to revise the “unreasonable risk” clause of DSHEA by significantly altering FDA’s burden of proving that an ingredient is unsafe for use in dietary supplements. The Dietary Supplement Access and Awareness Act (HR 3156) is co-sponsored by Henry Waxman (D-CA) and John Dingell (D-MI). This new bill is the same as one introduced in the last Congress, AHPA said, with the addition of one new section that appears to be a direct response to a recent decision by the U.S. District Court to overturn portions of FDA’s 2004 ban of ephedra. In that case the court was asked to rule on FDA’s use of risk-benefit analysis and on its reliance on data about one dose of ephedra to ban smaller amounts.

HR 3156 would establish legislative authority for the use of risk-benefit analysis in evaluating an ingredient’s unreasonable risk; would specify that “presence of even a relatively small risk of a serious adverse health effect” would be considered unreasonable in the absence of a “sufficient benefit;” and would specifically permit FDA to ban any dietary supplement “even though there are uncertainties as to the levels of a dietary ingredient that may present a risk.” “A risk analysis that does not consider the amount of the ingredient stands several hundreds of years of science on its head,” said AHPA president Michael McGuffin. “In the immortal words of Paracelsus: ‘All substances are poisons; there is none which is not a poison. The right dose differentiates a poison.’ Ignoring the amount of an ingredient by legislative fiat makes for bad science and for bad law.” In all of its other particulars, HR 3156, which excludes dietary supplements that consist only of vitamin and/or mineral ingredients, is identical to the version proposed in 2003 (HR 3377, 108th Congress).

AHPA says the bill would impact marketers of herbal dietary supplements by amending the law in several ways. It would, among other things, require companies to submit to FDA every six months a list of their products and product labels and, at the discretion of FDA, a quantitative listing of all ingredients. It would also mandate submission of serious adverse event reports to FDA. “AHPA has long stated its belief that submission of serious adverse event reports should be mandatory for supplements,” added McGuffin, “but this bill again fails to provide the protections to industry that are established by law for adverse event submissions by drug companies.”

The bill has been referred to the House Committee on Energy and Commerce, on which Mr. Dingell sits as the ranking member. Other members of the Committee include Mr. Waxman and Representatives Frank Pallone (D-NJ) and Greg Walden (R-OR).