Notes from the Naturopath 

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). 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 (see AHPA's notice on the 2003 bill for a discussion of each of the other parts of the bill: http://www.ahpa.org/members/update_03_1031.htm).

"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." McGuffin also expressed concern about other elements of the bill. “AHPA opposed HR 3377 in the 108th Congress and will oppose HR 3156 in the 109th."

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). The bill text is posted online at: http://www.ahpa.org/05_0630_HR3156.pdf.

Karen Robin
Director of Communications
American Herbal Products Association
8484 Georgia Avenue, Suite 370
Silver Spring, MD 20910

Telephone: (301) 588-1171, x-107
Email: KRobin@ahpa.org

www.ahpa.org

Please send this prepared fax (pdf) regarding HR 3156 to your Congressman!

(Find contact information for your Congressman here: http://www.house.gov/)

Freedom of Choice...

It's supposed to be the American way!

Vibraceous, ND

Mary Jo Eshelman, ND, CTN, CNHP, D.D.
All Natural HealthWorks!
Holistic Education and Research Unlimited...

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