New Democratic Paternalistic Supplement Bill

[Guest guest]

AHPA Update July 13, 2005

 

New Bill Targets Herbal Supplements

 

US 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 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 (see the AHPA Update of April 14, 2005,

online at: http://www.ahpa.org/members/update_05_0414.htm). 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. "