Waxman / Dingell / Davis Introduce New Supplement Bill: Legislation Targets Herbs and other Non-nutritive Ingredients

A very big step in a very right direction?

Congresswoman Susan Davis (D-CA), joined by Henry Waxman (D-CA) and John Dingell (D-MI), introduced legislation in the House of Representatives on 4th November 2003 that would amend the Federal Food, Drug and Cosmetic Act in several ways that would impact marketers of herbal dietary supplements.

The bill, identified as the Dietary Supplement Access and Awareness Act (H.R. 3377), excludes dietary supplements that consist only of vitamin and/or mineral ingredients from its provisions. The bill applies only to the other ingredients defined by the Dietary Supplement Health and Education Act (DSHEA), including herbs, amino acids, and the ingredients described in DSHEA as "dietary substance(s) used by man to supplement the diet by increasing the total dietary intake."

The legislation would establish a number of new requirements for marketers and new authorities for the Food and Drug Administration, (The legislation identifies the Secretary of Health and Human Services rather than FDA in each of these new authorities, but FDA would, in fact, be charged with these responsibilities) including:

1. A requirement for all manufacturers and processors of the affected dietary supplements to provide to FDA and to update every six months:
a list of all products;
labelling for each product;
a listing of all "major ingredients... including active ingredients,
as applicable);"
at the discretion of FDA, a quantitative listing of all ingredients;

2. A requirement for manufacturers and distributors of these products, unless specifically waived by FDA, to report serious adverse events to FDA within 15 days of receipt, to investigate any such reports, and to maintain certain records;

3. New authority for FDA to order a manufacturer to conduct postmarket surveillance of supplements for which there is "a reasonable possibility...[of] serious adverse health consequences;"

4. New authority for FDA to require a manufacturer to demonstrate safety of a supplement if the agency has "reasonable grounds for believing" that the supplement presents a significant or unreasonable risk of illness or injury or is an imminent hazard to public health or safety;

5. New authority for FDA to establish criteria for determining that a supplement may pose a significant risk to minors and for deeming the act of selling such product to minors as misbranding.

"AHPA has long stated its belief that submission of serious adverse event reports should be mandatory for supplements," stated Michael McGuffin, AHPA's President, "but it appears as if this bill fails to provide the protections to industry that are established by law for adverse event submissions by drug companies. Also, the idea of a product registration is one that may deserve discussion and cost evaluation, but Representative Davis should first explain why the proposed semi-annual burden for supplements should exceed the annual burden for drugs. In addition, the
subjective nature of FDA decision making for each of their proposed new authorities must be challenged."

In addition, the bill would provide funding to educate health professionals on the importance of reporting adverse health experiences associated with dietary supplements to FDA, and to educate consumers about the importance of informing their health professionals of the dietary supplements and drugs they are taking. It would also strike language from the current law, as amended by DSHEA, which states that the burden of proof is on the federal government for showing that a supplement is adulterated.

The bill has been referred to the House Committee on Energy and Commerce, the site of a recent hearing on ephedra that led to its Chairman, Billy Tauzin (R-LA), to state on the House floor the following day, "I voted wrong in 1994" in supporting DSHEA.

The bill has no additional cosponsors at this time other than the three original sponsors. You can download the bill from the AHPA website at http://www.ahpa.org/HR3377_Davis_DSAAA.pdf