New Bill Targets DSHEA

WASHINGTON--On Oct. 28, a new bill was introduced in the House that reportedly closes the loopholes caused by the Dietary Supplement Health and Education Act (DSHEA). Reps. Susan Davis (D-Calif.), Henry Waxman (D-Calif.) and John Dingell (D-Mich.), introduced HR 3377, the "Dietary Supplement Access and Awareness Act." The act, if passed, would amend the Federal Food, Drug and Cosmetic Act and would impact marketers of dietary supplements containing botanicals, amino acids or a "dietary substance for use by man to supplement the diet by increasing the total dietary intake." However, the bill would not apply to supplements containing only vitamins, minerals and/or a concentrate, metabolite or extract of any vitamin or mineral.

"The ephedra crisis has raised public awareness about dietary supplements and the absence of accurate information concerning risks and benefits," Davis said in her introduction to the bill. "Much of the confusion surrounding dietary supplements can be attributed to the changes made in 1994 by DSHEA." She added that, consequently, there has been an explosion of herbal remedies and stimulants in the marketplace. "The FDA, however, is prohibited from screening out any of these potentially dangerous dietary supplements," she said. "What if ephedra is only the tip of the dietary supplement iceberg?"

While HR 3377 has provisions that are similar to those found in Sen. Richard Durbin's (D-Ill.) SB 722, it also has a more focused scope than that found in the Senate bill. HR 3377, if passed, would require all manufacturers and processors of affected dietary supplements to provide an updated list of all products, with each product's labeling and ingredient list, every six months to the secretary of Health and Human Services (HHS). In addition, the legislation would require manufacturers and distributors of these products to report serious adverse event reports (AERs) to HHS within 15 days of such reports, to investigate any such reports and to maintain records of AERs for a time to be decided by the secretary.

Also, the legislation would allow the secretary to require a dietary supplement manufacturer to conduct post-market surveillance of a supplement if it is determined there is a reasonable possibility that expected use of the supplement may have serious health consequences. In addition, the secretary would have no more than two years after the enactment of the bill to have established criteria for making a determination as to whether a supplement poses a significant risk to individuals under age 18.

The bill would also commission $10 million to educate health care providers and consumers about reporting AERs associated with dietary supplements to the Food and Drug Administration (FDA).

"AHPA has long stated its belief that submission of serious AERs should be mandatory for supplements," stated Michael McGuffin, president of the American Herbal Products Association (AHPA), "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 Rep. Davis should first explain why the proposed semi-annual burden for supplements should exceed the annual burden for drugs."

Davis said the bill would address the gaps created by DSHEA by creating more accountability for both manufacturers and the government. "This legislation presents a balanced, reasonable approach to improving the safety of dietary supplements while maintaining market access for responsible supplement manufacturers," she said. "By providing their studies and other related data, manufacturers and the FDA would come together to make a comprehensive and accurate decision for American consumers. ... Despite claims to the contrary, the Dietary Supplement Access and Awareness Act will not take away vitamins and minerals from consumers."

The bill has been referred to the House Committee on Energy and Commerce, which held hearings about ephedra in July.

Share this article: Email, Slashdot, Digg, Del.icio.us, Yahoo!MyWeb, Windows Live Favorites, Furl
Add this article feed to: RSS, My Yahoo, Newsgator, Bloglines