Legislation that would significantly increase the costs of marketing herbal dietary supplements was introduced in the House of Representatives last week, designed to better prevent adverse events caused by herbal ingredients.
The bill, called the Dietary Supplement Access and Awareness Act (HR 3377), is sponsored by Susan Davis (D-CA), Henry Waxman (D-CA) and John Dingell (D-MI). It excludes dietary supplements that consist only of vitamin and/or mineral ingredients but applies to 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 require all manufacturers and processors of thementioned supplements to provide a list of all their products and all active ingredients used, and the labeling of each product to the FDA, to be updated every six months.
It also demands that manufacturers and distributors of these products, unless specifically waived by FDA, report serious adverse events to FDA within 15 days of receipt, to investigate any such reports, and to maintain certain records.
Finally the FDA would be given new authority to react to safety risks. It would be able to order a manufacturer to conduct postmarket surveillance of supplements for which there is "a reasonable possibility...[of] serious adverse health consequences'. FDA could also 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.
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 has also been tabled.
"AHPA has long stated its belief that submission of serious adverse event reports should be mandatory for supplements 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," said Michael McGuffin, president of the American Herbal Products Association (AHPA).
"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," he added.
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 andCommerce.