Regulatory threat for new year
introduced by US senators, which seeks to add considerably to the
government's current regulation of the dietary supplement industry.
Dubbed the 'Dietary Supplement Safety Act of 2003' by Senator Durbin (D-IL), bill S722 bill would require supplement manufacturers and packers or distributors to report any serious adverse experiences related to the product to FDA. Written procedures for surveillance, receipt and evaluation of the information concerning adverse dietary supplement experiences are also proposed.
However the supplements trade claims the legislation poses a serious threat to 1994's Dietary Supplement Health and Education Act (DSHEA) and the consumer's freedom of choice in health care.
"Despite its name, this bill would allow no more consumer protection than current law provides. It will, however, grant the Food and Drug Administration (FDA) more authority and directly violate your health freedom," claims the American Association for Health Freedom (AAHF), which is asking for support and funding to continue its campaign.
Adverse event reports will hand over to FDA responsibility for a supplement's safety, giving it the power to remove a product if its manufacturer presents insufficient safety data. Providing such data will be at the manufacturer's expense.
The bill also proposes a new definition for a stimulant, with all stimulant-containing supplements to be subject to FDA premarket approval. This would also raise costs for marketers.
Trade associations and industry members argue that FDA already has the authority outlined in the new bill - it can remove and destroy products that present risk to the public. Under DSHEA, a product found to be unsafe by FDA can be removed from the market. It can also regulate the types of ingredients that can be included in dietary supplements.
A second bill, S1538, introduced by Senator Hatch, aims to increase funds and research money so that DSHEA can be better enforced, offering less opportunity to criticise the regulation.
