Congress members move to hurry FDA decision on ephedra
FDA to immediately remove all ephedra-containing supplements from
the market. Industry continues to encourage a decision taken on the
science and not the politics.
A group of senators yesterday introduced a resolution urging the FDA to immediately remove all ephedra-containing supplements from the market
The resolution (H.Res.435), sponsored by four others, was introduced at the same time as an amendment to next year's agriculture spending, sponsored by Dick Durbin and backed by Senators Hatch and Harkin, to provide the FDA with additional funds ($250,000) to better regulate ephedra.
The FDA is currently considering tighter regulations, or a ban, on the herbal but has given no indication as to the outcome. Congress members are however clearly aiming to speed up the decision-making process and are hoping to schedule a vote before Congress adjourns this year.
The industry has encouraged FDA to make 'the decision that science supports' and claims that there is not enough evidence to support an outright ban. The herbal has however now been banned from OTC sales in three US states.
Davis was also behind a new bill introduced last week, designed to give FDA greater regulatory authority over supplements. It would also require all supplement marketers to submit adverse event reports on its products and to update lists of ingredients used in the manufacture.
However the new $79.7 billion agriculture spending bill for fiscal year 2004, voted in by the Senate this week, also includes the amendment proposed by Hatch and Harkin to increase the FDA's budget to fully implement and enforce the Dietary Supplement Health and Education Act (DSHEA) by $1 million in 2004.
The legislation (S.1538), introduced in July, aims to give the FDA the resources it needs to ensure that DSHEA is enforced. It will also add funding for dietary supplement research and hold the FDA accountable for its actions in regard to implementing and enforcing the law.
The bill will carry over into the next session, along with S. 722, introduced earlier this year by Durbin. Durbin's proposed rules would subject nearly all vitamins, minerals, herbal products and other supplements to a level of scrutiny 'both unwarranted and unnecessary', according to the NNFA.
