It is important to for the supplement industry to recommend a reasonable
person to replace Dr McClellan thru industry
organizations (via Nutraingredients)
- 2/23/2004 - Mark McClellan is to leave his post as Commissioner of the US
Food and Drug Administration (FDA), shortly after implementing the agency's
first ban under the 1994 Dietary Supplement Health Education Act.
President George W Bush has nominated Dr McClellan as his preferred
candidate to head up the Centers for Medicare and Medicaid Services.
Dr McClellan will be missed by the pharma industry as he has been
responsible for putting in place a number of reforms, including some
designed to reduce the time the agency takes to review new drug
applications. He has also been popular with the dietary supplements industry
and the recent decision to ban the weight loss herbal has been welcomed by
many as a sign of recognition that the agency does indeed retain powers to
regulate supplements under DSHEA.
The ban, published earlier this month, sets a precedent for the supplements
industry, which can expect further rule-making instead of waiting for
case-by-case enforcement on ingredient safety issues, said the NNFA
recently.
"The bottom line of FDA's lengthy scientific discussion is that it seriously
raises the bar on safety substantiation. A key indicator for future
supplement challenges is FDA's rejection of the safety studies because they
were not designed to detect serious effects in susceptible individuals-and
because the studies were too small," said the trade association.
An initial consequence will likely be further FDA investigation into ephedra
alternatives, with McClellan singling out bitter orange, aristolochic acid
and usnic acid as those with high potential risks last month.
However it is not yet clear whether FDA Deputy Commissioner Lester Crawford,
who previously led the agency from February to November 2002, and looks set
to become the acting Commissioner at the FDA when McClellan leaves, will
continue the campaign.
Meanwhile the industry is still waiting for debate on Senate and House bills
seeking to amend DSHEA, including S722, the Dietary Supplement Safety Act.
The future for the DSHEA 'Full Implementation and Enforcement Act', or S.
1538, which would provide additional funds for FDA to implement DSHEA
instead of dismantling it, also remains undecided.
