Senators call dietary supplement law, enforcement inadequate
By IRA DREYFUSS, Associated Press (Published June 8' 2004)
WASHINGTON (AP) - A decade-old federal law on dietary
supplement safety and the FDA's enforcement are not up to
the job of protecting Americans' health, two senators told
an FDA official Tuesday.
Sen. Richard Durbin of Illinois, ranking Democrat on the
Governmental Affairs Committee's subcommittee on
oversight, criticized the law as a failure. Subcommittee
Chairman Richard Voinovich of Ohio, singling out one
aspect, said it was unacceptable that Food and Drug
Administration has not set regulations for good
manufacturing processes in the 10 years since the law
was passed.
The Dietary Supplement Health and Education Act requires
the FDA to prove that a dietary supplement is harmful,
rather than having the manufacturer prove it is safe as
is required with drugs. The law also does not require
supplement manufacturers to report adverse reactions, as
drug companies must.
"If the object of this law is to protect American
consumers, it fails," Durbin told the director of the
FDA's Center for Food Safety and Applied Nutrition,
Robert Brackett, who is responsible for enforcing the
law. "How can you meet that responsibility when the law
is so weak?"
Durbin, who requested the subcommittee hearing, is
sponsoring a bill that would make manufacturers report
serious adverse reactions such as hospitalizations,
permanent injuries or deaths involving users of
supplements. The bill also would let the government
require manufacturers to prove a product is safe if FDA
had received information that suggested adverse reactions
from a supplement.
Before the agency would ask for any more power, it wants
"to maximize our activities under the current (law),"
Brackett responded. "The administration at this time has
no plans to make any changes."
He said the FDA is working with the National Institutes
of Health and with academic researchers to identify
ingredients and has set up a system to track adverse
reactions reported by consumers, health workers or
manufacturers.
The law requires require the FDA to set standards for
good manufacturing processes so products do not contain
contaminants such as bacteria and lead but do contain
labeled ingredients in the proper amounts. The agency
published a proposed rule in March 2003 and is reviewing
responses to it.
That's not good enough, Voinovich told Brackett. "I just
cannot believe that it has taken that long after this law
is passed," the senator said. "It's unacceptable that it
takes 10 years to get something done."
The regulations will be "done as soon as possible, that
is our goal," Brackett said.
The law allows the FDA to ban ingredients that are proved
unsafe, and the agency announced in April that its ban on
the diet aid ephedra had taken effect. The substance had
been linked to 155 deaths, including that of Baltimore
Orioles pitcher Steve Bechler in 2003.
"Consumers are endangered by the FDA's inability to act
on particular supplements," and ephedra is a case in
point, Durbin said. "It took years - literally years -
for the FDA to ban this substance under this law, DSHEA."