By Robert B. Bluey
CNSNews.com Staff Writer
September 15, 2003
(CNSNews.com) - Marlys Gilbert takes vitamins and herbs every day, so when
she heard about a bill pending in the U.S. Senate that could possibly limit
her selection, she naturally let her feelings be known.
At issue is the Dietary Supplement Safety Act being pushed by Sen. Dick
Durbin (D-Ill.) and three other liberal senators that requires manufacturers
to report adverse health reactions - such as heart attack, seizure, stroke
or death - for all dietary supplements on the market.
Gilbert said that, in her opinion, the Food and Drug Administration already
has too much authority over supplements, but to hand the agency greater
regulatory power would be a giant mistake.
"I don't think the FDA should be involved," said Gilbert of Panama City
Beach, Fla. "These are not drugs, they're food supplements. I've healed a
lot of things taking extra vitamins. I used to think I had carpal tunnel
syndrome, and I found out if I took enough [vitamin] B6, the pain went
away."
When Durbin introduced the bill in March, he said he was taking aim at the
dangerous effects of dietary supplements like ephedra. He said the bill
would put the onus on manufacturers - not the FDA - to prove their products
are safe. The legislation also classifies anabolic steroids as a controlled
substance rather than a supplement.
But the part of the bill that has consumers and manufacturers most upset is
the requirement that any adverse health events be submitted to the FDA. The
government, critics charge, already has sufficient authority and doesn't
need any more.
"This fits into that philosophical mindset that we as Americans are not
smart enough to make our own decisions, and the government ought to make our
decisions for us. We're too gullible and too stupid to go to the drug store
or GNC and pick up a bottle of vitamin C and a multivitamin," said Beth
Clay, director of Project: Freedom of Access to Nutritional Supplements.
Clay warned that Flintstones vitamins and St. John's Wort could be regulated
under the bill. She said Durbin's bill has particularly irritated her
because it's another attempt by elected officials to hand the federal
government responsibility.
The nutritional supplements industry does about $15.5 billion in sales per
year and has more than 28,000 products in the marketplace, Clay said. In
1994, Congress passed the Dietary Supplement Health and Education Act, which
was the last major federal action regulating the industry.
Clay said the existing law is adequate and gives the FDA plenty of authority
to regulate supplements. The recent death of Baltimore Orioles minor league
pitcher Steve Bechler and Illinois high school student Sean Riggins have
renewed interest in the issue.
The legislation has caught the attention of the National Nutritional Foods
Association, which is encouraging consumers to e-mail their elected
representatives.
Durbin's spokesman, Joe Shoemaker, said it's unfortunate that a handful of
manufacturers and suppliers have launched a misinformation campaign against
the bill. Shoemaker disputed the impact it would have on common supplements
like vitamins and herbs.
"In our opinion, the FDA has the power now to ban sales, but they've never
done it, nor would they ever do it," Shoemaker said. "I can't imagine a
scenario in which they've allowed ephedra to be sold in the way that they
have. There have been 17 deaths [connected to ephedra], and they haven't
pulled it from the market. Why in the world would they pull Flintstones
vitamins?"
Shoemaker said there's plenty of evidence and congressional testimony that
the makers of products like ephedra aren't conducting the necessary safety
tests prior to distribution. He said that's why Durbin's bill specifies that
stimulant manufacturers have to prove the product is safe. The makers of
vitamins and other supplements wouldn't be subject to those regulations.
"Contrary to what manufacturers tell you, their products are being tested.
They're being tested on the American public. We're the guinea pigs,"
Shoemaker said. "We think there's a better way to do it than wait until a
sufficient number of people drop dead from buying products over the
counter."
Durbin isn't alone in his concern about nutritional supplements. The
original sponsors of the 1994 law, Sens. Orrin Hatch (R-Utah) and Tom Harkin
(D-Iowa), have teamed together again this year to introduce the DSHEA Full
Implementation and Enforcement Act, a measure that has the support of the
National Nutritional Foods Association.
Hatch introduced the bill this summer to provide additional funding for the
FDA's enforcement efforts and provide more money to conduct scientific
research. He said his bill offers a balanced approach, while others would
undermine the supplement industry.
"If these natural products were required to meet the same safety and
efficacy standards as drugs, as some are threatening, it is extremely likely
that dietary supplements in the future would never make it to the market
place," Hatch said in a statement.
Another measure in the House, sponsored by Rep. Susan Davis (D-Calif.), who
was influential in California's effort to ban ephedra, would give the FDA
the authority to collect a greater amount of information about dietary
supplements and require manufacturers to send reports to the agency about
their products.
For the users of supplements, however, too much regulation ends up hurting
the consumer, said Gilbert, who prefers vitamins and herbs to prescription
medication issued by her doctor.
"I'm hoping they defeat [the Durbin] bill because it's just another
unnecessary thing to put on the public," Gilbert said. "Could you imagine if
they put all the health food stores out of business because one person took
a vitamin E pill or a garlic pill and had a negative reaction?"
