'Death knell' for Flintstones vitamins?

Opponents of a congressional bill regulating vitamins and other nutritional supplements warn of a "Hillarycare" approach to the issue that would cut off most consumers' access to the products.

A citizens' group called Project: FANS – Freedom of Access to Nutritional Supplements – says the bill "could kill the entire industry and remove nearly all vitamins and supplements from the market."

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"Instead of the Senate adding yet another new law to the books, creating more government bureaucracy, and increasing American's tax burden as a result, they should fully enforce the current law," said Project: FANS director Beth Clay in a statement.

The bill, known as the Dietary Supplement Safety Act of 2003, was introduced by Sen. Dick Durbin, D-Ill., and co-sponsored by Sens. Hillary Clinton, D-N.Y., Dianne Feinstein, D-Calif., and Chuck Schumer, D-N.Y.

The sponsors argue it's a response to a growing number of deaths allegedly associated with the use of dietary products containing the natural supplement ephedra, according to Insight magazine.

The most notable incident was the death of Baltimore Orioles pitcher Steve Bechler on Feb. 17. But Durbin says what pushed him to fight for regulation was the death of a 16-year-old constituent, Sean Riggins, who died from an ephedra-induced heart attack Sept. 3, 2002, Insight said.

Durbin wants to require manufacturers of dietary supplements to prove the product is safe before marketing it. His bill would expand the FDA's authority to require manufacturers to conduct extremely expensive tests if they receive a single report of an adverse reaction, according to the magazine.

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Project: FANS says the burden on manufacturers will be overwhelming, installing a system more complex and costly than the current $800 million process required of the prescription drug industry.

The legislation ultimately will strip the market of its ability to determine which vitamins, minerals and botanical supplements will be available, Clay contends.

Seven out of 10 consumers could lose access to nutrition supplements and important dietary aids necessary for their health and well-being, she claims.

The current law, the Dietary Supplement Health and Education Act of 1994, gives the Food and Drug Administration all the tools it needs to properly regulate the supplement industry, Clay insists, contending DSHEA has never been properly funded since it was passed in 1994.

"American consumers need to know their freedoms are about to be limited," Clay said. "If S. 722 becomes law it will affect everyone; from 5-year-old children who take chewable vitamins, to those who rely on iron supplements, to women who use calcium to help prevent osteoporosis."

Opponents dispute Durbin's claim that scientific reports have linked ephedrine and similar dietary supplements to 117 deaths and more than 17,000 other health-related problems, Insight reported. They point out in 2001, the Department of Health and Human Services received just 10 adverse-event reports from manufacturers for all dietary-supplement products combined.

Durbin contends the discrepancy shows "the voluntary-reporting system under current law is clearly not working."

Current regulations regard dietary supplements as a special category of food rather than as a drug, and notification of adverse reactions is voluntary, leaving responsibility for safety to the manufacturers.

Joe Shoemaker, a spokesman for Durbin, maintains opponents are exaggerating claims about the bill's impact, the Times of Northwest Indiana reported.

"It's a scare tactic to make people think, 'Durbin's after my vitamins,'" he said.

He disputes claims that supplements would be available only with a prescription, contending most vitamins and minerals would be unaffected by the legislation.

Supplements that act as stimulants would be treated as over-the-counter drugs, he said, according to the Times, and regulated in much the same way as aspirin is today.

But Clay points out "any product that has had one serious adverse event can be banned," adding that such widely used supplements as Vitamin C and Echinacea would fall into that category.

"Durbin's bill would hold long-used nutritional supplements, from calcium to Flintstone vitamins, to a higher reporting standard than is currently set for many prescription drugs," she said, according to the Indiana paper.