US manufacturers and consumers of food supplements have enjoyed a liberal regime - is the end in sight?
Report finds FDA has power to ban supplements Friday, April 2, 2004 Posted: 1:56 PM EST (1856 GMT)
WASHINGTON (Reuters) -- The U.S. government does not need direct evidence of harm to humans before banning suspect dietary supplements, a study commissioned by the U.S. Food and Drug Administration concluded Thursday.
The report by the Institute of Medicine and the National Research Council, independent scientific groups that advise the government, also said "a number of legal and regulatory barriers ... that hamper the FDA's ability to protect the public's health" should be addressed.
About 29,000 supplements such as vitamins and herbs are sold in the United States and annual sales top $18 billion, said the report into the regulation of the industry.
Under a 1994 law, supplements do not have to pass the extensive safety and effectiveness tests required for pharmaceuticals prior to marketing. Like foods, supplements are presumed safe unless the government shows they are risky.
In December, the FDA for the first time announced it would ban a supplement, the herbal weight-loss aid ephedra. The agency heard years of complaints linking ephedra to heart attacks and deaths, but officials said they could not have acted sooner because it took time to compile evidence.
While most supplements are safe, data on the safety for humans of some ingredients "are scant or nonexistent," said Barbara Schneeman, chairwoman of the scientific panel.
In those cases, the law "does not require the same level of definitive proof that would be needed to document actual harm," Schneeman said.
Animal tests, research on similar substances, or other data could build a strong case to conclude a supplement poses a "significant or unreasonable risk" to humans, the legal standard set for outlawing a supplement, the report said.
To address shortcomings in the supplements law, the report urged amending it to require manufacturers to turn over consumer complaints about possible side effects. That change also is advocated by some lawmakers and industry groups.
The report offers "a valuable process and a legitimate approach to building better tools to address the issues that have been raised with regard to safety," said Michael McGuffin, head of the American Herbal Products Association.
Dr. Susan Walker, director of the FDA's division of dietary supplement programs, said the agency "will look at the totality of the report and implement (suggestions) as feasible."
If American industry and consumers think they can resist the pressures against food supplements in Europe and through the UN's Codex Alimentarius Commission - think again!
The closing down of the liberal US regime has been on the drawing board for some time now. There are at leasttwo bills (S. 722 and S. 1538) going through Congress that could cause havoc to the free supply of innovative food supplements, then there's the Institute of Medicine/National Research Council's proposed dietary supplement evaluation scheme, ever tightening Good Manufacturing Guidelines and Health Claims proposals.
All the US and EU proposals put the onus back on manufacturers to prove safety. If you can't afford the costs of such tests - you're no longer part of the club. Such a system massively disfavours smaller companies, which have been the key innovators in this food supplements sector.
Challenging successfully the EU Food Supplements Directive is likely to be the single most important action for health freedom globally. Let it send a strong message to the FDA that they cannot impose restrictions on food supplements without evidence of harm.
If we are able to eliminate the ban implicit in the EU's Food Supplements Directive, this precedent would have implications on a global basis, including in the US.
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