Kiss Vitamins Goodbye - FDA proposes supplement standards

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http://www.msnbc.com/news/882166.asp?0cv=CB10

 

 

FDA proposes supplement standards

 

Guidelines will ensure dietary aids are accurately labeled

 

 

ASSOCIATED PRESS

 

WASHINGTON, March 7 — The government proposed the first manufacturing standards

for largely unregulated dietary supplements Friday, saying the long-awaited

rules could cut fraud and contamination and finally ensure consumers get what

they pay for. However, there still will be no guarantee that the pills or

powders work or even are safe to swallow.

 

‘Consumers should have access to dietary supplements that are accurately

labeled and free from contaminants.’

— MARK MCCLELLAN

FDA Commissioner

 

BUT THE Food and Drug Administration’s factory rules aim to ensure that the

ingredients and dosages promised on a supplement’s bottle really are contained

inside, without any dangerous contaminants.

 

They’re a cross between the manufacturing standards required for foods and for

over-the-counter drugs like aspirin. Until now, only a small portion of the

supplement industry has followed voluntary quality standards.

 

A ‘BUYER-BEWARE MARKET’

 

Too often, this is “a buyer-beware market,” said FDA Commissioner Mark

McClellan. “Consumers should have access to dietary supplements that are

accurately labeled and free from contaminants.”

 

 

The FDA estimates that are at least 1,000 makers of dietary supplements sell in

the United States, a $19 billion industry that is exempt from most safety

oversight. Under a 1994 law, supplements can be sold without first proving

they’re safe or truly deliver the benefits they advertise; there isn’t even any

way to ensure a bottle contains the promised amount of pure ingredients.

 

 

Over and over in recent years, scientists and consumer groups have tested

bottles of supplements and found fraud. The FDA cited a recall of a line of

supplements discovered contaminated with brain-toxic lead. In another case, a

maker of folic acid — a nutrient taken by pregnant women to reduce birth defects

— recalled the pills after scientists discovered they contained only a third of

the amount listed on the label, meaning women didn’t get the protective amount

necessary.

 

 

The new manufacturing standards aim to prevent such problems by, among other

things, requiring certain quality-control steps that include company testing of

ingredients and finished products for contamination and the promised dose.

 

The proposed rules will be open for public comment for three months. McClellan

said he expected to issue final regulations next year. Bigger manufacturers will

have to comply first, with small companies given up to three years to implement

the rules.

 

FDA inspections, focusing most on “the potential bad actors,” will ensure the

rules are followed, McClellan said.

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But a segment of the supplement industry has long called for the manufacturing

standards, and McClellan said he expected more reputable firms would implement

the proposed rules right away.

 

“The responsible manufacturers are happy to comply,” said John Hathcock of the

Council for Responsible Nutrition, which represents 80 companies that follow

voluntary quality standards. Other manufacturers “cloud our whole industry, and

we’re glad to see federal action to force them to ... get in line or get out of

business.”

 

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