FDA Seeks New Rules for PillsMar 8, 2003 | AP
The government proposed the first manufacturing standards for largely unregulated dietary supplements yesterday, saying the long-awaited rules could cut fraud and contamination and ensure that consumers get what they pay for.
There still will be no guarantee that the pills or powders work or even are safe to swallow.
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.
The rules are a cross between the manufacturing standards required for foods and for such over-the-counter drugs as aspirin. Until now, only a small portion of the supplement industry has followed voluntary quality standards.
Too often, this is ''a buyer-beware market,'' FDA Commissioner Mark McClellan said. ''Consumers should have access to dietary supplements that are accurately labeled and free from contaminants.''
The FDA estimates that at least 1,000 makers of dietary supplements sell their products 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 that they're safe or that they 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 lead.
The new manufacturing standards aim to prevent such problems by requiring quality-control steps that include company testing of ingredients and finished products for contamination and the promised dose.