Millions of users of St. John’s wort, calcium and other dietary supplements may soon know for sure they’re getting what they pay for: The government proposed the first manufacturing standards for the $19 billion supplement industry Friday in an attempt to cut fraud and contamination.
There still will be no guarantee that the pills and powders deliver the health benefits advertised or are even safe to swallow. Unlike drugs, supplements can be sold without any scientific proof of safety or effectiveness.
But the Food and Drug Administration’s long-awaited factory rules aim to ensure that the ingredients and dosages promised on a supplement’s bottle really are contained inside – without dangerous contaminants like bacteria and brain-damaging lead that have been found in some.
Today, it’s “a buyer-beware market,” said FDA Commissioner Mark McClellan. “Millions of Americans use dietary supplements every day, and we need to make sure they’re getting the products they pay for.”
There are more than 1,000 makers of dietary supplements, products that range from mainstream vitamins to herbs to controversial hormones and stimulants. Ephedra, an herbal stimulant blamed for dozens of heart attacks, strokes and deaths – is the most notorious, drawing an FDA warning last week.
Supplement makers are exempt from most safety oversight, thanks to a 1994 law. Nor has there even been federal quality control: Over and over in recent years, scientists and consumer groups have uncovered fraud when testing various types and brands.
The FDA cited a bee product found to be contaminated with lead, and a brand of folic acid required during pregnancy to reduce birth defects that contained only a third of the promised dose.
In another example, California researchers tested 12 different bodybuilding supplements and found only one contained the amount of androstenedione or related ingredients promised on the bottle. Far worse, one brand illegally contained testosterone, a controlled substance that should be sold only with a prescription.
The new manufacturing standards aim to prevent such problems with, among other things, certain quality-control steps that require company testing of ingredients and finished products to verify purity and dose. Also required are improvements in labeling and ways to handle consumer complaints.
The FDA characterized the rules as a mix of standards now required for foods and for over-the-counter drugs.
The rules are open for public comment for three months. Final regulations are expected next year, and manufacturers then would have time to start complying up to three years for the smallest companies.
Until now, only a small portion of the supplement industry has followed voluntary quality standards. Some companies paid for programs that did spot-testing to certify a product contained the ingredients advertised.
Some supplement makers have long lobbied for the standards, required under the 1994 supplement law, by arguing that less reputable competitors were harming the whole industry.
Consumer groups also welcomed the standards.
The proposal is “a step in the right direction,” said Bruce Silverglade of the Center for Science in the Public Interest. But the rules won’t ensure a supplement is completely safe, just that it has no impurities, Silverglade cautioned.
Consumers “can know it has the strength per dose of whatever ingredient it is they’re ingesting, but it could still be harmful to them,” agreed Janelle Mayo Duncan of Consumers Union.