FDA Rule Makers Tackle Supplements
March 2, 2000
Since 1994, makers of dietary supplements have been allowed to make more aggressive health claims without Food and Drug Administration approval as long as they don't claim to cure diseases. But deciding what's a disease claim and what isn't can often be difficult.
- A supplement used "for the relief of occasional sleeplessness" is fine.
- But the claim "helps to reduce difficulty falling asleep" isn't, because it implies a treatment for insomnia, a disease.
- A drug that promises to restore potency would be open to rigorous FDA approval because impotence is a disease, while one that simply promises to increase sexual desire and improve sexual performance wouldn't.
New FDA rules regulating product health claims will go into effect this month and cover about 29,000 dietary supplements.
Even the FDA admits the differences between acceptable and unacceptable claims may be hard to distinguish, but the best bet for sellers in the $10 billion supplement industry might be to completely avoid the mention of any disease, even in passing.
However, the FDA still faces difficulties enforcing the rules. All supplement makers are supposed to send in their labels for a cursory review, but many don't. And if they all did, the FDA wouldn't have the manpower to review them. Finally, there are at least 1,000 supplement makers marketing their products on the Web.
A recent study showed 70 percent of U.S. households used supplements, mostly vitamins or nonprescription herbal products, in a six-month period.
Source: Chris Adams, "FDA Putting Supplements' Claims Under A Microscope," Fort Worth Star Telegram, February 28, 2000.
Browse more articles on Government Issues