Splitting Hairs on Supplement Claims --- Under the FDA's Guidelines, Improving Health Is OK; Curing a Disease Isn't
Wall Street Journal; New York; Feb 22, 2000; By Chris Adams;

Edition:	Eastern edition
Start Page:	B1
ISSN:	00999660

Abstract:
Not to the Food and Drug Administration, which has been busy making numerous hair-splitting distinctions as it tries to regulate the $10 billion market for dietary supplements. In new guidelines that went into effect this month, the FDA says a supplement promising to restore "potency" implies that it treats a disease (impotence) and thus must undergo the rigorous FDA approval, such as that used for prescription drugs. The other label, by contrast, doesn't propose to cure a specific malady and so the FDA doesn't require lengthy approval.

The new rules are aimed at clearing up confusion in the supplement industry, which has become increasingly aggressive in making certain health claims since 1994. At that point, Congress gave supplement makers permission to do so without prior FDA approval as long as they weren't claiming to cure diseases. Since then, the FDA has attempted to refine the distinction between disease claims and other claims. It's a tough chore, as even the FDA's critics are quick to point out.

The agency itself acknowledges that the differences between acceptable and unacceptable claims may be hard to discern. Supplement makers wishing to avoid an FDA product review, however, might try to avoid the mention of any disease, even in passing. Instead of promising to "maintain healthy lungs in smokers," (a disease claim according to the FDA because it implies prevention of tobacco-related illness) a breathing-supplement company may instead say its product "maintains healthy lung function."

Full Text:
Copyright Dow Jones & Company Inc Feb 22, 2000

One herbal supplement claims it "increases sexual desire and improves sexual performance." Another supplement promises to "restore sexual vigor, potency and performance." Sounds about the same, right?

Not to the Food and Drug Administration, which has been busy making numerous hair-splitting distinctions as it tries to regulate the $10 billion market for dietary supplements. In new guidelines that went into effect this month, the FDA says a supplement promising to restore "potency" implies that it treats a disease (impotence) and thus must undergo the rigorous FDA approval, such as that used for prescription drugs. The other label, by contrast, doesn't propose to cure a specific malady and so the FDA doesn't require lengthy approval.

If this sounds bewildering, it's just the beginning. The phrase, "for the relief of occasional sleeplessness," for example, is acceptable. The claim, "helps to reduce difficulty falling asleep," is not, because it implies a treatment for insomnia, a disease. In all, the FDA came up with dozens of examples of acceptable and unacceptable language, drawn from both real and hypothetical labels after wading through some 235,000 comments from consumers, advocacy groups and supplement makers.

The new rules are aimed at clearing up confusion in the supplement industry, which has become increasingly aggressive in making certain health claims since 1994. At that point, Congress gave supplement makers permission to do so without prior FDA approval as long as they weren't claiming to cure diseases. Since then, the FDA has attempted to refine the distinction between disease claims and other claims. It's a tough chore, as even the FDA's critics are quick to point out.

The agency itself acknowledges that the differences between acceptable and unacceptable claims may be hard to discern. Supplement makers wishing to avoid an FDA product review, however, might try to avoid the mention of any disease, even in passing. Instead of promising to "maintain healthy lungs in smokers," (a disease claim according to the FDA because it implies prevention of tobacco-related illness) a breathing-supplement company may instead say its product "maintains healthy lung function."

The FDA's latest rules come as dietary supplements have become medicine-cabinet staples. A recent study showed that nearly 70% of U.S. households used supplements, generally vitamins or nonprescription herbal products, in a six-month period.

The FDA estimates that its new rules would cover some 29,000 dietary supplements in the marketplace, though officials warn that the number may not be accurate due to the highly fragmented nature of the industry. About 95% of all supplement companies sell less than $20 million in products a year. There are at least a thousand supplement makers pushing products, with many upstarts marketing themselves on the Web.

As a result, the FDA is finding it difficult to enforce its rules. All supplement makers, including those who don't make disease claims, are supposed to send their labels in for a cursory review. Many don't. In fact, the agency figures that manufacturers submitted only about 10% of the 22,500 labels that should have been reviewed over the past five years.

But if manufacturers suddenly were to send in all their claims, the FDA would have another problem: Lack of manpower. The agency only has about five people reviewing claims.

The FDA knows it needs more people watching the industry. The dietary supplement program "represents our biggest mismatch between the resources we have available and the job we have to accomplish," says Joseph Levitt, director of the the FDA's Center for Food Safety and Applied Nutrition.

Supplement makers say the new rules are confusing. John Hathcock, vice president of nutritional and regulatory science for the Council for Responsible Nutrition, an industry group, says manufacturers still don't fully understand where the FDA is drawing the line between disease and non-disease claims. The group has filed a petition objecting to portions of the FDA rules.

Pressed by consumers and manufacturers, the FDA did use its new rules to spell out positions on several issues. The agency, for example, said it believes that alcohol intoxication -- not only long-term alcoholism, but a mere weekend bender -- falls under its definition of a disease. "Alcohol intoxication causes temporary damage to brain function, causing impairments of judgment, attention, reflexes, and coordination," the agency says. The intoxication guidelines apply to manufacturers peddling supplements that promise to block or minimize the effects of alcohol.

The FDA also reviewed a whole host of "antiflatulent" statements, determining that most products in that category did not make disease claims. And it forcefully articulated the view that a good blow of the nose does not constitute a medical treatment. "Neither tissue nor Kleenex . . . treat, prevent, or otherwise affect nasal congestion in any way," the agency says.

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                   Fine Distinctions 

  The FDA has tried to draw the line between `structure/function 
claims,' which don't have to go through formal FDA review, and 
`disease claims,' which do. It's a fine line: 

  Acceptable structure/function claim: 

  Maintains healthy lung function 

  Arouses or increases sexual desire and improves sexual performance 

  Helps to maintain cholesterol levels that are already within the 
normal range 

  Supports the immune system 

  For the relief of occasional sleeplessness 

  `Resolving that irritability that ruins your ' day,' or reference to 
`nervous irritability' 

  Helps support cartilage and joint function 

  Unacceptable disease claim: 

  Maintains healthy lungs in smokers 

  Helps restore sexual vigor, potency, and performance 

  Lowers cholesterol 

  Supports the body's antiviral capabilities 

  Helps to reduce difficulty falling asleep 

  A reference to helping a `nervous tension headache' 

  A reference to helping `joint pain'

Credit: Staff Reporter of The Wall Street Journal

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