March 1, 2000

"Nutraceuticals": Do They Spell the End of FDA Regulation of Drugs?

The Pure Food and Drug Act was enacted in 1906 in response, in large part, to unscrupulous marketing of adulterated foods and of patent medicines lacking in efficacy and often containing addictive or harmful substances. Subsequent additions to the food and drug laws have attempted to insure that therapeutic claims for products are backed by scientific proof of safety and efficacy.

Anyone who recently has opened a magazine or watched television, however, is aware of a range of new product claims for a class of substances that are neither foods nor drugs. Dubbed "nutraceuticals" by Stephen DeFelice, M.D., they defy traditional FDA categorization and regulation. Estimates of current sales of these products exceed $30 billion per year. Sales of one segment of this market alone - so-called dietary supplements account for $12 billion annually.

The Rise of Alternative Medicine
These products are part of a growing interest in alternative medicine, which in turn reflects disenchantment with traditional medical services. This is due to a number of factors, including the corruption by managed care of the classic patient-physician relationship, frustration at the inability of modern scientific medicine to overcome diseases such as cancer, and an increase in patient outspokenness and access to medical information. A few managed care plans cover some forms of alternative medicine in the hope that patients will select them as less expensive treatment options. The National Institutes of Health (NIH) established an Office of Alternative Medicine in 1992. Congress has just elevated this to a Center for Complementary and Alternative Medicine with a $50 million a year budget.

Within the realm of alternative medicine, nutraceuticals represent one of the boldest challenges to government regulation. Historically, the FDA took the position that a product that made health claims was a drug. Beginning in 1976, vitamins and minerals were exempted from regulation as drugs, but only so long as they did not make health claims. Then, in the early 1980s, studies began to show that certain food ingredients, such as fiber, provided specific benefits to health. Food manufacturers wanted to proclaim these benefits to consumers without having to obtain drug approval. The FDA wrestled with this problem until Congress passed the Nutrition Labeling and Education Act of 1990. This law authorized the FDA to issue regulations permitting certain health claims for foods, which led the agency to allow claims associating low levels of calcium with osteoporosis, dietary fats with cancer and cholesterol with heart disease.

After passage of the FDA Modernization Act of 1997, a food could make a health claim without FDA regulatory authority so long as the claim was based on an authoritative statement by a governmental or quasi-governmental scientific body (such as the NIH or the Natinal Academy of Science [NAS]) and the agency was given advanced notice of the manufacturer's intent. This leeway did not apply to dietary supplements, however.

So, in 1994, Congress passed the Dietary Supplement Health and Education Act. Dietary supplements without drug approval can make so-called "structure/function" claims, such as "Vitamin A promotes good vision" or "St. Johns Wort maintains emotional well-being," so long as the label bears a disclaimer that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure or prevent disease. Until recently, dietary supplements could not make overt health claims (e.g., "Vitamin A prevents, cures or treats poor vision" or that "St. Johns Wort cures or treats depression") unless the FDA specifically permitted such a claim (as it has in the case of folic acid and the prevention of neural tube defects in babies).

Is the FDA Dropping the Ball?
Pearson v. Shalala (D. C. Cir. No. 98-5043, January 15, 1999), held that the FDA must allow a dietary supplement to make a health claim without it being based on an authoritative statement so long as the label bears an appropriate disclaimer.

These developments have some important consequences for doctors and patients. It becomes all the more incumbent for the doctor to provide accurate scientific information about these products to patients, particularly since patients may come to expect physicians to describe these products as alternatives to approved drugs. If the physician recommends a dietary supplement instead of an approved drug, the physician must be aware of the liability risk that the patient's health will suffer and that the patient will sue for malpractice.

Because dietary supplement products can not be patented and thus marketed as unique products, there is little incentive for manufacturers to spend the millions of dollars necessary to conduct large-scale clinical trials to substantiate any health claim they make about the product. To remedy this situation, it has been suggested that the manufacturer be given a period of exclusivity for the use of a health claim if the manufacturer conducts successful clinical trials to substantiate the claim. For example, a manufacturer that demonstrated that a dietary supplement successfully treated depression would be the only company allowed to make that claim on a product label for a certain amount of time. It remains to be seen if Congress will adopt such an approach and, if so, if it will spur a substantial number of clinical investigations that satisfy rigorous scientific standards. Otherwise, you, the consumer, should remember the slogan, Buyer Beware.
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