Fda Allows Supplement Industry To Expand On Health Claims

By Judy Foreman, Globe Staff, 01/07/00

The change delighted the supplement industry but shocked some consumer advocates, who fear it may weaken protections for patients.

Until now, the FDA's position has been that supplements could not claim to treat, prevent, or cure a particular disease but that manufacturers could make claims that products maintained the healthful "structure" or "function" of the body.

But that line - between disease claims and structure/function claims - has been fuzzy, and controversial, since 1994, when Congress passed the Dietary Supplement Health and Education Act, or DSHEA.

To remedy the confusion, the FDA decided in 1998 to make a rule defining "disease" so that supplement manufacturers could not make disease claims without prior FDA approval.

But supplement manufacturers protested. So did consumers - more than 100,000 of whom wrote to the FDA - and the FDA reconsidered. The new - and final - rule, which takes effect in 29 days, was published yesterday in the Federal Register.

The rule says that a number of common conditions such as aging and pregnancy are normal life stages, not diseases, and therefore manufacturers can make structurefunction claims for products aimed at them, said Peggy Dotzel, acting associate commissioner for policy at the FDA.

In other words, hot flashes are not a disease but a common condition that supplement manufacturers can make claims for on product labels. Products can also make claims that they may help with acne or maintaining a healthy attitude during premenstrual syndrome, she said. And they can address minor problems of aging such as wrinkles, liver spots, and mild memory loss.

Products cannot make claims to treat or prevent illnesses such as osteoporosis or Alzheimer's disease, she added.

In a prepared statement, the FDA said that it was making these changes "in response to comments from industry and consumers."

"These changes, which have the effect of expanding the number of acceptable structure/function claims, include revising the definition of `disease' in response to comments that it was too broad and permitting structure/function claims about certain common conditions associated with aging, pregnancy, menopause, and adolescence.

"Serious conditions associated with aging, pregnancy, menopause, and adolescence, such as toxemia of pregnancy and osteoporosis, will continue to be treated as diseases," the agency said.

To consumer health advocates such as Dr. Sidney M. Wolfe, director of Public Health Citizen Research Group in Washington, D.C., the change is an outrage, a "huge weakening" of the previous FDA proposal.

Bruce Silverglade of the Center for Science in the Public Interest said the new rule "allows supplement manufacturers to make claims regarding serious health conditions without any premarket review by the FDA."

On the other hand, industry representatives were delighted.

"The FDA has backed down from its previous, ill-considered proposal to redefine the word `disease' by broadening. . .to include nonpathological states that are a normal function of aging or the body," said Mark Blumenthal, executive director of the American Botanical Council in Austin, Texas, a nonprofit research and education organization funded in part by the herbal industry.

Under the FDA's original proposal, "menopause would be considered a disease. Even balding and graying of a beard would have been considered a disease," he said.

Some information from wire services was included in this report.