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FDA Loses Supplements Fight

From The March 1999 Issue of Natural Foods Merchandiser


Pamela Wyngate

Court rules that health claims are OK, information helps, not hurts, on labels

The FDA lost a key legal battle recently, and now the agency must define just what it means by "significant scientific agreement" for health claims on supplements labels.

The U.S. Court of Appeals ruling validated what many in the supplements industry have been saying for years: more information on supplements' labels translates into better educated consumers.

The natural products industry has served as the voice of the dietary supplements consumers in this matter, according to Susan Haeger, president and CEO of Boulder, Colo.-based Citizens for Health, a plaintiff in the five-year lawsuit. "[We are] extremely pleased that the appellate court has told FDA to define significant scientific agreement," she said. "This landmark decision is absolutely essential to allow consumers to make informed choices about their health care and is likely to have far-reaching implications."

The ruling overturned a lower court decision that had ruled that the FDA could continue to operate the way it had in the past. Lawyers for the FDA have not yet announced if they will appeal the latest decision to the Supreme Court.

Some of the implications of the appeal court's intent are apparent in the sharply worded comments in the ruling directed at the FDA. The court criticized the agency's argument that health claims lacking significant agreement are inherently misleading: "...It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled," according to the judges of the District of Columbia Appeals Court. "We think this contention is frivolous."

The ruling also included the right for dietary supplements manufacturers to put more information on labels than is currently acceptable. This includes disclaimers as well as health claims.

The ruling went on: "Although the government may have more leeway in choosing suppression over disclosure as a response to the problem of consumer confusion where the product affects health, it must still meet its burden of justifying a restriction on speech--here the FDA's conclusory assertion falls far short."

Retailers said they were excited about the ruling. "From where we are sitting, we see it as a good decision," said Jim Lee, president of Boulder, Colo.-based Wild Oats. "To define significant scientific agreement--simply put, it means that more information will be provided to our customers. And we know our customers want that."

The January decision came in a case originally filed by a group that included the American Preventative Medical Association, Citizens for Health, People Against Cancer and others. In 1994 those groups filed a lawsuit against the FDA, asking the agency to define "significant scientific agreement"--the standard FDA phrase for regulating health claims allowed on supplements' labels.

"I am absolutely thrilled that the court has recognized the validity of our position and instructed the FDA, finally, to define significant scientific agreement," said Ralph Miranda, M.D., president of the preventative medicine association. "Now, the FDA will no longer be able to get away with continually raising the bar for supplements manufacturers in an effort to prohibit the dissemination of truthful, scientific information."

In addition to defining "significant scientific agreement," the court ordered the FDA to reconsider the following four claims made in the 1994 lawsuit:

* Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.

* Consumption of fiber may reduce the risk of colorectal cancer.

* Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.

* A supplement with 0.8 milligrams of folic acid is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.

Watch for more work on this issue in the courts later this year, said Tony Martinez, New Jersey- and Washington D.C.-based attorney and lobbyist who worked for the natural products industry on the Dietary Supplement Health and Education Act of 1994. "This decision represents an important and significant victory for the attorneys involved. They deserve the thanks and congratulations from the industry," he said. "It will be interesting and significant to see what objective criteria the FDA develops for significant scientific agreement."

-- Substitute for a drug, through a name such as "Herbal Prozac" or claims that they contain aspirin or another well-known drug.

But supplement claims clearly targeted to help a well person stay well would be OK. The FDA said naming a supplement "Cardiohealth," for instance, is legal, as is saying it "supports the immune system," "reduces stress" or "helps maintain cardiovascular function."