Will the FDA crack down on homeopathy? - Food and Drug Administration

Vegetarian Times, Feb, 1995 by Steve Lustgarden

A GROUP OF 42 PHYSICIANS and consumer advocates have petitioned the U.S. Food and Drug Administration (FDA) to curb the sale of over-the-counter homeopathic products.

Led by Stephen Barrett, M.D., a prominent opponent of alternative medicine and an activist against health fraud, the petitioners call homeopathic preparations worthless and assert that manufacturers of homeopathics are wrongly exempt from laws that require other drug manufacturers to prove their products safe and effective. The petition asks that the agency require homeopathics to meet the same standards as other drugs; it also demands that the FDA issue a public warning stating that the agency does not recognize homeopathic products as effective.

"The definition of drugs within the [Food, Drug and Cosmetic Act of 1938] specifically includes homeopathic drugs," says Wayne Mitchell, a lawyer with the FDA's Office of Regulatory Affairs, who will draft the agency's response to the petition. "As far as the act is concerned, homeopathic drugs are regulated just as any other drug. The agency has not strenuously regulated homeopathic drugs, but that's been a matter of enforcement discretion rather than any sort of exemption under the act."

The FDA's take on homeopathics is that they are not unsafe. And what about the petitioners' contention that homeopathic drugs are ineffective? "As far as we're concerned," says Mitchell, "there is no evidence that the efficacy of homeopathics has been proved or disproved." Mitchell says that the requirement to prove a drug's efficacy never applied to homeopathics--as well as a large number of other drugs, such as codeine--which were grandfathered in without testing because they had a long history of use prior to 1938.

According to Jay Borneman, spokesperson for the American Homeopathic Pharmaceutical Association in Norwood, Pa., which represents manufacturers and retailers, the petitioners "absolutely refuse to admit the existence of several hundred years of clinical literature," proving homeopathics' safety and efficacy.

The petition arrives just as the National Institutes of Health's Office of Alternative Medicine is funding studies on homeopathy and as more research is appearing in peer-review journals. In May 1994, for instance, the journal Pediatrics published a study showing that homeopathic medicines effectively treated acute infantile diarrhea.

The FDA has until Feb. 27 to respond to the petition. And while the agency seems unlikely to take any immediate action to tighten restrictions on marketing homeopathics, Mitchell acknowledges that "we are certainly taking the issue [of stricter regulation] seriously. Homeopathy is growing tremendously right now. Many homeopathic preparations are being marketed in mainstream retail outlets and so we are seriously examining how homeopathics should be regulated."