Nostrums that promise to enhance the hairline and enliven the libido have run afoul of the federal government.
The Food and Drug Administration yesterday proposed to ban the sale of all nonprescription drug products sold to prevent or reverse baldness. It called the products an "area of considerable consumer fraud," and said there is no scientific evidence that such lotions and creams work.
In a separate action, the FDA is seeking to halt the sales of drugs sold as aphrodisiacs without prescription, saying that such products have not been proven safe and effective.
It urged those suffering from "decreased libido and impaired sexual performance" to seek professional treatment rather than "self-medicate."
The two proposals result from a review of over-the-counter drugs that has been under way since l972. Agency officials, while acknowledging that they have proceeded slowly, say that the proposed bans will help slow fraudulent sales of such products.
The proposals will be published in today's Federal Register and allow for public comment before final action is taken.
One of the first comments came from John T. Capps III, founder of Bald-headed Men of America, an international club of 15,000 based in Morehead City, N.C.
"Baldness is a sign of virility," Capps said. "Bald-headed men don't need any aphrodisiacs anyway. We say there is no room for drugs, plugs or rugs, because it's natural. We believe skin is in . . . . Most intelligent women like to rub, massage and manipulate a bald head."
Thomas Loesch, whose Houston-based Loesch Laboratory Consultants produces a "hygiene regimen for people with oily scalps," said that his company would fight the FDA action by submitting new data showing that their product works for a limited group of people who are going bald.
Dr. William E. Gilbertson, head of the FDA's over-the-counter drug review program, said yesterday the proposed ban is "due to a lack of demonstrated effectiveness of these products. None were found to be unsafe."
A recent FDA-sponsored review of 435 newspaper and magazine ads found that "hair restoration schemes are next in popularity to diet hoaxes," says the agency's Roger W. Miller. While 249 were for diet products, 89 were for hair-restoration -- 42 for products and 47 for clinics.
The products contain active ingredients applied to the scalp, including natural amino acids, vitamin C, the B vitamins, sex hormones, lanolin, antimicrobial drugs and wheat germ oil.
Miller said that while the proposed ban would apply to "all baldness prevention aids sold as over-the-counter drugs until they are shown to be effective," it would not apply to prescription drugs, massage treatments, surgical hair transplants or treatment centers.
The action does not apply to a potentially promising drug called minoxidil that has been under testing by the Washington Hospital Center and may be marketed in the future by Upjohn.
Gilbertson acknowledged that the attempt to ban baldness products is likely to proceed slowly, allowing manufacturers to provide whatever data they have, and may take two or three more years to become final. It has already been more than four years since an outside scientific review panel issued a report condemning the nonprescription hair growth products.
That panel said that most male baldness is inherited but that sudden or unusual hair loss can also result from malnutrition, iron deficiency, hormone imbalance or exposure to radiation and should be checked by a doctor.
In terms of aphrodisiac drugs, Gilbertson said that no companies had submitted data to the FDA but that a study of a chemical called yohimbine is underway in Canada.