FDA Targets Baldness and Sex Potions : Drugs: Regulators are cracking down on the big business in products that fraudulently claim to be miracle cures.
You say your hair is falling out? Stand on your head and rub your stomach three times. You say your problem is sexual? How about putting a new, copper penny under your pillow every night.
If that sounds ridiculous, more than a few Americans waste a lot of time and money on so-called cures for baldness and aphrodisiacs that have about the same chance of success, according to the Food and Drug Administration.
On Monday, the FDA began enforcing a ban on the sale of any non-prescription hair cream, lotion or any other over-the-counter product that promises to grow hair or prevent baldness. A similar ban also became effective on the sale of over-the-counter products labeled aphrodisiacs--products that claim to increase sexual desire. Compared to the so-called baldness cures, phony aphrodisiacs are a relatively small--but equally intolerable--problem, according to an FDA spokeswoman. But so-called hair growing potions make up a very big business.
Americans spend about $300 million a year on ineffectual cures for baldness, according to the American Hair Loss Council, a group of medical and non-medical professionals who promote “safe alternatives to baldness,” including the only prescription drug with FDA approval for stimulating hair growth.
The FDA announced the ban in July, but there apparently has been no effect on the availability of the hair products. With the ban formally in place, many who applauded the FDA action say they expect marketers simply to change tactics.
“They will just call them vitamins,” said Irv Dickstein, a spokesman for a Santa Monica clinic that performs hair transplants and in some cases prescribes minoxidil--the FDA-approved product. The agency approved Upjohn Co.’s Rogaine Topical Solution (2% minoxidil), the only product it said satisfies scientific standards for proven effectiveness. Rogaine was approved for distribution by prescription only.
The FDA ban specifically covers only products for external use, but the agency stressed that there is also no evidence that vitamins or food supplements prevent hair loss or promote grow hair. Those products may also be removed from the market on a case-by-case basis if such claims continue, the FDA said.
The FDA announced the ban on external products after a panel of experts examined products with ingredients such as lanolin, olive oil, wheat germ oil and vitamins. None were found to be effective, and marketers didn’t respond to invitations to present any evidence of effectiveness, the FDA said.
Dickstein said there are hundreds of sham products on the market and about as many different sellers. “I get stuff sent to me from all over the world,” he said. Most marketers are invisible entities that operate through post office boxes and barbershops. “All it takes is a post office box, and a ‘before’ and ‘after’ picture of a guy with a full head of hair and two or three women hanging on him,” Dickstein said.
