FDA Banning Non-Prescription Antibaldness Creams, Aphrodisiacs
WASHINGTON (AP) _ The Food and Drug Administration said Friday it is banning sales of non- prescription antibaldness creams and aphrodisiac products because none has been shown to work.
Over-the-counter hair-growth products - usually sold by mail or through barbers or beauticians - have dwindled in number since the FDA indicated in 1985 that it would ban the products.
But the FDA said these products ″have continued to be an area of considerable fraud. The ban of all such products will provide a greater and more uniform protection to the public.″
John T. Walden, a spokesman for the Nonpresscription Drug Manufacturers Association said: ″The industry has been anticipating this for a long time.″
The number of companies marketing nonprescription aphrodisiacs also has shrunk in anticipation of a ban.
The FDA said none of the products that claim to arouse or increase sexual desire or improve sexual performance is effective. No manufacturer even defended its product during the agency’s review, the FDA said.
The bans will become effective in six months.
For antibaldness products, the ban applies to those available without a prescription that are used externally.
The only product approved by the FDA for stimulating hair growth on the crown of the head is a prescription drug that is a 2 percent solution of minoxidil, which is applied externally. The drug is manufactured by The Upjohn Co. and sold under the name Rogaine.
The FDA also said it has no evidence that vitamins, food supplements or other products taken orally retard baldness or grow hair and warned it will remove from the market products for which such claims continue to be made.
The FDA’s ban on non-prescription antibaldness products is based on a recommendation of an advisory panel that evaluated a number of ingredients, including lanolin, olive oil, wheat germ oil and vitamins. The panel found none of these prevented baldness or promoted hair growth.
The FDA said that once the ban is in effect, manufacturers of any non- prescription remedy claiming to prevent baldness or grow hair will have to provide proof that it is safe and effective before it can be sold.
The FDA said that to demonstrate the effectiveness of a hair restorer, a manufacturer would have to show the product ″gets into the hair root and stimulates hair growth.″ Nothing that acts on the hair shaft after it emerges from the surface of the scalp will influence hair growth, the agency said.
FDA said baldness is an inherited trait, as is hair color, texture and curliness. The most common type of baldness occurs in men over an extended period of time, but hair loss can also result from malnutrition due to crash dieting, iron deficiency, hormone imbalance or exposure to radiation.
Ingredients commonly found in products billed as aphrodisiacs, according to the FDA, include cantharides, a chemical derived from the dried bodies of beetles; estrogens, the female sex hormones; strychnine, yohimbine, a poisonous substance obtained from the bark of a West African tree; fennel, mandrake, anise, licorice and zinc.
Some of these are contained in food products, but none of those would be covered by the ban unless specifically labeled as an aphrodisiac.
The FDA advised people with sexual problems to seek treatment by a medical professional and not to medicate themselves. Male sex hormones affect sexual drive and performance, but because they are powerful chemicals with potentially serious side effects they should be used only under a doctor’s care, the agency said.
The FDA review of both types of products is part of an ongoing evaluation of over-the-counter medicines that began in the early 1970s to ensure the safety and effectiveness of all of their ingredients.
Walden said he had no numbers of companies or sales estimates for either aphrodisiacs or antibaldness products, but he said there are very few.
The American Pharmaceutical Association’s Handbook of Nonprescription Drugs lists no aphrodisiac or antibaldness products.
Walden said none of his association’s members markets either type of product. The association’s members represent 95 percent of the FDA-regulated nonprescription drugs on the market, he said.