FDA Bans Over-the-Counter Products That Claim to Cure or Prevent Baldness

Prompted by evidence of consumer fraud, the Food and Drug Administration on Friday banned all non-prescription hair lotions or creams claiming to prevent baldness or stimulate hair growth.

Manufacturers of the lotions, creams and tonics--sold primarily through the mail and in barbershops--cannot prove scientifically that their products effectively cure or prevent hair loss, the FDA said. All such products will be pulled from the shelves by January, 1990.

The FDA’s rule states that “any over-the-counter hair grower or hair loss prevention drug product . . . is not generally recognized as safe and effective and is misbranded.”

Baldness cures “have continued to be an area of considerable consumer fraud,” the FDA said. “The ban of all such products will provide greater and more uniform protection to the public.”

Untouched by the ban is minoxidil--the sole product approved by the FDA for stimulating hair growth. The prescription drug, called Rogaine Topical Solution, is marketed by Upjohn Co.

“We’re glad that this happened,” said Robert Dreyfuss of Public Citizen, a consumer interest group founded by Ralph Nader.

But, he said, all over-the-counter drugs should be checked for safety and effectiveness, not just those dealing with hair loss.

“A journey of 1,000 miles begins with steps like this,” he said.

In a related action, the FDA also banned the sale of goods labeled aphrodisiacs, over-the-counter products that claim to increase sexual desire.

“Labeling claims for aphrodisiacs for over-the-counter use are either false, misleading or unsupported by scientific data,” the FDA concluded.

The bans came as part of the FDA’s continuing review of over-the-counter drugs. A panel of experts examined the main ingredients in hair-growth tonics and baldness cures, which include lanolin, olive oil, wheat germ oil and vitamins, and found none of the ingredients to be effective in stimulating hair growth or retarding hair loss.

Companies wishing to market over-the-counter baldness cures in the future must have their products approved by the FDA in advance, the new rule states.

Although the ban does not extend to pills or other products taken internally that claim to cure or slow baldness, the FDA warned that no evidence supports those products’ claims, either, and said they may be removed from the market on a case-by-case basis.

In 1980, the FDA issued a preliminary rule clearing the way for a complete ban on baldness cures. The agency since has moved against individual companies but Friday’s action was the first taken against the entire industry.

Barbara Gleason, a representative of the Non-Prescription Drug Manufacturers Assn. in Washington, said she is not aware of any major companies selling baldness cures. The association represents 95% of the non-prescription drug industry. The long time between the preliminary rule and today’s ban may have caused companies selling such products to leave the market, Gleason said.

With the baby boom generation aging, preventions and cures for baldness compose a lucrative market. The Upjohn Co. estimates that men spend $200 million annually on over-the-counter baldness cures.

“We couldn’t be more pleased by the issuance of these regulations,” said Mark Novitch, Upjohn executive vice president.

The ban should be a welcome boost to Rogaine, which has not generated as much money in sales as analysts had expected. Upjohn spokesman T. R. Reed refused to disclose sales figures for Rogaine, which was approved by the FDA in September. The drug, which was originally developed for treatment of high blood pressure, was found to increase hair growth in some patients.

FDA tests found that the drug’s hair-growth effects were limited and that it carried risks for people with heart disease. Reed said clinical tests of the drug showed that 39% of men tested experienced hair growth.

In response to the FDA’s ban Friday, Upjohn launched a new advertising campaign to encourage barbers and beauticians to tell their clients that their doctors can prescribe a drug that may help with hair loss.

Baldness, affecting more than 33 million men in the United States, is an inherited trait. Hair loss can also be caused by crash dieting, an iron deficiency, a hormone deficiency or exposure to radiation.