FDA May Ban Over-the-Counter ‘Aphrodisiacs’

The Food and Drug Administration said Wednesday that there is no such thing as a safe and effective over-the-counter aphrodisiac and proposed a ban on the marketing of non-prescription drugs that claim to arouse sexual desire.

The FDA issued a formal notice that it is tentatively adopting the conclusions of an advisory board that has been studying the drugs, a preparatory step to issuing a regulation banning them.

The ban would not take effect until six months after a final regulation is published. But, presuming that the final regulation also affirms that aphrodisiacs are ineffective and misbranded, non-prescription drugs claiming to arouse desire would be regarded as unapproved new drugs, the FDA said.

The agency said that its advisory committee had concluded that persons experiencing sexual problems should seek professional help and not attempt to medicate themselves.

“It’s a rip-off,” FDA spokesman Ed Nida said of the alleged aphrodisiacs. “The only effective ingredients are those administered by a physician.”

Of the non-prescription drugs available, the panel said, there is no conclusive scientific evidence that any are safe or effective, even among products that have been used historically as aphrodisiacs.

In addition, the panel said, serious health risks are associated with some substances, such as “Spanish fly,” a drug that is prepared from ground-up beetles.

Male sex hormones do have a proven influence on sexual arousal and performance, the committee said, but they also have potentially serious side effects and must be used under a doctor’s supervision.

The FDA noted that the panel’s conclusions dealt only with drugs, not with vitamins and minerals that are reputed to have aphrodisiac qualities.

However, the FDA added that it “is not aware of any data or information to support the effectiveness of any vitamin or mineral for use as an aphrodisiac.”