Good thing that Madame Ruth on Thirty-Fourth and Vine never mass produced her famed Love Potion # 9 or she may have had an issue with the Food and Drug Administration (FDA). In 1989, FDA concluded that all aphrodisiacs are unapproved new drugs and thus are prohibited from being sold without first obtaining FDA premarket approval through a new drug application.
What exactly are aphrodisiacs? According to FDA, an “aphrodisiac” is any product claiming that “it will arouse or increase sexual desire, or that it will improve sexual performance.” The following are examples of an aphrodisiac claim:
“acts as an aphrodisiac;”
“arouses or increases sexual desire and improves sexual performance;”
“helps restore sexual vigor, potency, and performance;”
“improves performance, staying power, and sexual potency;” and
“builds virility and sexual potency.”
21 C.F.R. 310.528(a).
When FDA issued this regulation in 1989, it concluded that even herbs and minerals that made these claims were drug products and thus unlawful without FDA premarket approval. However, a quick scan of the dietary supplement aisle will find numerous products for “sexual health,” which claim to:
Help with libido, energy, and vitality
Stimulate sexual desire
What’s going on; didn’t FDA ban these claims?
Well sorta, but it all goes back to the definition of a “drug” under the Food, Drug, and Cosmetic Act, which includes:
“articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals”
“articles (other than food) intended to affect the structure or any function of the body of man or other animals”
FDCA Section 201(g)(1).
“Foods” (including dietary supplements) are permitted to make structure/function claims: thank you parenthetical (as well as other statutory sections, but that can be another story). When FDA issued their aphrodisiac declaration in 1989, there was no such regulatory category of “dietary supplement,” which could make structure/function claims. Yet after Congress created this new category, FDA later acknowledged that several sexual desire/function claims are structure/function claims and thus do not classify the product a “drug.”
Alas, FDA never went back to revise the regulation with the categorical declaration that all aphrodisiacs are drugs. The Agency did explain that sexual health dietary supplements cannot be potent, because “potency” and “impotent” (a disease condition) share the same root and thus “potency” is an implied claim that the product cures impotency. So Madame Ruth needs to be careful about how she crafts her claims for Love Potion #9 to avoid needing premarket approval as a new drug.
There’s also this question about substantiation, but more for another day … …