[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.528]

[Page 38]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 310--NEW DRUGS--Table of Contents
 
        Subpart E--Requirements for Specific New Drugs or Devices
 
Sec. 310.528  Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.

    (a) Any product that bears labeling claims that it will arouse or 
increase sexual desire, or that it will improve sexual performance, is 
an aphrodisiac drug product. Anise, cantharides, don qual, estrogens, 
fennel, ginseng, golden seal, gotu kola, Korean ginseng, licorice, 
mandrake, methyltestosterone, minerals, nux vomica, Pega Palo, 
sarsaparilla, strychnine, testosterone, vitamins, yohimbine, yohimbine 
hydrochloride, and yohimbinum have been present as ingredients in such 
drug products. Androgens (e.g., testosterone and methyltestosterone) and 
estrogens are powerful hormones when administered internally and are not 
safe for use except under the supervision of a physician. There is a 
lack of adequate data to establish general recognition of the safety and 
effectiveness of any of these ingredients, or any other ingredient, for 
OTC use as an aphrodisiac. Labeling claims for aphrodisiacs for OTC use 
are either false, misleading, or unsupported by scientific data. The 
following claims are examples of some that have been made for 
aphrodisiac drug products for OTC use: ``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.'' Based on evidence currently available, any OTC 
drug product containing ingredients for use as an aphrodisiac cannot be 
generally recognized as safe and effective.
    (b) Any OTC drug product that is labeled, represented, or prompted 
for use as an aphrodisiac is regarded as a new drug within the meaning 
of section 201(p) of the Federal Food, Drug, and Cosmetic Act, (the 
act), for which an approved new drug application under section 505 of 
the act and part 314 of this chapter is required for marketing. In the 
absence of an approved new drug application, such product is also 
misbranded under section 502 of the act.
    (c) Clinical investigations designed to obtain evidence that any 
drug product labeled, represented, or promoted for OTC use as an 
aphrodisiac is safe and effective for the purpose intended must comply 
with the requirements and procedures governing the use of 
investigational new drugs set forth in part 312 of this chapter.
    (d) After January 8, 1990, any such OTC drug product initially 
introduced or initially delivered for introduction into interstate 
commerce that is not in compliance with this section is subject to 
regulatory action.

[54 FR 28786, July 7, 1989]