21 C.F.R. § 310.528

Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac

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(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]

Notes of Decisions

Cited in 6 cases, 1994–2018 · leading case: Troy Lambert v. Nutraceutical Corp., 870 F.3d 1170 (9th Cir. 2017).

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Troy Lambert v. Nutraceutical Corp., 870 F.3d 1170 (9th Cir. 2017). · cites it 2× “According to Lambert, Cobra Sexual Energy violated the FDA’s aphrodisiac drug rule because it claimed to increase sexual desire but had not been through clinical testing, as required by 21 C.F.R. § 310.528 (c); nor had it received FDA approval, as required by 21 C.”

Sandoval v. PharmaCare US, Inc., 145 F. Supp. 3d 986 (S.D. Cal. 2015). · cites it 3× “See 21 C.F.R. § 310.528 (b). Because Defendant does not have new-drug approval for IntenseX, Plaintiff asserts, the product is misbranded, in violation of FDA regulations, the Sherman Law, and the unlawful prong of the UCL.”

Kanfer v. Pharmacare US, Inc., 142 F. Supp. 3d 1091 (S.D. Cal. 2015). · cites it 2× “See 21 C.F.R. § 310.528 (b). Because Defendant does not have néw-drug approval for IntenseX, Plaintiff asserts, the product is misbranded, in violation of FDA regulations, the Sherman Law, and the unlawful prong of the UCL.”

Fed. Trade Comm'n, Plaintiff-Appellant-Cross-Appellee v. Pantron I Corp., Defendants-Appellees-Cross-Appellants, 33 F.3d 1088 (9th Cir. 1994). “has at least implicitly determined that the placebo effect may not be used to support a claim of effectiveness, since it has determined that “all labeling claims for OTC hair grower and hair loss products for external use are either false, misleading, or unsupported by…”

John Sandoval v. Pharmacare US, Inc. (9th Cir. 2018). · cites it 2× “21 C.F.R. § 310.528 (b) requires any over- the-counter (“OTC”) aphrodisiac drug to be approved by the FDA before marketing.”

United States v. McCullough, 891 F. Supp. 422 (N.D. Ohio 1995). “” The only reference to ginseng as a “drug” is found in 21 C.F.R. § 310.528 , where the Food and Drug Administration (“FDA”) regulates “drug products containing active ingredients offered over-the-counter for use as an aphrodisiac.”

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