# 21 C.F.R. § 310.528 (2026): Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac > Federal · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_528 ## Section - **Citation:** 21 C.F.R. § 310.528 (2026) - **Heading:** Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac - **Jurisdiction:** Federal - **Kind:** Regulations - **Status:** In force - **Text as of:** August 14, 2026 - **Source:** Compiled text - **Location:** Title 21 CFR: Food and Drugs / Chapter I / Part 310 / Subpart E / § 310.528: § 310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac. ## Text (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 d, 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] ## Nearby sections - [21 C.F.R. § 310.501 (2026) § 310.501 Patient package inserts for oral contraceptives.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_501.md) - [21 C.F.R. § 310.502 (2026) § 310.502 Certain drugs accorded new drug status through rulemaking procedures.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_502.md) - [21 C.F.R. § 310.503 (2026) § 310.503 Requirements regarding certain radioactive drugs.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_503.md) - [21 C.F.R. § 310.509 (2026) § 310.509 Parenteral drug products in plastic containers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_509.md) - [21 C.F.R. § 310.515 (2026) § 310.515 Patient package inserts for estrogens.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_515.md) - [21 C.F.R. § 310.517 (2026) § 310.517 Labeling for oral hypoglycemic drugs of the sulfonylurea class.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_517.md) - [21 C.F.R. § 310.518 (2026) § 310.518 Drug products containing iron or iron salts.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_518.md) - [21 C.F.R. § 310.519 (2026) § 310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_519.md) - [21 C.F.R. § 310.527 (2026) § 310.527 Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_527.md) - [21 C.F.R. § 310.528 (2026) § 310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_528.md) - [21 C.F.R. § 310.529 (2026) § 310.529 Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_529.md) - [21 C.F.R. § 310.530 (2026) § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_530.md) - [21 C.F.R. § 310.531 (2026) § 310.531 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_531.md) - [21 C.F.R. § 310.532 (2026) § 310.532 Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_532.md) --- Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_528. 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