US21 CFR21 CFR Part 340Secondary legislationIn force

Stimulant Drug Products for Over-the-Counter Human Use

FDA regulation establishing standards for over-the-counter stimulant drug products containing caffeine for oral use. Sets caffeine as the active ingredient, limits dosage to 100-200 mg every 3-4 hours for adults and children 12+, requires warnings about caffeine limits and sleep substitution, and specifies labeling as an alertness aid or stimulant.

Last changed 1 month ago.

Extracted view for reading · Original for compliance evidence

PART 340—STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart A—General Provisions

§ 340.1 Scope.

(a) An over-the-counter stimulant drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

§ 340.3 Definition.

As used in this part:

Stimulant. A drug which helps restore mental alertness or wakefulness during fatigue or drowsiness.

Subpart B—Active Ingredient

§ 340.10 Stimulant active ingredient.

The active ingredient of the product consists of caffeine when used within the dosage limits established in § 340.50(d).

Subpart C—Labeling

§ 340.50 Labeling of stimulant drug products.

(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “altertness aid” or a “stimulant.”

(b) Indications. The labeling of the product states, under the heading “Indications,” the following: “Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the Act relating to misbranding and the prohibition in section 301(d) of the Act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the Act.

(c) Warnings. The labeling of the product contains the following warnings under the heading “Warnings”:

(1) “The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.”

(2) “For occasional use only. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a” (select one of the following: “physician” or “doctor”).

(3) “Do not give to children under 12 years of age.”

(d) Directions. The labeling of the product contains the following information under the heading “Directions”: Adults and children 12 years of age and over: Oral dosage is 100 to 200 milligrams not more often than every 3 to 4 hours.

Source

https://www.ecfr.gov/current/title-21/part-340

Canonical document at the regulator. Always cite this URL — not the Vantage detail page — in compliance evidence.

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