C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 340—STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE › Subpart C—Labeling

21 C.F.R. § 340.50

Labeling of stimulant drug products

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(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.

Notes of Decisions
Cited in 2 cases, 2003–2016 · leading case: Alec Fisher v. Monster Beverage Corp., 656 F. App'x 819 (9th Cir. 2016).
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Alec Fisher v. Monster Beverage Corp., 656 F. App'x 819 (9th Cir. 2016). “21 C.F.R. § 340.50 (regulating the labeling of caffeine in drugs for human use).”
Wagner Ex Rel. Wagner-Garay v. Fort Wayne Cmty. Schs., 255 F. Supp. 2d 915 (N.D. Ind. 2003). “) Finally, common sense dictates that caffeine pills amount to over-the-counter medication, after all, they are sold alongside other non-prescription pharmaceutical products in various drug stores, department stores, and even truck stops, and, by law, their packaging must…”
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