Explore the full hierarchy of this title across chapters, subchapters, and parts.
Select a part from the tree to begin
Browse chapters and parts on the left to load sections
United States • Title 21 CFR • Part 340
This part of the CFR outlines the requirements for over-the-counter (OTC) stimulant drug products for human use. It defines what constitutes a stimulant, specifies the active ingredient (caffeine within dosage limits), and details the required labeling, including statements of identity, indications, warnings, and directions for use. The products must be generally recognized as safe and effective and not misbranded to be legally marketed.
(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.
The active ingredient of the product consists of caffeine when used within the dosage limits established in § 340.50(d).
As used in this part: Stimulant. A drug which helps restore mental alertness or wakefulness during fatigue or drowsiness.
Statement of identity.(a) 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.” Indications.(b) 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. Warnings.(c) 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,…
This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.