Advertising/Labeling Definitions

21 CFR 202.1(l)1 states that advertisements subject to Section 502(n) of the Food, Drug, and Cosmetic Act (FD&C Act) include advertisements published in journals, magazines, other periodicals, and newspapers; and broadcast through media such as radio, television, and telephone communications systems. This is not a comprehensive list of advertising media subject to regulation. For example, FDA also regulates advertising conducted by sales representatives, on computer programs, through fax machines, or on electronic bulletin boards.

Under section 502(n) of the FD&C Act, advertisements must include: the established name, the brand name (if any), the formula showing quantitatively each ingredient, and information in brief summary which discusses side effects, contraindications, and effectiveness. The brief summary is further discussed in 21 CFR 202.1(e)(1).

Yes, there are a few exceptions but only to the requirement to provide a true statement of information in brief summary as required under 21 CFR 202.1(e)(1). 21 CFR 202.1(e)(2) describes which ads are exempt:

1. Reminder advertisements - advertisements which call attention to the name of the drug product but do not include indications or dosage recommendations for use of the product, or any other representation. Reminder ads contain the proprietary name of the drug and the established name of each active ingredient. They may also contain additional limited information, such as the name of the company, price, or dosage form.

The exception does not apply to products with black box warnings in their approved product labeling.

2. Advertisements of Bulk-sale drugs - promote sale of the drug in bulk packages to be processed, manufactured, labeled, or repackaged and that contain no claims for the therapeutic safety or effectiveness of the drug.

3. Advertisements of prescription-compounding drugs - promote sale of a drug for use as a prescription chemical or other compound for use by registered pharmacists.

Section 201(m) of the FD&C Act states labeling ". . . means all labels and other written, printed, or graphic matter . . . accompanying such article."

The regulations provide examples of labeling under 21 CFR 202.1(l)(2):

"Brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides, sound recordings, exhibits, literature, and reprints and similar pieces of printed, audio or visual matter descriptive of a drug and references published (for example, the Physician's Desk Reference) for use by medical practitioners, pharmacists, or nurses, containing drug information supplied by the manufacturer, packer, or distributor of the drug and which are disseminated by or on behalf of its manufacturer, packer, or distributor are hereby determined to be labeling as defined in section 201(m) of the FD&C Act."

Labeling must include the established name, proprietary name (if any), adequate directions for use, and adequate warnings. The agency considers the approved product labeling, sometimes called the full prescribing information, to be adequate directions for use and adequate warning.

Yes. Reminder labeling is exempt from the requirements for adequate directions for use and adequate warnings. Reminder labeling, as defined in 21 CFR 201.100(f), is exempted. Reminder labeling calls attention to the name of the drug product but does not include indications or dosage recommendations for use. Reminder labeling may contain only the proprietary name of the drug, the established name of each active ingredient, and optionally, information relating to quantitative ingredient statements, dosage form, quantity of package contents, price, and other limited information.

The exemption does not apply to products with black box warnings in their approved product labeling.