United States

Advertising regulation in United States

Regulator: FDA (OPDP) ／ Basis: 連邦食品医薬品化粧品法

Claims of efficacyA prescription drug advertisement is false, lacking in fair balance, or otherwise misleading if it contains a representation or suggestion, not approved or permitted for use in the labeling, that the drug is better, more effective, useful in a broader range of conditions or patients, or safer than has been demonstrated by substantial evidence or substantial clinical experience.
Comparative advertisingAn advertisement is false, lacking in fair balance, or otherwise misleading if it contains a drug comparison that represents or suggests that a drug is safer or more effective than another drug in some particular when it has not been demonstrated to be safer or more effective in such particular by substantial evidence or substantial clinical experience.
Safety informationEvery prescription drug advertisement other than the listed exempt advertisements must present a true statement of information in brief summary relating to side effects, contraindications and effectiveness, and it fails that requirement if effectiveness information is presented in greater scope, depth or detail than section 502(n) requires and is not fairly balanced by a summary of true information relating to side effects and contraindications.
Direct-to-consumerFor prescription drug advertisements for human use presented directly to consumers in television or radio format, the major statement of major side effects and contraindications must be presented in a clear, conspicuous and neutral manner, and in television format it must be presented concurrently using both audio and text.
Materials for HCPsAdvertisements subject to section 502(n) of the Act include advertisements in published journals, magazines, other periodicals and newspapers and advertisements broadcast through media such as radio, television and telephone communication systems, so journal advertising directed at prescribers is subject to the brief summary and fair balance requirements of 21 CFR 202.1(e).
Pre-clearanceAn applicant must submit specimens of promotional labeling and advertising at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement, accompanied by Form FDA-2253 and a copy of the product's current professional labeling, and for drug products being considered for accelerated approval all promotional materials intended for dissemination or publication within 120 days following approval must be submitted during the preapproval review period, with later materials submitted at least 30 days prior to intended initial dissemination.
Digital and socialFor digital media the binding rule is 21 CFR 202.1. Paragraph (l)(1) states only that 'advertisements subject to section 502(n) of the act include advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems'; the full text of section 202.1 in the 2024 CFR (title 21, volume 4) does not contain the words internet, website or social media anywhere. Paragraph (l)(2) determines that brochures, mailing pieces, detailing pieces, reprints and similar matter are labeling as defined in section 201(m). The only recent binding medium-specific provision is (e)(1)(ii), which requires the major statement in direct-to-consumer television or radio advertisements to be presented in a clear, conspicuous and neutral manner; it does not reach the internet. The only FDA document addressing internet and social media platforms with character space limitations remains the June 2014 draft guidance, which recommends incorporating risk information within the same character-space-limited communication and providing a mechanism such as a hyperlink within each communication to a more complete discussion of risk; those are nonbinding recommendations.
EnforcementThe opening words of 21 U.S.C. 352 provide that a drug or device 'shall be deemed to be misbranded' in the listed cases. Section 352(n) provides that a prescription drug is misbranded unless the manufacturer, packer or distributor includes in all advertisements and other descriptive printed matter it issues with respect to that drug a true statement of (1) the established name, printed prominently and in type at least half as large as any trade or brand name, (2) the quantitative formula, and (3) such other information in brief summary relating to side effects, contraindications and effectiveness as the Secretary requires by regulation. Section 331 prohibits (a) the introduction or delivery for introduction into interstate commerce of a misbranded drug, (b) misbranding in interstate commerce, and (c) the receipt in interstate commerce of a misbranded drug and its delivery for pay or otherwise. The chain 'advertising violation to misbranding to prohibited act' therefore holds on the face of the statute. Under 21 U.S.C. 333(a)(1) a violation of section 331 carries up to one year of imprisonment or a fine of up to $1,000 or both, and under 333(a)(2) a violation after a conviction under that section has become final, or one committed with intent to defraud or mislead, carries up to three years or a fine of up to $10,000 or both. However, 18 U.S.C. 3571(e) preserves a lower statutory fine only where the law setting forth the offence 'by specific reference' exempts the offence, and the text of 333(a) contains no such reference. Consequently, under 18 U.S.C. 3559(a) the 333(a)(1) offence is a Class A misdemeanour and the 333(a)(2) offence a Class E felony, and under 18 U.S.C. 3571(b)(3) and (b)(5) and 3571(c)(3) and (c)(5) an individual may be fined up to $250,000 for the felony and up to $100,000 for the Class A misdemeanour not resulting in death, and an organisation up to $500,000 and $200,000 respectively. Section 3571(d) additionally permits a fine of up to twice the gross gain or twice the gross loss.

Every cell carries a summary, a source and a date checked. Topics whose source has not been verified are left marked “not researched” rather than filled with plausible text. Directives and statutes bind as to the result; what applies in practice is national implementing law. This is a research aid, not legal advice.