Exhibit 987

Food and Drug Administration Amendments Act of 2007, Pub. L. 110-85, Title IX, sec. 901(d)(3) and (4) (clear, conspicuous and neutral major statement; civil penalties for false or misleading DTC advertisements)

Exhibit 987 · Statute

Food and Drug Administration Amendments Act of 2007, Pub. L. 110-85, Title IX, sec. 901(d)(3) and (4) (clear, conspicuous and neutral major statement; civil penalties for false or misleading DTC advertisements)

the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner.

Amends FDCA 502(n) to require that the major statement of side effects and contraindications in TV and radio drug ads be “presented in a clear, conspicuous, and neutral manner”; directs HHS to establish standards by regulation not later than 30 months after enactment; adds civil penalties up to $250,000 for a first false or misleading DTC advertisement in 3 years and $500,000 for each later one; adds a voluntary advisory-review fee program for TV ads (sec. 104).

Source: United States Congress
Date: 27 September 2007
Quoted from: Sec. 901(d)(3)(A), amending FDCA 502(n)
Grade: Primary record
Document: https://www.govinfo.gov/content/pkg/PLAW-110publ85/html/PLAW-110publ85.htm
Accessed: 2026-11-10
Cited by: Findings citing this exhibit

Cited by

Finding INF-1.8: Primary record FDA issued final guidance on consumer-directed broadcast advertisements in August 1999, after announcing a draft on 12 August 1997. The Food and Drug Administration Amendments Act of 27 September 2007 required FDA to set standards for a clear, conspicuous and neutral major statement in television and radio drug advertisements within 30 months; FDA proposed a rule on 29 March 2010 and published the final rule on 21 November 2023, with compliance required from 20 November 2024.