Lorillard v. United States Food & Drug Administration

Tobacco companies challenged the composition of the Tobacco Products Scientific Advisory Committee (TPSAC), which was established by the U.S. Food and Drug Administration (FDA) to advise the agency on scientific issues related to tobacco products, including the use of menthol in cigarettes. The tobacco companies alleged that three of the scientific members of the Committee had both an actual and a perceived conflict of interest because each consulted with companies that developed nicotine replacement therapies and testified as expert witnesses in lawsuits against tobacco manufacturers. The court ruled in favor of the tobacco companies, finding that the challenged committee members had both financial conflicts of interest and an appearance of conflicts of interest, which fatally tainted the composition of the Committee and its work product, including the 2011 Committee report on menthol in cigarettes. The court concluded that if a Committee member stands to profit from the sale of tobacco cessation devices then he faces a conflict in his duty to render impartial advice regarding the regulation of menthol cigarettes. The court issued an order requiring the FDA to reconstitute the Committee’ membership to comply with ethics laws and barred the agency from using the Committee’s menthol report, which had recommended removing menthol cigarettes from the marketplace.


Lorillard, Inc., et al., v. United States Food and Drug Administration, et al., 56 F.Supp.3d 37 (D.D.C. 2014).

  • United States
  • Jul 21, 2014
  • U.S. District Court for the District of Columbia



  • Lorillard Tobacco Company
  • Lorillard, Inc.
  • R.J. Reynolds Tobacco Company


  • Food and Drug Administration
  • Kathleen Sebelius, the Secretary of DHHS
  • Lawrence Deyton, the Director of the FDA's Center for Tobacco Products
  • Margaret Hamburg, the Commissioner of Food and Drugs
  • U.S. Department of Health and Human Services

Legislation Cited

Food and Drug Administration, Standing Advisory Committees, Tobacco Products Scientific Advisory Committee, 21 C.F.R. § 14.100(5)

Administrative Procedure Act, 5 U.S.C. section 551 et seq.

Family Smoking Prevention and Tobacco Control Act

Federal Advisory Committee Act, 5 U.S.C. app. 2, section 1-16

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product