View source for FDA v. Brown & Williamson Tobacco Corp.

{{one source|date=October 2017}}
{{Infobox SCOTUS case
  |Litigants=FDA v. Brown & Williamson Tobacco Corp.
  |ArgueDate=December 1
  |ArgueYear=1999
  |DecideDate=March 21
  |DecideYear=2000
  |FullName=Food and Drug Administration, et al. v. Brown & Williamson Tobacco Corp., et al.
  |USVol=529
  |USPage=120
  |ParallelCitations=120 S. Ct. 1291; 146 [[L. Ed. 2d]] 121
  |Prior=
  |Subsequent=
  |Holding= The Food and Drug Administration has no authority to regulate tobacco products.
  |Majority=O'Connor
  |JoinMajority=Rehnquist, Scalia, Kennedy, Thomas
  |Dissent=Breyer
  |JoinDissent=Stevens, Souter, Ginsburg
  |LawsApplied=[[Food, Drug, and Cosmetic Act]]
  |Superseded = [[Family Smoking Prevention and Tobacco Control Act]]
}}
'''''FDA v. Brown & Williamson Tobacco Corp.''''', 529 U.S. 120 (2000), is an important [[United States Supreme Court]] case in the development of [[American administrative law]]. It ruled that the [[Food, Drug, and Cosmetic Act]] did not give the [[Food and Drug Administration|Food and Drug Administration (FDA)]] the authority to regulate tobacco products as "drugs" or "devices." This was later superseded by the [[Family Smoking Prevention and Tobacco Control Act]], which granted the FDA the authority to regulate such products.

==Legal principle==
{{Refimprove section|date=September 2019}}
The scope of authority held by an agency is determined by the agency's [[organic statute (USA)|organic statute]].  Where Congress repeatedly denies an agency the power to regulate a particular area and develops a comprehensive regulatory scheme outside the agency's control, the agency may not regulate that area.

The approach, in this case, balances the approach of ''[[US v. Southwestern Cable Co.]]''.  Whereas ''Southwestern Cable'' allowed an agency to regulate areas not explicitly contemplated by the statute when necessary to fulfill its ultimate goal even when legislative efforts to gain such power failed, ''FDA'' does not allow agencies to regulate areas for which Congress has developed a separate statutory scheme.

==Facts and procedural posture==
The [[Food and Drug Administration]] (FDA) attempted to regulate tobacco products.  Tobacco companies, including [[Brown & Williamson]] and [[Philip Morris USA|Philip Morris Companies]] (among others), challenged the regulations.<ref>{{Cite news |url=https://www.nytimes.com/2000/03/22/us/high-court-holds-fda-can-t-impose-rules-on-tobacco.html |title=High Court Holds F.D.A. Can't Impose Rules on Tobacco |last=Greenhouse |first=Linda |date=2000-03-22 |work=The New York Times |access-date=2019-05-15 |language=en-US |issn=0362-4331}}</ref>  The District Court granted in part and denied in part the plaintiff's claim.  The Circuit Court reversed, ruling for the tobacco company.

The Supreme Court ultimately affirmed the Circuit Court's ruling for the tobacco company, ruling that the FDA did not have the power to enact and enforce the regulations in question.

==Analysis==
The FDA's authority to regulate came from the [[Food, Drug, and Cosmetic Act]] (FDCA).  The FDA argued that nicotine was a "drug" and cigarettes and smokeless tobacco are "devices" that deliver nicotine to the body within the meaning of the FDCA.  Congress had enacted several tobacco-specific laws after the FDCA, and the FDA had never exercised any control over tobacco.  The Court concluded that Congress did not intend to give the FDA the power to regulate tobacco and that the regulations were therefore invalid.

==Further developments==
This decision was overridden by the passage of the [[Family Smoking Prevention and Tobacco Control Act]] of 2009, which gave the FDA the authority to regulate the tobacco industry and control the level of nicotine in cigarettes.<ref>{{cite journal |title=Randomized Trial of Reduced-Nicotine Standards for Cigarettes |journal=New England Journal of Medicine |volume=373 |issue=14 |pages=1340–9 |doi= 10.1056/NEJMsa1502403|pmid=26422724 |year=2015 |last1=Donny |first1=Eric C. |last2=Denlinger |first2=Rachel L. |last3=Tidey |first3=Jennifer W. |last4=Koopmeiners |first4=Joseph S. |last5=Benowitz |first5=Neal L. |last6=Vandrey |first6=Ryan G. |last7=Al'Absi |first7=Mustafa |last8=Carmella |first8=Steven G. |last9=Cinciripini |first9=Paul M. |last10=Dermody |first10=Sarah S. |last11=Drobes |first11=David J. |last12=Hecht |first12=Stephen S. |last13=Jensen |first13=Joni |last14=Lane |first14=Tonya |last15=Le |first15=Chap T. |last16=McClernon |first16=F. Joseph |last17=Montoya |first17=Ivan D. |last18=Murphy |first18=Sharon E. |last19=Robinson |first19=Jason D. |last20=Stitzer |first20=Maxine L. |last21=Strasser |first21=Andrew A. |last22=Tindle |first22=Hilary |last23=Hatsukami |first23=Dorothy K. |pmc=4642683}}</ref>

==See also==
* [[List of United States Supreme Court cases, volume 529]]
* [[List of United States Supreme Court cases]]
* [[Lists of United States Supreme Court cases by volume]]
* [[Y1 (tobacco)]]

==References==
{{reflist}}

==Further reading==
*''[http://www.press.umich.edu/titleDetailDesc.do?id=291047 Suing the Tobacco and Lead Pigment Industries: Government Litigation as Public Health Prescription]'' by Donald G. Gifford. Ann Arbor, [[University of Michigan Press]], 2010. {{ISBN|978-0-472-11714-7}}

==External links==
* {{caselaw source
 | case = ''FDA v. Brown & Williamson Tobacco Corp.'', {{ussc|529|120|2000|el=no}}
 | courtlistener =https://www.law.cornell.edu/supct/html/98-1152.ZS.html
 | justia =https://supreme.justia.com/cases/federal/us/529/120/
 | loc =http://cdn.loc.gov/service/ll/usrep/usrep529/usrep529120/usrep529120.pdf
 | oyez =https://www.oyez.org/cases/1999/98-1152
 }}

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[[Category:United States administrative case law]]
[[Category:United States Supreme Court cases]]
[[Category:United States Supreme Court cases of the Rehnquist Court]]
[[Category:United States tobacco case law]]
[[Category:Food and Drug Administration]]
[[Category:2000 in United States case law]]
[[Category:Brown & Williamson]]
[[Category:History of Louisville, Kentucky]]
[[Category:Smoking in the United States]]