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Court Brief (edited Table of Contents) Filed Dec. 2, 1996, by the Department of Justice in defense of FDA's determination of jurisdiction over cigarettes and smokeless tobacco products and its regulations restricting those products to protect children and adolescents. http://www.usdoj.gov/civil/cases/tocnts.htm Statement of the matter before the court; statement of material facts

1. The health effects of cigarettes and smokeless tobacco
2. The basis for the assertion of jurisdiction
   1. The evidence that nicotine in cigarettes and smokeless tobacco "affect[s] the structure or any function of the body"
   2. The evidence that the pharmacological effects of nicotine in cigarettes and smokeless tobacco are "intended"
   3. The evidence that cigarettes and smokeless tobacco are "combination products"

3. The rule
   1. Cigarettes and smokeless tobacco as combination products
   2. The regulatory goal
   3. Youth access restrictions
   4. Advertising and promotion restrictions

Questions Presented

Arguments

Congress has not precluded FDA from regulating cigarettes and smokeless tobacco under the FDCA.

1. "Customarily marketed" cigarettes and smokeless tobacco are not exempt from regulation under the FDCA
   1. Standard of review: Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc.
   2. Chevron, step one
   3. Chevron, step two: FDA's application of the FDCA to cigarettes and smokeless tobacco is "based on a permissible construction of the statute"

2. The Federal Cigarette Labeling and Advertising Act, Comprehensive Smokeless Tobacco Health Education Act, and the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act do not foreclose FDA from regulating cigarettes and smokeless tobacco under the FDCA
   1. No statute, or combination of statutes, can override the FDCA in the absence of express preclusion or other clearly expressed Congressional intent
   2. Federal Cigarette Labeling and Advertising Act
   3. Comprehensive Smokeless Tobacco Health Education Act
   4. Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act

3. The separation of powers doctrine does not prohibit FDA's regulation of tobacco products

Nicotine in cigarettes and smokeless tobacco is a drug, and cigarettes and smokeless tobacco are drug delivery devices under the FDCA.

1. Cigarettes and smokeless tobacco fall squarely within the Act's drug and device definitions
   1. Cigarettes and smokeless tobacco "affect the structure or any function of the body"
   2. Nicotine's effects are intended by the manufacturers

2. FDA's application of the medical device provisions to cigarettes and smokeless tobacco does not affect FDA's jurisdiction over these products
   1. Cigarettes and smokeless tobacco are combination drug/device products and may be regulated under the Act's device authorities
   2. FDA's application of device provisions to cigarettes and smokeless tobacco is reasonable

The restrictions imposed by FDA on advertising and other promotion of cigarettes and smokeless tobacco are fully consistent with the first amendment.

1. The agency's regulations must be judged pursuant to the Supreme Court's Central Hudson standard
   1. The Central Hudson standard and the proper First Amendment analysis
   2. Recent rulings by the Supreme Court in 44 Liquormart, and by the Fourth Circuit in Anheuser-Busch and Penn Advertising
   3. In applying the Central Hudson test, the Court's decision should be based on the record created by the Agency, and the reasonable determinations made by FDA are not to be disregarded

2. The government's interest here is plainly substantial
3. FDA has demonstrated that advertising affects tobacco use by minors, to the detriment of the public health, and that the agency's restrictions on advertising of these products should alleviate that problem to a material degree
4. FDA's advertising restrictions are narrowly tailored
   1. The restrictions are designed to preserve the flow of information to lawful consumers
   2. The availability of non-Speech related regulatory alternatives does not invalidate FDA's regulations
   3. Each of FDA's individual advertising restrictions is narrowly tailored

Conclusion

(accessed January 26, 1998)

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