The Supreme Court rules: The FDA and tobacco regulation. (Health Policy Update).

During the same month when 46 states are crafting plans to spend their portion of the $246 billion in tobacco company restitution funds, the U.S. Supreme Court ruled that the Food and Drug Administration (FDA) does not have the authority to regulate tobacco/nicotine products. The Court's 5 to 4 ruling in Food and Drug Administration et. al. versus Brown & Williamson Tobacco Corp. has altered the government's longstanding policy to classify nicotine as an addictive drug and to treat tobacco products and cigarettes as drug delivery devices. This decision dramatically alters the policy debate over how best to regulate tobacco to reduce teenage smoking. The Court's decision was based on its interpretation of current federal law and Congress' prior rejection of legislation to explicitly give the FDA the authority to regulate tobacco. (1)

The Court was clear, however, that it believed that tobacco is an addictive substance. Citing the public health issues related to tobacco products and noting that tobacco is a dangerous product when used as directed, Justice Sandra Day O'Connor, writing for the majority, stated, "By no means do we (the Court) question the seriousness of the problem that the FDA had sought to address." (1)

The FDA authority

For nearly ten years, the U.S. Food and Drug Administration has affirmed their authority over nicotine-containing tobacco products. In March 1994, then FDA Commissioner David A. Kessler, MD, testified before the Congressional Subcommittee on Health and the Environment that "Cigarette companies control the levels of nicotine in a manner that creates and sustains addiction in the vast majority of smokers." (2) The following month the Subcommittee also heard testimony from the representatives of seven tobacco companies who all denied tobacco products were addictive.

But two weeks later on April 28, 1994, two former scientists for Phillip Morris told the Subcommittee about their "company-sponsored research establishing the addictive properties of nicotine," (2) Additional testimony from FDA scientists revealed evidence of the cigarette industry's manipulation of nicotine, specifically the breeding of high nicotine levels in one strain of tobacco and the use of chemical compounds to enhance nicotine delivery to smokers. Following a series of public hearings on nicotine addictiveness, in 1995 President Clinton announced the publication of the proposed FDA regulations to curtail the access to and appeal of tobacco products to children and adolescents.

The President's Order and the FDA charge was bolstered by the April 25, 1997 decision from Judge William Osteen of the U.S. District Court for the Middle District in Greensboro, North Carolina, that ruled the FDA had the authority to regulate nicotine-containing cigarettes and smokeless tobacco as "drug-delivery devices." (3) While the Judge invalidated FDA restrictions on the advertising and promotion of cigarettes and smokeless tobacco, the Court supported the agency's conclusion that nicotine and tobacco products fall within the Federal Food, Drug and Cosmetic Act definition of "drugs" and "devices."

This landmark ruling upheld the restrictions that involved youth access, labeling, the prohibition of sales to anyone under 18 years of age, and a requirement that retailers check photo identification of purchasers under age 27. The tobacco companies immediately appealed Judge Osteen's ruling and in August 1998, the U.S. Court of Appeals for the Fourth Circuit in Richmond, Virginia reversed the decision of the lower court. The three-panel ruling invalidated the FDA's 1996 regulations that restricted the sale and distribution of cigarettes to children. The March 2000 Supreme Court ruling upheld this restriction.

The ruling's impact

The Court's decision on the FDA's regulatory authority curtailed enforcement efforts designed to ensure retailer compliance with legal restrictions on youth purchase of tobacco products. Since 1997, the FDA has committed more than $30 million to tobacco enforcement. States can determine if vendors are selling tobacco products to minors with FDA-supported compliance checks. Since its inception, more than 177,000 retail outlets have been inspected and nearly 50,000 vendors have been penalized for violations. (4) While the violation/noncompliance rates have remained around 26 percent, the number of retail stores and vendors found in compliance with the law has grown from 4,611 to almost 7,000 nationally. (4)

FDA-sponsored enforcement stings in the states were terminated as a result of the Supreme Court's ruling. States were only allowed to keep a small amount of their federal funds for an "orderly shut down" of these enforcement programs.

The next steps

It is up to Congress to pass legislation explicitly stating that the FDA has the authority to regulate tobacco products. There appears to be bipartisan support for this effort. Representative Henry A. Waxman (D-CA) has introduced two bills to give the FDA authority--H.R. 4041 and H.R. 4042. Others include Senator Tom Harkin (D-IA)--S. 2379, Senator Jack Reed (D-RI)--S. 2333, and Representative Greg Ganske (R-IA)--H.R 4207. Unless Congress acts, enforcement actions requiring federal oversight are limited and will have to occur at the state level. It is also important that Congress enacts legislation that will give the FDA effective enforcement authority.

Conclusion

Tobacco addiction is a significant public health problem. Hopefully, Congress will intervene and pass legislation to ensure a strong regulatory approach to reduce youth access to tobacco. The courts are taking a more active role in determining health policy issues. This is one example. Physician executives can help by ensuring that the programs under their control are aware of local efforts to reduce youth access to tobacco. They can also look for opportunities to integrate their community health programs into enforcement efforts at the state and local level.

Note

The stated views are those of the author and do not represent those of the State of Maryland or the Department of Health and Mental Hygiene.

Georges Benjamin, MD, FACP, is the Secretary of the Department of Health and Mental Hygiene in Maryland, Baltimore. He can be reached by calling 410/767-6505 or via email at [e-mail].

References

(1.) U.S. Supreme court, Food and Drug Administration et. al. versus Brown & Williamson Tobacco Corp., March 21, 2000.

(2.) U.S. Food and Drug Administration Fact Sheet, Reducing Children's Use of Tobacco, August 23, 1996.

(3.) Summary of U.S. court of Appeals for the Fourth Circuit, Ruling on FDA's Jurisdiction Over, and Regulation of, cigarettes and Smokeless Tobacco, August 21, 1998.

(4.) U.S. Food and Drug Administration Children & Tobacco Checker Data Reports, National Summary Results for September 1997 - February 2000, Updated February 2, 2000.