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Does FDA Have Authority Over Tobacco Products?

Oral Argument Before The Fourth U.S. Circuit Court Of Appeals
Warm Springs, Virginia
August 11, 1997

On Monday, August 11, lawyers for the tobacco industry and the U.S. Department of Justice will argue their appeals of the historic April 25 ruling by a federal judge in Greensboro, North Carolina that affirmed FDA authority over tobacco products.  Because the Greensboro court ruled for the government on some issues and for the tobacco industry on other issues, both sides are appealing portions of the ruling.  The 4th Circuit is expected to issue a decision very soon.  Key issues include the following:

FDA Jurisdiction.  The most significant ruling by the Greensboro court was that the FDA has full authority under the Food, Drug and Cosmetics Act (FDCA) to regulate cigarettes and smokeless tobacco products.  The tobacco industry will appeal this portion of the decision, arguing that FDA action is preempted by other federal statutes, including the Federal Cigarette Labeling and Advertising Act (FCLAA).  In addition, the industry will argue that the trial court judge granted undue deference to the FDA’s interpretation of Congressional intent.

Reducing Youth Access to Tobacco Products.  The tobacco industry will appeal the Greensboro court’s ruling that FDA has full authority to implement its rule prohibiting the sale of tobacco products to children.  The tobacco companies are challenging the FDA’s requirement that merchants check photo identification of customers who appear to be under 27 years of age.  The tobacco companies also are challenging provisions that have been put on hold pending the outcome of this case, including a ban on vending machines in places where children have access, prohibition of free cigarette give-aways, and prohibition of so-called “kiddie packs” of less than 20 cigarettes.

Marketing Restrictions.  The government is appealing the lower court’s ruling that FDA does not have authority to regulate tobacco marketing under the statutory provision cited by the agency.  At issue are FDA restrictions on billboards, magazines, point-of-sale promotions, free give-aways of non-tobacco products bearing tobacco logos, and brand name sponsorship of sporting and entertainment events.  The tobacco industry will argue that, even if the FDA does have statutory authority, the Court of Appeals should strike down these regulations on First Amendment grounds.  If the Court rules that FDA has

authority over marketing, it may choose to address First Amendment issues, but is not required to do so because the trial court below has not yet addressed them.  Both the tobacco industry and the government are urging the Court to rule on First Amendment issues in order to expedite a request for review of this case by the U.S. Supreme Court.

Labeling.  The tobacco industry is appealing the Greensboro court’s ruling that FDA has authority to require that all tobacco products bear labels that say “nicotine delivery device -- for persons 18 or older.” 

The Appeals Process.  The Court of Appeals is expected to issue a decision within the next few months.  One or both parties will seek review of that decision by the U.S. Supreme Court as soon as possible.  The Supreme Court may agree to hear the case during its next term, which begins in October.  It is also possible that the Court of Appeals will require additional proceedings by the Greensboro court, which could delay potential consideration of the case by the Supreme Court.

August 11, 1997