Tobacco Documents Online

Industry Continues Fight Against FDA Rules On February 10, the tobacco industry took another step in its effort to prevent the Food and Drug Administration from regulating the marketing, promotion, display and sale of tobacco products. In a federal courtroom in Greensboro, North Carolina, attorneys for the four leading cigarette companies and an ad agency made their case before Judge William L. Osteen. Additional arguments were presented by attorneys representing the smokeless tobacco industry, a group of major advertising plan. Richard Cooper, an attorney for the cigarette makers and a former chief counsel for the FDA, called the agency's regulations "an extraordinary assertion of power." He added that the court's decision would make an "important statement" about how our democracy works. In other words, will the elected members of Congress continue to set public policy, or will unelected bureaucrats at the FDA be permitted to make their own policy - and ignore They argued that the FDA does not have the authority to regulate tobacco products or tobacco advertising, and they asked the judge to prevent the agency from implementing its agencies and th? _N?fi~ €-Een the direction of Con Attorneys for the FDA argued that Congress had not ~ prohibited the agency from regulating cigarettes, and that ~ ,u~ ~ ~l VI~~ the agency had the right to regulate tobacco products because ',Q u (,,,,;Np1 of "new evidence" that tobacco_companies "control the level rW1or nrcoLine in cigareLZes." I In fact, manufacturers do not add nicotine to q ~ ,. J+ cigarettes,-and they pointed out that nicotine ratings are i d in d i ith f de al l d i tt d every c n accor ance w r nc u e gare e a e ,a1., ' H Ilaw. ~ I , 11;1~t~1 '"~`rv-~~rLJ:~.C.~ )UL i 15 U r~ . a1f r'

DISCUSSION DRAFT/February 27, 1997 page 2 The FDA's rules began to take effect on February 28 -- retailers are now required to verify with photo - fs identification, the age of any customer who aVpe ~r under the age of 27. If Judge Osteen decides he needs to hear more evidence to make a ruling, the lawsuit may proceed to trial. However, a ruling on the plaintiffs' "motion for summary judgment" is expected sometime in April. Regardless_of the court's decision, the tobacco companies made it clear that they will continue their efforts to reduce underage access to tobacco products. However, they object to the FDA's plan because they believe it is unreasonable and illegal. They also express concerns about the agency's claim that it has broad new powers, including the power to ban cigarettes altogether.

DISCUSSION DRAFT/February 27, 1997 The Arguments of February 10th page 3 In its "motion for summary judgment" in its suit against the Food and Drug Administration, the tobacco industry argues that even if all of the FDA's "facts" are correct, its plan to regulate tobacco products is still illegal and should therefore be thrown out on legal grounds. The industry and the other plaintiffs have asked the judge to make a "summary judgment" on the legal issues - and rule in their favor w ro a trial. At the Feb. 10 hearing, attorneys for the tobacco companies and an ad agency made three basic arguments: • Congress has never granted the FDA the authority to regulate tobacco products. • The Food, Drug and Cosmetic Act - the_federal law that defines the FDA's authority - does not permit the FDA to regulate tobacco products as "drugs," Vy" "medical devices" -\ • The FDA's restrictions on tobacco product advertising and other forms of commercial speech violate the First Amendment. If the judge does not grant a summary judgment and the case goes to trial, the plaintiffs will continue to argue on legal grounds - and also challenge the FDA's "facts," such as its charge that the companies manipulate the nicotine in cigarettes. Judge Osteen's final ruling - no matter which side it favors - may be appealed to the Fourth Circuit Court of Appeals, and eventually even to the Supreme Court.

DISCUSSION DRAFT/February 27, 1997 page 4 Tobacco industry attorneys continue to express confidence that they will win the suit against the FDA. # # #