Altria vs. the FDA: More than a Mild Dispute

Marlboro Lights are no more. From now on smokers will have to ask for "Marlboro Golds." Corporations do not change iconic brands lightly. In this case cigarette manufacturer Altria Group (MO) had no choice. The Food & Drug Administration, which as of last year regulates tobacco products, banned the use of the words "mild," "light," or "low tar" on packages effective on June 22. The agency says such cigarettes are just as harmful as regular ones.

Before Altria made the switch, it used the old packs to tell smokers that while the look of Marlboro Lights would change, the "cigarette stays the same." That got the FDA's attention.

The agency argues many consumers will continue to assume Marlboro Golds are safer than regular smokes and has ordered Altria to hand over market research showing why it used the tactic. "What we're concerned about is that it is potentially perpetuating this untruth that these products are somehow less harmful," says Dr. Lawrence R. Deyton, the agency's top tobacco regulator. Altria spokesman Bill Phelps says the company will cooperate with the agency.

Pharmaceutical companies frequently skirmish with the FDA, and Big Tobacco is widely expected to do the same. Altria was the only cigarette maker to support FDA oversight, says Phelps, because it wanted consistent rules of the game for the entire tobacco industry.

Still, this is the second time Altria has clashed with federal regulators in recent months. In March it challenged the membership of an FDA tobacco science panel studying the health risks of menthol cigarettes, which account for more than a quarter of U.S. cigarette shipments. If the panel deems that menthol increases the risk for smokers, the FDA could ban such cigarettes.

On Mar. 22, Altria sent the FDA a 16-page letter requesting the removal of four members of the 12-person panel. The company noted that the four had testified in more than 90 legal cases against the tobacco industry and said that as paid expert witnesses they had "grave financial conflicts and intellectual bias." One of the panelists, Gregory N. Connolly, a tobacco specialist at the Harvard School of Public Health, contends he hasn't been an expert witness in five years and that his research makes him uniquely qualified for the panel. "I take umbrage at Altria's challenge," he says. The three other panelists cited in Altria's letter did not return calls seeking comment. The FDA rejected Altria's request to have the four removed.

Some health-care policy experts and officials at anti-tobacco groups say Altria's challenge to the FDA may be only the first in a series of battles between Big Tobacco and the government. "This is the beginning of a significant series of regulatory actions by the FDA," says Gregg Haifley, a lobbyist for the American Cancer Society. "The industry will fight this hammer and tong. It will be a titanic fight."

Tobacco czar Deyton says the industry so far has cooperated with the FDA. He adds, however, that if tobacco companies resist new rules and policies, "the law gives [the] FDA quite broad and deep authority to enforce all provisions, everything from issuing warning letters to seizures, injunctions, civil money penalties, criminal investigation—the whole thing."

The bottom line: Disagreements between Altria and the FDA panel in charge of regulating tobacco could erupt into a full-blown battle.

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