Simply put, FDA regulation of tobacco, based on a determination that cigarettes are sold to satisfy an addiction, most likely would mean an end to tobacco as a legal product, knowledgeable sources say. At best, they speculate, the federal agency might create a new product category for tobacco, subject to a complex set of marketing regulations like those the FDA wields over prescription drugs.
Needless to say, that would mean an end to Joe Camel, the Marlboro Man, lifestyle ads and brand-sponsored concerts, races, rodeos and exhibitions. Or it might make tobacco advertising prohibitively expensive.
Either way, the FDA's unexplained decision to start carving out for itself a major role in tobacco's future sent ripples of fear through the industry last week. Shareholders watched tobacco stocks plummet, even as tobacco marketing executives downplayed the FDA's apparent shift in tolerance.
"Nothing has occurred that would warrant a change in that policy," Philip Morris said in a statement.
And R.J. Reynolds Tobacco Co., while agreeing with Philip Morris, wasn't optimistic about where an active FDA might end up.
"My understanding is that if they take over, they would have little option but to ban tobacco," said Maura Ellis, RJR director of public relations. "A societal change that profound is not something we can do with the stroke of a pen. Cigarettes are produced for the enjoyment and the pleasure of smokers and they should not be regulated as pharmaceuticals."
The FDA asked Congress for "guidance" on the subject but apparently wants to tighten regulation of tobacco, based on the letter FDA Commissioner David Kessler sent to Scott Ballin, chairman of the Coalition on Smoking OR Health. The letter was, in part, a response to longstanding coalition requests for FDA regulation of tobacco and its marketing.
"As far back as 1988, when our original petition to the FDA focused on low-tar claims by cigarette makers, 80% of the public believed they were making an implied health claim," Mr. Ballin said. "They were selling a product that kills with implied claims that low-tar and low-nicotine cigarettes were safe."
If the FDA were to gain such regulatory authority, he said, "it would likely lead to a ban because cigarettes can't meet the safety and efficacy standards of the FDA for drugs to be approved."
But even Mr. Ballin conceded that banning tobacco, with the ensuing black market to serve the remaining millions of users, might be extreme.
"There needs to be a midpoint compromise, maybe a separate class to allow the product to remain legal but be subject to the same strict standards as other products," he said. "Seductive ads would disappear; if they wanted to sell their products, they couldn't use the ad techniques they employ now."
Hal Shoup, exec VP at the American Association of Advertising Agencies, declined to comment on the FDA's announcement. But the former marketing executive said the economics of advertising tobacco might become unbearable under prescription-druglike regulation.
Then, Mr. Shoup noted, tobacco ads would be much longer-probably several pages, at least-to accommodate mandatory warnings and health data.
"If they had to do that, it's hard for me to see how anyone would want to spend that kind of money on cigarette ads," he said. "If it's going to cost you two or three times what it costs now just to communicate a brand message, that's a whole new set of economics ... that's not very cost effective."
Dr. Kessler, a holdover from the Bush administration, is likely to be the featured witness at upcoming congressional hearings. Rep. Henry Waxman (D., Calif.), a longtime enemy of tobacco, is expected to convene a hearing of his Energy & Commerce Committee's Subcommittee on Health & Environment in late March or early April. A similar Senate hearing is also expected soon.