WASHINGTON (AdAge.com) -- Fourteen years ago, Clinton administration Food and Drug Administration Commissioner David Kessler proposed that his agency regulate tobacco and impose unprecedented marketing curbs. Since that time, much traditional tobacco marketing has become all but illegal, and Congress is readying to finally grant his wish.
But amid dropping rates of tobacco usage and concerns about the FDA's recent struggles to properly oversee drugs and foods already under its domain, some are questioning the necessity -- and wisdom -- of granting oversight of the tobacco industry to the FDA.
In 1996, when Mr. Kessler formally promulgated the government rules, his goal was for a 50% reduction in tobacco smoking by youths within seven years. At the time, the government's Monitoring the Future Study said 21% of eighth-graders, 30.4% of 10th-graders and 34% of 12th-graders had smoked within 30 days. Even without FDA involvement, that goal was met for eighth-graders. It was also met for 10th-graders by 2005. It still hasn't been fully met for 12th-graders.
Major voluntary restrictions
In the meantime, under pressure from the government, the Federal Trade Commission, lawsuits and activists, tobacco companies have voluntarily agreed to major restrictions on their advertising and marketing since 1995.
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But that hasn't been enough to satisfy longtime tobacco nemeses Rep. Henry Waxman, D-Calif., and Sen. Ted Kennedy, D-Mass., who are ready to cap more than a decade of pushing for FDA tobacco regulation and legislation after Mr. Kessler's wishes were stymied first by a Supreme Court decision and then by the Bush administration and Republican opposition.
"This is a historic day in the fight against tobacco, but it has taken too long to get here," said Mr. Waxman on March 4, as the House Energy and Commerce Committee he chairs moved the legislation to the House floor. Indeed, he referred to it as a historic day when the legislation moved to the House floor last April. It passed the House at the time but was never voted on by the Senate.
Proponents of tobacco regulation say the FDA taking control of tobacco and further restricting its marketing is long overdue. The FTC, which currently regulates tobacco, doesn't have the resources to make scientific determinations like the FDA does, they say. They also argue that current marketing restrictions are merely voluntary, and tobacco makers continue to take steps that make tobacco more attractive to youths, including flavoring tobacco.
The proposed law would change that.
Vince Willmore, VP-communications for the Campaign for Tobacco-Free Kids, said the legislation would enact curbs that go "well beyond current restrictions on tobacco marketing. Perhaps most important, it for the first time gives the FDA authority to respond to future changes in tobacco marketing that appeals to kids or misleads the public," he said.
Republican legislators are concerned about the specter of the FDA being given additional duties amid repeated reports that it can't adequately handle its current responsibilities.
What's left to do?
In 1996, 46 state attorneys general signed the Master Settlement Agreement with big tobacco.
As part of the settlement, participating tobacco makers agreed to these ad curbs:
Subsequently, state attorneys general started taking the position that the ban on youth marketing effectively barred ads in publications with heavy youth readership. They used the FDA definition, even though the FDA proposal never became the law.
Phillip Morris USA complied with the state attorneys general and pulled back on tobacco ads, but R.J. Reynolds Tobacco Co. didn't and was sued in California by the state's attorney general. After the suit was filed, RJR restricted its ads to magazines in which more than 25% of the readership was over 18, but the suit went on.In 2004, a California appellate court ruled in the attorney general's favor, effectively extending the settlement to ban most magazine advertising as well.
The FDA has drawn criticism for two major salmonella outbreaks in the past 12 months -- one involving peanut butter, the other a case it took the agency months to connect to tainted jalapenos. On the drug front, the FDA came under intense fire for lax oversight that allowed drugs such as Vioxx on the market.
Rep. Steve Buyer, R-Ind., citing concerns about the FDA's ability to handle its food and drug inspection and review duties, proposed legislation that would create a tobacco program at the Department of Health and Human Services instead. His legislation encouraged states to treat youth purchases of tobacco like youth purchases of alcohol, with similar penalties.
Rep. Nathan Deal, R-Ga., a co-sponsor with Mr. Buyer, said FDA oversight is unwarranted.
"I have serious concerns about establishing a new regulatory regime in the FDA. It's a switch in its mission. A dramatic step in the wrong direction," he said.
Some of Republicans also warned that moving oversight to the FDA has the strange effect of suggesting that tobacco products can be safe.
The bigger question might be why Congress doesn't simply move to make cigarettes illegal if the dangers are so severe.
The rules proposed by Mr. Kessler in 1995 and 1996 would have sharply limited tobacco advertising and marketing, banning giveaways and the use of color or imagery in tobacco advertising and in tobacco signs, and requiring far more tobacco packaging to be devoted to warning labels. It would have also limited sponsorships under tobacco brand names.
Banning 'light,' 'ultralight'
Mr. Waxman's proposal would require the FDA to implement the same restrictions and add some new ones. It would ban the use of "light" and "ultralight" in brands and would ban flavored cigarettes. Mr. Kennedy has regularly proposed similar Senate legislation.
Maura Payne, VP-communications for RJR, warned that the legislation is written so broadly it could actually hurt tobacco-control efforts, making it difficult for companies to provide accurate information while also making if tougher to market any newly developed products that could lessen risks. "It's extremely restrictive on advertising. That's some of the issue we have with it."
She said that the advertising restrictions could serve to "lock in place" market shares. She also said the legislation would also put the onus of regulation on an FDA that is already struggling to fulfill its other responsibilities.
Mr. Willmore of the Campaign for Tobacco-Free Kids said despite the voluntary restrictions by tobacco makers, marketing spending for tobacco has continued to rise, reaching $13.4 billion in 2005, the last year for which the FTC has reported spending figures.
Advertising groups, fearing such restrictions could be applied to other products, have warned that the legislation crosses First Amendment bounds, saying that as long as tobacco remains a legal product available over the counter, any legal basis for limiting its advertising is dubious.
"Don't start down this road to content-based censorship of advertising," the American Association of Advertising Agencies, the Association of National Advertisers and American Advertising Federation said in a letter sent last week to legislators. It also suggested the FTC has a better understanding of advertising than the FDA.
The debate over the tobacco bill is playing out as many of Mr. Kessler's initial goals for cutting tobacco use by youth in half have already been achieved, whether due to higher tobacco prices, increased anti-smoking ads or voluntary marketing steps taken by tobacco makers.
President Barack Obama said last week he supports FDA regulation of tobacco. "We're probably going to have an announcement on this fairly soon, so I don't want to step on my own story. But I do think that the FDA has an important role to play on an issue that obviously has an enormous impact on the health of the American people. That's all you're going to get out of me," he told regional reporters during an interview.