FDA moving cautiously on tobacco regulation

July 8, 2009

Congress gave the Food and Drug Administration (FDA) jurisdiction over tobacco in June, but don?t look for any quick changes in tobacco policy, products, or marketing. The agency is asking the public for guidance before jumping into regulation.

Congress gave the Food and Drug Administration (FDA) jurisdiction over tobacco in June, but don’t look for any quick changes in tobacco policy, products, or marketing. The agency is asking the public for guidance before jumping into regulation.

“We’re interested in receiving input from across the country as the FDA begins to implement this important new authority intended to reduce the enormous toll of suffering and death caused by tobacco products in the United States,” said Commissioner Margaret Hamburg, MD.

In asking for public comment, the FDA noted that tobacco is responsible for more than 430,000 deaths yearly and results in death or disability for half the estimated 60 million adult smokers in the United States. Tobacco imposes an annual economic burden of $193 billion in medical expenditures and lost productivity.

“My tobacco-control brethren are sharply divided on this,” said longtime advocate Barry Bleidt, professor at Texas A&M Health Science Center Rangell College of Pharmacy in Kingsville, Texas, and advisory board member for the Smoking Cessation Leadership Center at the Robert Wood Johnson Foundation. “It is not realistic to take cigarettes off the market, because tobacco is so easy to grow. Prohibition would be a social disaster.”

The FDA is creating a new Center for Tobacco Products that will be funded by fees levied on the tobacco industry. Cigarettes and other tobacco products will be regulated under a new standard, “appropriate for the protection of public health,” and not under the more familiar “safe and effective” standard.

Links to the Act and FDA’s request for public comment can be found at www.fda.gov.

The public-comment period expires in late September. “Asking for public comment is as reasonable a first move as any,” said Stanton Glantz, professor of medicine and director, Center for Tobacco Control Research and Education, University of California San Francisco. “The new law is problematic at best. It is structured in such a way that FDA will have a problem implementing any significant change.”

Wall Street analysts are already shrugging their shoulders. Standard & Poor’s analyst Elena Serdyuk wrote that the new legislation gives the FDA the authority to restrict tobacco marketing and advertising, oversee manufacturing, and demand detailed disclosure of all ingredients. She also noted that the legislation is unlikely to affect S&P’s ratings of tobacco firms.

What the new act may mean for tobacco sales is not clear. Pharmacy associations, retail chains, and tobacco firms contacted by Drug Topics either declined to comment or failed to return phone calls and e-mails. Anti-tobacco groups supporting the act were jubilant.

“We’re excited that special protection for tobacco companies is finally over,” said Danny McGoldrick, vice president for research, Campaign for Tobacco-Free Kids. “The broad authority the legislation gives FDA on the sale, use, and manufacture of tobacco will finally apply good science to the reduction of tobacco use. The key is to appoint a strong Center director to get things up and running as soon as possible.”

Other tobacco control advocates are less hopeful. Glantz said the law will simply institutionalize current products and market conditions, giving existing manufacturers a significant market advantage.

Phillip Morris, the largest U.S. cigarette maker, supported the bill. R.J. Reynolds and Lorillard, the second- and third-largest manufacturers, opposed it. He also noted that the act reserves three seats on the FDA’s scientific advisory panel for tobacco companies.

“That’s like appointing Mafia members to the FBI task force on organized crime,” Glantz said. “These guys are tobacco racketeers. They will have a negative effect on any action FDA takes.” Michael Siegel, professor of social and behavioral sciences at the Boston University School of Public Health, said assigning tobacco regulation to the FDA is a bad idea.

“People will assume that FDA is regulating for safety,” he said. “You have an agency whose mission is to ensure safety being asked to approve a product that kills. FDA has been put in an untenable position.”

Like it or not, tobacco is now FDA’s responsibility, Bleidt said. What the agency needs are effective strategies to reduce harm and risk from tobacco use. That suggests a strong emphasis on marketing and advertising restrictions and public education. “Tobacco is a legal industry, whether we want them or not,” he said. “Now that tobacco is professionally regulated, there should be an expanded role for healthcare professionals.”