August 2009
Tobacco Law Gives FDA Unprecedented Authority
 
 

 

MARY ELLEN SCHNEIDER
Public health advocates are applauding a new law that gives the Food and Drug Administration unprecedented authority to regulate the sale, marketing, and even ingredients in tobacco products.
President Obama signed into law the Family Smoking Prevention and Tobacco Control Act (H.R. 1256) at a White House ceremony. The new law gives the FDA the power to regulate the levels of tar, nicotine, and other ingredients in tobacco products. While the law does not give the FDA the authority to ban tobacco products, it does give the agency broad authority to regulate labeling, packaging, and advertising of such products.
During a Rose Garden signing ceremony, President Obama said the law would “save lives and dollars” and would aid health reform efforts by reducing tobacco-related health care costs.
The law bans the use of cigarette additives or flavoring such as strawberry or grape that many public health advocates have said has been used by tobacco manufacturers to make smoking more appealing to minors. The law also prohibits tobacco companies from using descriptors such as “light” or “mild.”
Additionally, the bill calls on the FDA to consider fast-tracking the approval of smoking cessation products.
The new law also aims to prevent youth smoking by placing restrictions on outdoor tobacco advertising within 1,000 feet of schools and playground, as well as sponsorships of entertainment and sporting events. Cigarette packs themselves will also be designed to deter smoking. Under the law, about half of the front and back of the package will be taken up by the warning label. Manufacturers can choose from a selection of warnings such as “WARNING: Smoking can kill you” or “WARNING: Cigarettes cause cancer.”
These types of restrictions will help chip away at some of the ways tobacco companies have successfully created an aura of “cool” around smoking, said Danny McGoldrick, vice president for research at the Campaign for Tobacco-Free Kids.
Physician groups hailed enactment of the new law. “The new law represents an important break from the past, as it signifies broad acceptance that nicotine is a drug harmful to people's health,” Dr. J. James Rohack, president of the American Medical Association, said in a statement.
“This is great news for family doctors,” said Dr. Ted Epperly, president of the American Academy of Family Physicians. “To now have this kind of statement coming out in terms of control of tobacco products is a huge shot in the arm for the health of America.”
Dr. Epperly said he hopes the attention from this new law will spur physicians to make it routine to ask patients about smoking and follow up with advice on quitting. The AAFP has its own program—“Ask and Act”—which includes tools and information on prompts for physicians to ask about patients smoking, coding for cessation counseling, and resources for patients who want to quit (www.aafp.org).
For those physicians who think they don't have the time, Dr. Epperly pointed out that it doesn't have to be the physician who asks about smoking, it can also be a nurse or medical assistant. He also advised physicians to be patient about seeing results from patients. “I've had multiple patients that aren't ready yet to stop smoking. But I always remind them, ‘I'm here for you if and when you decide [to quit],’” Dr. Epperly said.
But not everyone praised the new law.
Dr. Alan Blum, professor and endowed chair in family medicine at the University of Alabama, said he opposed the legislation because cigarettes are now going to appear to John Q. Public to be “regulated” by the same agency that oversees cancer drugs. “The absurd difference is that if a chemotherapeutic agent is found to cause serious side effects, it can be pulled from the market. Not so for cigarettes, which the bill specifically prohibits the FDA from doing.”
The FDA will be able to use its new authority to assist in smoking cessation by regulating the ingredients in tobacco products. But finding the best way to do that may take some time, said Erika Sward, director of national advocacy for the American Lung Association.
Aside from the concrete elements of the law, Ms. Sward said she hopes the law will also help people understand that tobacco addiction is powerful and that most people can't quit “cold turkey.” It's important for physicians to talk to patients repeatedly about the need to quit smoking, she said.
Mr. McGoldrick of the Campaign for Tobacco-Free Kids added that while the law offers a number of useful tools to tackle the supply side of the tobacco problem, the public health community does not expect one law to accomplish everything. Federal and state lawmakers need to continue to increase taxes on tobacco products, pass more smoke free laws, and increase funding for prevention and cessation programs, he said.