The tobacco bill signed into law by President Obama on June 22 is a compromise that acknowledges a few hard political facts:
More than 43 million Americans remain addicted to the nicotine in tobacco (indeed, 70% of smokers say they wish they could quit, and 40% try yearly).
For The Record
Los Angeles Times Wednesday, July 01, 2009 Home Edition Main News Part A Page 4 National Desk 1 inches; 58 words Type of Material: Correction
'New' tobacco products: An article in Monday's Health section about the Food and Drug Administration's new regulatory powers over tobacco said that the agency would consider any tobacco products introduced after June 2003 "new" products, and could therefore consider whether they may remain on the market. The law defines new products as those introduced after Feb. 15, 2007.
For The Record
Los Angeles Times Monday, July 06, 2009 Home Edition Health Part E Page 6 Features Desk 1 inches; 58 words Type of Material: Correction
'New' tobacco products: A June 29 Health section article on the Food and Drug Administration's new regulatory powers over tobacco said that the agency would consider any tobacco products introduced after June 2003 "new" products, and could therefore consider whether they may remain on the market. The law defines new products as those introduced after Feb. 15, 2007.
Taxes on the sale of tobacco products are a major source of revenue for states.
Even without adding tobacco to its regulatory portfolio, the Food and Drug Administration is straining to carry out its other responsibilities, including the safety of the nation's food, drugs and medical devices. The law stipulates that the FDA's regulation will be underwritten by user fees levied on the tobacco companies.
Finally, regulating tobacco is a pretty tricky job for an agency given the task of protecting the nation's health.
Tobacco is simply not like the drugs, medical devices and foods the FDA regulates: There are no demonstrable health benefits to tobacco against which the FDA can weigh the risks that go along with its use. In fact, some in Congress argued the FDA has no place in trying to merely limit the damage caused by a product that causes only addiction and harm. By giving its blessing to the sale of some tobacco products and denying others, they argue, the FDA may lead consumers (perhaps those who haven't had contact with the outside world for the last 44 years) to think those products are safe.
Rep. Henry A. Waxman (D-Beverly Hills), chairman of the House Energy and Commerce Committee and the author and champion of the FDA-tobacco bill, acknowledges that this is an unusual role for the FDA. But short of tobacco prohibition -- which, he says, "isn't going to work" -- the FDA is the only agency equipped to limit and reduce the damage that tobacco use does to the nation's health, and stem the recruitment of new smokers among the nation's youth.
"The FDA is the exact agency that should have that authority -- it's a scientific organization with regulatory powers," Waxman said in an interview.
Here are some of the bill's principal provisions, and the FDA's plans for carrying out its new mandate.
What are the FDA's orders? The newly signed law grants the FDA broad authority to require changes in tobacco products currently on the market and those proposed for future sale "appropriate for the protection of the public's health."
That broad mandate would allow the FDA to reduce or remove from tobacco products ingredients, additives or constituents that it considers harmful. Some of the items likely to come under scrutiny -- such as ammonia and formaldehyde -- are probably unfamiliar ingredients to many consumers. But the list also will include flavorings. Chocolate and cherry, which enhance the appeal of tobacco to young people, are banned by the new law. Though menthol is not automatically banned, the FDA's new jurisdiction would allow it, if it chose, to place limits on or even ban this flavoring, which is favored by 27% of all smokers and three-quarters of African American smokers.
The law gives the FDA responsibility for the pre-market approval of new tobacco products, which are defined as any tobacco product that has been introduced on the U.S. market since June 1, 2003, or are proposed for marketing here in the future. Companies sponsoring such products will have to submit to the FDA studies detailing their health effects. And the Secretary of Health and Human Services can, on the FDA's recommendation, deny approval if the sponsoring company fails to show that the marketing of their product "would be appropriate for the protection of the public health."
In short, new cigarettes, cigars or chewed or eaten tobacco products are unlikely to enter the market -- and several current products are likely to be pulled -- if it can't be shown they reduce dependence or limit the harm of tobacco use.
Significantly, that assessment can consider a product's ability to reduce harm to those who do not currently use tobacco products -- the bystanders who are affected, for instance, by secondhand smoke. That may open the way for some so-called bridge products, including smoke-free cigarettes or edible nicotine disks, to enter the market.
What are the limits of the FDA's authority? The law prohibits the FDA from banning outright all tobacco products or any class of tobacco products -- such as cigarettes, cigars or chew. The agency may require the reduction of nicotine, tobacco's most potently addictive ingredient, but is not permitted to require the chemical's total elimination. Experts agree there are nicotine levels greater than zero that are not addictive but may provide some of the chemical's pleasurable and energizing effects. But plunging more than 45 million Americans into nicotine withdrawal with the stroke of a pen was not considered a viable option.