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
'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.
'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."
