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.
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The tobacco law: What the FDA can and can't do
The new legislation extends oversight but bows to economic and administrative realities.
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.
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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.
