Will the current tobacco products on the market be removed?

Tobacco products that were commercially marketed in the United States as of February 15, 2007 may continue to be marketed, but must comply with all provisions of the Act.

Will new tobacco products now be subject to FDA approval?

The Agency will need to conduct a premarket review of applications for tobacco products not commercially marketed in the United States as of February 15, 2007, unless those products are exempt for certain reasons outlined in the FSPTCA. For those products requiring premarket review, FDA will review, among other things, information submitted regarding the health risks of the tobacco product, ingredients, methods used for manufacture, and labeling.

How do these products differ from those approved by other FDA Centers, such as those approved under the Center for Drug Evaluation and Research (CDER)?

The products which go through the CDER review process are ones which meet the definition for drugs under the Federal Food, Drugs and Cosmetic Act and are not defined as a tobacco product. In addition, CDER primarily approves nicotine replacement products to reduce withdrawal symptoms associated with quitting smoking.

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