• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Tobacco Products

This Week in CTP - August 28, 2013

New Tobacco Product Review Decisions and a Final Guidance Announced

Today, FDA issued additional tobacco product review decisions, denying the marketing and sale of four new tobacco products through the substantial equivalence review path. The products were found to be “not substantially equivalent” to the predicate products to which they were compared. The products under review were not on the market and cannot be introduced into the market. These decisions follow the first tobacco product review decisions, which authorized the marketing and sale of two new tobacco products and denied the marketing and sale of four others on June 25, 2013.

For more information on our substantial equivalence actions, please visit our Tobacco Product Marketing Orders webpage.

Last week, FDA published a notice in the Federal Register announcing the release of the final guidance document titled, “Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents” (also known as the reissued 1996 rule). The final guidance explains the provisions of the final rule, for instance, retailers are prohibited from selling tobacco products to youth under the age of 18; are required to verify the age of all customers under the age of 27 by checking a photo ID; and are prohibited from distributing free samples of cigarettes.

Click here to view the full notice, read the guidance document, and post your comments.