This week the U.S. Food and Drug Administration (FDA) announced that certain tobacco products introduced or changed after Feb. 15, 2007 would have to be reviewed by the agency in order to prove the product is “substantially equivalent.”  “Substantially equivalent” means the products in question must be the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health.

Below is additional information on the most recent FDA announcement:

FDA to require substantial equivalence reviews for new tobacco products

The U.S. Food and Drug Administration announced today that certain tobacco products introduced or changed after Feb. 15, 2007 must be reviewed by the agency. In FDA guidance published today, the agency outlines a pathway for marketing a product whereby the company marketing the product must prove that it is “substantially equivalent” to products commercially available on Feb. 15, 2007.  
 
“Substantially equivalent” means the products must be the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health.

Learn more:
•    Substantial Equivalence Webpage  
•    Press Release
•    Frequently Asked Questions
•    Final Guidance for Industry and FDA Staff
•    Proposed Rule – Exemptions from Substantial Equivalence Requirements for Tobacco Products  

Webinar Series

FDA Center for Tobacco Products (CTP) will hold Webinars with stakeholders to inform them of the substantial equivalence regulation and requirements.
•    Tobacco Industry: Small and Large Business - January 12, 2011, 11:30 a.m. – 2 p.m. ET
•    Public Health and Tobacco Control Organizations - January 14, 2011, 10:30 a.m. – 12 p.m. ET
•    Small Business Follow-up - January 25, 2011, 11:30 a.m. – 2 p.m. ET
 

The webinars will feature a presentation about the new requirements and a question and answer session.  Participants are encouraged to submit questions in advance to AskCTP@fda.hhs.gov.  Webinar information is available on the Substantial Equivalence Webpage.