This Week in CTP - June 25, 2013
Decisions on New Tobacco Products and Upcoming TPSAC Meetings
Today, FDA authorized the marketing of two new tobacco products through the substantial equivalence (SE) pathway, and denied the marketing of four others. Additionally, the Agency announced the refusal to accept 20 Exemption from SE requests and the withdrawal of 136 SE reports by industry sponsors.
FDA’s responsibility is unprecedented. No new regulated tobacco products can come to market without FDA review. Every SE submission undergoes a rigorous scientific review to determine if the new product has the same characteristics as a predicate tobacco product identified by the manufacturer or if it has different characteristics, but the new product does not raise different questions of public health.
As part of FDA’s mission to reduce tobacco-related death and disease, the Agency is working to ensure that any new tobacco product brought to market through the SE pathway will not present more harm to public health than a valid predicate product.
FDA has published two separate Federal Register notices announcing meetings of the FDA Tobacco Products Scientific Advisory Committee (TPSAC) that will take place on August 15 and 16, 2013.
The meeting on August 15, which will be a joint meeting with the FDA Risk Communication Advisory Committee, will focus on the results of FDA consumer research that may provide insight into how FDA can best share information with the public on harmful and potentially harmful constituents (HPHCs) in tobacco products.
On August 16, TPSAC will discuss possible approaches for evaluating information on the risks and potential benefits of a proposed modified risk tobacco product to the population as a whole.
For both meetings, interested persons may present data, information, or views, orally or in writing. For more information, including how to get involved, visit our TPSAC webpage.