Pre-Market Tobacco Application Process (PMTA)
The 2009 Tobacco Control Act authorized the FDA to regulate not only cigarettes and other tobacco products, but to also “deem” other products containing “nicotine made or derived from tobacco” to be a tobacco product. On May 5, 2016, the FDA announced the final Deeming Rule, which deemed certain products to be “tobacco products” and subject to the Tobacco Control Act. Electronic cigarettes, or electronic nicotine delivery systems (ENDS), were deemed to be a tobacco product under the Deeming Rule.
The agency also issued guidance for the tobacco industry to instruct manufacturers in the Pre-Market Tobacco Application (PMTA) process. This PMTA process requires a manufacturer of a new tobacco product introduced in the market after February 15, 2007 to submit an application to the FDA for review and action. The FDA can refuse to accept an application if the documentation is insufficient, refuse to file an application if all of the requirements of a PMTA are not met, issue a Marketing Granted Order if the FDA finds the product “appropriate for the protection of the public health,” or issue a Marketing Denial Order if the agency finds that a product does not meet this health standard.
Click here to view the FDA’s PMTA Metrics webpage which provides data on the number of PTMAs submitted and the status of these PMTAs.
In addition, the FDA has placed on its website a set of lists of PTMAs submitted to the agency by September 9, 2020. These lists are voluminous and arranged alphabetically by the name of the manufacturer that submitted the application. Please note that these lists are not comprehensive, and the agency has not at this time included in these lists PTMAs submitted after September 9, 2020. Click here to view the FDA webpage with these PMTA lists.
Questions? Contact Tom Briant (tomb@cdaweb.net; (703) 208-1641),
Kathee Facchiano (kfacchiano@capitoldecisions.com; (202) 638-1950)
or Sarah Herbert (sherbert@capitoldecisions.com; (202) 638-0326).