May 11, 2022
On March 15, 2022, President Biden signed H.R. 2471 – the Consolidated Appropriations Act, 2022. A provision of this law amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include specific language that establishes that the FDA can regulate tobacco products containing nicotine from any source. Manufacturers, distributors, importers and retailers of tobacco products containing non-tobacco nicotine (NTN)—that is, nicotine not made or derived from tobacco, such as synthetic nicotine—must now comply with applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
One of those requirements is the need to submit a Premarket Tobacco Product Application (PMTA).
Manufacturers of NTN products on the market as of April 14, 2022 that wish to continue to market their products are required to submit a PMTA by May 14, 2022. (Note: this is the deadline for applicants submitting electronically, as required. Applicants can, however, request a waiver from FDA to submit a PMTA in a different format. An application submitted in hard copy must be received by FDA no later than 4:00 p.m. EDT on Friday, May 13, 2022).
The new law provides that an NTN product with a tobacco-derived “previous version” that received from FDA a negative action on a PMTA, such as a ‘refuse to file’ or ‘marketing denied order,’ may not continue to be marketed after May 14, 2022, without receiving a marketing granted order from FDA. Such products must be removed from the market, even if a new PMTA is submitted, until the marketing granted order is received.
Further, for products on the market April 14, 2022, a PMTA must be submitted by May 14, 2022, and the product must receive a marketing granted order from FDA by July 13, 2022, in order to remain on the market. Products on the market after July 13, 2022 without an FDA marketing granted order are in violation of section 910 of the FD&C Act and may be subject to FDA enforcement.
For products not on the market April 14, 2022, an application must be submitted to FDA and marketing authorization received before the product can be sold in the United States.
Below are some resources to help guide manufacturers of NTN products through the application submission process:
- The PMTA final rule helps ensure applications contain sufficient information for the FDA’s evaluation, including details on the physical aspects of a tobacco product and information on the product’s potential public health risks. The final rule describes the information an applicant must include in a PMTA for the FDA to complete a substantive review of an application, such as content and format requirements, as well as how applicants may submit a supplemental PMTA or resubmission, which may improve efficiency by not allowing for duplicative information.
- Electronic application submissions help industry and the FDA to efficiently transmit and receive applications. The following steps are required to submit an application electronically:
- Request an Industry Account Manager (IAM) account to establish CTP Portal account, if your company does not already have an IAM.
- Prepare your submission electronically using FDA's eSubmitter software and the eSubmitter template “CTP Transmittal Form.”
- Submit online via the CTP Portal.
Note: The CTP Portal provides more functionality than the Electronic Submissions Gateway, or ESG, and CTP recommends using the CTP Portal. However, if you already have an ESG WebTrader account, you may use it to submit documents to CTP.
- FDA provides three forms for the submission of PMTAs, which help ensure applications contain sufficient information for FDA’s evaluation. The PMTA forms include the Product Grouping Spreadsheet, which will assist both FDA and industry in identifying the products of submissions where an applicant groups multiple PMTAs into a single submission.