If a PMTA has not been filed for a specific product or “SKU”, that product will not be authorized to be sold in the US Market. The FDA has 1 year to approve all PMTA submissions, therefore allowing products that have been filed for to continue to be sold in the US until they are either approved or denied.
The FDA has stated that they plan to release a public list of manufacturers that have submitted a PMTA on or before the September 9th deadline. Before releasing this list, the FDA will need to ensure the publishing of any information complies with federal disclosure laws and regulations.
The FDA has recognized that there are “Over 400 million deemed products listed with the FDA”. They have a one year period to review the products that were filed on time, but due to the magnitude of applications that have been submitted, the FDA has stated that “as a matter of practicality we may not be able to fully complete review of all tobacco product applications that we receive by Sept. 9, 2020 within the year.” However, the FDA has been preparing for this for years, so they plan on receiving, processing, and reviewing the applications in a timely manner.
The FDA has stated that they “intend to prioritize enforcement decisions on a case-by-case basis, such as prioritizing enforcement based on the likelihood of youth use or initiation.” They are also encouraging vendors to “explicitly identify any content that may be missing from an application and clearly explain how COVID-19, a recent natural disaster, or other unforeseen circumstance has affected ability to provide such information.”
The FDA is planning on taking appropriate actions regarding tobacco products that are marketed without premarket authorization. The most efficient way for the FDA to use its enforcements recourses is by targeting manufacturers and importers rather than distributors or retailers. The FDA has stated that they will be “continuously evaluating new information and adjusting its enforcement priorities in light of the best available data, and it will continue to do so with respect to these products.”
The FDA has stated that there will be no sell through period for non-compliant products after September 9th, 2020. This means that a manufacturer who has not submitted a PMTA to the FDA cannot continue to legally sell their products in the US after September 9th.
Only vaping products and devices that have been filed for are legally allowed to be sold in the US after September 9th. If the manufacturer/importer has filed for PMTA for a product on market on or before August 8, 2016, the product may legally be sold within the United States while under review.
Yes. The PMTA only applies to products sold in the US.
Nicotine free e-Liquid is included in the PMTA so it will only be available if it has been filed for.
The FDA reports the PMTA process is costing manufacturers “several hundred thousand” dollars per SKU (sku = each milligram, flavor, etc.), so it is possible for there to be a slight effect on the price of compliant US products in the future. Early reports from Brand owners show the investment per Product Application is in fact much, much higher than initially advised. Impact to per ml price is TBD.
What flavor profiles to receive a Marketing Authorization is to be determined based on scientific data supplied to the FDA on the chemical composition of the flavoring, if appeals to youth uptake, etc. Stay tuned and be the first to know for every flavor and brand.