The FDA promised long ago that it would provide a list of products that were allowed to be sold during the PMTA’s one year grace period. After many delays, the list has been released, and it is huge. It consists of fifteen files, each of them tens of thousands of lines long.

Sadly, it is not as useful as it could have been. Not only is it rather difficult to navigate, the FDA admits that it is not a comprehensive list. Products that were excluded from the list include:

• Products from companies that did not provide their information in time to be included
• Products subject to a positive marketing order before April 5, 2021
• Products that were commercially marketed in the United States as of Feb. 15, 2007 and have not been modified
• Products that were subject to negative actions before April 5, 20201
• Products whose submissions are still pending

Most confusingly, manufacturers were not required to submit more than one application for products that have different names or labels if the products were physically identical. That makes this list even more difficult to use as a tool for reference and enforcement. Only the FDA and the companies themselves really keep track of all the alternative names for a product.

Although the list is difficult to use, it still exists and is finally published. However, it may not be worth using, as there are only four months left until the grace period expires. The list will need to be navigated, and then someone has to reach out to companies for alternative names. By the time that can be established, there may only be a few more weeks this list is relevant.

The next question that needs to be answered - what happens after September 9th, 2021, after the grace period for the products on this list expires?

References:

Update on FDA’s Application Review: PMTA List Posted, Metrics Updated

Deemed New Tobacco Product Applications Lists | FDA