The FDA has long promised that it would release an itemized list of all products that can be sold under the PMTA’s grace period. After several years of delays, it has finally been made public, and it’s massive. It is comprised of fifteen files, each one hundred thousand lines.
Unfortunately, it’s not as effective as it could be. Not only is it difficult to navigate, but the FDA acknowledges that it is not a complete list. Some of the products excluded from this list are:
- Companies who haven’t provided their information on time for inclusion
- Products that are subject to a positive order for marketing on or before April 5, 2021.
- The products were being commercially sold within the United States as of February 15, 2007, and have not been altered
- Products that were the subject of negative action prior to April 5, 20201.
- Submissions for products that are waiting to be submitted
In the most baffling way, manufacturers weren’t required to submit multiple applications for products with distinct labels or names in the event that the product was physically similar. This makes it more difficult to use an instrument for reference or enforcement. The FDA or the company itself can manage all alternatives for the name of a product.
While the list isn’t easy to access, it exists and has finally been released. But, it might not be worthwhile because there only remain four months before the grace period ends. The list needs to be explored, and one must seek out companies for other names. Once the list can be established, it could just be a few months that this list will be useful.
The next question to be answered is: what happens following September 9, 2021, after the grace period that was granted to the items on this list ends?
