You may be wondering what the FDA’s PreMarket Tobacco Application (PMTA) List means for you as a consumer of tobacco products. Although the final rule for this list was displayed in the Federal Register on January 19th earlier this year, they were not published and were subsequently withdrawn following a memo from the White House Chief of Staff. However, the FDA will be working with the new administration to review any rules that have been withdrawn before making a decision whether to advance them.
Any person or entity who wishes to seek an FDA marketing order for a new tobacco product can submit a PMTA. The purpose of a PMTA is to provide scientific data and evidence to demonstrate that the product is suitable for public health protection purposes. Below are some of the factors that will be considered before approving a PMTA:
- Benefits and risks to the general population for both users and nonusers
- Whether current users and nonusers of tobacco products are more or less likely to stop using such products if the new product becomes available
- The process in which the new product will be manufactured; the facility in which it will be processed and more
Clauses of a PMTA
Now that you know the purpose of a PMTA, what needs to go into it? Below is a list:
- Full reports that have been made known to the applicant or which they can reasonably be expected to know concerning the health risks of the new product, including whether the new product carries less risk than existing tobacco products.
- A comprehensive list of the ingredients, components, additives and properties of the new product as well as the principles of operation.
- A full description of the methods, facilities and controls employed in the manufacturing, processing, packing and installation of the new product.
- If applicable, a reference to an established tobacco product standard. These can be provided through a report of information to show how the new product meets standards and to justify any deviation. Samples and specimens can be attached if necessary.
After a PMTA has been submitted, a review process will take place. This includes:
- A voluntary pre-submission meeting where the applicant can meet with FDA officers to discuss an intended submission.
- Filing review to ensure that the application contains all the required documents.
- Substantiative review to evaluate all the scientific data included in the application.
- Acceptance review, where the applicant will either receive an acceptance letter or a Refuse to Accept (RTA) letter.
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