The Pre-Market Tobacco Product Application, also known as the PMTA, is an application created by the FDA for potential tobacco product retailers. A PMTA must be submitted and approved by the government before an applicant can begin retailing tobacco products. A PMTA must provide scientific evidence and data showing that the tobacco product provides safety for public health.
The FDA considers the following, among other things in their approval process;
- Risk and benefit analysis to the population as a whole, including users and non users.
- Whether people who currently use tobacco products would be more or less likely to switch over to the new tobacco product if it were mad available and
- Whether non tobacco users would now use this new tobacco product if made available.
How Much Does a PMTA Cost?
The costs associated with submitting a PMTA can vary depending on many factors such as, the type of product and testing of the product to inform the application.
On Page 94 (Table 14) of “deeming” Regulatory Impact Analysis (RIA), the FDA has estimated the overall cost of a PMTA to be in the mid hundreds of thousands of dollars to the low millions of dollars.
Keeping cost in mind, the FDA has taken some steps to ease the heavy financial burden a PMTA can have on small businesses.
These steps include;
- Creating financial guidance on tobacco product master files, which helps applicants use existing information instead of conducting their own research.
- Issuing guides on deeming and PMTA user fees.
- Posting training videos and live webinars to assist the industry.
Do I Need to Submit an Application For Each Nicotine Flavor/ Strength and Product?
The FDA considers information on each product as a separate, individual PMTA, especially when dealing with new tobacco products. You can technically submit a pre market application for multiple tobacco products using one cover letter and table of contents for each product. But, as stated above, the FDA considers each ENDS product with different nicotine content or flavor as a different product.
What is the PMTA Review Process?
The PMTA goes through a 4 step review process before being rejected or accepted. These phases include;
Pre-Meetings: A formal meeting between an applicant and the FDA to discuss a planned PMTA.
Acceptance Review: An administrative review that confirms the product falls within the Center for Tobacco Products jurisdiction and confirms that the regulatory requirements of an application have been met.
Filing Review: A determination of whether the application contains sufficient information to proceed to the next phase, a substantive review.
Substantive Review: An FDA evaluation of the scientific information collected by the applicant, as well as recommendations from the TPSAC (Tobacco Product Scientific Advisory Committee).
Action: Output of this phase includes, marketing granted order letter or marketing denial order letter.
Even if you’ve been lucky enough to have your application approved, it doesn’t end there. Post market requirements have to be met. Applicants are required to create and maintain records and make reports that FDA requires as necessary to determine whether the tobacco product should stay on the market or not.
Unfortunately, the PMTA due to its nature and cost, has put many businesses out of business once it was approved on February 15, 2007. The pre market application is a lengthy and costly process requiring applicants to conduct extensive research on the products they wish to sell. The PMTA also costs anywhere from $100 000 to over $1 000 000 making it almost impossible for small businesses to apply and stay open.
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