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PMTA Trends in Rejections

Premarket Tobacco Applications (PMTAs) Since Program Inception

Since the Premarket Tobacco Application (PMTA) program was established in October 2014, approximately 417 Premarket Tobacco Applications have been submitted. A majority of these were in the summer of 2016. However, to date, only 15 PMTAs have been approved.

According to the FDA, 85.2% of submitted PMTAs are listed as refuse-to-accept, but why is that? What was in their submission, or missing from their PMTA, that led the FDA to this conclusion?

PMTA Rejection Trends & How to Avoid Them

The Environmental Assessment

Of the 85.2 percent of refuse-to-accept PMTAs the FDA estimated 80-90 percent were due to a lack of an Environmental Assessment. An Environmental Assessment (EA) is a public document that serves to provide evidence for an agency to determine whether to prepare an Environmental Impact Statement (EIS) or a Finding of No Significant Impact (FONSI).

The FDA requires EA include:

  • Discussion of the need for the proposal
  • Alternatives as required by Section 102(2)(E) of NEPA
  • Environmental introductions related to the proposed action
  • Environmental introductions related to action alternatives
  • Environmental impacts relating to the use of the tobacco product
  • Environmental impacts relating to the disposal after use of the tobacco product
  • Listing of the agencies and persons consulted

EA’s are a required component of both PMTA and Substantial Equivalence (SE) Reports. Failure to include it may jeopardize the review process. Remember, EA’s are product specific and relevant analysis is constantly changing so make sure your information is accurate and up-to-date when submitting. The EA must also standalone outside of the PMTA for review, so duplicating information is not uncommon.

Marketing Tactics

The FDA and FTC are taking action against E-Liquids manufacturers who market or target minors. This is another huge reason for PMTA rejection. If your product flavor, labeling, or advertising resembles any kid-friendly food products, the FDA will reject it. Products should not appear similar to candies, cookies, juice boxes or have a cartoonish appearance. Names like fruity freeze, so berry good and root beer float are not recommended.

The FDA will not accept any tobacco product that is marketed or appears to be marketed to children. In a statement, the FDA said, “While we continue to encourage the development of potentially less harmful forms of nicotine delivery for currently addicted adult smokers, we will not allow that work to come at the expense of our children.”

Incomplete Applications

Incomplete applications are another major reason why PMTAs are rejected. This could mean one of a few things. The application could be missing a required form, missing the Environmental Assessment or claim of a categorical exclusion, does not include applicants’ contact information or does not include a signature of a responsible official who is authorized to represent the applicant.

Because of this, it is extremely important to triple check any PMTA before submitting it to the FDA. Submitting a “PMTA Lite” is a different approach and is not considered an incomplete application as you are in the midst of completing the required testing or waiting on results from said testing.

Avomeen Can Assist With PMTA Testing

Avomeen provides all levels of service related to custom analysis and testing protocols for e-liquid and ENDS manufacturers of all sizes. We understand submitting a PMTA may be difficult and we as experts in PMTA testing are here to help. Our laboratory offers a variety of services that are required for PMTA testing. If you’re in the vaping industry and need help complying with the FDA’s PMTA guidance, let’s partner.

Additional Resources

Worried about meeting the FDA’s PMTA deadlines and complying with the 2-year stability requirements? Check out our blog post for more information.
Interested in learning more about bridging studies and how they work with the PMTA? Read more here.
If you haven’t received marketing authorization for your product yet, read up on our blog: FDA Issues Warning Letters for E-Liquid Products without Marketing Authorization.
If you have questions about the FDA’s PMTA requirements get some clarity with our blog, 2019 FDA PMTA Guidance FAQs.

 

Our expert blogger is Dr. Derek Beauchamp, Avomeen’s Sr. Technical Director, Analytical Sciences. Derek epitomizes the role of technical director, with expertise in both highly-regulated and newly-regulated industries and applications. Derek serves as Avomeen’s foremost expert in nicotine and e-liquid regulations and analysis, and his expertise and knowledge of e-liquid regulations and analysis has been showcased in trade publications and regulatory-focused conferences. His experience extends to a wide breadth of characterization techniques and the respective instrumentation and software. Derek continues to innovate and push forward in his field, keeping Avomeen at the leading edge of the life sciences.