PMTA Clarification

30 April 2021

ADACT have received clarification on General Enforcement Discretion Related to Sept. 9 Premarket Tobacco Applications from the FDA.

We received the following on 29 April 2021.

“Per a court’s order, for new deemed tobacco products on the market as of Aug. 8, 2016, submissions of applications for marketing orders were required by Sept. 9, 2020.  As part of FDA’s outreach to companies to develop a public list of premarket tobacco product applications (PMTA) received by the Sept. 9, 2020 deadline, we have learned that there may be some confusion about the one-year review period and FDA’s exercise of enforcement discretion for certain tobacco products that are the subject of a pending application. To clarify, per the court order, FDA may (and generally intends to) defer enforcement of premarket requirements for certain deemed new tobacco products (i.e., those not subject to FDA’s enforcement priorities as described in Agency guidance) on the market as of Aug. 8, 2016 for which applications were submitted by the Sept. 9 deadline for up to one year, or until Sept. 9, 2021. If a negative action is taken by the FDA on an application during that year, the product(s) must be removed from the market or risk FDA enforcement.
“While processing PMTA submissions received by the Sept. 9, 2020 deadline, FDA continues to enforce the law. As previously stated, FDA is prioritizing enforcement against any electronic nicotine delivery system (ENDS) product that lacks a product application after Sept. 9, 2020, in addition to those described as priorities in the Jan. 2020 guidance. Additionally, for other deemed tobacco products that do not have premarket authorization, other than premium cigars, FDA will make enforcement decisions on a case-by-case basis and intends to prioritize enforcement based on, among other things, the likelihood of youth use or initiation to make the most efficient use of its resources.
“If you have any further questions on this topic, please contact us at [email protected].”

We can help your business succeed

We care about our customers and ensuring they have access to affordable compliance services to enable their businesses to grow.

Compliance strengthens brands – consumers naturally have a higher level of confidence in tested, approved products. Compliant products have a leading edge in the market place, when compared to non-tested brands and products.

Work with scientists, work with us

Experts in science

Consult with a compliance agency with an excellent in-depth understanding of the science behind their work.

Reliable results

Our testing is completed in our own state of the art ISO 17025 accredited laboratory, providing results you can trust.

Numbers to trust

We have immense experience in providing compliance with over 1,500,000 TPD notifications since May 2016.

Get in touch today

We’re delighted to meet with you and look forward to working with you soon. Contact ADACT using the buttons below…

Get in touch with ADACT

Call or email ADACT using the buttons below