What it is and how it affects you
Overview of PMTA
A PMTA (Premarket Tobacco Product Application) must provide scientific data that demonstrates a product is appropriate for the protection of public health. To reach such a decision and to authorize marketing, the FDA considers, among other things:
- Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers.
- Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available.
- Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available.
- The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product.
- The current deadline for PMTAs is Sept. 9, 2020. This date has changed multiple times since the initial publication of the deeming regulations.
- For companies that submit applications, the product can remain on the market for up to one year or until a decision is made.
What products will be affected?
- Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007.
- Any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.
- This includes nearly all E-Liquid, Hardware, and accessories currently on the market.
What does the PMTA Process look like?
What is AVAIL doing for PMTA?
We have been planning for PMTA for years and have developed wonderful relationships with both our suppliers and our customers, and we are excited to use these relationships to continue to offer the best selection in the industry! AVAIL is also putting our best-selling flavors through the PMTA process so our customers can continue to enjoy AVAIL’s Premium E-Liquid through September 9th and beyond!
We chose these flavors based on their popularity and wanted to maintain a diverse assortment of fruit, bakery, tobacco, and menthol to satisfy all our customer’s needs. Our manufacturing is done in an ISO certified clean room, and every batch we make has a QR code on it to verify the cleanliness of our liquid, as well as dedicated testing for Diacetyl and other unsavory chemicals compounds. We are focused on providing a transparent, safe, and innovative product.