The Premarket Tobacco Product Application (PMTA) application deadline was September 9, 2020. If you haven’t heard about the PMTA process or you’re still not really sure what it means, then keep reading, because we’re going to tell you all you need to know about how it has impacted the vaping industry.
Let’s start from the beginning. On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (TCA) was signed into law. This act gave the U.S. Food and Drug Administration (FDA) the authority to regulate how certain tobacco products were manufactured, distributed, and marketed in the United States. Additionally, it set the requirement that any tobacco product regulated by the TCA and introduced into the market or modified after February 15, 2007, needed to be approved by the FDA before being marketed.
Per the TCA, any product derived from tobacco was now considered a tobacco product under federal law. Although the TCA requirements initially applied specifically to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, the Act also gave the FDA the leeway to determine which other tobacco products would be subject to the federal requirements. So in May 2016, the FDA issued the “Deeming Rule,” which formally extended the TCA requirements to electronic nicotine delivery systems (ENDS) and e-liquids that met the statutory definition of a tobacco product.
As part of the “Deeming Rule,” the FDA established a deadline of August 8, 2018, for manufacturers to submit premarket authorization applications for new tobacco products that were introduced into the market as of August 8, 2016 (products that had not been on the market as of that date could no longer be sold without receiving FDA market approval). In May, 2017, the FDA proposed to extend the submission deadline by three months. Then, in July 2017, the agency announced its intention to extend this deadline even further, to August 8, 2021, for combustible products (e.g., cigars) and August 8, 2022, for non-combustible products like e-cigarettes. (In March 2019, the FDA published a draft compliance policy to move enforcement dates for flavored ENDS to August 8, 2021.)
Two years later, in July 2019, in a lawsuit brought against the FDA by a number of parties, the U.S. District Court for the District of Maryland ordered the FDA to require manufacturers to submit premarket applications by May 12, 2020, for any newly deemed tobacco products. The court order also gave the FDA a one-year grace period to allow these products to remain largely available on the market, provided that applications had been submitted for them by the May 12 deadline. Nevertheless, the FDA still was given the discretion to enforce the premarket review provisions before the submission date and during the one-year grace period.
In February 2020, the FDA began prioritizing enforcement against flavored ENDS. Flavored cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product) that had not been given premarket authorization by the FDA could no longer be offered for sale in the United States.
Due to the extraordinary circumstances surrounding the COVID-19 pandemic, the FDA requested a 120-day extension to the PMTA deadline. The court approved the FDA’s request on April 22, 2020, and extended the initial deadline to September 9, 2020.
All applications for premarket authorization had to be filed by September 9, 2020. Because the deadline has now passed, any products for which premarket authorization applications were not submitted can no longer be marketed legally in the United States. As outlined in the original court order, if a manufacturer filed an application by the deadline, then the submitted products will generally be allowed to remain on the market for one year (now September 9, 2021). However, the FDA may still choose to exercise enforcement at its discretion and take negative action against such products during this time, even though a PMTA has been submitted.
So what does PMTA mean for vapers?
Now that the deadline has passed, you won’t be able to purchase any products for which premarket authorization applications were not been submitted. Because the PMTA process was rigorous and expensive, many smaller manufacturers chose not to file applications at all, whereas some other companies submitted applications for only one or two products. Keep in mind that even if a manufacturer submitted an application, there is no guarantee that the FDA will approve it.
Click here to see which brands and products we understand to have submitted PMTA applications by the September 9 deadline.
Again, any product that did not go through the PMTA process is no longer available for purchase, so you may want to think about starting to replace your vape lineup with products that did go through. If you haven’t already done so, make sure you sign up for our newsletter because we’ll be sending out suggestions for alternative products.
If you have any questions about PMTA, please don’t hesitate to contact our Help Desk for more information.