PMTA, which stands for Premarket Tobacco Product Application is a directive of the U.S. Food and Drug Administration (FDA) in compliance with the Family Smoking Prevention and Tobacco Control Act (TCA). The directive is intended to register and regulate all tobacco products manufactured, distributed and marketed in the United States.
The PMTA seeks to confer government approval on tobacco products and tobacco derived products including electronic nicotine delivery systems (ENDS), e-liquids, vapes and vapes devices.
What does this mean, why is it important and how does it impact the vaping industry? Are some of the questions we would answer in this article.
Technically, the final deadline for submission of application for the PMTA has passed (September 9, 2020) as such, all applications not received before this date do not fall within the catchment of products that can be approved. Products not in the catchment can no longer go on sale or be marketed by manufacturers neither can products which fail the authorization process.
To give a sense of perspective, let us go back to the beginning.
How it Started
On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (TCA) was signed into law. The act conferred on 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. It also set approval requirements for all tobacco products regulated by the TCA and required that all tobacco products manufactured or modified after February 15, 2007 needed to be approved by the FDA before being marketed.
To become approved, product manufacturers are expected to make applications for premarket authorization. Irrespective of manufacturer, products are applied for and approved on an individual basis. Meaning it doesn’t matter how many products a manufacturer has on the market, they must apply for and obtain approval for each product.
Although the initial requirements of the TCA applied specifically to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, the law gave the FDA regulatory powers to determine what tobacco products would be subject to the law. In view of this, the FDA in May 2016 issued the “Deeming Rule,” which formally extended the TCA requirements to include electronic nicotine delivery systems (ENDS) and e-liquids that met the statutory definitions as tobacco products.
As part of the “Deeming Rule,” the FDA set a deadline of August 8, 2018, for the submission of all premarket authorization applications for new tobacco products that were introduced into the market on or before August 8, 2016, but this was not to be.
Several compliance challenges forced the FDA in May, 2017, to propose an extension of the submission deadline by three months. In July 2017, there was another postponement. Several postponements and a lawsuit after, the FDA was instructed by the U.S. District Court for the District of Maryland to accept as final date, May 12, 2020 for the submission of all premarket authorization applications for newly deemed tobacco products. The court also ordered that the FDA give a one-year moratorium period to allow products that have applied for the PMTA to remain on the market, provided that applications for them had been submitted by the May 12 deadline.
In February 2020, the FDA began prioritizing enforcement against flavored ENDS. From this date, Flavored ENDS product that had not been given premarket authorization by the FDA could no longer be offered for sale in the United States.
Following the COVID-19 pandemic, a 120-day extension was granted by the courts and a new deadline of September 9, 2020 was fixed. That deadline has since passed.
What does this mean?
All applications for premarket authorization had to be filed by September 9, 2020. Since there hasn’t been any further postponement, any product for which premarket authorization applications were not submitted on or before the said date can no longer be marketed legally in the United States. It is expected that manufacturers whose tobacco products did not meet this deadline would pull them from the market and desist from marketing such products.
The statues of the TCA allow the FDA defines what products can be considered tobacco or tobacco derived and under what regulatory purview they exist. Going by the TCA, the FDA was also given the discretion to enforce the premarket review provisions before the submission date and during the one-year grace period. This way, the FDA could choose to exercise enforcement at its discretion or take negative action against products during this time, even though a PMTA has been submitted.
It’s important to keep in mind that not all applications for authorizations would be approved but 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 – meaning irrespective of the outcome of the application, products have until September 9, 2021 before they can be deemed illegal.
How does it impact the vaping industry?
Although the PMTA process lends some credence to the quality of the product however, due to the cumbersome workflow and huge cost associated with obtaining the approvals, many small business were unable to follow through with the process and for some who did, only a few of their products were entered.
The vaping industry has begun to feel the impact of the PMTA as many smaller manufacturers who couldn’t muscle through the process are left with having to exit the market. Therefore, there is a likelihood that many of your choice brand products are no longer on sale and those which are yet to be pulled from the market would exit the scene in a short time than expected.
Obviously, the market dynamics would change and consumers should expect increase in prices, limited choices but in turn better quality products and a more regulated market.
You would have to make a change, that’s if you haven’t already. By end of September, it is almost certain that a lot of other products would have to be pulled from the market. While this is evidently disheartening for most manufacturers, regulatory oversight and endorsement would help to sanitize the vaping industry for the benefit of the consumer.
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