PMTA UPDATE: Looming Approval Deadline and Factors for Approval

The PMTAs or Pre-Market Tobacco Applications have shifted the vaping industry. These applications are being used by the Food and Drug Administration (FDA) to determine which vaping goods can legally market and sell their products in the United States. However, the FDA has a deadline it must meet, Sept. 9, 2021, and with various applications still waiting for review, it seems like the FDA will miss the court ordered deadline. 

Table of Contents:

1. How It Started
2. How It’s Going
3. Restrictions: A Way to Get FDA Approval?
4. Conclusion

How It Started

In 2009 the Obama Administration created a federal law known as the Tobacco Control Act. In this act, the government gave the FDA authority to regulate any new tobacco product that entered the market. This meant that the FDA would have to approve the distribution, marketing, and manufacture of tobacco products before they could be sold in the United States. 

However, products that had already entered the market prior to Feb. 15, 2007, would be considered grandfathered in, which means they do not need FDA approval to continue being marketed in the United States. 

Every other nicotine product introduced after the Feb. 15, 2007 date will need to get FDA approval to continue being sold. In order to get approval from the FDA, vape companies must submit one of two applications. 

Vape companies can either submit a Substantial Equivalence (SE) application that compares the new product to one of the products that were grandfathered in, or to a product that has already received an approved SE application, or they can submit a Pre-Market Tobacco Application if the new product is not similar to a product that was grandfathered in and entered the market after Feb. 15, 2007. The deadline for filing these applications was September 9, 2020. 

Once a vape company files one of these two applications, the FDA has a four-step process for approval. First, it creates a review to see that all items asked for are in the application. Next, if the evidence, studies, and other data are found in the application, the FDA files the application. Third, the FDA will review all the information filled, which may take up to a year or until the review deadline of Sept. 9, 2021. Fourth the FDA will issue marketing authorization to the vape company, or it will deny it. 

How It’s Going

With the deadline to turn in all the applications looming closer and closer (Sept. 9, 2021), it looks like the FDA will be unable to meet the deadline. According to the agency, there are almost 15,000 applications that have been filled and are pending reviewal by the FDA. In a statement, the FDA went on record saying that “the likelihood of FDA reviewing all of the applications received by Sept. 9, 2021, is extremely low.”

There is a high probability that the FDA will extend the deadline on a case-by-case basis in order for all the applications to have a fair chance at being reviewed and will delay enforcement to all against vape companies who filled their applications in a timely manner. 

So far, the FDA has sent “Refuse to Accept” letters to vape companies, effectively rejecting almost 59,229 vape products. It also has sent “Refuse to File” letters to vape companies that included 3,628 vape products. However, the agency has approved applications and is having them move forward to the third “Filing” stage, and in these applications, there are about 138,377 vape products that are covered. 

Restrictions: A Way to Get FDA Approval?

There is one main factor that plays into FDA approval, whether the vape product(s) being submitted “is appropriate for the protection of the public health.” If the product can prove that it is less harmful than smoking, in order to be “appropriate for the protection of public health,” it has to accomplish two things. 

First, the e-cigarette has to increase the likelihood of smokers quitting cigs and picking up said product or e-cigarette, and second, it must reduce the number of youths that would otherwise become addicted cigarette smokers and instead pick up an e-cigarette.

However, because the data on whether e-cigarettes are less harmful than cigarettes is difficult to prove, what the FDA might end up doing is creating labeling, packing, sale, and marketing restrictions to make sure the products being reviewed are “appropriate for the protection of public health.” With the burden of proof relying heavily on vape companies that must submit the evidence and scientific studies, it is expected that some vape companies might or already have applied these restrictions on their products with their applications to increase their chances of approval.

Conclusion

Now that the deadline to turn in the PMTAs is coming closer, it seems very likely that many companies will receive an extension on a case-by-case basis. This also means that these companies will be allowed to continue marketing their products until their applications are reviewed. While it remains unclear how PMTA applications are being approved, it seems that companies that included restrictions in the way they will sell, market, label, and package their products have the highest likelihood of being approved by the FDA.