In a move largely precipitated by its own internal regulatory mismanagement, the U.S. Food and Drug Administration (FDA) recently announced it would be launching a new task force with the U.S. Department of Justice (DOJ) to tackle the increasing problem of illegal vaping products from foreign countries like China being sold in U.S. stores.

This is yet another example of how government policy, and its implementation, directly impacts Pennsylvanians when it comes to trade-related issues with foreign countries. This falls on the heels of President Biden’s announcement at the Pittsburgh headquarters of United Steelworkers that he plans to triple tariffs on Chinese steel to help protect the domestic steel industry.

As the election season heats up, both presidential candidates are rightly taking a tougher stance on China in light of this and a range of other policy and economic issues. U.S. Senator Bob Casey has long been a supporter of policies that are tough on China and protect working Pennsylvanians. Senator Casey can continue this support by ensuring that we have a properly functioning FDA to regulate the smoke-free products.

The FDA’s recent pledge to help stop sales of illegal e-cigarettes in the U.S., while welcome, would never have been necessary if the agency’s own approval process for new, smoke-free tobacco products was not so broken in the first place. From the top down, this process needs drastic reforms to ensure the FDA is not only keeping illegal, unregulated products off the shelves, but also building a larger market of less harmful products that will meet the demand of adult consumers while promoting public health.  

At the heart of the problem is the lengthy and costly premarket tobacco product application (PMTA) process overseen by the FDA’s Center for Tobacco Products (CTP). The CTP is required to review and decide on a PMTA for a new tobacco product within 180 days. However, in practice, it is taking the CTP up to nearly three years for some of these products with little to no transparency or explanation for the delay.

In the meantime, U.S. companies are pouring millions of dollars into not only developing their products, but also in navigating a PMTA process that seemingly leads to nowhere. Findings by the Reagan Udall Foundation suggest a glaring lack of transparency, clarity and communication by the CTP that leaves businesses trying to take the legal route to FDA authorization in the dark about if or when their products would ever see the light of day.

While the CTP continues to fail to meet its statutory requirements for reviewing PMTAs or providing any insight into their decision-making process, millions upon millions of these applications have piled up over the past 15 years. Since 2009, the CTP has authorized fewer than 50 out of the more than 26 million PMTAs that companies have submitted for FDA review.

Unfortunately, the inability of the FDA and CTP to ensure a well-regulated market of smoke-free tobacco alternatives is not going to stop adult consumer demand for these products. As the rise in illegal e-cigarettes being sold today illustrates, these products will find a way to market if there are not viable alternatives on store shelves. A paralyzed, inefficient FDA approval process has created this situation and its inability to act is only making a bad situation that much worse. 

A task force to stop the rise in illegal sales of e-cigarettes from China is fine, but a functioning FDA with strong enforcement and a clear, efficient and working regulatory process for authorizing legal smoke-free tobacco products to prevent the proliferation of illegal tobacco products would be better. As a retailer, I believe the issue of illegal disposable sales is a serious concern and believe it could and should be controlled locally by state and municipal governments — this could be addressed by imposing fines on retail locations that do not carry tobacco permits but still sell e-cigarettes.

These are the kinds of reforms at the FDA that both presidential candidates and Keystone State leaders such as Senator Casey should be fighting for in Washington.

Matas Smakotinas is the owner/operator of Vape 02 as well as an analytical and proactive Finance Associate/Business Analyst with a diverse background in Finance, Operations and Technology.