How the FDA Is Saving the Cigarette


The traditional cigarette will receive the greatest boost it has gotten in many years thanks to federal law and a federal agency that is supposed to be focused on the protection of public health.

A large part of the e-cigarette industry may soon be put out of business and the Big Tobacco companies’ positions as the leading providers of vapor products could be cemented.

Wednesday, Sept. 9, is the deadline for e-cigarette and other vaping-related products to submit their pre-market tobacco applications (PMTA) to the Food and Drug Administration (FDA).

If these applications are accepted, the product can remain on the market until FDA determines whether or not to authorize the products.

The PMTA is a consequence of the Family Smoking Prevention & Tobacco Control Act (TCA), which gave the FDA the authority to regulate tobacco products in 2009. E-cigarettes were deemed tobacco products in 2016 and the original deadline for PMTAs was set for 2018. But after several extensions, the final deadline was set for Sept. 9, 2020.

The law says that any existing vaping-related product that doesn’t submit its pre-market tobacco application by the Sept. 9 deadline must be withdrawn from the market.

The pre-market tobacco application process is extraordinarily expensive and fiendishly complicated. FDA estimates the cost of each application to be between $117,000 and $466,000. But industry experts and those trying to comply with the rules believe the actual cost can easily run into the millions of dollars. These costs are unaffordable for the vast majority of e-cigarette businesses, which typically have hundreds of products—each of which must have its own PMTA submitted.

In addition to being expensive, this unnecessary and burdensome process is not protecting public health. In Europe, e-cigarettes are also regulated for consumer safety but the process is vastly simpler than the FDA’s byzantine system. European consumers benefit from a wide variety of choices and have not made sacrifices in product quality or safety.

The coronavirus pandemic has made compliance with FDA’s rules even more challenging for some companies, with many labs shuttered and some of the clinical studies needed for applications suspended. The worst-case, short-term result of this regulatory nightmare is that as many as 14,000 small businesses could be forced to close with more than 100,000 jobs potentially lost. There are scenarios where nearly all vaping products from entrepreneurs and small businesses disappear from the market.

The results would likely be a vaping industry dominated by a few large companies and an increase in black market e-cigarette products that seek to fill the holes left by companies forced to pull their products from the market.  It’s also likely that many smokers who shifted to safer vaping products could lose access to those products and return to smoking. There may also be a lot of smokers who would’ve switched to these safer alternatives but continue to smoke instead.

Read full article here.

Guy Bentley – Reason Foundation | Commentary – September 8, 2020.

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