How the FDA Is Saving the Cigarette November 24 2020

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existing vaping-related product that doesn’t submit its pre-market tobacco application by the Sept. 9 deadline must be withdrawn from the market.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

These devastating impacts are not a bug or unintended consequence of the PMTA process but a feature celebrated by some of its supporters. It’s designed to stop as many new products coming to market as possible, no matter their benefit to the public health. This process advantages only the biggest companies with the deepest pockets. The number of deemed products that may need to submit PMTAs, according to FDA, is a staggering 400 million. If only a fraction of these products actually submitted PMTAs, it would amount to bureaucratic mayhem with little precedent.

These applications are ostensibly intended to help FDA ensure new products are “appropriate for the protection of public health.” In practice, however, the system created by the Tobacco Control Act makes it easier for a new cigarette or cigar to enter the U.S. market than it is for an e-cigarette to enter the market.

This should come as no surprise when we look at who were the biggest boosters for the Tobacco Control Act (TCA). Unsurprisingly, the Campaign for Tobacco-Free Kids was a cheerleader for the legislation. But they found an ally in the world’s biggest tobacco company—Philip Morris. At the time, other tobacco companies argued Philip Morris’s support for the TCA was driven by a desire to enshrine its position as the market leader and erect barriers to competition. It’s not for nothing that the Tobacco Control Act was nicknamed the “Marlboro Monopoly Act” by some in the industry. The alliance of Philip Morris and the Campaign for Tobacco-Free Kids is enough to make bootleggers and baptists blush.

Contrary to the claim of its advocates, the PMTAs will do nothing to protect children from tobacco use. As data from the Center for Disease Control and Prevention demonstrates, the main reason why kids choose to experiment with vaping is not because of the availability of different flavors, appealing advertising, or cool product design — kids say they try vaping because they’re curious and have seen family members or friends use the products.

The story is the same across a whole range of products from alcohol to marijuana. You can regulate products and push them into the black market but you can’t regulate away the impulse of teenagers to try new things.

Thanks to e-cigarette flavor bans that have already been implemented in some states, a limited flavor ban passed at the federal level, and a campaign of demonization and fearmongering, we’re already seeing some vapers return to smoking.

Now, the traditional cigarette is about to 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.

The modern-day e-cigarette was invented almost 20 years ago. It was a consequence not of government-funded research or Big Tobacco companies. It was the result of a Chinese pharmacist tinkering away to find his own alternative to smoking. Hon Lik’s invention was adapted and transformed in thousands of different ways, gifting the world the greatest tool to quit smoking ever invented—research shows e-cigarettes are far safer than smoking traditional cigarettes, creating thousands of businesses and hundreds of thousands of jobs in the process.

Unfortunately, thanks to a bureaucratic process that seems compromised by industry and idealogues, the U.S. could be about to severely hobble one of the greatest public health advances of the last 100 years. As of this writing, only one electronic nicotine product has successfully navigated the pre-market tobacco application process and been approved— and it had more than a million pages of documentation in support: The IQOS tobacco heating system made by Philip Morris International.