Today's Deadline for Seeking FDA Approval of Vaping Products Means Small Businesses Have To Pray for Bureaucratic Flexibility
The industry's fate depends on the whims of an agency charged with deciding what is "appropriate for public health."
When the Food and Drug Administration (FDA) first outlined its plan to regulate vaping equipment and nicotine e-liquids as "tobacco products" in 2014, it estimated that it would receive 25 applications a year. Since the vaping industry includes thousands of manufacturers, ranging from big companies like Juul to mom-and-pop shops that mix the e-liquids they sell, the implication was that FDA regulation would wipe out almost all of them. Today the deadline for submitting applications, which has been moved repeatedly by the FDA and the courts, finally arrived, and the outlook for small businesses, though still daunting and highly uncertain, is not quite as dire as the agency initially suggested.
Under the Family Smoking Prevention and Tobacco Control Act of 2009, which the FDA is using to regulate nicotine vaping products, the entire industry officially exists only by the agency's sufferance. The law required FDA approval of all tobacco products that were not marketed prior to February 15, 2007, before the vaping industry emerged in the United States. Once the FDA decided to treat nicotine vapes as tobacco products, it was only the agency's enforcement discretion (combined with the practical difficulties of eliminating an industry with millions of customers) that allowed them to remain on the market. For companies that managed to meet today's deadline, that sufferance will now be extended for a year as the FDA considers their applications.
The requirements for a "premarket tobacco application" (PMTA)—a misnomer in this context, since all of these products are already on the market—initially seemed so cumbersome and expensive that only the largest manufacturers would survive. But as Vaping360 reports in a detailed summary of the current regulatory situation, a surprisingly large number of small manufacturers have submitted applications, hoping that the FDA will be patient and flexible enough for them to stay in business.
Under the Tobacco Control Act, the FDA is supposed to approve a PMTA only if it is "appropriate for the protection of public health," taking into account "the risks and benefits to the population as a whole." The FDA's interpretation of that standard, which demands reams of data concerning not only the product's specific properties but its anticipated impact on smoking and nicotine use, seemed beyond the means of small businesses to satisfy. Juul's PMTA, for instance, included "detailed scientific data from over 110 studies totaling over 125,000 pages evaluating the product's impact on both current users of tobacco products and nonusers, including those who are underage."
But notwithstanding its doom-implying projections six years ago, the FDA has indicated that it will take into account the limited resources of small businesses, along with unanticipated obstacles such as the COVID-19 epidemic and (perhaps) a product testing bottleneck created by the limited number of FDA-accredited laboratories, in accepting and processing applications. Paraphrasing Amanda Wheeler, co-owner of the Arizona e-liquid company Jvapes, Vaping360 says "the FDA has received direction from the White House and HHS to try to accommodate the small vapor companies without abandoning its scientific standards."
President Donald Trump has acknowledged the harm-reducing potential of e-cigarettes (as does the FDA) and, in the context of the FDA's restrictions on flavored vaping products, promised to accommodate the interests of vapers and the companies that supply them while trying to reduce underage consumption. Last January, Health and Human Services Secretary Alex Azar, whose department includes the FDA, said the agency would "streamline approval" for small businesses.
What might that mean in practice? U.S. District Judge Paul Grimm—who has changed the PMTA deadline twice, moving it up to last May in response to a legal challenge by anti-vaping groups and granting a six-month reprieve in response to the COVID-19 epidemic—says the FDA has the discretion to make case-by-case exceptions for companies struggling to meet its requirements. The FDA has indicated that it may accept incomplete applications on the understanding that companies will fill in the gaps later. The FDA also could make other accommodations—for example, by accepting references to the existing scientific literature on the relative hazards of vaping and smoking rather than demanding new, product-specific research.
Although Grimm limited the grace period for companies that have met the PMTA deadline to one year, it seems quite unlikely that the FDA will be able to process all the applications in that amount of time. "Although we do not know how many applications will be submitted by the September deadline, we do know that there are over 400 million deemed products listed with FDA," Mitch Zeller, director of the agency's Center for Tobacco Products, said last month. "Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced."
It is not surprising that many vaping companies have chosen to give up rather than invest time, money, and effort in a process that might (or might not) give them a one-year reprieve and might (or might not) keep them in business longer than that. As Vaping360 notes, if you run a vape shop that sells house-mixed e-liquid or offers a wide range of brands that may no longer be available, you are apt to think twice about signing a new three-year lease in the face of all this regulatory uncertainty. But for the intrepid companies that are trying to navigate the PMTA process, the outlook seems a bit more hopeful than it did a few years ago.
One reason to be hopeful is that the FDA does not have the enforcement capacity to track down unapproved products, which include a vast range of foreign-made devices and parts as well as a bewildering variety of e-liquids, and remove them from the market. People will continue to vape, and manufacturers will continue to supply them, legally or not. If the FDA does not want its regulatory system to become a laughable pretense, it will need to come to terms with that reality.
Consider the issue of flavored e-liquids, which anti-vaping politicians and activists portray as an intolerable threat to the youth of America. If the FDA gives in to their demands and refuses to approve flavored products, which are overwhelmingly preferred by former smokers, it will simply expand a black market over which it has no control. That would not be good for the agency's reputation or the "public health" it is supposed to be protecting.
The FDA deserves a lot of blame for creating an opaque, complicated, and intimidating regulatory process. "It didn't have to be this way," writes the Competitive Enterprise Institute's Michelle Minton. "If only the FDA had done its job as a regulator, promulgating rules that promote compliance, a vibrant above-board market, and public health, an entire industry would not face extinction, the illicit market would have been kept at bay, and FDA itself would not be dealing with a paperwork nightmare."
Still, the root of the problem is the regulatory standard decreed by Congress. The FDA is required to consider "the population as a whole," including nonsmokers (especially teenagers) who may start vaping as well as smokers who replace conventional cigarettes with a much less hazardous alternative. That assessment requires predictions and value judgments that invite arbitrary regulation.
It is not enough to demonstrate that the benefits of vaping products outweigh the risks for the millions of Americans who use them instead of smoking. Manufacturers are also supposed to show that the benefits for those consumers outweigh the risks for everyone else, a collectivist calculus that is impossible to perform in any rigorous or objective way. That situation, which Congress created, makes the entire industry subject to the whims of bureaucrats who may or may not prove to be as pragmatic as vapers and the businesses that serve them are hoping.
[This post has been updated with a quote from Michelle Minton.]