FDA announced today it turned down 55,000 tobacco pre-market (PMTA) applications from three small e-liquid manufacturers. This removes about two percent of the more than two million remaining of the 6.5 million PMTAs originally submitted by the September 9 deadline of last year.
More importantly, the federal regulator has appeared to indicate that it will likely not allow any bottled e-liquids in flavors other than tobacco. With two weeks until the end of the grace period of September 9, 2021, that will likely mean the rejection of almost all remaining PMTAs.
The agency calls the letters sent to the three companies “refusal to market orders” (MDOs), and these are the first outright rejections of all products that have been submitted. Products receiving MDOs must be immediately withdrawn from the market or risk FDA application.
The companies that sent MDOs are JD Nova Group LLC (Vapolocity), Great American Vapes, and Vapor Salon. JD Nova has been the subject of previous action by the FDA; The FDA refused to file PMTAs for 4.5 million of their products. According to the FDA, all three companies still have products (presumably tobacco flavored) under scientific review.
All of the products were “flavored,” which means the FDA meant flavored with anything but tobacco flavoring. In its explanation, the agency seems to point out that no flavored product in an open system (bottled e-liquid) will be authorized. This is exactly the kind of “regulation” that anti-vaping organizations like the Campaign for Tobacco Free Children and top politicians like many state attorneys general have demanded.
“In light of the threat to public health posed by the alarming and well-documented levels of youthful use of flavored ENDS, the agency has reviewed the applications submitted to this action to determine whether there are sufficient product-specific scientific evidence to demonstrate sufficient benefits for adult smokers that would overcome the risk posed to youth, ”the FDA said.
“Based on existing scientific evidence and the agency’s experience with pre-market reviews, evidence of the benefits for adult smokers of these products would be likely take the form of a randomized controlled trial or longitudinal cohort study, although the agency does not rule out the possibility that other types of evidence may be adequate if they are strong and reliable enough. Because this evidence was absent in these applications, the FDA issues MDOs. ” (I underline.)
While possible, it is unlikely that an independent vaping company has developed “product-specific evidence” for the value of the aromas. The agency calls for randomized controlled trials. Designing and performing such a test for a specific bottled e-liquid would cost millions of dollars.
The unpublished standard that the FDA appears to apply to most products under review is only accessible to tobacco companies and perhaps the larger independent companies, like Juul Labs and NJOY.
“The onus is on the applicant to provide evidence demonstrating that the marketing of their product meets the legal standard of ‘appropriate for the protection of public health’,” said FDA Tobacco Products Center Director Mitch Zeller. “If this evidence is lacking or is not sufficient, the FDA intends to issue a refusal to market order, which requires that the product be withdrawn or not brought to the market. “
The FDA said it would “continue to review other tobacco pre-market applications for non-tobacco flavored ENDS to determine if there is sufficient product-specific scientific evidence of a benefit for adult smokers to overcome. the risk posed to young people, “but the agency is well aware that such evidence will not be found in these PMTAs – at least not for the more than 500 companies that do not have billions of disposable dollars.
“If the applications contain such evidence, the FDA will conduct a thorough scientific assessment to determine whether the evidence meets this legal standard for authorization. But in the absence of such evidence, the agency intends to issue an MDO.
The FDA’s announcement is likely to cause panic among small e-liquid companies, which depend on non-tobacco flavored products for the bulk of their revenue. Many companies have already spoken privately about reformulating their e-liquid with synthetic nicotine or shutting down and operating as black market sellers. Others may hope to gain approval for tobacco flavorings and attempt to survive with them.
One of the three companies that received an MDO today has already announced that it will be relaunching its synthetic nicotine products. The mandate of the FDA’s Tobacco Control Act is to regulate “tobacco-derived” nicotine. The regulation of synthetics may require new regulations from the FDA or an act of Congress.
What is clear is that the FDA never intended to fairly regulate open system vape products. From the 2014 version of the agency’s draft rule of presumption until today, the Center for Tobacco Products has been eagerly awaiting the moment when it eliminates the “wild west” of the independent industry and entrusts vaping to the same corporate tobacco giants that this disruptive technology was designed to replace.
That day is near, and soon the FDA will face an angry army of disorganized small businesses that will be proud to break its unfair rules that fail to protect public health.
Smokers created vaping without any help from the tobacco industry or anti-smoking activists, and vapers have the right to continue to innovate to help themselves. My goal is to provide clear and honest information about the challenges vaping faces by lawmakers, regulators, and disinformation brokers. I recently joined the board of directors of CASAA, but my views are not necessarily those of CASAA, and vice versa. You can find me on Twitter @whycherrywhy