This week the Food and Drug Administration (FDA) has finally released its long-awaited Premarket Tobacco Application (PMTA) guidance for e-cigarettes and vape juice, as the entire vaping industry scrambles to see what the changes might mean for them. Will the FDA kill vaping altogether? It seems unlikely, but the news is not good: The new FDA PMTA deadline and guidance, is no doubt, the FDA’s response to the American Pediatric Association’s (AAP) lawsuit alleging that the FDA was derelict in its responsibility to public health by dragging its feet to regulate e-cigarettes. The federal judge in that case, Hon. Paul Grimm, ruled last month that the FDA’s delay in reviewing vaping products was “so extreme as to amount to an abdication if its statutory responsibilities” and gave the FDA just thirty days to begin reviewing e-cigarette products.
The AAP filed a proposed remedial order in that case asking Judge Grimm to order the Agency to move the FDA PMTA deadline to 120 days — a mere four months from the judge’s order. The FDA filed a response to the APA’s proposed order this week including a statement from FDA Commissioner Mitchell Zeller, that a four-month deadline would “cause significant public health concerns as well as implementation challenges”. The FDA’s response states “It could suddenly clear the market of thousands of e-cigarette products, raising the risk that some former smokers addicted to nicotine might migrate back to conventional cigarettes, and is likely to flood the Agency with thousands of low-quality applications that would strain Agency resources and significantly delay processing… if the Court orders a deadline for the submission of premarket applications, it should set that deadline no sooner than 10 months.”
The FDA response went on to say that as of April 30, 2019 the Agency had received 401 PMTAs, 373 of which were for deemed products and of those “more than 99% (369/373) were closed as insufficient to accept or file, largely for failure to include an environmental assessment” and that only 4 products remained for deemed products, “none of them for e-cigarette products.” The remaining PMTAs are for “heat not burn” products, Big Tobacco’s brainchild.
Will the FDA end vaping as we know it? At this point it may be out of their control, depending on the timeline in Judge Grimm’s final ruling. If the FDA can’t review products in time (or if e-cigarette companies can’t afford to go through the approval process or don’t have enough time to complete it) thousands of products will likely be pulled from the market.
Even if the FDA is granted the 10 months it is requesting, the new PMTA guidelines will in all likelihood be too onerous for many smaller e-cigarette and vape juice companies to afford or comply with – potentially wiping out all but the biggest e-cigarette companies — which just happen to be owned by Big Tobacco companies, who not only have plenty of money, but also a strong incentive to see all their competitors wiped out.
The FDA’s new PMTA guidance includes a lot of requirements for approval, and you can read more about it here.
In a nutshell, the FDA will be considering risks and benefits to the population as a whole – including tobacco users and non-users – and the product’s impact on that behavior, especially with regard to youth. The FDA will also be reviewing “a tobacco product’s components, ingredients, additives, constituents and health risks, as well as how the product is manufactured, packaged and labeled.”
Further, the FDA will be looking for manufacturers to address public health issues, specifically “the design and manufacture of their products” as well as “accidental nicotine exposure and battery safety.”
The Agency also recommends that manufacturers provide information, “describing the kind of packaging their product will be sold in to mitigate the risk of accidental exposure to e-liquid and that manufacturers provide information on: “amperage, voltage, wattage, battery type (chemistry), whether the battery is consumer-replaceable, testing certificates for any voluntary electrical standards for the battery or device—including UL 8139, the recently published, first-ever standard specifically for ENDS products—and under- or over-voltage protections, as well as plans for addressing the likelihood of use and foreseeable misuse leading to overheating, fire and explosion during operation, charging, storage and transportation for distribution.”
The FDA also provides recommendations for “chemical testing, applying existing scientific literature or analyses about similar products to the proposed new tobacco product, including multiple distinct products in a single submission and referencing tobacco product master files.”
How much will PMTA cost the vaping industry? The FDA’s early estimates were that PMTA would cost vaping manufacturers between $117,000 to $400,000 per product – and approval would be required for each product. Which means that every nicotine strength of the same flavor your favorite vape juice would count as a new product.
And experts believe those cost estimates are low.
Whether vape juice and e-cigarette manufacturers have a month, a few months, or ten months to comply, the salad days of the industry that tried to save us from killing ourselves with cigarettes seem to be coming to an end. If you’re a fan of open systems, you might want to start stockpiling your favorite vape juice while you still can. This FDA PMTA deadline is the real deal — this is not a false alarm.
Soupwire will continue to bring you updates on this developing story and other vape news.