Your Quick Guide to Proposed FDA E-Cig Regulations
Big Announcement From FDA Imminent
As we wait for the FDA’s official announcement this week, here is what we know already: Big changes are afoot and the fast growing e-cigarette industry faces a new wave of regulations. This week Scott Gottlieb led FDA is expected to move forward with a series of new restrictions ostensibly designed to end the teen “vaping epidemic”. Unfortunately, the FDA’s heavy handed approach shows how popular myths about vaping continue to cloud regulatory decision making.
The FDA may move this week to bar the sales of fruit, candy and dessert flavored e-cigarettes from convenience stores and gas stations. They are also expected to impose more stringent age verification guidelines for online sales. The full range of flavors will still be available at vape stores, which have a better track record of enforcing age restrictions.
Earlier this fall, the FDA took action against 1,300 retailers and 5 manufacturers for their failure to strictly enforce existing laws on age verification. This shot over the bow was followed by a request that these manufacturers provide a plan for limiting sales to youth within 60 days. The 60 day deadline is fast approaching and it appears the FDA is ready to act.
E-cigarettes: Science versus Hysteria
There are two critical assumptions that underpin the FDA’s move against e-cigarettes. The first is that some classes of brick and mortar establishments are incapable of adhering to the law by carding teenagers. The second is that fruit and dessert flavored e-juices are widely available because of their appeal to underage vapers.
The first of these two assumptions is about to lead to severe restrictions on the sales of e-cigarettes at gas stations and convenience stores. Juul, the industry giant that controls 72 percent of the market, has already responded by opting to pull their fruity flavors from brick and mortar retailers. Industry insiders report that Juul’s cucumber, crème, fruit and mango pods will now only be available through their website.
Juul’s preemptive compliance was not a complete surprise. They have been heavily criticized for their marketing strategies and their pod-based nicotine salt product is often cited as the catalyst of the teenage vaping epidemic.
Convenience stores will still be able to stock tobacco, and mint flavored pods. Both analogue and electronic menthol flavors will also be available but as a long standing target of the FDA, this popular flavor faces a bleak future.
Questions About Legality of Brick and Mortar Ban
The FDA’s decision to differentiate between vape shops and convenience stores may face its day in court. A National Association of Tobacco Outlets (NATO) editorial run in CSP News outlines a number of issues with the FDA’s approach. In a letter to Scott Gottlieb, their director Thomas Briant argued that 96.7 percent of convenience stores passed FDA sponsored compliance checks this summer and that the FDA’s own 2016 Tobacco and Health assessment found that nearly 90 percent of underage users of e-cigarettes relied on “social sources” (read legal buyers) to obtain these products.
Briant also questioned the legal basis of the FDA’s declaration. The congressional authority given to the FDA to control all aspects of tobacco and e-cigarette sales is limited. Specifically, it “Prevents the FDA from restrictions that would prohibit the sale in a face-to-face transaction by a specific category of tobacco outlet.” Gas station and convenience store owners are likely to challenge the FDA’s power to limit the sales of e-cigarettes for a specific class of retailer.
Fruity Flavor Fallacy
The second premise of the FDA’s move, that fruit flavors are exist to hook the under aged, is also questionable. An exhaustive online survey of 69,000 adult vapers examined why people vape and the preferences of vapers and e-cigarette users. Conducted using FDA compliant software to remove duplicate IP addresses, the survey found that non-tobacco flavors are extensively used by vapers over the age of 18. Over 95 percent of the respondents were current or former smokers. The primary reason for using electronic cigarettes was because they were viewed as a less harmful smoking alternative.
For vapers who had ceased smoking altogether, over 85 percent were using fruit or dessert flavored e-juice. In other words, the wide range of fruity and dessert flavors does not represent a ploy to hook children but is rather a response to the avid vapers. The study’s authors concluded, “Overly restrictive regulation, such as banning the sales of specific flavor groups (especially fruit and dessert/pastry/bakery flavors), might prevent smokers from switching to e-cigarette use or may increase the relapse rate among former smokers who have managed to quit with the help of cigarettes”.
The FDA has only paid minimal lip service to the obstacles these new barriers place in the way of adults looking for cigarette alternatives and potential harm reduction. In a September 2018 FDA press announcement, Scott Gottlieb conceded in September that “E-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products and onto nicotine delivery products that may not have the same level of risks associated with them.”
We Deserve a Science Based Approach to E-cigarette Regulation
It remains to be seen if the FDA is willing to take a science based approach to the issue or if the hysteria surrounding the teen vaping epidemic will continue to drive important policy decisions. In just a decade of existence, e-cigarette industry has evolved quickly. From cig-alikes to mods and back to pods, the e-cigarette industry has come full circle. The FDA’s moves this week are reactionary in nature and fail to take into account how reputable manufacturers have already taken tremendous strides to restrict access to their products.