Puff Bar continues to thumb its nose at FDA

When FDA announced that it was going to clamp down on flavored e-cigarettes that are popular with kids, it left a couple huge loopholes, including disposable e-cigarettes like the popular Puff Bar even though Puff Bar is a big hit with kids.

Now, embracing the time-tested strategy of never letting a crisis go to waste and instead seizing the opportunity it presents, the vaping industry has swooped in with ads targeted at the millions of teens who are stuck at home and glued to their smart phones and computer screens for school, entertainment, and socializing. Puff Bar’s ads have been especially brazen.  For example, in April Puff Bar urged kids to “stay sane with Puff Bar this solo-break” since it’s the “perfect escape from the back-to-back zoom calls” and “parental texts.”

FDA’s Guidance for Industry on its Enforcement Priorities for electronic nicotine delivery systems (ENDS or e-cigarettes) on the market without premarket authorization (i.e., all e-cigarettes currently being sold) states that FDA intends to closely monitor promotional activities and prioritize enforcement action against companies marketing “any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors.”  There can be no doubt that these ads are targeting minors and/or are likely to promote their use by minors. (How many adults do you know who need to take a break from “parental texts”?)

The Guidance also states that FDA intends to prioritize enforcement against any flavored “cartridge-based” e-cigarettes products (other than tobacco- or menthol-flavored products). However, Puff Bar took advantage of the inexplicable pass FDA gave to companies marketing flavored disposable e-cigarettes (see page 9, footnote 21 of FDA’s Enforcement Priorities guidance) and boldly reminded kids that “the force is strong with these flavors” when it launched its “May the Fourth be With You” (with its obvious Star Wars allusion) ad on May 4, displaying six kid-enticing flavored disposable Puff Bars in eye-popping colors.

Whether these flavors are delivered in disposable versus cartridge-based products, or in open versus closed systems, we know that they are designed to and do attract kids.

At a time when the FDA and others frequently remind us that “we’re all in this together,” e-cigarette companies are exploiting the COVID crisis by marketing their products with health and safety themes, free gifts of sanitizers and masks, and with donations to COVID relief agencies to burnish their corporate images.  Meanwhile, emerging evidence about the pulmonary effects of e-cigarettes suggest that exposure to e-cigarette aerosol may impact immunity, increase the risk of infection, and may otherwise increase COVID risks.

Every e-cigarette on the market today is illegal because no e-cigarette has received premarket review or authorization by FDA.  Although FDA convinced a federal court to extend the deadline for submitting premarket review applications for e-cigarettes until September 9, 2020, FDA stated in its April 23^rd announcement regarding the extension that “this new deadline does not detract from our efforts to prioritize enforcement of certain e-cigarette products currently on the market.” FDA should use its authority immediately to enforce against Puff Bar and other e-cigarette companies who are flagrantly violating the law by marketing to kids.

Lauren Lempert wrote this blog and I edited it.