FDA should enforce the law to order Juul to stop making unauthorized cessation claims

On May 9, Tobacco Free Kids, AHA, ALA, ACS CAN, and Truth wrote the FDA asking them to investigate unauthorized smoking cessation claims Juul is making in its new ads. 

In fact, the health groups' letter is the investigation.  FDA should simply use this information and start enforcing the law.

Juul is taking advantage of FDA’s about “switching” that the FDA included in its rule on what is and is not considered a cessation claim.  Essentially, what the FDA did was gave Juul (and other e-cigarettes and now PMI’S IQOS) direction on how to sidestep an otherwise FDA’s well-crafted rule to prevent precisely what Juul is doing.

While the FDA continues to look the other way, an excellent AP story states the obvious in its lead when it says, “Under intense scrutiny amid a wave of underage vaping, Juul is pushing into television with a multimillion-dollar campaign rebranding itself as a stop-smoking aid for adults trying to kick cigarettes. But the strategy is raising concerns from anti-smoking experts and activists who say the company is making unproven claims for its product.”

The letter from the health groups carefully examines Juul’s claims against the FDA’s regulation and shows that, despite the fact that Juul is following FDA’s hint to talk about “switching” as a way to evate the law, the FDA’s regulation does, in fact, mean that Juul’s claims are cessation claims that need FDA approval.

(FDA gave Phillip Morris the same direction on how to get around the rules in its premarket order for IQOS, which also talked about “switching.”)

I have little doubt that, if used as a prescription drug under clinical supervision Juul could be helpful in getting people to stop smoking.  That is what Hajek’s RCT of other e-cigs showed.  (It should be under prescription because of its very high abuse liability, which is why FDA requires a prescription for NRT inhalers.) 

That does not, however, mean that FDA should approve Juul as a medicine, because doing so requires a risk-benefit analysis.  Hajeck also found that, while e-cigs led to more quitting than conventional NRT in their clinical trial, at the end of the trial 80% of the e-cig users were still vaping compared to 4% of NRT users.  As the evidence continues to pile up that e-cigs cause substantial heart and lung disease risk, approaching that of conventional cigarettes, the increase in cigarette cessation may not be worth the risk of continued vaping.

In any event, the health groups have done the FDA’s work for it in analyzing how Juul’s marketing compares to the FDA’s rules and found Juul is violating them.

The question is whether FDA will start doing its job as a law enforcement agency or continue telling Juul, and other e-cigs (and now IQOS) how to avoid the law.