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The FDA, Vaping and the “Nicotine Arms Race”

JUUL sought to circumvent EU limits

As state officials urge the FDA to limit the amount of nicotine allowed in U.S.-market vaping products, internal documents reveal that JUUL tried to circumvent the nicotine limits set by European regulators.

Call for Nicotine Limits

The Food and Drug Administration is currently reviewing thousands of premarket applications for e-cigarettes and other tobacco products to determine whether they can continue to be legally sold in the U.S. after September 2021.

On August 18, 31 state attorneys general, including California AG Rob Bonta, issued a letter calling on FDA Acting Commissioner Janet Woodcock, M.D., to end the ongoing “nicotine arms race” among e-cigarette manufacturers by denying all premarket applications for high-nicotine vaping products.

U.S. e-cigarette manufacturers presently offer e-liquids with up to 59 mg/mL of nicotine, almost three times what current European regulations permit. Woodcock has previously said that “fewer kids would become addicted … if there were no e-cigarettes in the U.S.

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More Kick per Puff

While reducing nicotine content seems like an easy way to make e-cigarettes less addictive, documents released for a recent House Oversight Committee hearing reveal that in 2018, JUUL, the present e-cigarette market leader, sought to circumvent the EU nicotine limits with a new vaping device delivering more nicotine per puff.

Internal emails from Ian M. Fearon, JUUL senior director of clinical and regulatory affairs for Europe, the Middle East and Africa, make clear that the goal of the new product, called Turbo, was to “counteract the regulatory ceiling.”

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The device allows delivery of as much nicotine as JUUL’s American products, despite the lower nicotine content of European e-liquids.

A subsequent independent study in Archives of Toxicology concluded that machine tests “suggest a similar addictiveness of the enhanced European version and the original American product.”

Waiting for a Decision

It’s not clear whether those disturbing emails will affect JUUL’s premarket tobacco product applications or the FDA’s regulatory stance on e-cigarettes.

However, Woodcock told Rep. Jackie Speier (D-Calif.-14) that evidence of a company attempting to circumvent regulations “will definitely be taken into account” in FDA decision-making.

Fearon’s emails are among various internal documents that have come to light in the multiple state lawsuits against JUUL, which allege that the company illegally marketed its products to kids.

In their August 18 letter, the state attorneys general also asked the FDA to take stronger action to keep e-cigarette promotional materials away from kids and “rein in all youth-appealing [nicotine] products before irreversible damage is done to the public health.”


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