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The FDA’s Challenge on E-Cigs

Scott Gottlieb, M.D.

Electronic cigarettes are less harmful than traditional cigarettes, but they aren’t safe. There’s evidence they can damage the lungs, and they’re also a path to nicotine addiction. Last year the percentage of teenagers using nicotine grew at the fastest rate ever recorded for an addictive substance, according to a survey funded by the National Institute on Drug Abuse. The same organization also published a survey that found that children who use e-cigs are more likely to become long-term smokers of regular cigarettes than children who never use them.

Regulators at the Food and Drug Administration have a tough job. How can they preserve e-cigarettes as a tool to help adult smokers while snuffing out the teen smoking epidemic? The answer depends on recognizing the differences between types of e-cigs.

E-cigs are regulated by the FDA under the Tobacco Control Act of 2009. The FDA has a legal obligation to reduce death and disease from tobacco and to assess youth initiation as a key factor in determining the “net public health benefit” of a new tobacco product like e-cigs.

Policies I advanced as FDA commissioner aimed to get smokers off cigarettes and onto less-harmful forms of nicotine delivery. The plans recognized that products for delivering nicotine exist on a continuum of risk, with cigarettes being the deadliest form. Medicinal products such as gum and patches are so safe they can be bought over the counter without a doctor’s prescription. E-cigs are somewhere in the middle.

But the dramatic rise of e-cig use by young people in 2018 demanded that FDA take action. Under policies I implemented, the FDA moved up the deadline for market-approval applications from the e-cig manufacturers to continue selling their products. The FDA will also put new restrictions on the flavored, cartridge-based products favored by kids.

Some vapers are worried that these legal obligations could be burdensome for the more than 15,000 vape stores that sell products primarily used by adults. To address this, the FDA can sharpen the regulatory distinction between of products meant to help adult smokers quit and products widely abused by children.

Data show that refillable liquid vaping devices—so-called open systems—are primarily used by adults while disposable, cartridge-based e-cigs—“closed” systems like JUUL—are favored by minors. The former are typically sold in vape shops; the latter are available in convenience stores. Both types are currently subject to similar regulations. Yet their different potential benefits and patterns of use mean they could be treated differently.

The FDA could allow vape stores that follow common manufacturing processes for e-liquids to band together to file a common application for market approval. If the application is approved, the FDA would confer individual licenses on each store. Pooling data could help the vape retailers who sell the open-tank system and also want to be e-cig manufacturers to meet the public-health standard for FDA authorization more easily. This approach could also yield efficiencies for FDA’s application-review process.

As for cartridge-based e-cigs, widespread use by kids will make it hard for those brands to prove a “net public health benefit,” which is the legal standard. If the makers of these products want to keep them on the market, the FDA can carve out a more explicit path for approving them as over-the-counter drugs. The e-cig manufacturers would need to run clinical studies to prove that their products don’t create undue risks relative to their ability to help smokers quit cigarettes. The OTC pathway would treat cartridge-based e-cigs similarly to nicotine gums and patches, requiring them to clear a higher bar to prove they are effective smoking-cessation tools. But it also would provide more-stringent safeguards against products that appeal to kids but don’t help adults.

Not all e-cigs are equal. Policies that account for the different risks and patterns of use are our best chance to help adults quit smoking while keeping kids from picking up a deadly addiction.

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