FDA’s e-cigarette rules are a public-health hazard

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Since they first were introduced in the United States in 2006, electronic cigarettes have helped millions of U.S. smokers to cut down or quit and diverted teens from smoking. But recently announced Food and Drug Administration (FDA) rules on e-cigarettes, which start taking effect this week, could undo that progress, damaging public health and creating a political and administrative quagmire.

If unchanged, the FDA rules will eliminate from the market more than 99 percent of e-cigarettes and related nicotine vapor products. And millions of vapers who now use these products as a substitute for cigarettes will be forced to return to smoking or to find black-market sources. This is especially troublesome for teens who use e-cigarettes to help quit smoking combustible cigarettes or who never smoked “real cigarettes” in the first place.

The problem stems largely from requirements spelled out in the Family Smoking Prevention and Tobacco Control Act, passed by Congress in 2009. The law requires any tobacco-related product that was not on the market as of February 2007 — a category that includes nearly all e-cigarettes — to submit to a “pre-market tobacco product application” (PMTA).

The FDA estimates the cost of these PMTAs to be $334,000 for each combination of device, flavor and strength of nicotine, and each separate component of an e-cig product. Industry sources put the figure higher still, in the range of $3 million to $5 million per application. At that price, only the largest corporations could afford to apply. Meanwhile, all of the major Big Tobacco company cigarette products are exempt from the PMTA requirement.

The Tobacco Control Act requires manufacturer-sponsored research to prove for each individual vaping product not one but two negatives: First, that the product will not recruit nonusers to nicotine use; and second, that it will not inhibit smoking cessation. At a minimum, five to six years of study would be required to answer these questions. But the FDA is giving manufacturers only two years to submit their completed applications or else remove their products from the market.

The FDA is also imposing costly requirements for detailed chemical analyses, but no guidance is offered as to what results would be considered good enough for approval. What’s more, it’s not even clear how much illness and death would be prevented by reducing or eliminating the specified toxic chemicals.

Multiple lawsuits have been filed to block implementation of the FDA rules. But whichever way the lawsuits go, the American public is likely to lose. Why? If the FDA prevails, a large and relatively mature industry will be destroyed and recent substantial gains in smoking reduction may be reversed. But if any of the lawsuits prevail — as seems likely — the FDA would be  empowered to regulate the new tobacco products via other means.

As currently formulated, the PMTA requirements do not protect public health. Instead, they protect the sales and profits of the Big Tobacco cigarette companies and the drug companies that make nicotine-replacement gums, patches, lozenges, and other smoking-cessation treatments.

It doesn’t have to be this way. Congress could change the grandfather date for PMTA applications from February 2007 to August 2018 (the date the new regulations come fully into effect). This would buy time to work out the kinks in the Tobacco Control Act that are, as written, technically infeasible and will only increase tobacco-related addiction, illness, and death.

For instance, by focusing on the Tobacco Control Act’s provisions on “filth and adulteration,” the cost of mandated laboratory studies could be substantially reduced and the public-health benefits expanded. Dropping requirements for tests whose results can’t be interpreted in terms of the risk of addiction, illness, and death would also be sensible. Predatory marketing could be addressed by requiring strict controls for advertising, packaging, and labeling. Such an improved regulatory process could rapidly secure public-health benefits not likely achievable by any other means.

Reforming the PMTA process in this way is preferable to eliminating it entirely as that would not weaken FDA regulation of tobacco products. On the contrary, eliminating the PMTA would only empower the agency to regulate e-cigarette manufacturing and marketing directly as well as to banish rogue operators from the market.

The lawsuits should serve as a wake-up call to the FDA and others in the tobacco-control movement to reconsider how best to protect and enhance the health of the public. Lawmakers and regulators should act now before permanent damage is done — and before they destroy a major new industry that’s saving lives.

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