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The FDA’s War on E-Cigarettes

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The Food and Drug Administration has finalized its plan to bring electronic cigarettes under its authority. Among other changes—such as a ban on sales to minors, a step that some states haven’t yet taken on their own—this means that nearly every e-cigarette product will need to go through the FDA approval process. Each flavor and device will require a separate application, and each application will cost hundreds of thousands if not millions of dollars to complete.

When it comes to regulating a product like e-cigarettes—which are not risk-free but are far safer than smoking—striking the right balance is inherently difficult. But it’s especially hard under the framework established by the 2009 Family Smoking Prevention and Tobacco Control Act, which underpins the new rule and was endorsed by tobacco giant Philip Morris. While claims that the rule will “kill the industry” may be slightly exaggerated (it was worth billions last year), the policy could wipe out small e-cigarette companies, stymie innovation, and slow the decline of traditional cigarette smoking. It may also be an example of crony capitalism, with older players in the tobacco industry exploiting regulation to stifle competition.

First, a primer on e-cigarettes and their safety implications. With a traditional cigarette, the user lights tobacco on fire and then inhales the smoke, which contains numerous carcinogens. By contrast, e-cigarettes vaporize an “e-liquid” that contains nicotine and various additives (such as flavors). E-cigarettes are only about a decade old, so it is not known with exact certainty how dangerous they are. But the best available estimate, endorsed by the UK’s Royal College of Physicians, holds that the risks of e-cigarettes are “unlikely to exceed 5%” of the risks of smoking. That’s 1/20th the danger.

Roughly speaking, this implies we could maintain our current level of safety even if 19 nonsmokers took up vaping for every smoker who switched (or would-be smoker who vaped instead). The real ratio is likely to be much lower, considering that (A) nonsmokers outnumber smokers by just five-to-one in the American adult population and (B) CDC survey data indicate that current and recent smokers are many times as likely as nonsmokers to use e-cigarettes. Further, there’s research suggesting that e-cigarettes are an effective way to quit nicotine entirely.

Viewed in context, even the much-discussed rise of teen vaping over the last half-decade might be something to celebrate, given the enormous difference in risk between vaping and smoking. Approximately 16 percent of high-school students vape—but traditional cigarette smoking fell more than six points among this demographic between 2011 and 2015, and e-cigarettes may have played a substantial role in that trend. One study found that when states banned e-cigarette sales to minors, they counteracted 70 percent of the previous downward trend in smoking among 12-17-year-olds.

Enter the 2009 Family Smoking Prevention and Tobacco Control Act, which allows the FDA to regulate new tobacco products. (The term is defined broadly, and e-liquids’ nicotine is extracted from tobacco.) As it made its way through Congress, many labeled the law a Baptists-and-bootleggers arrangement, with public-health advocates celebrating new opportunities for regulation while the industry’s leading business, Philip Morris, relished the chance to make life difficult for its smaller competitors—especially when it came to brand-new products, like e-cigarettes. As Time explained,

[t]here is nothing in the FDA legislation that expressly favors Philip Morris when it comes to innovation and new product development, but the company has far deeper pockets, putting it at a distinct advantage over its competitors. In 2007, the same year that nearly identical FDA legislation was introduced in Congress, Philip Morris opened a 450,000-sq.-ft. (42,000 sq m) research facility in Richmond, Va. The complex is filled with hundreds of employees, including scientists studying new tobacco technologies that Philip Morris is hoping to get through the new FDA approval process.

When the FDA decides to regulate a tobacco product under the law, it must take a specific approach. Products that were on the market as of February 15, 2007, are grandfathered, while those wishing to sell a new product must gain FDA approval. One pathway to approval is to demonstrate that the product is “substantially equivalent” to a grandfathered product—but this will rarely be possible with e-cigarettes, because nearly all of them debuted after the grandfathering date and they differ dramatically from earlier tobacco products. They’re not equivalent to, say, Marlboro Reds; they’re much safer.

Instead, e-cigarettes will go through the law’s most rigorous and expensive approval process, under which companies must show the FDA, with extensive scientific evidence (sometimes including clinical research), that approving the product is “appropriate for the protection of the public health.” Companies have two years to comply, and the FDA will hold off on enforcement for an additional year for companies with applications pending.

The effect of the new rule—on public health and on the e-cigarette market—is uncertain, even according to the FDA itself. Here, for example, is the rule’s speculation about health benefits:

The direct benefits of making each of the newly deemed tobacco products subject to the requirements [of the law] … are difficult to quantify, and we cannot predict the size of these benefits at this time. …  Among other effects, new products will be subject to an evaluation to ensure they meet the appropriate public health standard for the pathway before they can be marketed, labeling cannot contain misleading statements, and FDA will be made aware of the ingredients in newly deemed tobacco products. If, without the final rule, new products would pose substantially greater health risks than those already on the market, the premarket requirements made effective by this final rule would keep such products from appearing on the market and worsening the health effects of tobacco product use. The warning statements required by this final rule will help consumers better understand and appreciate the risks and characteristics of tobacco products.

As for the effect on the market, the FDA touts some special considerations it offers to small manufacturers, such as more generous time limits and help preparing their applications. But nonetheless, the agency concedes that thousands of the smallest-scale operations—e-liquid mixing at local vape shops—will come to an end.

The FDA reports a “high level of uncertainty” as to how many other e-cigarette businesses even exist, but its best guess is 200. Many of these companies will shut down, reduce the number of products they offer, or cut back research efforts to avoid the costs of offering a new product under the rule. “There are currently a large number of electronic cigarette products being marketed, some of which have very little market share while others represent minor product variation among larger market players,” the FDA wrote two years ago, analyzing an earlier version of the rule. “Products that do not have sufficient sales to justify incurring the costs of complying with the proposed rule would exit.”

Some experts have suggested we could see a contraction so severe that most vape shops would shut down entirely, as they would have nothing to sell besides the major products available at convenience stores—and so severe that vaping may no longer continue to grow at smoking’s expense, as a diminishing selection of products would fail to attract as many tobacco users.

Before the rule was finalized, numerous comments were filed suggesting milder forms of regulation. The FDA could create a “model” e-cigarette and approve products that are similar, it could create a list of approved ingredients, it could interpret “substantial equivalence” broadly, etc. In the rule, the FDA reports that these ideas are inconsistent with current law.

At this point, a different approach would require the involvement of Congress, which, as it happens, is considering legislation to change the FDA’s course. The proposal would grandfather all products currently available and require the FDA to create safety standards for e-cigarettes.

The FDA has thrust itself into the midst of a promising trend: the growing tendency of vaping to replace smoking as a way to consume nicotine. Whether the agency will ensure e-cigarettes’ basic safety, or drive addicts back to traditional tobacco products, remains to be seen.

Robert VerBruggen is managing editor of The American Conservative. Twitter: @RAVerBruggen

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