The FDA's E-Cigarette Regulations, Mostly Mild for Now, Could Set the Stage for a Crackdown


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Today the Food and Drug Administration (FDA) finally proposed regulations for electronic cigarettes. The rule, which probably will take effect in a year or so, does not include any restrictions on advertising or flavors, steps that some activists and politicians had urged in the name of protecting the youth of America from the menace supposedly posed by e-cigarettes. Nor would the rule require the immediate removal of existing products, although it creates a process that may eventually have that result. Much hinges on whether the FDA, which currently claims to be agnostic on the subject, ultimately views vaping as a threat to public health or a harm-reducing alternative to smoking.

The rule would prohibit e-cigarette sales to consumers younger than 18, as most states already have done. It would ban free samples and e-cigarette vending machines in settings open to minors but allow online sales, which are an important distribution route for the industry, with age verification. It would require manufacturers to put the following message on e-cigarette packaging:

WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.

E-cigarette companies would have to register their products with the FDA, report ingredients, and flag potentially harmful chemicals. They would not be allowed to advertise their products as safer than conventional cigarettes or make comparisons that might lead to that conclusion unless they went through the process required for approval of a "modified risk product." That process entails presenting enough evidence to convince the FDA that a product "will benefit the health of the population as a whole." It is not enough for a company to show that the comparisons it wants to make are accurate.

In fact, says Boston University public health professor Michael Siegel, "an electronic cigarette company cannot even inform consumers that the product does not produce smoke because such a claim would be considered a 'reduced exposure' claim." Siegel, who sees e-cigarettes as a promising smoking cessation tool, worries that the FDA's censorship of accurate information will "undermine the public's appreciation of the health hazards of smoking and prevent companies from telling consumers the truth: that e-cigarettes are a lot safer than tobacco cigarettes."

Attempts to get e-cigarettes approved as "new tobacco products" face a similarly daunting barrier: The applicant has to persuade the FDA that "permitting such tobacco product to be marketed would be appropriate for the protection of the public health." Companies can avoid that requirement, which probably would entail prohibitively expensive and time-consuming research, if their products were on the market as of February 15, 2007, or if they are "substantially equivalent" to products that were. "Substantial equivalence" means having "the same characteristics" as a grandfathered product or raising the same public health issues, although the FDA may require "clinical data" to support the latter conclusion.

The U.S. e-cigarette industry was just getting started in 2007, but there were a few brands, including NJoy, that arguably can serve as acceptable "predicate products" for the hundreds of e-cigarettes available today, since the basic technology—heating a propylene glycol solution to produce a nicotine-laced aerosol—is the same. Yet the FDA expresses doubt on that point:

For some products, there may not be predicate products that were on the market as of February 15, 2007, to which to claim substantial equivalence. This may be particularly true for e-cigarettes and similar novel products.

Chip Paul, founder of the Oklahoma-based e-cigarette franchise Palm Beach Vapors, believes existing products generally will qualify as substantially equivalent to the early brands, meaning companies can continue selling them without presenting data they do not have. "I think everybody will be able to make that argument, that they are just furthering the technology that existed in 2007," says Paul. One major change has been the shift from disposable cartridges of e-cigarette fluid to refillable tanks, but the underlying principle remains the same. "We don't think what's on the market today is substantially different from what was on the market in 2007," Paul says. "There have been improvements in the technology, and there have been some design changes, but the way the liquid is delivered to the user is fundamentally the same, and the liquid is fundamentally the same. I think everybody who is in business today will be able to [satisfy that test] and be OK."

Paul does worry that FDA regulation could deter future innovation. The more innovative a vaping device, the less likely it is to be deemed substantially equivalent to the products available in 2007. Siegel expresses a similar concern:

This provision is going to present a huge obstacle to innovation in this category. The newer products tend to be safer and more effective, so it makes no sense to allow the older products to remain on the market while requiring pre-approval for the newer and better products. The implications of this regulation is going to depend on the evidence that the agency requires to approve these applications. A stringent interpretation of the regulations will put a huge dent in electronic cigarette innovation and could limit the expansion of the market. In addition, this provision is going to place an undue burden on smaller companies and give a huge advantage to larger companies, including the tobacco companies that have entered the e-cigarette market.

None of this will happen for a while. The FDA is giving companies two years after the rule becomes final to submit applications for product approval. In the meantime, and while the FDA considers the applications, existing products can remain on the market, so it will be years before any of them are removed, assuming regulators ultimately rule against them.

The adjustment period suggests the FDA is considerably less hostile to e-cigarettes than it was when it tried to ban them as unapproved drug-device combinations (a move that was rejected by the courts). Paul also takes comfort from the proposed rule's scattered references to evidence that e-cigarettes are safer than the real thing and that they can help smokers quit. "There is a lot of optimism in that document regarding the electronic cigarette industry," he says. "They are holding their powder in the hope that further study will show this is a viable smoking cessation method."