The FDA’s Incomprehensible Answer To A Crucial Question About Its E-Cigarette Regulations

July 29 2016

The Food and Drug Administration’s legal rationale for regulating e-cigarettes as “tobacco products,” even though they do not contain tobacco, is that they deliver nicotine derived from tobacco. But e-cigarettes do not always do that. There are many varieties of nicotine-free e-liquids, sold in disposable e-cigarettes,replaceable cartridges and bottles for refilling vaporizer tanks. Do those liquids and the systems in which they are used also qualify as tobacco products?

The answer to that question is vitally important for manufacturers, including vape stores that mix their own liquids, since it will determine which products are subject to the onerous, expensive FDA requirements that are expected to put all but the biggest e-cigarette companies out of business. But judging from correspondence that Boston University public health professor Michael Siegel posted today, the FDA is incapable of giving a succinct—or even comprehensible—answer to this basic question.

Siegel, who supports the use of e-cigarettes as a harm-reducing alternative to the conventional kind, says “someone” (presumably a business owner) shared with him the FDA’s response to this question: “Are e-cigs that do not contain nicotine (or any other tobacco extracts) also covered by the FDA deeming regulations? If so, will they also require pre-market approval like products that do contain nicotine?” The agency’s reply, which you can read in its entirety (if you dare) on Siegel’s tobacco policy blog, is more than 1,300 words long and consists mostly of irrelevant boilerplate. When the FDA finally attempts to answer the question, in the 10th paragraph of its missive, the answer makes no sense:

As it relates to e-liquids that contain zero nicotine, generally, if your zero-nicotine productis not made or derived from tobacco, it may still be a tobacco product subject to FDA regulation if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product; or intended or reasonably expected to alter the performance, composition, constituents, or characteristics of a tobacco product (with certain exceptions relating to controlling moisture or temperature for storage and initiating external heat source), your product issubject to FDA regulation. These products will be evaluated on a case-by-case basis. This applies to closed and open system devices that contain zero-nicotine.

“Despite having 11 years of post-secondary school education and a great deal of experience reading and interpreting legislation and regulations,” Siegel writes, “I have no clue what the heck the FDA is talking about.”

As he notes, it is hard to imagine how a nicotine-free e-liquid could be “used with or for the human consumption of a tobacco product.” Possibly the FDA is referring not to liquids but to vaping equipment that can be used with liquids that contains nicotine as well as liquids that do not. If so, it seems to be saying that such equipment counts as a tobacco product even if it is never used to deliver nicotine, provided that it could be used to deliver nicotine. By that logic, a disposable nicotine-free e-cigarette or a closed vaping system that accepts only nicotine-free cartridges would not qualify as a tobacco product—except that the last sentence (“This applies to closed and open system devices that contain zero-nicotine”) seems to say otherwise.

Comprehension of this crucial paragraph is not aided by the syntactically faulty first sentence, which seems to consist of two differently constructed sentences mashed together without regard to grammar or sense. Even if a business owner could figure out what the FDA meant to say, the warning that “these products will be evaluated on a case-by-case basis” makes it impossible for him to predict whether the agency will view him as a lawbreaker.

This exchange gives you a little taste of what’s in store for companies trying to comply with the FDA’s regulations. For most of them, compliance will be prohibitively expensive, costing anywhere from several hundred thousand dollars (according to the FDA) to $1 million or more (according to the FDA’s critics) for every product variation. But as you can see, even figuring out whether a product is covered by the regulations is no small task.


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