A simple question
Will the FDA allow zero-nicotine e-liquids to be sold after August 8, 2018? (That is the deadline for submitting Premarket Tobacco Applications for all “tobacco products” covered by the deeming regulations.) A lot of people would like to know the answer to that question, and one curious person who asked the FDA’s Center for Tobacco Products for an explanation got a double-barrelled blast of the FDA’s frightening pretzel logic.
As Dr. Michael Siegel told the story in his blog Monday, the question posed was simple: “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?”
Siegel doesn’t say if the questioner was a vaper, a vendor, or a legal professional. It doesn’t matter really, but considering the number of vendors who are losing sleep wondering whether the FDA will be able to shut down their small businesses, my money is on a vape shop owner.
"A non-sensical regulatory approach"
The answer contains over 1,300 words. Most of it is legal gobbledegook that is just about as incomprehensible as the deeming document itself (which indeed is the source for most of it). Siegel makes some excellent points about the regulations being so convoluted that none of the businesses being regulated could possibly understand what they mean.
The time and resources necessary to even understand what is regulated and what is not regulated are prohibiting for most small business owners in the vaping market. And that’s before even getting to the issue of what would be required in a pre-market application if the product is regulated.
This is quite obviously a nonsensical and non-workable regulatory approach and for that reason alone, it is not going to protect the public’s health. Quite the opposite, it will harm the public’s health by decimating the e-cigarette market, forcing thousands of owners of small entities out of business, and protecting real cigarettes from competition, thus increasing smoking-related disease and death.
In my opinion, this response from the FDA could be used by the plaintiffs in litigation against the agency in order to demonstrate the arbitrariness and capriciousness of the regulations, as well as their undue complexity and burden on small business owners.
What is a tobacco product?
Dr. Siegel is right, of course, but I thought it might be fun to break the FDA’s logic puzzle into its parts. Let’s have a look at the small section of those 1,300 words that actually deals with the question that was asked:
“As it relates to e-liquids that contain zero nicotine, generally, if your zero-nicotine product is 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 is subject 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.”
As far as I can figure, here is the thought process from the trained public health professionals at the FDA:
- All nicotine-containing liquid is a tobacco product
- Anything (devices) that can be used to consume nicotine-containing liquid is a tobacco product
- If your non-tobacco product is consumed in a device classified as a tobacco product, it also becomes a tobacco product
- However, we’re not really sure, so please spend about a million dollars to submit a PMTA, and we’ll get back to you
This would be funny if the livelihoods of thousands of small business owners weren’t at stake — not to mention the lives of millions of ex-smokers and potential future ex-smokers. Let’s hope the judges on the various federal courts hearing challenges to the deeming regs, and the members of Congress considering the legislation that would change the 2007 predicate date, are as mystified and disgusted by the FDA’s deliberately twisted logic as we are. These regulations are a maze full of dead ends. And we’re the rats.