ENDS… how about them nicotine distributors?
Last time I wrote, it was about how the FDA was extending the scope of a previous regulation for electronic cigarettes (which they renamed ENDS for Electronic Nicotine Delivery System). Shortly after writing this, while reading a post about the Royal College of Physicians and watching Suck My Mod new advocacy videos, I noticed some details that previously eluded me.
Let’s come back to do ENDS and the extension of FDA regulations shall we?
The FDA announced in a recently updated post entitled “Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah:” “Previously, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule – Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act – which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipes) tobacco, pipe tobacco and nicotine gels, among others.” This is nothing new, I already pointed this out previously.
OLD REGULATIONS, NEW TECH
Now, bear with me, it gets (slightly) tricky – but fear not, I won’t go too much into details. The FDA’s authority that is to be extended is in fact “based on the laws set forth in the Tobacco Control Act and the Food, Drug, and Cosmetic Act (FD&C Act). FDA regulations are also federal laws.” Let’s leave the federal laws for the moment and have a look at the two other ones instead.
The Tobacco Control Act was passed in 2009. As for the Food, Drug, and Cosmetic Act, it is dated… 1938.
Both of them of course will and have been amended over time, depending on many factors (changes in society, technology, etc.). Nevertheless, as opposed to cigarettes, ENDS (sic) are a technology – and I do insist on the word “technology,” it is not merely setting fire to a bunch of rolled leaves to which chemicals have been added. As a technology e-cigs are rapidly evolving and will continue to do so unless somebody puts a stop to it.
So how do you make them fit into old sets of laws that have virtually nothing to do with electronical devices? And why? If I want a shirt, I buy my size, I don’t buy an overly big pullover and tailor it until it fits! Even though updating laws is a common legislative process (supposedly to avoid normative inflation), this one looks like somebody is splitting hairs in 4 at the FDA.
One of the obvious issues – and one that should be of discontent to all the vaping community – is that the FDA considers Electronic Cigarettes as a tobacco product.
In purely legal terms, it would not be appalling to make Electronic cigarettes fall under the Tobacco Control Act. Why? Because as an alternative to tobacco, it would allow e-cigs to share the same Act so to speak. However, the FDA refuses to acknowledge vaping as a substitute to tobacco, preferring to call it ENDS or “tobacco product”.
“…Whether ENDS products are on balance used as substitutes or complements to traditional tobacco products is also uncertain and possibly changing over time. Evidence on the relationships among the various products is still emerging and long run relationships may differ from what has been observed in the short run. Whether consumers will turn to ENDS products for long-term use (for consumption experience or for nicotine) or use them as an alternative to traditional nicotine replacement products for quitting (and with what effectiveness) is also uncertain. Therefore, the welfare effects of including ENDS in [the Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products] are uncertain.” [Responses to the preliminary economic analysis of impact, p 19 of ]
So, in order to make e-cigs fall under the Deeming Tobacco Products… regulation, FDA just considered them to be a tobacco product. Even though they do not contain tobacco (to the extent of my knowledge, even the tobacco e-juice contains only flavoring, no real tobacco – if you know otherwise, please do use the comment section below) and the FDA refuses to acknowledge them as a substitute to tobacco.
My last concern is about the nicotine part. Not being a health professional, I will not address the health part of the debate. What I will do instead is get into the rhetoric.
Again the FDA labels electronic cigarettes as Nicotine Delivery Systems. How about those of us who vape at 0 mg? If you consider vaping as a substitute to cigarettes, then your final goal will be to vape nicotine free.
Then the whole terminology is wrong. Shouldn’t it be “PENDS” for Potential Electronic Nicotine Delivery System” instead? Maybe that nicotine part is something to explore, in case it ends up being a loophole… what if the nicotine was systematically sold separately?
So, how will the FDA justify applying its regulations to products not containing tobacco and not delivering nicotine? Other than through a “because we said so” type of explanation?
What the FDA – and they are probably not the only one – was not expecting, was a vaping community, strong, proud and actually using their brain cells to fight back. Let’s give them exactly that.
Think. Research. Act.
That is what vaping will be about for the next two years. And that’s also what being a citizen means.
Spread the word. Use your rights.
As a bonus, you might succeed exactly where the FDA failed: to help people quit smoking.
Colin Vettier is a French native writer / lawyer who recently immigrated to the United States. He is fascinated by the vaping culture in the US and how the FDA regulations will affect it.