In a comment to the FDA on their work to ultimately regulate e-cig totally out of business for any actor not Pharma or Transnational Tobacco or other International FMCG enterprise like Nestlé or similar. Simply by making the FDA process so onerous, time consuming and uncertain that only companies with a couple of million dollars in pocket change per every 6 months or so will ever have a chance. Especially so since any problem will mean sunk money and lost months of vital revenue. Completely unnecessary deeming regulations will be put in place instead of reasonable consumer protection and child protection measures like with other products, um yeah, like cigarettes for example.
This is pretty much what I wrote to them in a comment:
I am commenting on ANPRM “Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products” (Docket No. FDA-2015-N-1514)
August 18th, 2015
My name is Atakan Befrits and I am a THR consumer and advocate (Snus and vaping products with high nicotine concentrations). I fully support tamper and child resistant packaging and reasonable and appropriate warning labels, reasonable requirements that will not prove overly onerous or prohibitively difficult to include unless the FDA make them so.
I strongly object to any form of overly ambitious regimens for producers, to satisfy requirements from the FDA, that serve no practical purpose for consumer protection. The current proposed deeming regulations serve no such practical purpose for consumer protection but serve well to protect both smoking and protecting large industrial actors (such as the Tobacco Industry) if and when they chose to intensify their efforts in sales of reduced harm consumer nicotine products. I am, smoke-free thanks to snus (before e-cig were invented) and also with a lot of pleasure and very little harm from occasionally using e-cig. This does not make me more prone to relapsing to smoking cigarettes, it makes me less prone to do so.
I have hundreds if not thousands of instances of inadvertantly swallowing entire pouches of snus and also spilling e-liquid in larger amounts on my skin or splattering in my eyes without any other effects than slight discomfort. Furthermore I would like to add that in the 70’s my mother rushed me to the hospital no less than 4 times to get my stomach pumped after eating cigarettes or cigarette butts. It is now perfectly clear that these instances were completely unnecessary traumas for me, since overdose of nicotine would have induced vomiting and solved the problem. Not unlike most other forms of food poisoning or accidental ingestion, but not applicable to most of the very easily accessible household chemicals causing countless hospitalizations and several (too many) child fatalities every year.
All of the refills and snus products that i buy are already in child resistant packaging and with clear +18 warnings and produced according to food grade standards or GMP.
I keep all my tobacco out of reach for my 2.5 year old. Her access to bleach, detergent, kitchen knives, table top sharp edges and about a million other hazards are infinitely more accessible to her than my nicotine products.
If there will come overly ambitious warnings or claims on e-liquid or smokeless products it would make me angry and less likely to ever trust other information that comes from the FDA. I know quite a bit about who wants what in terms of e-liquid and other nicotine products. From the end result I will therefore also know who was most successful in “swaying” the sentiments of the FDA in any particular direction. Any deviation from a science and evidence based center position by the FDA will be completely evident, including an unwarranted “precautionary principle” direction. FDA knows more about nicotine and nicotine containing products than most other consumer products and there simply is nothing left to be very afraid of, therefore very little need of further precaution.
Simple science based regulations empowering consumers to exercise tobacco harm reductions while protecting children and never users is quite sufficient. No more and no less!
I am a member of CASAA as well as internationally active in the Tobacco Harm Reduction field globally, with a special focus on the Middle East, Asia and Africa regions.
I would like to point out to the FDA that too onerous regulations in the USA will, without any doubt whatsoever as it is already happening, send signals to the rest of the world that Low Risk Nicotine products are actually HIGHER in risk compared to conventional cigarettes. The amount of regulation and the amount of paperwork required in the USA in their eyes reflect the amount of risk with the product.
Too high demands and too onerous processes by the FDA will be quite detrimental to US consumers, and will have the unintended consequence of inadvertently causing hundreds of millions of deaths outside the USA this century through protecting cigarettes from low risk competition. Exactly the opposite of what we all strive for.
The FDA and the EU SANCO and the WHO are the world’s largest net exporters of Health Policy. It is therefore absolutely imperative that also the “bigger picture” implications are factored in when deciding on policy, simply looking at the USA exclusively, although correct in principle, would be to grossly underestimate the impact FDA policy has on Health Policy in LMIC countries globally.
Thank you very much for your consideration,