How is the FDA Regulating the E-Cigarette Industry?

Way back in the murky distant mists of time, a trip to your primary care physician might include him listening to your heart, giving you a quick tap on knees to test reflexes, a guffaw about your three martini lunch, and a lungful of second hand smoke from the cigarette burning down in a glass ashtray next to his prescription pad. This would not have seemed odd: as the ‘Mad Men’ of the era would have had you believe ‘More doctors smoke Camels than any other cigarette.’

It’s hard to imagine that happening now. And, given the overwhelming evidence on the health implications of passive smoking, that is probably a good thing.

But while the choking gray fug of the traditional cigarette is now firmly banished from the doctor’s office and is increasingly marginalized in society, the broader use of tobacco products is not yet dead. In fact, in a decidedly 21^st century spin on the cigarette, sales of one product are actually growing, and the Federal Drug Administration is sounding the alarm.

Electronic cigarettes, or e-cigs for readers in a hurry, are battery-operated devices that deliver nicotine and flavorings to the user via a vapor system. Increasingly fashionable among teens and those seeking to gain a bona fide addictive habit before graduation, they are created to either resemble traditional cigarettes or are disguised as hip tech items such as USB sticks or…pens. Puffing on the device actives a heating element which vaporizes liquid in the cartridge for the smoker to inhale. To users, this is known as ‘#vaping’; to the rest of us, it is merely obnoxious. Broadly and falsely considered safer than lighting up their conventional counterparts, e-cigs are deceivingly noxious. Although they don’t produce smoke, they do contain toxins and carcinogens such as formaldehyde and acetaldehyde in addition to metal nanoparticles from the manufacturing process.

And this is where the new FDA guidelines come in…

According to a press release dated May 5^th 2016, the FDA has broadened the scope of its reach for all tobacco products, now including #e-cigarettes and hookahs within its sphere of regulation. And the part of the Deeming Rule (Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act) that is of specific relevance here is the FDAs interest in the standards to be upheld by the device manufacturers. Following a staggered timeline, all e-cigarette manufacturers will now be required to register their establishments and provide a full list of the products and their ingredients.

But does this go far enough to ensure public safety?

Given that one of the dangers of electronic cigarettes is the potential vaporizing of residual metal nanoparticles from the manufacturing process, it is clear that further regulation is necessary. So it is with some degree of interest that we note the involvement of the American E-Liquid Manufacturing Standards Association (AEMSA). A professional trade association (and registered nonprofit 501(c)(6)) for #e-liquid manufacturers, the AEMSA seems at first blush to back standards in creating responsible and safe practices in manufacturing, and is a fierce proponent of self-regulation. According to their own SOP guidelines, components used in the creation of Electronic Nicotine Delivery Systems (ENDS) should conform to food preparation standards. These include using a non-porous sanitized preparation area, cleaning floors, surfaces, counters etc with anti-bacterial agents, and decontaminating equipment in an autoclave or via FDA-approved chemical sanitization processes.

And if we didn’t already know about the unconscionable laxity of standards in some sectors of the food processing industry, this might all sound well and good. (A salient reminder of the risks can be found in our earlier article on seafood processing.) But let’s return to a crucial point that might have flown under the radar. Self-regulation. According to the AEMSA’s website, the voluntary acceptance of these standards should be sufficient for the FDA to back off from governmental regulation of this newly emerging industry. With a couple of dozen big names in the e-liquid manufacturing world as members, the AEMSA is seeking to challenge the FDA in federal court. By creating a coalition of interested parties – Consumer Advocates for Smoke-free Alternatives Association (CASAA), Smoke-Free Alternatives Trade Association (SFATA), and several others with equally lengthy acronyms – the AEMSA is preparing to file a lawsuit against the Deeming Rule, drumming up support with a claim that vendors and vapers are united in a fight for survival.

Drama much?

Clearly an FDA insistence upon regulatory oversight in product manufacturing is more than the vaping industry can countenance. And yet this coalition has only one member that manufactures their products in an ISO Class 7 cleanroom. According to Nicquid’s website it is ‘one of the only elqiuid [sic] companies that completely manufactures all of our eliquid in an ISO Class 7 / FED STD 209E Class 10,000 Clean Room.’ One of the only companies. If this is true, the vast majority of other eliquid manufacturers is not creating their products with this same level of contamination control and consumer protection in mind. And with that as a basis, self-regulation by these same companies and all-volunteer oversight entities such as AEMSA is not likely to hold much weight.

The FDA is just starting to flex its regulatory muscles in this issue and it will be interesting to watch how the landscape changes. At this moment, it seems unlikely that the coalition of vaping proponents – both on the manufacturing and on the consumer level – could succeed in forcing a retreat of governmental oversight and a lengthy battle may be ahead. As always, we are interested in knowing your thoughts on this topic and welcome all your comments.

References:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm

Home Page

https://www.drugabuse.gov/publications/drugfacts/electronic-cigarettes-e-cigarettes

http://www.fda.gov/TobaccoProducts/Labeling/ucm388395.htm

http://vapefight.com/casaa-sfata-aemsa-ava-and-nbs-form-coalition-to-fight-the-fdas-vaping-regulations/?ao_confirm

http://sfata.org/

http://www.nicquid.com/aboutus.html

http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm394909.htm