As I’m very sure you’re aware, the FDA’s newly enacted “deeming regulations” are upon us.
Deeming e-cigarettes as subject to the same stringent requirements as cigarettes, tobacco and e-cigarette manufacturers alike are required to submit a PMTA, an extensively expensive and time-consuming application with the projected purpose of preventing problems for the public populace from entering the marketplace as originally specified in the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA).
Such applications are estimated to take as much as 5000 man-hours and up to several million dollars PER product.
Brightest Day, Blackest Night...
Considering that the vast majority of the e-cigarette industry consists of small- and medium-businesses that could never dream of affording such an astronomical price-tag, the industry as whole—the jobs, the products, the entire economic force—would essentially cease to exist. While not in full effect quite yet, the deadline for these applications is fast-approaching—threatening to terminate a bright industry brimming with vibrancy and verve—with little hope in the hearts of vapers everywhere for any alternative fate...
But who’s that up in the air, surfing the clouds? Is it Cole? Or maybe Bishop? No, it’s the Vaping Congressman, Representative Duncan D. Hunter!
The Hero We Need
Ready to swoop in and save the day, Representative Duncan Hunter (R–CA-50) announced last week preparations to submit his own bill to Congress in response to these “deeming regulations”. Hunter’s bill would not only make e-cigarettes exempt from the PMTA process similarly to Cole & Bishop’s “FDA Deeming Authority Clarification Act of 2017” (H.R. 1136) presently under review in the House, but would also redefine e-cigarettes as something entirely separate and unique from tobacco as a whole—and that’s only the tip of the iceberg.
Titled the “Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017”, this prospective piece of legislation begins by correctly clarifying many misconceptions about vaping as compared to smoking.
This is absolutely essential to combating the swathes of misinformation that must undoubtedly be present in our legislature in order for such corrective legislation to be required—it’s best to attempt to educate our congressmen using personally gathered information rather than relying on lobbyists and special interest groups who, by definition, have their own agendas.
Secondly, Hunter’s bill reasserts the FDA’s regulatory authority over both tobacco and e-cigarettes—which remains a move most welcome as there’s little opposition to the FDA’s ability to regulate e-cigarettes. There's simply opposition to how it decides to do so given e-cigarettes’ contrasting effect on the public when compared to cigarettes. With the implementation of Hunter’s bill, however, the distinction is crystal-clear—Rep. Hunter wanted the divide between the two classes of nicotine consumption to be so present that in his new bill, he amends the title of the FDA’s “Center for Tobacco Products” to the “Center for Tobacco Products and Tobacco Harm Reduction”, even going so far as to create an Office of E-liquid and Personal Electronic Vaporizer Standards Compliance within this updated department.
In addition to asserting its ability to regulate these nicotine products, Rep. Duncan Hunter’s bill will have the FDA assert its sole authority to do so—meaning State legislatures cannot enact their own versions of the “deeming regulations” within their State legislation in order to replace their waning tax income typically sourced from traditional tobacco products—as well as the FDA’s right to inspect manufacturing facilities for compliance with standards and the right to lambaste those who do not comply with these guidelines.
A Class All Their Own
Next, Rep. Hunter’s bill does what no other piece of legislation so far has dared—rightly remove e-cigarettes from its incorrect categorization and create an entirely new definition of nicotine product within our legislation. By separating e-cigarettes from the legal definition of a “tobacco product”, e-cigarettes are no longer subject to the implications of the Tobacco Control Act and as such will not need to undergo the dreaded process of preparing and submitting a PMTA—this move alone is sure to return the much needed hope, maybe even optimism, we so desperately desire in the e-cigarette industry.
Taking a Closer Look At Inspections
In addition, in lieu of having vapor products undergo the same manufacturing guidelines as those implemented for traditional tobacco by the FSPTCA, Hunter’s bill sets manufacturing and inspection standards using those already implemented in the e-cigarette industry by the American E–Liquid Manufacturing Standards Association, American National Standards Institute, and International Electrotechnical Commission. This decision to leave the industry to essentially do what it already has been doing all along—regulating itself responsibly and efficiently—is an exceedingly wise choice, especially when implemented on a federally applicable and therefore essentially universal scale. Failure to do so would no doubt cause cases where guidances and policies may clash between the members and retailers of different organizations.
Verbal Agreement In Black-And-White
Hunter’s bill also calls for mandatory safety protection features in every model of e-cigarette—a smart response to the influx of horror stories from the media involving injured vapers lacking a proper battery charger, battery case, and/or ohm meter—as well as legal material guidelines that outline in no uncertain language the requirement for temperature-appropriate materials to be used in the construction of e-cigarettes. While clearly possessing only the best of intentions, this calls into question what would happen if, say, an insulator melted under normal conditions? Would that then be a recall and substitution with a better material? Maybe just a refund? Either way, it seems prudent for manufacturers to use the best materials they can get a hold of. Perhaps this isn’t quite so relevant to 3rd+ generation e-cigarettes, but in 1st and 2nd, where the materials aren’t the greatest, we may very well see a sudden jump in quality with the introduction of this legislature. Plus, with the requirement of circuitry-driven features like short circuit protections and charging/discharging monitoring, it seems that mechanical mods as we know them would be a thing of the past. Sure, unregulated mods would undoubtedly take off and essentially cannibalize the market share of mechanical mods, but it just wouldn’t really be the same.
The Hunter Bill goes on to describe guidelines setting the standards for interstate commerce. It also outlaws retailers from providing youth with e-cigarettes. In addition, Hunter’s bill sets the requirement for models of e-cigarettes to come with a serial and/or lot number in order to better assist in the unfortunate event there needs to be a recall of a product. And if any of these guidelines should not be met, Hunter’s bill has explicitly described any prohibited behavior and the consequences for such actions—most likely a stop to any market activity.
Put To The Test
The final point of Hunter’s bill may come last, but is without a doubt an equally important facet of this innovative enactment: in the bill’s closing section, it calls upon the Secretary of Health and Human Services (currently Dr. Tom Price) to complete a thorough review, scientific testing, and comparative health risk assessment of all tobacco products and other nicotine delivery alternatives—this includes: cigarettes, loose tobacco, cigars, dry snuff, snus, “heat-not-burn” devices, e-cigarettes, and hookah, as well as most other tobacco/nicotine products. The implications of this final point are huge, as it sets the stage for an unbiased, thoroughly conducted, and scientifically driven analysis of the risks behind the tobacco products we’ve come to hate as well as begins a well-founded debate on the comparative threats behind each product. Then, hopefully in the near future, world governments and health organizations will take the results of these findings—published no later than 18 months after its enactment—and use them to guide the direction and implementation of future tobacco harm reduction strategies.
What About Cole & Bishop?
While most proponents of vaping are applauding Rep. Hunter’s tenacity and thorough defense of e-cigarettes, some raise qualms with his timing—these opposing proponents argue that considering how Cole & Bishop’s own legislation is still up for approval and inclusion in the federal budget of this fiscal year, introducing another (admittedly stronger) piece of legislation could distract lawmakers from passing Cole & Bishop’s law, which would begin working immediately to exempt e-cigarettes from the draining PMTA process. In sharp contrast, if we were to forgo Cole & Bishop’s bill, it’d be years until Congressman Hunter’s bill is passed by both the House and Senate, then implemented as official law.
Only set to be released to Congress when they reconvene in late April, it’s difficult to say when the House will come to a vote on Congressman Duncan Hunter’s bill. That in mind, although Hunter’s bill could have a massively beneficial effect that would preserve the e-cigarette industry as it needs to be, it’s important to keep a pragmatic attitude when dealing with our legislation—if we see an easy way out, we should take it, and Cole & Bishop’s bill is so far the easiest path to eased regulation. So call, email, berate, and pester your local Congressmen to tell them about your continued support of bills from both the Representatives Cole & Bishop as well as Representative Hunter.