FDA Proposes Deeming Regulations for E-Cigarettes, Finally
By Lindsay Fox Posted April 30, 2014
It’s been a very, very long time coming, but the FDA has finally revealed its plans for the regulation of e-cigarettes. For vapers, the situation could undeniably be worse, but that isn’t to say that the proposal is completely devoid of the sort of idiotic reasoning and senseless requirements we were all fearing. The basic idea is that e-cigarettes (along with cigars, pipe tobacco, hookah tobacco and dissolvable tobacco) are being deemed as tobacco products and thereby come under the agency’s jurisdiction through the Family Tobacco Control and Prevention Act. The entire contents of the proposed regulations are detailed within a characteristically-longwinded 241-page document, but the core changes can be summarized pretty simply.
Summary of the New Rules
- E-cigarettes cannot be sold to minors (aged under 18).
- Pre-approval or substantial equivalence determinations (equivalent to a product marketed in the US before February 15th, 2007) must be provided for all new e-cigarette products and all existing products.
- Free samples of e-cigarette products will be banned.
- Health warnings must be displayed stating that nicotine is an addictive drug.
- Full ingredients listing and reporting of harmful and potentially harmful constituents required.
- Companies are only allowed to make direct or implied claims of reduced risk if the FDA agrees that scientific evidence supports the claim (to clarify, the FDA is currently unsure whether e-cigarettes are safer than tobacco cigarettes), and that marketing of the product would be beneficial to public health as a whole.
- Vending machines selling e-cigs (or other tobacco products) can only be placed in locations where youths aren’t permitted.
- No ban on flavorings.
- No ban on advertising.
- No ban on online sales (to adults).
- Following 75 day public comment period, the final rule will be published and age restrictions will come into effect 30 days later. Other requirements (such as health warnings) will not come into effect until two years after final publication of the rule.
- Companies will have two years from the final publication of the rules to submit substantial equivalence or premarket approval applications, and products can remain on the market at least until the applications have been responded to.
- The regulation is generally open-ended, meaning further rules (such as restrictions on flavors, for example) could be introduced in the future as separate measures.
The Director of the FDA’s Center for Tobacco Products, Mitch Zeller, commented that “the proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims.”
Not as Bad as We’d Feared
There are many issues with the proposals, but it’s only fair to acknowledge that many things aren’t quite as bad as many had feared. Firstly, there are no senseless caps on nicotine limits or other such arbitrary measures (such as maximum e-liquid bottle and tank sizes) like those that have been approved by the EU. Flavors are untouched, despite considerable fear-mongering and effort from numerous anti-smoking groups; suggesting that the FDA is well-aware that there is no convincing evidence whatsoever that e-cigarette companies are marketing to youth and including sweet flavors for that purpose. That doesn’t stop them raising the point several times throughout the document (for example, “many of the products proposed to be covered by this rule are offered in fruit and candy flavors, such as chocolate and grape flavors, making them especially attractive to children and young adults”), but it’s good that they haven’t taken potentially catastrophic action related to these unfounded concerns.
The ban on sales to minors is similarly acceptable to the vast majority of vapers and companies in the industry. We might controversially suggest that teens or children who smoke shouldn’t be prevented from switching to a healthier alternative, but such a rule was expected and is largely supported by people on both sides of the issue. Additionally, the lack of rules relating to advertising and online sales to adults is a good thing, because it would be actively damaging to take any action that could prevent adult smokers from obtaining or learning about a product with the potential to vastly reduce their risk of tobacco-related illness or death. However, the subject of advertising regulations is very likely to crop up at some point in the future.
The biggest thing about the new rules that should allow vapers some relief is that your e-cigarettes, mods, liquids and components will not be taken away or swiftly removed from general sale. The substantial equivalence/premarket approval thing is one (very significant) issue, but as long as the applications are submitted within the two-year period, everything can still be sold at least until the FDA actually responds to the applications (which in the past has taken quite a while), and new products can even be brought to market within those initial two years.
Just as Bad as We’d Feared
However, the regulations couldn’t be released without some of the token stupidity we’ve come to expect whenever pretty much anybody in a professional capacity (aside from actual reputable researchers)is saying anything about e-cigarettes. The biggest and most obvious problem is the entire “grandfathering date” debacle. This basically means that a tobacco product would be much more easily approved if it can be shown to be substantially equivalent to a product marketed in the US prior to the February 15th, 2007. It’s abundantly clear to everybody that this is not a suitable date for e-cigarettes, given that the US market was barely getting going by that point, and the FDA knows this too:
“FDA is aware of new product category entrants into the market after the February 15, 2007, reference date and that the [substantial equivalence] pathway may not be available to these newer products. Because this date is written into the statute, we do not believe that we have the authority to amend it with respect to e-cigarettes or other products.”
Anybody who knows anything about the variety of e-cigarettes available knows that the product is evolving rapidly. Substantial equivalence can be demonstrated if the tobacco product either has the same characteristics as a previously available tobacco product or if it has different characteristics but doesn’t raise different questions of public health, but the overall lack of e-cigarettes available as of February 2007 in the US means that premarket authorization is likely to be the only option available.
This is approach is going to be a costly and time-consuming process, but just how costly and time-consuming isn’t immediately clear. The FDA estimates that it would take 5000 hours to submit one premarket authorization application, and as Steve K points out, this would require almost a year’s worth of work from three full-time employees. Much of the time is estimated to be taken up by conducting studies of the products, but it’s possible that not every product would require that. However, the definition of a tobacco product given includes components (anything included as part of a “finished tobacco product,” with the document specifically mentioning e-cig cartridges and product flavorings used as examples), so it’s possible that the legislative burden would be higher, but the details of this are ill-defined. Even if just one application was required by each company (most of them being pretty small operations), the financial and legislative requirements could be crippling. Unless you happen to be a tobacco company, of course.
The reason they’re sticking with the February 2007 date is because they don’t think they have the authority to change it, but regardless of whether or not they do, the potential implications are exceptionally serious. Recent research has shown that first generation e-cigs (as any available prior to the grandfathering date surely would be) are ineffective at nicotine delivery in comparison to newer products. So, if the process of gaining premarket authorization (which requires demonstrating that the new product is appropriate for the protection of public health) is stringently enforced, it will undeniably mean that less effective (and also probably less safe) products are allowed just because they’ve been around for longer, while the modern, improved versions aren’t. Dr. Michael Siegel rightly points out that this could effectively freeze the e-cigarette market and prevent new products emerging with the potential to actually have a significant and lasting impact on the sales of combustible, deadly cigarettes.
Even Worse Than We Would Have Imagined
But this isn’t all that’s wrong with the proposal. The strangest element, undeniably, is the FDA’s flat-out refusal to acknowledge that e-cigarettes are safer than cigarettes. These choice quotes from the document illustrate the issue:
“Many consumers believe that e-cigarettes are “safe” tobacco products or are “safer” than cigarettes. FDA has not made such a determination and conclusive research is not available.”
“Once again, there is not adequate evidence that e-cigarette use is a safe alternative to conventional cigarette smoking.”
So, to be clear, the FDA isn’t sure that e-cigarettes are safer than cigarettes. Frankly, the entire discussion of the evidence relating to e-cigarettes in the regulations is one-sided to say the least, mentioning that they found diethylene glycol in one cartridge in 2009 (which has never been found since), for example. They first mention the fact that various chemicals (like formaldehyde, acrolein and several metals) are present, and then somewhat begrudgingly admit that the levels are overwhelmingly tiny, and many times lower than is found in cigarettes. Despite this acknowledgement (and admitting that levels of harmful chemicals are similar to or lower than those found in existing nicotine replacement therapies), they still conclude that:
“As such, given the existence of toxic chemicals in at least some e-cigarettes and the fact that most contain nicotine, FDA believes that its oversight of these products (which would occur if this deeming ruling becomes final) is appropriate for the protection of the public health.”
Why does this all matter? Well, according to the regulations, in order to make a health claim about e-cigarettes, such as the abundantly obvious fact that they’re safer than cigarettes (a point which the vast majority of researchers agree with), the FDA has to confirm that scientific evidence supports that position. Of course, there’s no evidence to support the opposing position (that e-cigarettes, with vastly smaller quantities of harmful components, are somehow magically as dangerous as smoking) and quite a lot of evidence to support the notion that they’re safer than cigarettes, but for the FDA, all of the information we have so far isn’t enough.
We’re not saying that e-cigarettes are 100 percent safe, but there is no serious dispute about their safety in comparison to cigarettes. It’s reasonable to say we need long-term evidence, but it’s wholly unreasonable to say that everything we know so far is wrong (especially if you don’t have the good decency to explain why that might be). So the situation emerges whereby e-cigarette companies won’t be able to state that their products reduce harm in comparison to cigarettes until the FDA decides that there is enough evidence. To be clear, there is (at very least, currently) no scientifically or logically justifiable reason to assume that e-cigarettes aren’t a reduced harm alternative to cigarettes, and refusing to admit that is beyond comprehension.
The FDA seems to be allergic to rational thought. Take this gem: “there is no evidence to date that e-cigarettes are effective cessation devices.” This is followed by a summary of the randomized controlled trial that showed that first-generation (i.e., lower nicotine delivery) e-cigarettes are as effective for smoking cessation as FDA-approved nicotine patches. So the FDA clearly thinks nicotine patches are effective (otherwise they shouldn’t be approved as medicines), but apparently also thinks that e-cigarettes aren’t. And they didn’t provide additional evidence for that, either, apart from studies arguably designed specifically to find people who’d tried e-cigs but who couldn’t quit using them. How the “no evidence” part can be justified is impossible to imagine. They themselves provided some evidence, and there is still more. Hell, even anecdotal evidence is “some” (albeit very weak) evidence.
This wouldn’t be relevant if the FDA’s scientific opinion was so instrumental as to the sort of claims e-cigarette sellers will be allowed to make when the regulations come into effect. In short, the FDA is making it increasingly apparent that they aren’t particularly interested in making reasonable estimations of risks and benefits based on current scientific knowledge; they’re just interested in cherry-picking studies to support their pre-formulated opinions. So how are manufacturers going to be able to correctly tell smokers that they can reduce their harm and maybe even quit smoking altogether? Well, they’re not, because the FDA is not interested in the truth when it comes to e-cigarettes, and they’re clearly not too interested in motivating smokers to make the switch to a healthier alternative, because they don’t realize (or probably just won’t admit) it is one.
Conclusion – A Disaster, or a Complete Disaster?
So there are problems. There are plenty of problems. We can at least take some solace in the fact that it could have been worse. Even among the stupid statements and the flat-out refusal to admit the safety of vaping in comparison to smoking, the FDA hasn’t yet reduced the available flavors or nicotine levels, or impacted on marketing or sales, so that should be praised. The public comment period will undoubtedly see them inundated with complaints from angry vapers, researchers and public health experts who recognize the potential harm inherent in their proposed actions, and we can only hope that they actually paysome attention. Whether they will is highly doubtful – most of the time it seemed like they were mainly looking for more justification to come down hard on e-cigarettes – but vapers will definitely (and already are) having their say. The story isn’t over yet, and the newest chapter is in no way what we wanted, but we can all breathe just a little bit easier now we at least know what the FDA has in mind.