The FDA E-Cigarette Regulations Explained
On May 10th, 2016, the FDA published its deeming regulations for e-cigarettes and other vaping products. These regulations have been widely-criticized as effectively amounting to a ban on vaping products, or at least on the most effective products. But there is a lot to take in. There’s a lot of talk of grandfather dates, premarket tobacco applications and esoteric terms like “covered tobacco product,” and even learning the basics can be tough because of the dense, legal language used.
So what do the FDA e-cigarette regulations mean for vapers? Why are e-cigarettes being regulated as tobacco products? What rules will be brought into force and when? Here’s everything you need to know.
What Are the FDA’s Deeming Regulations?
The “deeming regulations” are so-called because they represent the FDA deeming e-cigarettes to be tobacco products and thereby asserting their authority over them. Mitch Zeller is in charge of the FDA’s Center for Tobacco Products, and regularly stresses that the FDA regulations are “foundational,” meaning that further restrictions will likely follow in the future.
Why Are E-Cigarettes Classed as Tobacco Products?
When you first hear about the FDA e-cigarette regulations, it may seem strange that a product containing no tobacco would be classed as a tobacco product. It’s counter-intuitive, but the reason is enshrined in the legal definition of tobacco product:
“Any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.”
It’s clear from this why e-liquid in particular meets the definition, but the precise meanings of component, part or accessory cover most vaping products you can think of. The FDA provides a list of example products that would be covered:
- A glass or plastic vial container of e-liquid
- Certain batteries
- Cartomizers and clearomizers
- Digital display or lights to adjust settings
- Tank systems
- Drip tips
- Flavorings for ENDS
- Programmable software
Simply put, the regulations will cover virtually everything. However, as the next section shows, there are a few things that aren’t particularly clear at all.
Are No-Nicotine E-Liquids Covered by the FDA Regulations? A Case Study in Confusion
The FDA has “deemed” quite a lot of different products to be “tobacco products” because they fall under the definition of “component or part.” They define this as being anything that alters the performance, composition, characteristics or constituents of a tobacco product, or that is used with or for the consumption of a tobacco product. This is why silly things like software are covered: they impact the e-liquid, which is made or derived from tobacco.
However, things get more complicated pretty quickly. If an e-liquid has no nicotine, it isn’t made or derived from tobacco. This means that it shouldn’t meet the definition of a tobacco product. A question about this was met with a long, nigh incomprehensible response from the FDA, which probably created more confusion than it cleared up. The answer seems to be that they won’t be covered, but, “in certain circumstances” they are considered tobacco products.
According to the industry guidance document, the short version is:
“E-liquids containing zero nicotine that are not otherwise made or derived from tobacco and are not intended or reasonably expected to be mixed with liquid nicotine or other materials made or derived from tobacco are not tobacco products, and are thus not subject to FDA’s tobacco control authorities under the FD&C Act.”
In other words, “no unless they’re intended or expected to be mixed with nicotine, or contain other tobacco.” This is a bit odd, but the “situation” is that it would be a tobacco product if it was a “just add nicotine” bottle of PG, VG and flavorings, but not if it was a ready-to-vape zero nicotine e-liquid. It doesn’t seem to matter that those two things are actually identical when you get right down to it.
(Incidentally, since our juice at Black Note is made using real tobacco leaves, our e-liquid falls under “tobacco product” with or without nicotine.)
Things like kanthal wire are also confusing when it comes to the FDA regulations. If sold to a vaper, it would be used to modify the performance of a tobacco product (i.e. making a new coil, which impacts your e-juice), so should it be covered? If it wasn’t for the multitude of other uses for kanthal wire, it would seem like it should be. The same goes for cotton used in rebuildable atomizers – when you use it in coil building, it does alter the performance of a tobacco product, but the FDA can hardly regulate cotton balls as a tobacco product.
Despite these obvious issues, the way the regulations are written makes it hard to see why they wouldn’t meet the definition, from a legal perspective. The question is: would regulating cotton as a tobacco product be much sillier than regulating programmable software as a tobacco product?
The overall point here is simple: the FDA e-cigarette regulations are surprisingly broad in scope, and finding out what is covered by them isn’t simple – especially when the FDA responds to even simple questions with a long, convoluted and confusing wall of text.
The Legal Background for the FDA E-Cigarette Regulations
The Family Smoking Prevention and Tobacco Control Act 2009 basically dictates how tobacco products are regulated. The FDA is operating within this framework, so they pretty much have to create regulations similar to the ones we’ve seen. They tried to regulate e-cigs as medicines originally, but they lost a legal battle relating to this, so the Tobacco Control Act approach is the only way they could do it.
However, as Clive Bates explains, this really ties their hands in terms of what they can do. The Tobacco Control Act didn’t have e-cigarettes in mind when it was created. In fact, the main motivation was to restrict the ability of tobacco companies to make substantial changes to their products and to stop them from making claims that could be interpreted as meaning some cigarettes are less dangerous than others.
For e-cigarettes, both of these restrictions are crippling. It all comes down to the massive hurdles put up in the legislation to bringing new products to market and the difficulty in being allowed to make even factual claims about reduced risks.
Ways to Bring a New E-Cigarette to the Market
The problems with the regulations really start to become obvious when you consider the process of bringing a new e-cigarette to market. Although there are actually four ways to bring a product to market, the fourth is only for very small changes to products already on the market, so we’ll focus on the most important three here.
The Substantial Equivalence Pathway: Closed to Almost All Vaping Companies
The simplest approach is the “substantial equivalence” pathway, which is suitable for anything that’s substantially similar to a pre-existing product.
This would be fantastic, but the “grandfather date” – February 15th, 2007 – is entirely unsuitable for most vaping products. To apply through substantial equivalence, your e-cig has to be similar to something that was on the market before this date. As most vapers will know, there was basically nothing on the market at this time. The e-cigs which did exist were rudimentary and far from equivalent to the devices vapers use today.
Since the regulations weren’t designed with e-cigarettes in mind, the grandfather date is completely devastating to the vaping industry. When the Tobacco Control Act came into force, though, traditional cigarettes could be easily ushered onto the market on the basis of substantial equivalence.
The Modified Risk Tobacco Product Pathway
With the conclusions reached by Public Health England and the Royal College of Physicians in mind, this seems like the most appropriate option for e-cigarettes on first glance. However, the main reason to try this approach is if you want to make the claim that your product is safer. In the past, claims of “light” or “mild” cigarettes (which imply they are safer than others) caused a big problem, and were found to be completely unsubstantiated.
The result is that it’s incredibly difficult to make this approach work for you. The manufacturer basically has to prove to the FDA that they are making a valid health claim. Swedish Match, who manufacture a form of smokeless tobacco called snus, have made an application under this pathway. It’s formidable in length, at around 130,000 pages. The key claim made by Swedish Match – that snus is substantially safer than cigarettes – has been categorically shown to be true by decades of research.
You’d think their application would be successful, but so far the reception has been frosty at best. Carl V. Phillips talks about one frustrating discussion of the issue on this blog post. The upshot is that this option is completely off the table for any e-cigarette company, despite the fact that a reduced risk claim would almost definitely be true.
The Premarket Tobacco Application (PMTA) Approach: The Only Option for Vaping Companies
So this leaves the premarket tobacco application (PMTA) approach as the only real option for vaping companies. This application requires seven elements:
- Full reports of all published (or unpublished) information that should be known to the company regarding the risks of the product, both overall and in comparison to other tobacco products.
- Full ingredients listing and a description of how the product works.
- A full description of the manufacturing process and the facilities used during production.
- A reference to appropriate tobacco product standards which would apply to some aspects of the product, and evidence that your product meets said standard.
- Provide samples of the product to the FDA.
- Provide specimens of the label.
- Any other relevant information.
These are the main requirements, but the FDA could request additional information, and even inspect facilities to check the reliability of the claims in the application.
This might not seem all that bad, but in reality it’s a Herculean undertaking, estimated to cost over $1.3 million per product in both administrative expenses and conducting studies to support the application. The situation only gets worse when you realize that the estimated $300k admin cost is for every single product (and you’ll undoubtedly need extra studies for some too), and even the same e-juice available in two different nicotine levels would be classed as two separate products. More realistically, most juices come in four or five nicotine levels. Throw in a healthy selection of flavors and the expense is too much for all but the biggest companies.
However, the whole thing gets worse. E-cigarette companies have to show that “permitting this product to be marketed would be appropriate for the protection of the public health,” considering it’s effect on the likelihood that existing tobacco product users would quit and that non-users would start. In other words, which is bigger, the supposed “gateway” or the path to being smoke-free.
The idea that any vaping company is going to be able to show the product would be “appropriate for the protection of public health” is questionable. If we could show conclusively that e-cigarettes (in general) will stop more people smoking than they will cause to start, it would still be a challenge to show that your specific product will have the same effect.
For example, if we knew that most e-liquid helps people quit but doesn’t lead too many to take up vaping, could you really produce evidence to show your 0.3 % nicotine version will too? If you add menthol to an existing e-juice flavor, would you be able to show that this won’t make kids more likely to switch from smoking to vaping or reduce the number of smokers who quit?
It’s hard to see how the answer could be anything other than “no.” The information you’d need simply doesn’t exist.
The FDA’s suggestion is that you can use evidence relating to other tobacco products to fill these gaps, but this isn’t exactly an easy task. The only result is a patchwork of arguments pulled from a variety of different products that barely even relates to the question of whether your dripping atomizer is going to have a negative effect on public health.
The big question is how the FDA will evaluate applications. They do understand the issue of providing such evidence, and make some positive-sounding statements about trying to place each product on the spectrum of risk. However, it’s not at all clear if they’ll take such a forward-thinking approach when it actually comes to making the decision.
In summary, the PMTA process is an inordinately expensive administrative nightmare, and you have to go through it all in the hope that the FDA will accept the application. Since you’re trying to show that a sub ohm tank or ice-cream flavored e-juice is going to benefit public health, the risk of failure is very real. You’re basically taking a million-dollar gamble on each product in your repertoire. Vaping companies will disappear faster than they appeared.
The FDA Deeming Rule Timeline
The combined issues with the grandfather date and the PMTA process are what could easily spell the end for vaping. However, there are other rules in the deeming regulations too, and although most are versions of rules already in place in most states, it gives the full picture of what the FDA’s e-cigarette regulations mean for companies.
There are a several really good timelines – like these from Vaping360 and FDARegs.info, as well as the FDA’s own non-timeline version – that cover everything that vaping companies, retailers and stores that mix e-juice will need to do over the next few years. Here’s a quick run-down of what’s going to happen (and the big thing that has happned):
August 8th – The Market Freezes
Last month, the final new vaping products to be marketed in America without going through the PMTA process were released. The market is now frozen, and several provisions have come into effect:
- Age restriction: Most states have minimum age laws for vaping products, but the regulations make this nationwide.
- No free samples: Allowing people to sample an e-juice for free is no longer allowed, but you can do it if you charge a reasonable fee. It does appear that nicotine-free juices aren’t covered, so these could be used for sampling purposes.
- No vending machine sales: The only time this doesn’t apply is when the machine is located somewhere youths can’t go.
- No “misbranding”: The FDA will now start coming down on false or misleading advertising claims, including claims that your products are less harmful than other tobacco products. To do this, you’d need approval as a modified risk tobacco product.
- Ensure manufacturing areas are sanitary: From the 8th of August, manufacturers (whether of e-liquid or other devices) are required to ensure your manufacturing facility is sanitary and you avoid “product adulteration.” It’s important to note that vape stores or other retailers who mix their own e-liquids or even make coils for customers are now considered “manufacturers,” and also need to comply with this rule.
December 31st – Registering and Listing Products
- Register with the FDA: Anybody who manufactures, repackages, relabels, processes or prepares tobacco products needs to register their business with the FDA. This needs to be done every year, and in future (when further rules are established) foreign businesses selling in the U.S. will have to register too.
- Provide the FDA with a List of Your Products: This is self-explanatory – you give the FDA a list of your products, including your labelling and advertising material. This information is updated every six months.
February 8th, 2017 – List Your Ingredients
- Provide Ingredient Listings: You must provide a full ingredients listing for all “finished tobacco products,” that are sealed in packaging and ready for the consumer to use. However, at this point, this requirement only applies to manufacturers with annual revenues above $5 million and with more than 150 employees.
- Tobacco Health Documents: Large-scale manufacturers also have to submit “tobacco health documents,” which look at health issues, including toxicology, behavioral and physiological effects of the products themselves, ingredients, components and additives.
August 8th, 2017 – More on Modified Risk Claims
- Substantial Equivalence Exemption Requests due in: Vaping products won’t be eligible for substantial equivalence exemptions, but this is the deadline for any request to be exempted.
- Ingredient Listing and Health Documents: Small-scale manufacturers now have to submit the documentation large-scale manufacturers did on February 8th.
- No Modified Risk Claims: All terms like “light” or “mild,” which imply reduced risk, are banned from this date. Although you can’t manufacture new products with terms like this on the label, manufacturers have 30 days (until September 7th) to send them out, and retailers can continue until they exhaust their stock of any such products.
February 8, 2018 – Substantial Equivalence Applications
- Substantial Equivalence Applications Due: Although vaping products won’t have a valid “predicate” product to be substantially equivalent to (i.e. something similar that was on the market in February 2007), if your product is similar to an early e-cigarette, your substantial equivalence application would be due in. However, if the grandfather date is changed, then this could be the most important date in the timeline for most vaping companies.
May 10, 2018 – Labeling and Advertising Requirements
From this date, all packaging produced and all advertising must comply with the FDA’s requirements. For products, as long as they were manufactured before the 10th of May, 2018, they can be distributed until the 9th of June.
- Nicotine Warning: “Covered vapor products” (which excludes “components” or “parts,” meaning that this just applies to e-liquid or pre-filled clearomizers/cartomizers) must have “WARNING: This product contains nicotine. Nicotine is an addictive chemical” printed on labels, packaging and on advertising material. It has to occupy 30 % of the packaging (on all but very small products) and 20 % of all advertising. If your product doesn’t contain nicotine, the warning statement has to read “this product is made from tobacco.”
- Other Information: Labels must have the name and address of the company, a weight, count or other measure of the contents, percentages of domestic and foreign tobacco used, and “Sale only allowed in the United States” on the packaging and on the boxes they’re shipped out in.
August 8th, 2018 – PMTAs: The Vaping Industry Crumbles
- PMTA Deadline: This is your last chance to submit your PMTAs. If you submit, your product can remain on the market for a year, unless the application is denied before then. This means that any products without a PMTA filed will be gone from sale.
August 8th, 2019 – The FDA Reshapes the Vaping Industry
- Approved Products Only: The only products on the market where the manufacturer submitted a PMTA and has been given a marketing order by the FDA. What the vaping industry will look like from this point depends primarily on the FDA’s judgment.
- Report Harmful and Potentially Harmful Constituents: E-liquid manufacturers will have to submit the results of required tests for the presence and quantity of harmful chemicals. More information on this will be released in the future.
Is There Hope for The Vaping Industry?
The situation definitely looks grim. Substantial equivalence is out. PMTAs are time-consuming and very expensive, and you’ll have a lot of them to do. On top of this, showing that an e-cigarette would be “appropriate for the protection of public health” is hardly easy. And then the result is still dependent on the FDA, who don’t seem all that positive about vaping.
So is there any hope? Can the vaping industry survive?
The Cole-Bishop Amendment and HR 2058
These Cole-Bishop amendment and HR 2058 are distinct pieces of legislation, but have the same aim: to change the predicate date (the “grandfather” date) from February 15th, 2007 to the effective date of the FDA regulations, August 8th, 2016. In one swoop, either of these bills would open up the substantial equivalence pathway for most of the products on the market. This means companies wouldn’t have to submit PMTAs, and the industry would likely be saved.
HR 2058 is the simpler bill: it just proposes changing the date. The Cole-Bishop amendment accomplishes the same thing by stopping the necessary funds from being used to enforce the original predicate date. This would mean that the effective date of the regulations would become the new predicate date. The amendment also includes several other provisions – like more labeling requirements, advertising restrictions and battery safety standards – but still could save the industry.
HR 2058 hasn’t seen much activity for a while (but is gaining cosponsors thanks to vapers’ campaigning), and the Cole-Bishop amendment is still in the early stages of the process, but was accepted by the House Appropriations Committee in April.
Lawsuits Against the FDA
There have been several lawsuits filed against the FDA in response to the regulations. These argue that the FDA is pushing the definition of “tobacco product” too far, that there are many arbitrary restrictions (banning new products from entering the market from August 8th, for instance), that the FDA’s cost-benefit analysis underestimates the costs and doesn’t quantify supposed benefits, and finally, that the companies rights to free speech – to inform consumers that their products are safer than cigarettes – are being violated.
Whether these will be successful remains to be seen, but it’s another possible avenue for saving the industry.
Conclusion: Is the FDA Going to Kill Vaping?
The FDA’s regulations are a dark cloud hanging over vaping. In their current form, they represent the end for 99 % of companies on the market. The cost of submitting PMTAs is huge, and it’s not clear they’ll even be accepted if companies do go through with it.
We need to continue to fight, and there is a lot of potential for positive change on both legislative and legal fronts, but the unavoidable fact is that these regulations could spell the end for vaping as we know it.
Big companies – especially tobacco companies – most equipped to cope with the bureaucratic burden will flourish and the ones who suffer will ultimately be the smokers yet to switch, and the small American businesses that depend on vaping for their income. The future of vaping could be very bleak, but there are still glimmers of hope.
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