The Clarifying Authority Over Nicotine Act, House Bill HR 6286, was introduced to the House of Representatives on December 14, 2021. If passed, the bill would make synthetic nicotine subject to the 2009 Tobacco Control Act and force the FDA to regulate it. Such a move would impact customers and vape wholesalers looking to obtain flavored e-liquids that take advantage of the synthetic nicotine “loophole”.
HR 6286 is part of a full-court press on synthetic nicotine. Earlier this fall, Tobacco-Free Kids petitioned the FDA and demanded that they regulate synthetic and non-tobacco nicotine. The FDA is already responsible for regulating tobacco.
The FDA was wary of such a move and the risky legal challenges that would follow such a power grab. The reason for their hesitation is the precise wording of the 2009 Tobacco Control Act: “The term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).”
If the HR 6286 were to pass into law, the language of the Tobacco Control Act would be changed to say, “Any product made or derived from tobacco, or containing nicotine from any source.”
The anti-synthetic nicotine law would also cover plants that contain nicotine. Food and plant products, “Shall not be considered a tobacco product if it contains not more than trace amounts of nicotine and such nicotine is naturally occurring.”
Plants Containing Nicotine
Members of the nightshade plant family, such as tomatoes and eggplants, can avoid being classified as tobacco. But only if their naturally occurring nicotine is present in trace amounts. Currently, tomatoes and eggplants are not used commercially as a source of nicotine. The leaves of current tobacco cultivars are generally 5 to 7 percent nicotine. Tomatoes and eggplant contain a fraction of that number.
Under the proposed law, a genetically modified tomato that contains more than trace amounts of nicotine would be considered tobacco. Of course, the approval process of genetically engineered and genetically modified vegetables is not all that easy. Even with CRISPR technology, the approval of GE plants requires a lot of legwork.
The more plausible scenario would be the selective breeding of tomatoes or eggplants to increase their nicotine. Such a plant would also be considered tobacco and subject to the Tobacco Control Act.
Anti-Vaping Activists
In what kind of messed up a world would a tomato be considered tobacco? In a world where lobbyists go to great lengths to prevent adults from accessing vape juices in any flavor other than tobacco.
If this sounds like a fevered nightmare from 1984, keep in mind that pinball was illegal in New York from 1940 to 1976. Is there a more Orwellian name than “The Truth Initiative”? These Michael Bloomberg funded anti-vaping lobbyists are obsessed with flavored vapes and remain convinced that fruit, beverage and cereal flavors exist only to lure the younger generation. That many of these flavors have nostalgic names appealing to Millennials, Gen Xers and Baby Boomers is conveniently ignored. Quick reminder, Millennials are not minors. Many are middle aged.
Comparing an addictive chemical like nicotine to a wholesome recreational activity like pinball may seem like a stretch. Except pinball was not viewed as wholesome at the time. It was viewed as a corrupting influence on children, a game of chance, and an alien activity that had to be suppressed.
We are not looking to sell our products to adults who are not currently using nicotine, whether through combustible tobacco products or vaping. We assume this is also the case for our vape wholesalers, who deal face to face with avid vapers seeking the flavors they prefer. But in comparison to pinball, there weren’t many traditional nicotine users in the 1940s who chose this game an ash free alternative to cigarettes. Flavored e-liquids have value for adult vapers. Everyone in the vaping business knows this. It is just a matter of communicating this fact to the country.
Prospects for Bill
House Bill HR 6286 has been referred to the House Committee on Energy and Commerce. Hearings have not yet been scheduled but are expected early this year. With mid-terms this fall, the shelf life on this bill is hopefully minimal. Vaping may not have a huge number of allies in the US Congress, but the perception is that the GOP would be less willing to regulate an entire industry out of existence.
HR 6286 is sponsored by New Jersey Democrat Mikie Sherrill. In a press release, she says the bill closes a “Loophole allowing bad actors in the vaping industry to evade Food and Drug Administration (FDA) regulations and sell nicotine products targeted to the younger generation.”
HR 6286 was co-sponsored by Illinois Democrat Raja Krishnamoorthi, and the lone Republican backer is Utah’s Chris Stewart. If the bill were to make it to the Senate, an identical combination of Democratic Senators joining arms with a lone Utah Republican who is opposed to adults consuming nicotine in any form is all but guaranteed.
Decline in Youth Vaping Ignored
As evidence for Representative Sherrill’s bold ad hominin attack on “Bad Actors”, she cited the Youth Tobacco Survey of 2018.
Why did our White Knight, looking to protect the children at the expense of adult smokers and vapers, choose the Youth Tobacco Survey from 2018? There have been three subsequent surveys which have more useful insights.
The reason is that the data from subsequent Youth Tobacco Surveys does not support increased restrictions on adult access. The 2018 Youth Tobacco Survey was taken at the height of what is framed as the “Teen Vaping Epidemic.” At time it was clear that minors vaping posed an exponential threat to the independent vaping industry.
It was also clear in 2018 that a single company and their potent salt nicotine pods were largely responsible. This was an opinion that then-FDA chief Scott Gottlieb shared with Vox, “The dramatic spike of youth [vaping] — that was driven in part at the very least if not largely by Juul.”
Other developments that have occurred since 2018: Tobacco 21, the federal ban on flavored vape pods, the PACT Act, adult signature on delivery, and the vape mail ban. Fed-EX, UPS and USPS restricting the b-to-c vaping transactions has forced online retailers to ship their products using private carriers.
Relying on an outdated survey that has been superseded by several more recent surveys was an intentional move to cast vaping in the worst light possible. The numbers in this survey have no relevance in the current regulatory landscape. The number of minors vaping has continued to fall by the year, from 5.4 million to 3.6 million to 2 million between the 2019 and 2021 Youth Tobacco Survey.
Regulatory Capture
The attacks on synthetic nicotine are just one prong of the systematic effort to hamstring the independent vaping industry. Whether it is their intention or not, the measures enacted to reduce youth vaping are beginning to resemble regulatory capture. Regulatory capture is form of corruption. It describes when regulatory bodies or policymakers are dominated by special interests and are not working in the public’s interest.
In this case, there is a perverse scenario where Michael Bloomberg funds anti-vaping lobbyists but every move they make to restrict adult access to flavored e-liquids furthers the interests of legacy nicotine. Juul is in a partnership with Altria. Prefilled vapes are limited to tobacco flavors. Juul was hit hardest, losing their best-selling mint pod. They are now in a great position to benefit if the fruit and beverage inspired nic salt juices popular with adult vapers are removed from the market.
It is unlikely that giving legacy nicotine a stranglehold on the vaping industry was the intention of anti-vaping lobbyists and politicians. They seem to hate tobacco, nicotine, the tobacco industry and vaping with equal fervor. But they have proven to be useful dupes and this how it is playing out. Even with flavor bans in major metro areas and states, tobacco flavored e-liquids make up less than half of the independent vaping industry’s e-liquid sales.
Save Money by Switching to Refillable Vapes
What if you are a wholesaler who is unable to sell flavored vapes? When discussing the benefits of refillable vapes versus gas station prefilled pods, we recommend relying on a basic argument pointing out the tremendous difference in cost. This is very useful information for wholesalers in a state with a flavor ban who are trying to make a sale and only able to offer tobacco flavored e-liquids.
Prefilled vaping devices cost many times more per ml than bottled e-liquids. Four 0.7ml Juul Pods runs $20. A 30ml bottle of nicotine salts landed will cost a customer about the same. You could literally throw your refillable vape pod kit away after every bottle and still end up ahead financially as it would take 43 pods to equal that single bottle. Depending on the rate at which a customer vapes, you are talking $5 or more a day versus less than a dollar.
Modern refillable vape pods are extremely easy to use, and their coils last much longer than they did three years ago. There is no reason to not use a refillable device, even if you are denied access to characterizing flavors.
Flavor Bans
Juul Mint, and mint e-liquids in general, were only last minute additions to the flavors banned in the state of New York. In 2018, Senators Romney and Markley posed with bottles of Unicorn Milk, a high-VG and low nicotine vape juices that is consumed in the large and noisy box mod. Unicorn Milk was public enemy number one because of a name that is perceived as kid friendly.
The product itself is most certainly not formulated for minors. Anyone involved in the wholesale vaping industry knows this. As a high-VG juice, Unicorn Milk in a vape mod is literally the least stealthy way to vape. You can hear vape mods through walls. They generate huge plumes of vapor. They require large amounts of e-liquid to keep them fueled. This is not a product that can be enjoyed in silence in the commode or a high school bathroom stall. It was only chosen by grandstanding politicians because the name is viewed as nefarious, and they do not have the foggiest clue what vaping is about.
The most popular product with minors, a silent, and odorless prefilled vape pod kit flavored with mild notes of mint, was nearly given a free pass.
Only at the last minute did the vaping industry receive a reprieve. The Trump administration chose to ban the flavored prefilled pods that minors actually used, although these were also the most popular flavors and devices with adults as well.
PMTAs
The PMTA process has also benefitted the tobacco industry’s e-cigarette subsidiaries and partners. Apart from the fact they can only offer tobacco flavors after the prefilled pod ban, they have the legal firepower to slice through the PMTA application process. The tobacco giants have fewer product SKUs, more lawyers, more money, and are barred from selling flavored vapes. Is it any mystery why they are in favor of flavor bans?
As if the PMTA process is not difficult enough, anti-vaping Senators are attempting to strong arm the FDA into rejecting all flavored vape applications. Such meddling blurs the line between oversight and undue influence. This is especially true as they demand specific scientific outcomes. Political posturing by Democratic Senators such as Dick Durbin is at loggerheads with the Biden administration’s promise to not let politics get in the way of science.
In the past, courts have taken a dim of politicians attempting to force desired regulatory outcomes through political pressure. That certainly would appear to be what is happening and such practices fly in the face of Pillsbury Co. v. FTC.
PACT Act
No piece of legislation has done more to hand the vaping business back to the tobacco industry than the PACT Act. By denying adult vapers access to USPS delivery options, any adult looking for e-liquids or hardware needs to visit a brick and mortar store or rely on private carriers. Unfortunately, private carriers do not reach every location. We are working hard to improve the delivery experience and efficiency of regional carriers. They are key to a viable independent vaping industry.
In many areas remote and rural areas, where health outcomes for lung cancer are the worst, regional carriers are not an option. The only way to obtain an electronic nicotine delivery system (ENDs) is at the local convenience store and gas station. In areas where private carriers can reach, wholesale vape suppliers are a crucial beachhead. Providing the best products to local vape shops that compete with conventional tobacco product gas station and C-Store monopoly.
The convenience store shelf space is dominated by the Vuse, MyBlu, NJoys and Juuls of the world. Coupled with flavor bans that eliminated the flavor profiles that most adults prefer, tobacco cigalikes have been provided an unfair advantage in a field that is being systematically cleared of competition. That they are sold next to combustible tobacco products is interesting turn of events to say the least. But these products cannot compete in terms of price or quality with tobacco e-liquids and refillable vapes. This is a case that must be made and is self-evident.
Adult Vapers Prefer Flavors
The quest of Tobacco-Free Kids, and the Orwellian-named Truth Initiative to deny adult vapers the flavors they prefer is never ending.
In only the narrowest sense do their attacks on “kid friendly flavors” have any validity. It is true that minors prefer flavored vapes. The vast majority of adult vapers also prefer characterizing vape juice flavors. As a rule of thumb, humans generally prefer the most palatable version of any consumer product. Less appealing flavors are not as popular as those deemed delicious. Sure, there are fans of anchovy pizza, but for the average person sausage is a safer bet. Vape juices are no different.
Flavored vapes are the most popular product with adult vapers for a variety of reasons but the most common reason is they simply taste better to most vapers. Former smokers also have every reason to steer clear of a flavor profile that may remind them of their previous vice.
Doctor Farsalino’s provided the most rigorous accounting but additional studies have backed this up. Vaping initiates often start with tobacco but switch to the more popular characterizing flavors. The preference for flavored vapes over tobacco increases in likelihood the longer an adult vapes.
Why Youth Vape
The Youth Tobacco Survey of 2019 found that minors start vaping for reasons that have nothing to do with the availability of flavors. Which makes sense. Are we to believe that a high school senior craves the blue raspberry flavor to such an extent they will pay $20 for the privilege, risk getting addicted to nicotine and face expulsion or suspension from school if caught?
The top three reasons minors vape are curiosity, friends or family who vape, and vape tricks. And it is through peers that they were obtaining vapes back in 2018, which is why Tobacco-21 was the most effective piece of legislation for reducing the rate of teen use. For the record, I chose 2019 because this was the year that vaping rates began to drop among minors.
Never About Nicotine
Perhaps the most interesting aspect of the attack on synthetic nicotine is that it has nothing to do with nicotine. The UK limits nicotine strengths 20 mg. This potential solution has never been seriously suggested on the national level in the United States. We always encourage using the lowest nicotine strength level possible and working to reduce that level. The goal should always be a lifestyle free of nicotine and vaping. Flavor bans do nothing to further this goal.
The ban on synthetic nicotine prevents small vape companies from selling flavored products. It does nothing to reduce nicotine consumption or underage vaping. It simply denies wholesalers the ability to distribute the flavors that adult vapers prefer. These are products manufactured by small and mid-sized vaping companies.
Here is what former FDA chief Scott Gottlieb said in a 2018 press release:
“What primarily causes death and disease from tobacco use isn’t the nicotine in these products. It’s the act of lighting tobacco on fire to free that drug for inhalation. While it’s the addiction to nicotine that keeps people smoking, it’s primarily the combustion, which releases thousands of harmful constituents into the body at dangerous levels, that kills people.”
Gottlieb stated on many occasions that it would be a net gain if all adult combustible tobacco products users were to switch to vaping. He was no fan of the vaping industry but was too much of a scientist to deny this obvious reality.
UK a Beacon of Hope for Vapers
The UK also has a more humane view of vaping’s value. They host the website, Using E-Cigarettes to Stop Smoking. Prescription vapes will soon be offered and applications by vape companies are being accepted.
Prescription vapes will incentivize adult smokers to switch to e-cigarettes. The NHS identified the fact that marginalized groups and those without access to resources are more likely to inhale combustible tobacco products. Looking to save taxpayer money over the long haul, incentivizing a switch simply makes financial sense.
The NHS has skin in the game. They are taxpayer funded. Moreover, the NHS has proven ruthless when it comes to eliminating popular health modalities that they deem ineffective. Chiropractic medicine, homeopathy, herbal medicine, and most medical supplements are not covered.
Giving these favorites of the worried well off the axe created a huge outcry from the most influential Britons. Prince Charles himself lobbied to have them reinstated. It appears that in the UK a single man cannot dictate national policy or rely on the power of money to foist strongly held beliefs on the nation.
The availability or rejection of chiropractic medicine is not likely to cause a public health crisis that will disproportionately hit marginalized and economically disadvantaged individuals. On this side of the pond, our own ruling class is not so easily thwarted.
Adult Smokers Accidentally Quitting
In a phenomena Jim McDonald of Vaping 360 dubbed “Accidental Quitting”, a recent open access study found many adult smokers switch to vaping and end up quitting smoking, even though that was not their intention.
The study surveyed 1600 adults who at the beginning of the study smoked combustible cigarettes, didn’t vape, and had no intention of quitting combustible tobacco products. A full 28 percent of the group who vaped daily quit combustible tobacco products. Another 45.5 percent inhaled less frequently.
To reiterate, these are individuals who expressed no interest in quitting combustible tobacco products. They are the hardest to reach group with the worst health outcomes. This group contains a disproportionate number of marginalized adults, inhaling and vaping rates are highest in the LGBTQIA+ community. Anecdotes such as these have been common in the vaping community since day one. It is hard to find a vape shop owner who does not have a client base composed largely of such cases.
What Can Vape Wholesalers Do?
It is up to vapers to advocate for what the FDA calls characterizing flavors and the importance they have played in our vaping journey. To date, it has been difficult to match the intensity and funding of vaping’s enemies. Unfortunately, the wealthiest and most influential Americans have largely quit smoking and the pleas of vapers ring hollow. We don’t deserve these flavors seems to be the message.
It is not the time to give up. Vaping remains a popular and viable option with adults. A study published in the New England Journal of Medicine demonstrated it was far more effective than nicotine replacement therapy for cessation. The truth is on our side. Feel free to cite any of these studies or quotes. The logic of the anti-vaping lobby is full of holes, and they are unwittingly aiding one some of the greatest villains in American commerce.
The PACT Act’s most severe restrictions on shipping only recently took effect, and already there are some grim signs. According to the FTC, cigarette sales increased for the first time in 20 years in Q3 2021.
Unless we make it clear we are organized and will be heard, our efforts to educate will be ignored. Casaa.org is an excellent source for staying apprised of what is going in. It is also crucial for vape wholesalers to pivot to an economic argument if flavors are restricted in your region. The economic case for refillable vaping devices versus legacy nicotine’s prefilled is even stronger than the flavor advantage enjoyed by bottled e-liquids.