This episode is a bonus, which was planned to release as a regular episode today, but my husband/editor was sick and running a fever last night and we couldn’t get it out. So, I’m not even sure when I’ll get the show notes up but I’ll just have all the links for you right there in the description where you’re listening.

I wanted to research the regulatory issues regarding vaping - with the FDA and the age restriction and the flavors because I couldn’t understand why we still have all of these fruity, candy, desert flavored vapes still sitting on store shelves in the US,  addicting kids when I thought that was illegal.

If you’ve listened to the 2 previous episodes on vaping (109 and 111) I hope you’ve come to the realization that your kid is simply not immune from picking up a vape and trying it. As much as we like to think we’ve gotten it through their heads not to even try some of these risky things – that reward system in their brain is so strong that it can very often, win out.

And if your teen doesn’t vape, there’s no question they know someone who does – they most likely hang out with someone who vapes. And if they’re in high school, they hang out with a lot of people who vape. It’s just a fact at this point. And the vape in that other person’s hand – well, it’s super easy for it to get into your kid’s hand.

And the sad thing is, that for the most part, this is an industry that started out altruistically. The makers of Juul, for example, were smokers and wanted to not be smokers. They wanted to invent a device that would give smokers the same ritual as smoking, the same head rush of nicotine but without the combustion of a cigarette - the most harmful part of smoking.

They really didn’t think about the monster they were creating for people who’d never smoked in their lives.

And how is this happening? What are the laws and are they being enforced? Can you do anything about it yourself? Stay with me – you’ll want to hear this.

This is Speaking of Teens, the podcast that helps parents who are struggling to find peace and connection with their teens. My name is Ann Coleman; I’m an attorney turned parent educator and a mom who’s been there - and I want to help you build a stronger relationship and decrease the conflict with your kid so you can help them grow into the young adult they’re meant to be.

Let’s look at some fairly recent numbers first.

The CDC and The Truth Initiative analyzed data from retailers and found that between 2020 and 2022, overall unit sales of e-cigarettes or vaping products and devices (all the same thing – I’ll call them vapes) they found sales increased by 47%.

But when you break down that data by tobacco flavored products, menthol and mint flavored and the rest (the desert or fruity flavors) you can really see what’s going on.

During that same period, tobacco flavored products and mint flavors decreased, menthol stayed about the same. But those yummy flavored vapes – sales increased from 29% to 41%.

And at the same time, the type of devices people were buying changed significantly as well. Those little pre-filled cartridge – pod-type devices like Juul – their share decreased from 75% to 48% and the disposable device sales (the Esco Bars, Elf Bars, PuffBars, increased from 25% to 52%.

So, you see the overall picture – fruity, desert flavored disposable vapes are what’s hot and selling in the US.

What the hell is going on here? Aren’t these things illegal? How are sales increasing and how are kids still getting these things?

Well, there’s plenty of blame to go around; several presidential administrations, congress, the FDA, money-hungry importers from China, along with their distributers and retailers in the US, and lax state and local laws and even lazier enforcement of existing laws.

Let’s start with the FDA – the Food and Drug Administration. I can remember when my son started talking about vaping in around 2016 – he told us about vape juice and how it’s just water vapor and flavored juice and no, there’s no nicotine in it – you can buy the non-nicotine variety and it’s perfectly safe. I remember being completely caught of guard along with all the other parents at that time and not understanding how this stuff could be sold at all, much less to kids. And the battle at our house started.

At the time, there was no regulatory oversight at all with these vape devices or the liquid/juice the filled them with. It was completely the wild west, and I can remember trying to explain how anything could be in these liquids that vape shops were mixing them themselves and putting the nicotine in it themselves. It was insane.

Where was our FDA, why wasn’t this agency that is “responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation….” Where the hell were they?

Well, people assume the FDA, because it is “responsible for protecting the public health” that it makes sure all these products they “regulate” are indeed not harmful to our health. Fair assumption. But that couldn’t be further from the truth, of course.

The FDA makes sure that manufacturers comply with regulations in order to sell their product in the US. But this varies from product to product. You see lots of products that say “FDA approved” but did it really approve it for sale?

No. Not all products that the FDA has regulatory authority over are pre-approved for safety, quality, and effectiveness before they are sold to consumers. In some cases, the FDA’s enforcement efforts focus on products after they are already for sale. It can act and do something if a safety issue arises. And it’s generally up to Congress to decide the FDA’s authority.

The FDA does have authority over tobacco products. But here’s what it says about that:

“There’s no such thing as a safe tobacco product, so the FDA’s safe and effective standard for evaluating medical products does not apply to tobacco products. Instead, the FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population, including users and nonusers of tobacco products.”

“To legally sell or distribute a new tobacco product in the U.S., manufacturers must receive authorization from the FDA.” So these products can get to market through 3 different types of application processes and the main one is the pre-market tobacco product application.

But just because the FDA approves this application for a new product can be sold in the US, it does not mean that the tobacco product is either safe or “approved.” It just means that the manufacturer has complied with the requirements under the law to bring its product to market.

So, a couple of things here. You notice that a) we’re talking about NEW tobacco products and b) even going through pre-market approval to sell a tobacco product, doesn’t mean it’s safe.

Let me back up. And give you a little history on how we got here with vapes and the law.

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In 2009, President Obama signed The Family Smoking and Tobacco Control Act, which amended the Federal Food, Drug and Cosmetic Act (FD&C Act) to give the FDA authority to regulate tobacco products – specifically, cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and smokeless tobacco but also gave the FDA the ability to deem other tobacco products subject to the FD&C Act.

The Tobacco Control Act also did several positive things like banning flavored cigarettes (other than tobacco and menthol flavor), adding warning labels to smokeless tobacco products like Skoal, prohibits companies from calling their tobacco products “light” “low” or “mild” (which sounds too much like – these cigarettes are healthy”

But that law also forbids the FDA from banning nicotine in tobacco products, forbids them from requiring a prescription for tobacco products, from banning certain classes of tobacco products or from banning in person sales in certain categories of retail stores.

In other words, the FDA got slapped with some hefty handcuffs by the good ole’ Big Tobacco lobby through the politicians in congress.

So this effectively protected all cigarette companies with products already on the market other than flavored cigarettes. So, no one could touch them – can’t make them by prescription only, ban certain kinds, limit sales any further. Total protection for Big Tobacco.

This law also did not ban flavored mini-cigars, hookah, smokeless tobacco or e-cigarettes or vapes. (again, I’m calling them vapes here) And, in fact, at that time, the FDA didn’t even have clear regulatory authority over vapes. Were vapes a tobacco product? There’s no tobacco in a vape – it’s a heated atomizer containing liquid…chemicals…mostly nicotine.

Now, the FDA had been trying to regulate vape devices since they came on the scene in 2007 but the FDA was trying to call them a “drug delivery device” which they had regulatory authority over. The weren’t calling it a tobacco product at the time. But the vape companies fought back with law suits and tied the FDA up in court for a few years.

By 2014 vapes were the most popular nicotine delivery system among young people. Juul came on the scene in 2015 with its little discrete device and yummy flavors – teens were all over it.

So, between 2011 and 2015 vaping in middle and high school students in the US increased 900% - 900%. It’s truly scandalous.

Studies around 2014 and 2015,  showed that 97% of teens who vape, use flavors and that 81% of 12-17 year olds said they use vapes “because they come in flavors I like.” (Surgeon General Report) They can stomach the nicotine better with a little tango mango or dragon’s breath or pineapple bubble gum or whatever.

Vaping in general increased by another 78% between 2017 and 2018. As of that point 1 in 5 high schoolers and 1 in 20 middle schoolers were vaping.

Finally, in 2016, (called the Deeming Rule) after all sorts of legal wrangling between vape companies and the FDA, it was settled that the FDA has regulatory authority over vapes as a tobacco product (if it has nicotine, nicotine is derived from tobacco therefore – tobacco product.) So, their authority also covers all cigars, hookah (waterpipe) tobacco, pipe tobacco, and nicotine gels – so the Zyns are under their authority as well.

But what does it even mean that vapes are under the FDA’s authority?

Well it means that manufacturers have to register with the FDA and provide it with product lists, report the ingredients and any harmful elements of the product, health warnings would now be placed on packages, no selling them with light or low or mild on the package unless the FDA approved it and several other limitations.

Restricted sales to people 18 and up (in person and online)

The really huge revelations that came out of this Deeming Rule in 2016 were that any new tobacco product (cigarettes, cigars, and now including vapes and hookahs, etc.) – any new product manufactured or imported into the US to be sold here, would require premarket review and authorization by the FDA.

But there was a big exemption here – any product already on the market before February 15, 2007 were grandfathered in. So, you know what that meant? Well, Vapes didn’t come on the market until 2007 but every cigarette and cigar being manufactured by the big tobacco companies had already been on the market for years by 2007. So, they didn’t have to do anything – they were good. Keep selling those cancer sticks.

That’s good old fashioned politics at work – the tobacco lobby won again.

But what it did mean was that every single vape device on the market and every single mom and pop vape store that had been mixing their own nicotine cocktails (because that’s considered manufacturing), now had to go through a lengthy and expensive process to be approved by the FDA.

And the dates varied, but generally all these products had a couple of years before they had to jump through all the hoops and in the meantime the FDA said, you know what, it’s okay, just leave your products on the shelves and we won’t do anything during this grace period – but then we’re going to start enforcement actions (and I’ll tell you about that in just a minute).

Now, we’re talking about a complicated, lengthy, and expensive application process that all of these manufactures, who were already making vapes and selling them on the shelves, would now have to do go through if they wanted to keep selling them after this grace period. And they would only be allowed to do so if they were approved by the FDA in that process.

But the hard thing for the vape makers was that the only standard the FDA articulated for this process was that the manufacturer had to prove the device was “appropriate for the protection of public health” Just this past month The FDA stated, it evaluates these applications “based on a public health standard that considers the benefits (e.g., benefit from adult users of more harmful tobacco products completely switching) and risks (e.g., initiation among youth) of the product to the population as a whole. - EXPLAIN

The FDA didn’t say, you can’t have flavored vapes and it didn’t say you have to prove your device or juice doesn’t contain this list of certain chemicals (you just had to list what you did have in it.) It didn’t say, you have to prove the coil doesn’t heat above this temperature or that you have to use a certain type of battery or charger – they didn’t even mention nicotine limits.

There was this tremendous lack of clarity and the possibility that the manufacturers might have to resubmit products over and over to get approval – if they ever did get approval – it would be a really expensive process that not many companies could likely afford (like millions per product).

And apparently, that’s what the FDA was hoping for – that most of these vape device companies would, would close their doors and give up and go home and importers would just stop coming into the country.

In 2018 Juul had decided to go ahead and pull their flavored vapes (except for mint and menthol) from stores and only sell them online to buyers over 21 - because they were under intense pressure from every direction about their marketing methods aimed at young people, then EVALI was coming on the scene and people were getting sick.

By September of 2019, the Trump administration was threatening to ban flavored vapes altogether but by January of 2020 what actually happened was much less effective – they ended up only banning flavored cartridge or pod-based systems and exempting the tank-based devices that you’d buy the little bottles of flavored juice for and mix them up yourself. They did raise the federal age minimum for the sale of tobacco products however, from 18 to 21.

But in the meantime, since it announced in 2016, the FDA had been doing this premarket application process for vape manufacturers and had denied the applications of around 55,000 vape products, all of which were flavored with something other than pure tobacco flavor.

As of July 2023 the FDA has only approved 23 e-cigarette or vape products and those are all tobacco flavored and all from a Big Tobacco companies (because they’re really the only ones who can afford it.

 

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Wait – what? So why the hell are store shelves still covered with fruity, minty, yummy colored vapes? Why is the FDA not doing something about it. The grace period is long passed – years ago. And a lot of parents and politicians would like an answer.

A story ran in July 2023 on the NPR podcast, ALL Things Considered, that might even sound like something that’s happened at your house. It was about a mom, Nancy, who completely lost control when she discovered her daughter, a freshman in high school was vaping.

I’ll tell the story and you think about where all these parents went wrong. The daughter came home one day and her backpack was hanging open a bit and when Nancy went to zip it up for her, the daughter – can you guess – she pulled it away, got really defensive, and they ended up in a tug of war, which the daughter won and then promptly escaped with to the bathroom – door locked.

Nancy and her husband now, got into the bathroom and in her own words, “we, like, tore the whole bathroom apart, and we found four vapes behind the bathroom mirror.”

Mom and dad were shocked and mortified that their 14-year-old soccer player was vaping and they had no idea. And secondly, where the heck did she get them because aren’t these things illegal under federal law and actually under New Jersey law - where they live.

So somehow this mom found out where her daughter and the other kids her age were buying these vapes and enlisting the help of another mom, decided to go down to this store and confront the clerk – and they videoed it – and they posted it on a mom’s group online – it goes viral.

You may be able to guess what happened next. First of all how do you think that worked out for her daughter, or between her and her daughter?

The whole family was getting death threats – lots of them from the kids who was buying them there – likely some of the daughter’s ex-friends. And Nancy says, “I didn't even realize until that happened that it was such a huge issue. All the kids in all the local towns and cities all knew about that place, and they were upset that I had brought to light that they were selling to underage kids.”

Nancy, Nancy, Nancy – so many don’t here – but that’s another episode (or several)

You tell a bunch of teenagers who are addicted to nicotine that you’re closing down their one and only source and see what happens. This was war for these kids. And we’ll talk about the addiction side in the next episode.

So, all of these products – the disposable candy colored, fruity flavored vapes you see on store shelves, out in the open, being sold without apology (and often to teenagers) – most of them are actually being brought into the country and sold illegally.

Not only are they not going through the FDA’s approval process but the FDA has recently banned the import of some specific black-market products like Elf Bar and Esco Bar and others – they put them on a list to be checked at customs, which is ridiculous because the manufacturers are just constantly changing the names of the products and they also sneak them in.

For example, this past July the FDA with the help of the US Customs and Boarder Protection seized 1.4 million illegal fruity flavored vapes coming from China into LAX. The value of that seizure was $18 million. The shipment was Elf Bar, Lost Mary, Funky Republic, and other brands. This is the only seizure I can find any record of.

Some of these containers were mislabeled as toys, batteries, shoes, and flashlights to get by customs.

And what is sort of mind blowing about these products coming into the country – containers and containers full – is that someone has to pick them up at the loading dock and distribute them all over the country to the retailers. Who are these distributers? Anyone want to stake out your local convenience store and see where these things are coming from? It makes me want to!

And get this – Ef Bar is extremely popular with teens. As a matter of fact, the US government says 56% of teens who vape now say they use Elf Bar – a few years ago that would have been more like 90% Juul.

Elf Bar is made in China, imported into the US by the hundreds of millions of dollars’ worth. They’re normally able to dodge customs and avoid paying any taxes or import fees.

And not unlike TikTok which isn’t available young people in China, China has banned flavored vapes supposedly for the health of their youth but it was really because they were hurting the sales of the government owned national cigarette company. And when they were banned there, the Chinese manufacturers couldn’t make money any more so they doubled down on shipping it into the US and likely other countries.

According to government officials, about 95% all of the world's e-cigarettes come from China.

Now, the company that makes Elf Bar has changed the name to EB Create and the company spokesman in China says all the Elf Bars in the US now are counterfeit. The AP news article I read quoted a distributor from New Jersey (who clearly has no issue with doing something illegal) – he said they sold over $132 million worth of Elf Bar products last year, which was almost a 1/3 of its yearly profits. He said he could sell them faster than he could get them in. One reason, as this guy pointed out, is that they’re so cheap (made in China) and retailers can make a 30% profit which is double that of other vape devices – the ones made in the US that have also not been approved by the FDA to come in fruity flavors.

So, let me tell you, besides putting the name of these vape manufacturers on a list to check at customs, what is the FDA doing about the illegal sale of these vapes?

Well, the FDA’s “enforcement action” consists of sending out cease and desist letters to retailers (including online retailers) that say, “hey, you need to stop selling these products or we’re going to fine you $20,000 or we might seize your products or enjoin you from selling them.” To date, the FDA has sent out over 600 warning letters to manufacturers about 440 to retailers and around 14 to online sellers and has filed civil monetary penalty complaints against 50 or so manufacturers and filed injunctions against 6.

Just to put that in perspective, there are somewhere around 150,000 convenience stores in the US. There are over 9,000 vape shops in the US. I’m not saying they all sell flavored vapes or non-FDA regulated vapes but you can certainly buy them in all the gas stations around where I live and at the vape shops. And I can go online to hundreds of retailers, check a box that says that I’m over 21 and buy anything I want – no picture ID, nothing.

You can actually submit a complaint about a violation to the FDA via their website. I’ll have the link in the show notes. It says on their website that they will conduct a compliance check of a retailer or check out a website or even a manufacturer and says, “FDA may determine that there is no evidence of a violation, or we may find evidence of the reported violation or of other potential violations that requires additional surveillance, monitoring, and/or inspections.” Says nothing about fines, confiscation, shutting them down…I didn’t quite dig deep enough to even see if they have the authority to do that but it doesn’t appear that they do.

Because the FDA and Customs is so inept at keeping these goods out of the country, off the shelves and out of the hands of kids, some American companies have decided to file legal actions against these Chinese manufacturers and importers.

Many states have passed clean air laws that include vaping, tax vapes, require retail licenses to sell them and require certain product packaging, and a few states and local governments have banned the sales of vapes or flavored vapes either locally or online. I found one site that gives this information so I’ll link to everything in the show notes.

The question is how well are these laws enforced? If you live in New York, New Jersey, California, can you buy them under the counter or in a backroom somewhere? Or are kids driving across state lines to get them in maybe Pennsylvania, Connecticut? If they have a friend in another state, are they getting them shipped in and selling them to other teens? I can assure you this is happening.

Now outside of the US, some countries have a complete prohibition on vaping – usually in Asia and the Middle East and some in South America. Australia is apparently by prescription only (they must consider it a smoking cessation device). Again, I’ll have the link for you to what I found.

Now that you’re up to date and can check up on your local laws, I wouldn’t do what Nancy did because that’s not going to promote connection with your child and it could get you in major hot water. But there are ways to do things that aren’t so public or dramatic. So, think about it. What can you do to help?

And on Tuesday I’m going to talk to you about how you keep your kid from vaping to begin with and how to help them quit if they’ve already started.

That’s it for speaking of Teens today – thanks for sitting through all of that, I know what I find interesting isn’t always what everyone else does so thanks for indulging me. Please share it with another parent if you found it helpful or informative. And if you’d like to come into the Facebook group and chat about it, you can join at the very bottom of the episode description.

Until next time, remember a little change goes a long way.