FDA Considers To Ban All Flavors Except Tobacco And Menthol… Now What ?
On Wednesday, the FDA announced a major crack-down on the vaping industry to tackle what they frequently described as an “epidemic” of youth vaping. The move represents a strong step towards the sort of hard-line attitude preferred by groups such as the Campaign for Tobacco-Free Kids, using concerns about “the children” to drive a stake through the heart of the vaping industry. The two most notable threats coming along with the announcement are the potential to ban “characterizing flavors” in e-liquid and to revoke the extension on the pre-market review process the FDA granted last year.
Shockingly, FDA commissioner Scott Gottlieb said that the impact the actions will have on youth vaping are justified even if it makes it harder for adults to switch to vaping. Any light vapers might have thought they saw at the end of the tunnel after the extension was announced has been well and truly extinguished. One thing is for sure: if the changes the FDA are hinting at go through, the industry will be populated by a different type of vaping company.
What the FDA is Doing
- The FDA has sent warning letters to over 1,300 retailers who were found to be selling to youth.
- They’ve sent 12 warning letters to companies selling products that look like candy or cookies.
- They have requested that Juul Labs, Altria, Japan Tobacco International, Fontem Ventures and Reynolds American detail a plan for keeping their products out of children’s hands within 60 days. If not, they’ve threatened further action.
- They’re checking whether any new products have been introduced since August 8th, 2016, which should have been the date the market froze.
What the FDA Might Do
- They may ban “characterizing flavors” in e-liquid. This means anything other than tobacco or menthol.
- They may revoke the extension granted to companies last year. This could mean that any companies who want their products to remain on the market would have to get FDA approval first.
An “Undercover Blitz” and Warning Letters
The FDA has conducted what it refers to as an “undercover blitz” of online and brick-and-mortar vape shops between June and August, with the intention of cracking down on sales of vaping products to minors. This “blitz” – which the FDA refers to as “historic” – resulted in the agency sending over 1,300 warning letters and fines to retailers. These were mainly related to Vuse, JUUL, Blu, MarkTen XL and Logic, which dominate the convenience store, non-specialist vaping market.
The list of companies makes some sense in that the non-specialist end of the vaping market does account for the vast majority of vaping products sold. Additionally, they note at various points that these are all cartridge-based products, and argue that these – rather than “open system” refillable devices with tanks – are what youth are most likely to use.
However, it doesn’t escape notice that the products targeted include four sold by tobacco companies and the Juul, which has been at the center of a media panic for some time now.
Letters to Five Specific Companies – “Tell Us What You’re Doing to Fix the Problem”
The FDA has continued its assault on the bad guys du jour, sending letters to the four tobacco companies – Reynolds American (Vuse), Altria (MarkTen XL), Fontem Ventures (Blu) and Japan Tobacco International (Logic) – and Juul Labs, demanding a response from them within 60 days. This response must contain clear plans “describing how they will address the widespread youth access and use of their products.”
This will undoubtedly be a challenge, and that seems to be the point. Since vaping is already banned for minors, it’s quite difficult to imagine there’s much a vaping company that sells products youth might enjoy can actually do to stop it. It’s kind of like going to Smirnoff and asking them what they’re doing to stop youth drinking.
Nevertheless, the companies will have to respond and detail these actions, with the FDA’s suggestions including discontinuing sales to establishments found to sell to minors as part of the FDA’s “blitz,” which seems reasonable, through to more extreme suggestions such as halting online sales or ceasing the sale of flavored products until the FDA has reviewed them as part of the pre-market authorization application. The last option is going to be very difficult for a company selling flavors that are deemed to be attractive to youth, and halting online sales is going to hit any vape company pretty hard. And really this is the bare minimum the FDA is expecting from them.
The short version is: we can’t fix this problem, so why don’t you do it for us. If the companies don’t do this to the FDA’s liking, they threaten to “enforce the premarket authorities in the TCA with respect to [your] Products.” In other words, they will demand you jump through the intensive and potentially impossible series of hoops to keep your product on the market.
Are New Products Being Introduced?
One key part of the FDA e-cigarette regulations is that the market was effectively frozen as of August 8th, 2016. After this point, any new product introduced was supposed to obtain pre-market authorization from the agency. This is highly unlikely to have happened within this time, if it’s possible at all, so any new products introduced into the US market are taking a bit of a risk.
The FDA reports that they’re in the process of investigating whether products were brought to market after this date. While it’s unclear whether there have actually been offences with regards to the US market, it shouldn’t have escaped the notice of many vapers that most (usually China-based) manufacturers are still putting out new products at an apparently ordinary rate.
Warning Letters to Retailers Still Selling Misleadingly Labelled Products
On top of all this, they sent 12 warning letters to online retailers selling products which were misleadingly labeled or advertised in a way that made them look like candy or cookies. These types of products aren’t exactly popular with vapers either, largely because they make the industry look bad and feed into the types of fears that generate actions such as this latest FDA move. These were already put in the crosshairs in May, but not all retailers stopped selling them, and these are the recipients of the warnings.
This is pretty irresponsible of the companies originally selling the products and especially the retailers who continued to do so after the FDA came down on them. If the industry was viewed differently it would have been OK, but in the current climate, releasing something like that was bound to backfire. This is one of the many reasons that our branding and overall approach with Black Note is focused very clearly on adult smokers. If you make products that can’t be misconstrued to be targeted at youth, then you’re safe; if you make your e-juice look like a kids’ cereal, it’s going to be much more difficult to stay afloat.
Banning Characterizing Flavors and the Future of Black Note
Throughout the communications from the FDA and Scott Gottlieb’s speech, the familiar rhetoric surrounding flavors was regularly rehashed. Gottlieb said:
“One factor we’re closely evaluating is the availability of characterizing flavors. We know that the flavors play an important role in driving the youth appeal. And in view of the trends underway, we may take steps to curtail the marketing and selling of flavored products. We’re now actively evaluating how we’d implement such a policy.”
They’re “actively evaluating” how they’d put a policy like this in place, and unfortunately for much of the vaping industry, this likely means that the industry will change a lot more in the coming years. Characterizing flavors – that is, anything apart from tobacco and possibly menthol – are on the chopping block.
Also note how he says, “we know” flavors play an important role in youth appeal. We’ve looked at the evidence on youth vaping in detail and the evidence addressing flavors is pretty clear: they increase the appeal of vaping to everybody, not just youth. However, the way the FDA and the US public health establishment overall have been speaking about flavors this whole time suggested that the days of flavorful vapor were likely numbered. The Surgeon General’s report, many communications from the CDC and the local-level flavor bans long hinted that this was the way the industry was going.
Here at Black Note, we kind of knew this. That’s one of the reasons we focused on tobacco e-liquid from the get-go. Our aim was to put out the very best e-juice for the adult smokers who need it, and we didn’t want our goal to be derailed by some – admittedly ill-conceived – legislation coming around the corner. We avoided the suspect designs and childhood nostalgia from the get-go, and just focused on serving the market of adult smokers looking for a tobacco replacement. We don’t appeal to minors and you couldn’t even make the argument that we do. As the FDA looks set to stop sales of e-juice with characterizing flavors, Black Note is ready to step to the forefront of a new, more responsible industry.
But it’s hard to view this as good news. We know that there are many different types of vapers, and while it’s predictable that there would be some action on flavors at some point, that isn’t much consolation to the smokers who only managed to quit thanks to all of the sweet and fruity flavors on the market. Nothing the FDA is doing will affect us personally – we’ll still be here doing what we’ve been doing since we were founded – but the industry looks set to become a less vibrant place very soon. It’s bad news for vaping, overall.
The “Epidemic” of Youth Vaping: Show Us the Data!
Throughout all media communications, Scott Gottlieb has been keen to use the word “epidemic.” We know pretty well that based on all of the evidence we actually have, “epidemic” is an inappropriate word to use, to say the least. But, you see, the FDA knows more than any of us do. As Gottlieb states, commenting on what they saw as their previously permissive attitude to the issue:
“Well, I’m here to tell them that this prior approach is over. The FDA is closely watching the trends in youth use. And if, as we expect, preliminary data that’s in our possession and will be finalized and released in the coming months confirm our present observations that the youth use of e-cigs is rising very sharply; we’ll swiftly change course.”
Apparently, they have access to preliminary data that shows that all of these actions are actually justified and not a massive overreaction to an overblown issue. This is supremely convenient. “Don’t criticize us based on all the data we have so far,” they’re saying, “because this secret data that only we can see shows that we’re actually right. What, you want to have a look at it? No, unfortunately you’ll just have to wait.”
It hardly needs to be said how ridiculous this is. The “preliminary data” they have is mentioned several times, but not so much as a single figure from it is mentioned. They’re taking extreme action on the basis of admittedly preliminary statistics that only they have seen. It doesn’t take much of a cynic to assume that the data is going to be similar to all of the data so far and these moves are a response to the media and single-issue pressure groups more than the reality of the situation.
What They’re Willing to Sacrifice
Finally, this quote from Scott Gottlieb tells you pretty much everything you need to know about the FDA’s latest move:
“It’s now clear to me, that in closing the on-ramp to kids, we’re going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs.”
There, in plain black and white, is what is being proposed. They know this will be bad for many adult smokers. They say that they still want to acknowledge a “continuum of harm” from nicotine-containing products, but in reality, they’re willing to throw adult smokers in front of the bus if it makes them look like they’re doing something to tackle the so-called “epidemic.”
With all of this in mind, who is really surprised that tobacco stocks rose at the time of the announcement?