Sounding the Alarm
So today, September 25th, 2019, the acting commissioner of the FDA, Ned Sharpless, and the lead CDC director, Anne Schuchat, sat with members of Congress to discuss the recent events surrounding vaping. Watching through this, it’s clear to see that misinformation, misidentification of products, and misuse, dominated the convo. For instance, the clear distinction between nicotine and THC e-liquid wasn’t made. They barely differentiated between vapor devices themselves, and the e-liquid inside. This is vital, because the main reason for calling this committee is the recent health issues from Vitamin E laced THC cartos. Instead of addressing the issue at hand, this pivoted to flavors involved in nicotine e-liquid. And what ensued was terrifying.
The Coming Ban
In the opening statements with FDA Commissioner Sharpless, it was made clear a guidance will be issued, and the removal of all flavored nicotine e-liquid on the market will be removed. This would happen in the matter of weeks. I repeat, a guidance will be issued, then a comment period, then the removal of all flavored and unregistered e-liquids – across the nation. This will single-handedly destroy thousands of companies, and close thousands of shops, and sends millions back to smoking. It may be considered one of the worst public health decisions we’ve seen, in US history.
So..What’s This Mean?
The future is quite unclear. From the hearing, the FDA will issue market guidance. This guidance will give rules and restrictions on what is allowed to be approved and sold on the market. I suspect much of this is already in the PMTA. What is worrying is that you need to prove your flavored e-liquid is flavored, because it creates a net positive for public health. This is quite difficult to prove. Now, this has been known for sometime now. It’s nothing new or surprising. I’ve been saying it for quite some time. But this could change – and the new guidance may be drastically different. It may include language that makes it impossible for ANY flavored e-liquid to be on the market.
But I do want to state, that there may be reprieve. There seems to be some interest in allowing flavored e-liquids to be sold ONLY in adult-only shops with heavy age-verification. This also includes online (with BlueCheck implementation). This thread by Paul Blair, member of American’s for Tax Reform, explains why this could be an outlet.
It seems most likely that without a change of opinion, they will definitely discontinue allowing sale of flavored e-cigs which are available in stores that are not adult-only (convenience stores, big box retailers, etc.). To be seen is whether there is a mint/menthol exemption.
— Paul Blair (@gopaulblair) September 25, 2019
Then once guidance is released, there will be a comment period. This is where all the businesses, industrymen, and consumers will send the FDA their comments on these products – both pro-vape and anti-vape. The comment period is nothing but political theater, and from my understanding, has never been used to sway a decision the other way….ever.
And finally, there will be enforcement. This means the FDA will scour the web and travel across the country, ensuring that every retailer (if there are any left) is following protocol. Those who are not following protocol will be fined, and, or, can be arrested, for selling unauthorized products. This is a very expensive endeavor, and is coming right out of your tax money. So yes, you’re paying to lock up your industry. Isn’t American fun?
What About DIY?
This is where things get interesting. As it stands currently, it’s not illegal to posses or use flavored e-liquids (unless you’re in Nazi Michigan). This means, you are free to enjoy it as much as you can – just obtaining it is a bit more difficult. I also don’t suspect many of the components to be regulated under the TCA (Tobacco Control Act). Vegetable glycerin, propylene glycol, and food flavorings do not fall under the jurisdiction of the TCA, and therefore, should remain easily accessible and obtainable. Flavorless nicotine base only remains the concern. Again though, it is not illegal to posses nicotine base (not yet). So importing this product and using it, will remain a legal option. I also suspect companies to attempt to PMTA a flavorless e-liquid product. Meaning, you may not even need to import it.
And in terms of One-shots – this may come down to a state level. I also suspect that if One-shots are sold, they would need to be sold separately from any “vaping” business or nicotine products. The combo of Flavor Shots and Nicotine bundled together may prove to be regulated – though I’m not too sure about the grey area of these products. For my own products, it’s up to my manufacturers to continue to produce and sell them. For anyone thinking the entire market will follow the UK short-fill market, I’m here to tell you to not get your hopes up.
But overall, for the DIY mixer, it’s business as usual. I don’t suspect much to change on that front. It will be up to you to encourage your friends and family members to quit smoking with vapor products – and it will be up to you to provide them with liquids. But know, this can put you in the crosshairs of regulators and may get you in legal trouble. Education will be critical.
War
Like I mentioned last week – this is an all out war against vapor. And as the saying goes “all is fair in love and war”. This statement could not be more true. All of the companies and individuals who are not providing help on our side, must be met with opposition. Anyone who is detracting from our fight to provide safer alternatives to smoking, must be called out and vilified. The time for fun and games ended a long time ago, and the time for decency ended today. Our officials are getting paid to ensure we stop harming their profits, and will stop at nothing to put us out of business. It’s time we make sure there are more of us, than them.
