To quote Clive Bates in an interview with Regulator Watch, “That is why they (our government) retaliated with a barrage of disinformation and regulatory overkill that they hope will suppress this (the vaping industry). Effectively they are prohibitionists. They are trying to use regulation, taxation, and disinformation to kill these products off.” This sums up exactly what’s been happening to the vaping industry over the past year.
Starting in August, a new ‘mysterious lung illness’ swept the nation that had many becoming ill and even leading to some deaths. The media ran with headlines like; “Vaping illness outbreak surpasses 1,000 cases, 18 deaths with no sign of slowing, CDC says” and “Death toll rises from mysterious lung illnesses linked to vaping, prompting CDC to sound alarm on e-cigarettes“. With help from the FDA and the CDC, lead to the perfect storm of mass hysteria and misinformation spread across the country leading vaping as the media’s new target in their onslaught of fear-mongering. Anytime you heard vaping, it was immediately associated with this ‘mysterious illness that was killing innocent people’. One couldn’t step outside and vape without someone telling them how vaping was going to kill them. This lasted for weeks before reports finally started coming out that illicit THC cartridges were the cause of this outbreak of illnesses. It took even longer before the FDA and CDC would share that this was the culprit as well.
Needless to say, this situation was completely mishandled and blown out of proportion. But the damage was done, leaving many vape shop owners feeling the effects as they soon saw a decline in business. Then on September 3rd, 2019, Democratic Governor Gretchen Whitmer became the first to announce a statewide flavor ban by signing an executive order in Michigan. This quickly became a dangerous precedent as many other state governors decided to follow her lead and set their own flavor bans; states like New York, California, Washington State, and Utah just to name a few. It’s still happening, New Jersey’s Governor just signed a bill that will take effect April 20th, 2020. This will and has caused many vape shops within these states to close either temporarily or permanently. Without the selection of flavors, vape shops were left with only tobacco and in some cases menthol flavors for sale. Many vape shops can attest that a majority of their profits come from candy/dessert/fruit-flavored eliquids. Some of these state’s flavor bans did not take effect or were even stopped by a judge thankfully. Regardless, some states didn’t get this saving grace and even those that did already seen the negative impact on their sales.
Between the numerous amounts of bogus; ‘medical studies’, the ‘youth vaping epidemic’ and the mishandling of the EVALI outbreak, the vaping industry has taken quite the beating. In the general public’s eyes, vaping is deadly and has been wrongly assumed by some to be more dangerous than smoking. It’s extremely disappointing for anyone who advocates for vaping, to see just how quick the public opinion has changed. Many of the stories that have been circulating have cherry-picked data that highlights ‘risks’ associated with vaping to scare and intimidate the public, rather than providing an unbiased and educated overview. Not only has this been fueled by the media, but even the anti-vaping organizations have played a huge part in pushing these cherry-picked reports and information. Just recently the Truth Initiative’s most recent campaign even asks kids to destroy their Juuls to quit vaping. The campaign shows a lot of younger people ‘creatively’ destroying their Juul devices in ways that could cause the lithium battery to explode. This type of campaign is not only suggesting dangerous actions, but it presents it in a ‘fun and cool’ manner trying desperately to appeal to a younger demographic. There is no excuse for spreading misinformation – not only is it causing harm to our industry, but it can also put many in harm’s way. That is why it’s so important to keep educating about vaping.
Then the FDA released its new guidance on January 2nd, 2020 titled – Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization. This 53-page document goes into detail over the ban on all flavored cartridge-based ENDS products; excluding tobacco and menthol flavors, how they plan to enforce the PMTA deadline on May 12th, 2020 and covered points regarding cigars. The key takeaways are as follows:
- The agency will prioritize the enforcement of pre-filled flavored cartridge/pod based ENDS, other than tobacco and menthol flavors. On February 1st, all retailers/manufacturers must remove and stop production of any cartridge/pod based ENDS product immediately, no matter where it is sold. Open tank systems (i.e. Box Mods, Tanks, etc) will not be affected.
- The FDA does realize that in order to utilize their resources effectively, they have to prioritize how they enforce these policies. After May 12, 2020, FDA intends to prioritize enforcement regarding the lack of marketing authorization (those who haven’t filed their PMTA) specifically against:
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access.
- Any ENDS product that is targeted to minors or whose marketing is likely to promote the use of ENDS by minors.
- Any product still offered for sale after 5/12/2020 without a PMTA submission.
- The guidance also reviews the PMTAs and their enforcement priorities when it comes to premarket applications. After May 12th, 2020, any product on the market without a premarket application will be considered illegal and can face penalties. The FDA reserves the right to refuse any application for any reason, resulting in permanent expulsion from the market. Those who do get their applications accepted will have a 12-month extension for their products to remain on the market.
With this guidance, it seems like the FDA may not have plans to help streamline the process for small businesses. There’s no telling what exactly will happen as the deadline inches closer and closer. Through everything; youth vaping epidemic, EVALI, bogus medical studies, raising the minimum age to 21 and over, and our government’s ever-changing regulations, our industry has been fighting to keep this amazing technology available to adult smokers looking for an alternative to smoking combustible cigarettes. We strongly believe in what we do and will continue with a fiery passion to keep these products on the market. With the help of numerous advocacy groups, we couldn’t have made it this far. If you haven’t joined an advocacy group or are looking for ways to become more involved in the fight, please consider donating to your local advocacy group like PSFA. As more updates come out on the new FDA regulations, we’ll be sure to post them on our social media accounts and on our website. If you have any questions or concerns, feel free to contact us at firstname.lastname@example.org.