On May 5, 2016, the landscape of the vape industry was forever changed. All future plans, ideas, products – everything came to a crashing halt when the Food and Drug Administration published new regulations severely diminishing the freedom and luxuries that for nine years we have so enjoyed.
Did we know it was coming? Absolutely.
Still that foresight did nothing to diminish the shock and fury that descended upon this vast and yet tight knit community of four million people and counting. The ability of this government agent to pass legislation without any regard for proven studies and research infuriated us all, and yet we are frustrated by our own inability so far to change the law.
That ends today.
I am Lena Bee, and I own Bumble Bee Vapor with my husband Chris. We’ve been in the vape game for quite awhile now, and in that time, we have watched the industry shift and change. We, like so many others, have lost sleep and agonized over the pending regulations, and while they are certainly not as favorable as we had hoped, instead of feeling defeated, we have instead chosen to stand up. We are invigorated by the challenge, up for the fight, and by god, we are going to follow our leaders into our battle. We hope you will join us.
Since the regulations passed, there has been a lot of speculation and gossip. Of course, when a 500 paged document is published in legalese, there are only a select few who can properly decipher it, and even then, it takes time. More details will continue to emerge over the coming days, weeks, and even months, and I will certainly be here to pass them along in what I hope will be a clear and concise manner for you.
There are a number of topics I want to explore on this blog, but first let’s start with a brief overview on where we currently stand. This is based on the SFATA call held on May 6, 2016 with SFATA Executive Director Cynthia Cabrera. Also on the call were SFATA’s lobbyist firms, Venable LLP and Alpine Group.
TIMELINE
- May 5, 2016 – Pre-Publication Notice – OMG it’s happening!
- May 10, 2016 – Regulations published in Federal Register – SMH no going back now…
- August 8, 2016 – Regulations officially become law – FML it has happened.
- October 20-21, 2016 – SFATA Annual Conference in Hollywood, Florida. For more information, see here: http://sfata.org/2016ConferenceandExpo. Regulations will be addressed, as well as the general landscape of the industry at that time and plans moving forward.
THE REGULATIONS
- All products made in 2007 or later fall subject to the regulations.
- All flavors with nicotine will be considered new tobacco products.
- Any flavors that could be considered appealing to children will absolutely be rejected. Bubble gum has been cited over and over again as a specific flavor that will be banned by the FDA.
- Nicotine is the qualifier that turns e-liquid into a tobacco product.
- Non-nictone e-liquid flavors do NOT fall subject to these regulations.
- Companies cannot market 0mg e-liquid as being intended to have nicotine added to product.
- Synthetic nicotine, including vegetable-based nicotines, are still considered a tobacco product because regardless of what they are made from, they will have the same effect on the human body.
- Regulations also specify requirements for packaging and labeling, although specific details have not emerged at this time.
- Bottles must be tamper proof.
- There will be a vending machine ban for all e-cigarette products.
- No free samples of e-liquid may given.
- 0mg samples (no nicotine) are okay and are not subject to regulations at this time.
- If stores want samples with nicotine, they must be pay for them.
- No specification has been given on the actual cost that stores must pay for samples.
- PMCA application will need to be submitted, one for each flavor AND each nicotine level.
- Cost for applications unknown at this time will likely go into the millions due to testing and support required to accompany application.
- If application is denied, no refund will be given.
- If application is not approved within 12 months, all products must be removed from shelves.
- It is the responsibility of all companies to show substantial relevance to any vape products available prior to 2007. In other words, the FDA has made a few companies founded before 2007 exempt from these laws; if we can prove that are products are alike, then we could fall exempt as well, but it was on our dollar and our watch, and it won’t be easy.
- CBD (cannabidiol, a main ingredient in cannabis/mariujuana) is a huge concern for the FDA, and they may contact companies to specifically ask if CBD is being used in their flavoring.
LEGISLATIVE SPECIFICS
- There are two separate routes that can be taken here:
- Convince Congress to move the grandfather date
- Regulate deeming regulations.
- It is reasonable to argue that the FDA does not have grounds to deem e-cigarettes tobacco products.
- Main arguments is that Tobacco Act was not intended for electronic cigarettes, only actual tobacco, and therefore does not apply to the vape industry.
- Act also does not give consideration to small businesses.
- To litigate, it will come with a price tag in the millions.
- Ultimately depends on judge.
- Judge is unlikely to overturn regulations.
- Even with a victory there there, FDA will appeal in higher court.
- Litigation will continue like this for quite some time and no guarantee of a victory.
- Therefore, the most promising path is to change the law.
- Congress are the only ones above the FDA, and Congress answers to the people. Holding them accountable through phone calls, emails, and letter, as well as solid and steady media pressure, could change the grandfather date and allow us more time to argue our position.
- Many politicians have been unable to take a position prior to the regulations; now that they have been released, it will be easier to push them to take a stand and hopefully sway their support to our side.
- One solution is to develop devices that would work across multiple brands. Would require everyone working together and potentially revealing proprietary information.
- Currently, the regulations do not affect web orders, although it has certainly been mentioned and could easily become part of future legislation.
- Age verification is something that should become a priority for all e-commerce.
- Keeping driver’s licenses on file for online customers and requiring an adult signature upon delivery is recommended; however, if the personal data of customers is stored by a company, that company must disclose this on this website and may require cyber insurance which can be very costly.
EDUCATE, EDUCATE, EDUCATE!
The FDA & tobacco companies are talking – why aren’t we? Congress MUST hear our side of the story!!!
These are the steps EVERYONE should take! Enlist your friends, family, coworkers, favorite barista, bartender, etc. The more voices, the better!
- Contact your local papers and news stations.
- Submit testimonials and articles to local and national publications.
- Engage with vapers AND non-vapers in person and social media.
- Rally as much support as possible, and ask EVERYONE to call in and write letters. Spread the word, and make Congress hear our voice!
Check out the other pages on this site for links to support and donate to SFATA, CASAA, and Not Blowing Smoke!
More information to come soon!
Goodnight,
Lee
Fighting For Our Lives 