Hey guys, Dawn here again and with everything going on there is very little time for small talk so let’s get right to it.
First Some Important Terminology:
Grandfather/Predicate Date: When the FDA originally issued its new deeming rule in regards to electronic cigarettes they stated that products on the open market BEFORE February 2007 would be exempt from most of the regulatory requirements instated by the deeming rule regulation.
Cole/Bishop Amendment: Also known as HR1136 is an Amendment that has been introduced in Congress that is intended to amend the Federal Food, Drug, and Cosmetic Act. While it does a number of things, it’s primary objective is to move the predicate date (grandfather date) from February 2007 to the effective date of the Deeming Regulation. (August 2016).
2017 Omnibus Budget: This is the budget that runs most government affairs. it came about due to the Deficit Reduction Act of 1993.
Cole/Bishop language in regards to the 2017 omnibus budget: Unlike the full Cole/Bishop Amendment, which does a variety of things, when people refer to the language “being added to the 2017 budget” they are referring only to the language regarding the move of the predicate date from February 2007 to the effective date of the Deeming Regulation. Getting that part of the amendment’s language placed into the omnibus budget would save the time it takes to get an entire amendment through all the red tape that is our political system. On the upside of this, the language has been added to the Omnibus Budget of 2017.
August 1st, 2018: The date in which all electronic cigarette need to have completed their pre-market application per the FDA if they are not exempt via the grandfather date loophole. Currently, no brand of electronic cigarette qualify for this so if left unchanged it is also the date that 99% of all electronic cigarette and vapor companies will go out of business.
June 30th, 2017: Deadline to register all products that businesses intend to complete a pre-market application for. May people refer to this as the August 1st, 2017 deadline, but in all actuality, the information required, such as ingredients list and other data, must be in by the june 30th deadline.
What’s been going on:
Okay, now that we have some of the terminologies straight let’s figure out what happened with the Omnibus Budget yesterday that through the electronic cigarette industry for a bit of a loop. It is important to keep in mind that what did happen yesterday is very typical.
First, both sides Dems and Reps negotiate (or argue depending on how you look at it.) about what all belongs in this budget. Then, in theory, they all come to an agreement each year and bam you have a budget.
What should come as no surprise to anyone who watches the evening news is that this plan rarely works that easy. In fact, what often happens is that an agreement can not be reached in time. If an agreement is not reached then the threat is the government will shut down. We saw an example of this in 2013 with the Obama Administration that resulted in a huge uproar.
No one wants to see that happen so yesterday because the fiscal year is nearly over and instead of closing down the government, they agreed to pass a simple water-downed version of the budget to fund us through the rest of the fiscal year. (September) then re-open with negotiations.
Here is a copy of the press release that the Democrats put out in regards to what Did and Did Not make it into the simple budget. (Press Release)
What does that mean for the Cole/Bishop Language that was added to the budget?
It means that we will have to wait until October for the 2018 budget negotiations if we would like to try to add the Cole/Bishop language again. The problem is that since they will not start with negotiations until September and our next deadline is on July 30th, many people in the industry are worried.
What are our options?
First, let’s talk about the upcoming July 30th deadline. Apparently, industry stakeholders are not the only ones noticing the problems ahead if the due dates are not adjusted. While the FDA rarely does great things for this industry the U.S. Food and Drug Administration has given manufacturers of electronic cigarette equipment a three-month reprieve on all upcoming deadlines. Which apparently officially moves the registration date scheduled for July 30th to October 30th. The reason for the extension according to the FDA’s Lindsay Tobias of the Center for Tobacco Products:
Many industry experts expect these dates to keep getting pushed back until all of the lawsuits and litigations in regards to the FDA’s Deeming Rule are cleared up. That is not expected to happen anytime soon. So at least, for the time being, we in the industry are kinda holding our breath while we wait for confirmation of this information. It could be that the deadlines keep getting pushed back until this all get’s sorted out.
Keep in mind that these extensions will not affect deadlines that have already past. So things like underage sales and warning labels will not be affected, and we are okay with that here at A Clean Cigarette.
In The Meantime:
On April 27th, 2017 Rep. Duncan Hunter (R-CA) introduced The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017 also known as HR 2194. Click HERE for a link to the bill itself. This bill is by far the most optimistic option for the electronic cigarette industry.
What it does in a nutshell:
- Separates electronic cigarette regulations from burning tobacco regulations.
- Adopts the e-liquid standards developed by the American E-Liquid Manufacturing Standards Association. (AEMSA)
- Put an end to the requirement for e-cigarette companies to submit pre-market tobacco applications.
- Set’s up actual standards for electronic cigarettes
- Provides protections for consumers in regards to electronic cigarette batteries and establishes regulations for said batteries.
- Requires tracking of all devices by serial and lot numbers.
- Authorizes the FDA to establish regulations to prevent marketing of vaping products to minors.
- Requires the FDA conduct a health safety assessment comparing the risks of different tobacco products, as well as vaping products and submit this report to Congress.
- Renames the FDA’s Center for Tobacco Products as “Center for Tobacco Products and Tobacco Harm Reduction.
Not bad eh? We agree! This piece of information is by far the best information that I have heard for this industry in quite some time. Things are looking good for it too, although it’s way too early to tell exactly how it will go. With any luck, dates will keep getting pushed back until this bill or one like it can clear the necessary red tape and take effect.
We wait and watch. Remember to keep an ear open for upcoming announcements and I will do my best to keep us all on the same page here at A Clean Cigarette. Regardless of which way all of this goes, we are committed to the fight for your rights, but we can not do it alone. We need your voices and your stories to make real differences. If you have not already done so consider sending me your success stories to AccAnswers@gmail.com. Every story counts and we appreciate everyone who has already done this for us!
Check back often to stay on top of all the most current news regarding electronic cigarettes!
Bye and Thank You,