A few days ago the FDA released the Final Rule for Vaping. I’ve been digesting the 499 pages and lurking in social media to measure the actions, behavior, and tone of my fellow vapers. I plan to make multiple Blog posts on the Final Rule and this is my first post on the details. Generally speaking, many vapers are mad as hell and I concur. Some still have their head in the sand with self serving thoughts about how they can outsmart the FDA with their bloviating about a “loophole” they have found. The FDA is many things that are repulsive BUT they are NOT dumb and are way ahead of the curve by anticipating actions by vapers. Some vapers have suddenly decided that they are activist which in one sence is good but it begs the question: Where the hell were you in April of 2014 when the deeming was released and myself and others began our fight? Some vapers even attacked other vapers with snarky and insulting comments about what they should do or should not due. Others seem to satisfy their need for publicity by attacking CASAA and other advocacy groups. Let’s begin by clarifying some issues that have confused vapers.
The time line
– The clock starts ticking the day the Final Rule is published in the Federal Register which has not yet occurred but per the FDA will occur on 5/10/16. Nothing will change from the document we are reading today.
– Vendors/Manufact etc have 90 days from the Publication date of 5/10/16 for introduction of new products. And these products do not require a PMTA. Look for a flood of products with less than desirable testing and quality control.
– The clock starts clicking on the Congressional Review Act and Congress has 60 days from the Publication date to reject (no changes permitted for the Final Rule under this law) the Final Rule. NO extensions. IMHO, doubtful they will accomplish anything. If they do nothing or wonder around in the bushes and can’t properly complete a “Joint resolutions of disapproval”, then the Final Rule becomes the law of the land 90 days from the Publication Date in the Federal Register. My post on this issue.
– Vendors/Manufact/B&M’s etc have two years from the effective law of the land date for the Final Rule to submit a PMTA. Thus the drop dead deadline date is 8/18. During this two year period to file a PMTA, Vaping products etc. can and will remain on the market. A PMTA is estimated to cost millions and only BT can afford this huge costs and perhaps a very very small number of large Vaping centric companies. Lets assume 8/10/16 as the start date so in this case they have two years from this date to submit a PMTA. They DON’T have three years. ONLY IF they properly submit a PMTA and it’s not bounced or suspended, then they may be granted an additional 12 months and this additional time is at the discretion of the FDA which is an opaque organization.
The zero NIC Ejuice issue
I constantly read about this alleged loophole. Forget it! It’s not going to happen. You haven’t read the entire 499 pages. Your also assuming that to a certain exstent the FDA has not done their homework. Believe me, they have. They are acutely aware that vapers intend to mix the zero NIC ejuice with their own NIC. Page 222 of the Final Rule says and bolded by me:
“Also, as stated earlier, nicotine-free e-liquid that is intended or reasonably expected to be used with or for the human consumption of tobacco products in most cases would be a component or part of a tobacco product and, therefore, within the scope of this rule.”
The FDA’s “intended or reasonably expected” catch all
That’s a core issue and is solely at the discretion of the FDA. An agency which essentially operates in secret with no Congressional oversight. It’s essentially a CYA by the FDA and permits them to unilaterally lower the boom. If you or me don’t like it, screaming yelling, petitions, and other actions are an exercise in futility. To resolve this issue requires a huge amount of political pressure followed by effective legislation or you sue! Period! Let’s take 18650 batteries as another example. After the two year deadline (8/18) to file a PMTA, your local Vaping B&M won’t be selling them unless they have obtained a PMTA or the manufacturer of the batteries has obtained a PMTA, with the chance of this happening being slim to none. Given the huge monetary cost. Your vaping centric web site won’t be selling them either unless they or the manufacturer have obtained a PMTA. Yes, in this case purchasing an 18650 from Amazon is still a realistic and viable option and we should be fine. So, it’s the context of the marketing and if a component part covered by the Final Rule is used in another industry. In this case some flashlights use 18650 batteries. Some other component parts which should be available are wire for coils purchased from a vendor who has no marketing connection with Vaping like TMC. Their wire is used in other industries. The same theory holds true for KGD, where it is sold and marketed as a beauty product and thus it will still be available BUT NOT from your B&M or a vendors Vaping centric ecommerce web site. I strongly suggest you read the following detailed article about the PMTA issue titled: “FDA Draft Guidance Confirms that Deeming Regulations Will Decimate the E-Cigarette Industry”
The SE (Substantial Equivalence) Pathway via the Final Rule
I’m not going to write a great deal about this issue because it’s NOT going to happen. I’ve also spoken to other experts and higher powers and they all agree. Briefly, you may wish or dream that your vaping component part currently regulated via the Final Rule is substantially equivalent to another component part which was available and sold in the USA on or before the current grandfather date of February 15, 2007. Your trying to avoid the PMTA pathway via a SE. Please consider that the FDA has a deplorable record of approving any SE applications and is years behind. Your going to spend millions of dollars trying to prove to the satisfaction of the FDA that your component part fits the SE guidelines. NO WAY Jose! Not to mention that all the pre February 15, 2007 devices/compenent parts are no longer a viable option for most vapers. Please stop trying to find a loophole via the SE pathway in the Final Rule.
I’m going to continue to fight with every fiber of my body. I didn’t spend the last two years fighting and Blogging, only to throw in the towel and stop fighting. I’m also not going to sugar coat these issues and will continue to provide you with my own candid views. If I make a mistake or you wish to take me to task, please do so via our Contact Us page.