Revolutions are not victorious overnight, and any victory is undoubtedly dependent upon both the unity and active participation of the masses. Many of our industry’s advocacy efforts have failed, but we are thoroughly inspired to see more and more organizations and businesses becoming increasingly creative in working to revise and delay implementation of the FDA’s deeming regulations. Many of us were sincerely hopeful about the potential of the Cole-Bishop budget rider to change the predicate date and exempt all vapor products on the market as of August 8, 2016 from the arduous PMTA process. However, this recently-announced latest failure means that the ticking time bomb on our industry continues and that the FDA’s approach to vapor products continues to influence the approach at the state and local levels to our industry; with an onslaught of state/local threats to the vape industry, whether through astronomical tax rates (California’s tax on vapor products will rise to 65% as of July 1, 2017) or proposed e-liquid flavor bans, there is no time for despair. If you care about this industry and if this industry has helped you in any way, please take action today; whether you are a consumer, a representative of an interested organization, or an industry member, this is an important opportunity to have your voice heard.
From SFATA’s federal lobbyist, Mike Hogan:
“Changing our nation’s policies requires a disciplined, strategic approach. At SFATA, we set goals, then develop strategies to get there, then implement tactics to make those strategies move forward.
Today, I want to talk about one tactic within our near-term strategy, which we have recently been involved with to move the Administration to reassess the application process and significantly delay the deadlines for all vapor product applications: The Citizens’ Petition to FDA.
No, this is not the same as an ordinary petition that a number of private citizens may sign and send to Congress or an agency. This is a formal regulatory process that carries with it certain privileges and puts specific requirements on the FDA.
The Vapor Products Citizens’ Petition was filed last Friday (5/12), and was spearheaded by NJOY with the help of SFATA, and was signed by several other tobacco and vapor products manufacturers, VTA, and retailers.
Our Petition requests that FDA issue revised guidance extending the compliance periods for filing premarket submissions for such products to no earlier than 24 months from FDA’s publication of FINAL guidance (or regulations describing the recommended or required contents of premarket submissions for the applicable category of tobacco products).
Some may not realize that the FDA started a clock ticking on our industry, but never finished the final guidance to explain what we actually needed to do in order to put in a proper PMTA application! This left us with this “shot in the dark” lack of certainty that anything we are doing could result in an approval at all, much less what would be acceptable for the submission.
This Petition also requests that the revised guidance provide for the continued marketing of a subject product throughout the Agency’s period of review. (Currently, the deeming rule only allows only 12 months to market your products after submission, regardless of how long the FDA takes to approve your PMTA).
With the FDA already backed up with over 4,000 submissions which are languishing while awaiting delayed decisions, the influx of vapor submissions will bury them even further. It is highly unlikely the FDA will decide on vapor PMTA submissions with an unprecedented 12-month turnaround. We think we ought to be able to sell our products while we wait for them to make a determination otherwise.
Both of these are very reasonable requests, such that the FDA should have a very easy time justifying putting a hold on the deeming regulations to straighten this out. But, they could do a lot more than just address these two items in their response.
A “friendlier” and more reasonable administration will hopefully seize the opportunity to make additional corrections to our regulations. Let me explain how this could play out.
The FDA is required to respond to our petition within 180 days, and they can take one of three actions to respond:
- Approval of the petition, which may result in appropriate administrative action such as publication of a FEDERAL REGISTER document changing the procedures, deadlines or application process;
- Denial of the petition, which generally will include a discussion of the basis for denial; Note: A petitioner whose petition has been denied may request administrative reconsideration. A request for reconsideration is normally required to be submitted within 30 days of the denial.
- A tentative response, indicating why the agency is unable to reach a decision on the petition. The tentative response may also indicate the likely ultimate agency response, and may specify when a final response may be furnished.
The Petition could be a helpful catalyst for the Administration to take an action that it is already contemplating, but does not otherwise have a “forcing event” on which to act.
It could open the entire regulation to revision. For instance, FDA could examine the processes under which the rule was promulgated. The FDA could also look at consideration of alternate methods of application procedures or different regulation (such as a standards-based approach).
While it was submitted quickly to speed consideration and potential relief, your voice can help show support for the petition now.
The FDA accepts comments on this! So, you can submit your comments on how the deeming rule will hurt you if not delayed or changed.
Here are the steps you will take if you choose to weigh in and be heard:
- Go to the docket page.
- Click on the ‘Comment Now!’ button
- You can type your comment in the comment box or you can enter ‘see attached’ in the comment box and upload a PDF or word document containing your comment.
- Enter the requested information and click continue.
- Check the ‘I read and understand the statement above’ concerning the fact that all comments are public and click the “Submit Comment” button.
- You will receive a receipt and the comment will be posted in the public document generally within a few days.”