Last weekend in Pasco, Washington, West Coast Vape Expo hosted a convention to help bring awareness and help raise money for the advocacy of vaping. The Not Blowing Smoke Organization, represented by founder Stefan Didak, made an appearance and sat down with me to discuss the current and upcoming issues of advocacy and compliance in the vaping industry.
Not Blowing Smoke was created to help protect the vaping industry. Their focus in the past year has been on defeating or amending the imprudent flavor bans that have been spreading through California and possibly to other states soon. Mr. Didak assures readers that Not Blowing Smoke is not slowing down on strategizing against the tactics their opponents are deploying, “We are looking forward to the referendum in San Francisco on this subject as it may help set a precedent where voters tell their elected officials that denying adults access to legal products that keep them from smoking tobacco is just bad policy.”
One of the main concerns addressed at this meeting is that it is hard to be sure what the FDA is going to implement and what is idle talk.
Some vendors share horror stories of competing industry leaders who paid to start the Pre-Market Tobacco Application (PMTA) and how unnecessary it is now that they’ve moved the deadline to four years from now. Since the date has been changed it could leave those who started the process feeling vulnerable to any changes the FDA will make to the application from now until then. While I agree with them on their concerns, Stephen Didak also urges caution to those viewing the extension with complacency, “While the FDA provided a four-year extension on the requirement to file PMTAs for products, it can easily be considered four more yards, of rope, for the industry to hang itself with. We have noticed that this, considerably lengthy, extension is leading to an equally considerable amount of complacency amongst industry stakeholders who feel that they will be fine for that number of years.”
What is the danger of extending the PMTA?
With the extension of the PMTA also comes an extension for new policies to be pushed through at local and state levels that would hurt our industry. Mr. Didak implores industry leaders to keep in mind the real threat of this postponement, “Unfortunately, that federal extension comes at the cost of an increased effort by our opponents at the local and state levels where the battle becomes much harder because of the unequal playing field. Our opponents have millions of dollars to spend on harming the product category, while the vapor industry does not have enough resources or manpower to battle every single ordinance. This is where the real danger lies in the coming years and requires everyone to keep their eye on the ball.”
What guidelines manufacturers should be following?
It was reassuring to hear so many of the vendors have taken the first steps towards compliance with the FDA by starting the registration process and product listing, though there were a few who admit being a little behind, but there was a lot of frustration revolving around the irresolute and wavering policies being administered by the FDA. A shared thought between Mr. Didak and myself is that the FDA still has a lot to learn when it comes to the product category. Mr. Didak even infers, “I suspect that they may want to educate themselves by learning as much as they can from being at the manufacturing facilities.”
There are a multitude of possibilities but not a lot of decisions when it comes to the FDA auditing e-liquid manufacturing facilities. Regardless of not issuing exact manufacturing guidelines, the FDA announced earlier this week how we should be handling FDA audits.
What are manufacturers supposed to do to remain compliant, while not spending unnecessary funds to meet standards that the FDA may or may not implement?
Mr. Didak and I had an extensive but collaborated discussion on this issue. Everyone should already comply with various registrations and reporting requirement deadlines that have been defined by the FDA. If you haven’t yet, this needs to be accomplished as soon as possible.
While there is not a firm guideline, manufacturers can use basic practices that the FDA enforces on other industry manufacturers, within reason. “It is easy to spend a lot of money on an ISO7 lab when perhaps that’s beyond what might be required.” Mr. Didak suggests “Instead I would encourage manufacturers to focus strongly on their GMP (Good Manufacturing Practices) as those will most definitely come into play at some point and being ahead of the curve now will save a lot of headaches later.”
Is GMP necessary?
While the FDA has not defined any policies, logic would lead us to believe that the GMP standards will be implemented eventually. Mr. Didak explains, “Proper batch codes, being able to track ingredients and shipments, having policies and procedures in place for potential recalls, how materials and ingredients are handled, stored, etc., is going to be of tremendous value towards things that will remain a critical issue.” Auditing these facilities may even help educate the FDA on how to create proper guidance for the vaping industry. While these guidelines have not been set yet, manufacturers should begin preparing now for Rome was not built in a day and your GMP will not be either.
What can we, the vape community, do to combat growing regulations?
Mr. Didak urges all stake holders in the diverse open vapor industry to become more involved on local issues where they arise. He advises that we should be forming good relationships with stakeholders in our local business communities, “Join the local Chamber of Commerce. Be apart of some of the local events and meetings with your city council members. Be a face for the industry and show that you are a responsible business owner. When bad policies and legislation arise locally, it will be easier to deal with if you have the support from other businesses around you.”
Lastly, while we are nowhere near the end of the road, there is gratuitous amounts of support that can be found to help guide you through the regulations. Keep yourself informed on local issues as they arise, prepare for regulations versus procrastinating, and never be complacent. To learn more about what to expect from FDA audits, please join our free Webinar December 19th.
Stay Competitive, Stay Compliant.
NGS Operations Manager