Everyone can agree that July 28th was a big day for the vape industry. After one week of talking in DC with capitol hill about solidifying vape policy, FDA held a press conference. There they spoke about nicotine addiction and FDA’s thinking on tobacco usage. I listened closely and felt pride and fear at the same time. After that day, I would say 90% of my clients called me, wanting to know what did this mean for their business. I have always felt that the hardest part of the industry is separating truth from opinion. Everything is cloaked in rhetoric and political jargon we can only assume FDA’s actual “intention.” I “intend” to make blogs everyday but my practice and intention are two different things. Whether those intentions, proposed by the Commissioner, are positive or negative is based on the viewer and their personal viewpoints.
What I heard was hope for a new understanding of our industry as a potential harm-reduction product. On the other hand, I heard flavors being a proponent for kids to start smoking. The truth of the matter is, FDA intends to create a comprehensive guideline that will possibly help or hurt us. I admit, I am not part of any special group that has a magic ““FDA INFORMANT.” I have spoken with the FDA staff on many issues regarding E-liquid manufacturing and manufacturers. I have spoken to them about registration, client issues, and “hearsay.” The FDA staff has informed me on many different occasions to instruct my clients to do their BEST to comply. I don’t hold the magic wand on these issues, I am bound to the ruling just as you are. Even with their informants, those special agent groups are also bound to the ruling. The truth is in the guidance. With that in mind, I have attached a quick recap of the current guideline changes.
TRUTH:
The FDA has extended the Pre-Market Date
· Applications to market newly-regulated non-combustible products, such as electronic nicotine delivery systems (ENDS) or e-cigarettes, would be submitted by August 8, 2022.
FALSE:
The FDA has also, extended the registration/product listing, health submission and ingredient listing.
“All other compliance deadlines for manufacturers will remain the same. Importantly, the anticipated new enforcement policy does not affect any current requirements from the deeming rule that have already passed.”
I can’t sit here with confidence that everyone will make the cut into this newly regulated era. FDA has given us the opportunity to help us fix our problems in small bites. This is NOT the time to go back to the “Wild West”, but to start making strategic plans to be ready for the next regulation that will be coming out. The question every company must ask themselves is, what side of the 8-ball do you want to be on?
Stay Competitive, Stay Compliant.
Monica Schick
The Nerd in the Back