LOOMING SEPTEMBER 30 DEADLINE COULD TURN VAPE SHOPS INTO CRIMINALS

 

by CARL V. PHILLIPS

September 30 is the deadline for U.S. “manufacturers” of vape products to register their business and their products with the Food and Drug Administration. According the the FDA, “manufacturers” include mom-and-pop vape shops, since many such small businesses make products like refill liquid on-site. 

In July, FDA Commissioner Dr. Scott Gottlieb announced a four-year delay of the near-ban of vapor products, so vapor businesses now have until 2022 to work on obtaining expensive and uncertain FDA approval for each product. However, that welcome news did not change administrative deadlines. This includes the requirement that all vapor product manufacturers must register by the end of this month. This registration deadline has been extended several times, but so far Gottlieb has given no indication it will be extended further.

In a recent article, Vaping360’s Jim McDonald suggested that “hundreds or even thousands” of small manufacturers do not understand that they need to do this.

As with many regulations, the burdens from this paperwork fall most heavily on small operations. The requirement is the same whether a manufacturer sells a hundred units of a product or a million. Although the task of “registration” may sound simple, this process is not trivial. Many vape shops have hired consultants to help navigate the process. 

The fate of any small manufacturer who fails to register will be in the hands of the FDA. Of course, the agency could choose to be lenient. But any familiar with the FDA’s past actions knows that such a scenario is unlikely. FDA tobacco regulators appear to delight in enforcement: In fact, a large portion of their public statements proclaim the tough steps they are taking toward enforcement. They stop short of perp walks and press conferences in front of mountains of seized products. But seemingly just short. Some optimistic observers believe the FDA’s delay in enforcing its near-ban represents a more positive attitude toward vaping at the agency’s highest levels, perhaps as a result of the new administration. But even if true (and that is far from clear), it might not change the FDA’s behavior at the enforcement level.

To date, the FDA’s “regulation” of e-cigarettes, smokeless tobacco and other tobacco products has consisted entirely of red tape, including bans-by-paperwork that chip away at the market. There are basically no substantive regulations, such as manufacturing or content standards. But the FDA has banned products from the market on what might be called technicalities, refusing to accept applications or registrations for arbitrary reasons. All this suggests that the agency could and would use failures to register as opportunity to eliminate more products.

The FDA’s desire to paint the vaping marketplace (and the agency’s strict enforcement therein) as “the Wild West,” creates problems for all vapers and vaping businesses. Any manufacturer who is unaware of the registration requirement is likely to remain unaware and continue manufacturing. Some small manufacturers who fail to register might choose to comply by ceasing manufacturing, such as by no longer mixing their own liquid. But most will probably keep manufacturing, creating a target-rich environment for enforcement actions and PR victories for the regulators.

Asked if it is already too late for a small manufacturer to be able to comply with the requirements, McDonald replied “probably not,” though he warned that the FDA’s online system is causing long delays. He advises that anyone who cannot meet the deadline because of technical glitches should at least try and notify the FDA of what happened as soon as possible.

If you believe your favorite vape shop may not be aware of what is required of them in the next 10 days, tell them now. They may still have a chance.

 

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Friday, September 13th, 2019 at 3:36am
My own mother just told me that she believes the #ejuice makers literally rubbed their hands and thought "I know how to addict the children ! #FLAVORS ! .. Well Mom, #flavorssavelives. Is her candy flavorless ? Her ice cream ? Her cereal ? #Tobacco flavor is 'adult' ? Gross...! https://t.co/gswwLBdv8F TheVaporNinja photo
Thursday, September 12th, 2019 at 6:08am
Confusing #THC delivery systems with #vaping #ecigs is rampant, and getting worse. Headlines like "Vaping causes hospitalization/death' are spreading WORLDWIDE.
Do what you can to educate your friends, family, neighbors, about this issue when they see you vaping your #ecig. https://t.co/jqZMkpvp6R
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Wednesday, September 11th, 2019 at 9:23pm
These same "officials" who have desperately tried to ban vaping have CANDY DISHES with many FLAVORS in their OFFICE !!
Flavors are for children ?? Well, let's ban everything flavored that's remotely bad for you ! To "Save The Children" (tm) !!
Pushing vapers to the black market. https://t.co/UFYAPBk5GZ
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Wednesday, September 11th, 2019 at 8:55pm
"SAVE THE CHILDREN"... more like "SAVE OUR TAX REVENUE".....
The orange man just pissed off 13 million voters (vapers). Will THIS make you go to the voting booth, vapers ?
Did you think the orange man was about de-regulation ? Free market economy ? Small business incentives ? HA https://t.co/WGqbAR1y2r
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Wednesday, September 11th, 2019 at 1:34pm
I AGREE. https://t.co/N8REbgaO86
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VapingIT, SPE, EEI @Vapingit
I predict within 5 years of a flavor ban, cigarette smoking -18 will be back where it was before vaping products were available. https://t.co/qlZreH2c98 https://t.co/45nz0tXjuv
Wednesday, September 11th, 2019 at 1:24pm
YES, THE ORANGE MAN DID IT.
He is going to ban all vape flavors, citing concerns about 'many deaths'... well how about the 33K deaths this month from TOBACCO, @POTUS ?? What about the 88K deaths a year from booze ? Are you sure you're banning the right thing?
Wednesday, September 11th, 2019 at 1:20pm
@KnowNicotine Well I hope you're happy, Aaron, Trump is now going to BAN all flavored vape liquids nationwide to "protect the children"...
Congratulations. You win this round.
Friday, September 6th, 2019 at 3:01pm
Do NOT go back to smoking !! IF you are afraid of the latest outbreak of vaping related illnesses, or know someone who is, share this post with them. There's every reason to NOT return to smoking !! https://t.co/PiwAckGtA5
Tuesday, September 3rd, 2019 at 9:52am
@LizaSoho Yes, ANY smoke is harmful to the lungs.
So this is a safe thing to say, sure.
I recommend people VAPE their cannabis and nicotine.
VAPING cannabis goes beyond using illicit cartridges with unknown pollutants.
Tuesday, September 3rd, 2019 at 9:48am
@LizaSoho OK look.
ANY smoke from ANY substance is BAD for your lungs and body.
This is why I advocate for VAPING over combustion.
I'm not sure why you are targeting @TheVaporNinja with stories of SMOKE.
As the nickname indicates, I recommend to folks to VAPE their cannabis, nicotine, etc.

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