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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Thursday, July 9th, 2020 at 2:06pm
CALL or WRITE the California Assembly members about the upcoming California #flavor ban ! https://t.co/XvNgmqGZpQ
Thursday, July 9th, 2020 at 4:57am
Incense, sage, cedar, myrrh.. many things have been vaporized or smoked by our ancient cultures... was it to, as they claim, purify the space ? Perhaps it purifed biologically also. https://t.co/EvHkPQjGfU
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Eliana Golberstein Rubashkyn 👩‍🔬⚗🧪💛💜 @ElianaGolber
Is the smoke aura the one that creates effective air disinfection around smokers? Can this explain why they are less likely to get #covid19?

Ancient traditions all over the world used smoke for air purification.

What they knew that we as scientist are ignoring? https://t.co/J9QupLV7vx
Tuesday, July 7th, 2020 at 1:47pm
@Seglectic This is really nice man
I'll DM you my snail mail address for one !
😃
Tuesday, July 7th, 2020 at 1:46pm
@Seglectic Wow. What the.....!
Radical, nice dude this is pretty.
Can I get one ? For your ol' buddy pal ? 😃
Tuesday, July 7th, 2020 at 1:42pm
There's a sale at the @CASAAmedia store until 7/10/2020. Shop now, and help #CASAA raise some funds. https://t.co/34ioPR5uun
Thursday, July 2nd, 2020 at 1:16pm
S. 1253, which would prohibit mailing vapor products through the USPS and require signature on delivery (with added cost) may be heading to a vote by the full senate within the hour. https://t.co/NvpCHbImWB
Sunday, June 28th, 2020 at 3:53pm
The Royal Australian and New Zealand College of Psychiatrists (RANZCP) came out in favor of the use of vaping products for people who have a psychiatric diagnosis in 2018. https://t.co/mOxMdr8kmo
Sunday, June 28th, 2020 at 1:31am
This is inexcusable. Rewards for stamping out #vaping.
San Francisco has banned all flavored vape liquid. https://t.co/yiA7Qk2APr
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GrimmGreen @GrimmGreen
I’ll say it again, where is the state government’s motivation to actually get people to stop buying combustible tobacco cigarettes? https://t.co/xYxfnPKKZb
Sunday, June 28th, 2020 at 1:27am
California Vaping Ban moves ahead - Take action NOW to save flavors in California vape shops ! https://t.co/XvNgmqYAOq
Saturday, June 27th, 2020 at 10:00pm
@Seglectic Yeah meanwhile every mosquito that draws blood from you is female !
Sunday, June 21st, 2020 at 5:08pm
@ElianaGolber Nicotine is water soluble.
Extracting nicotine from tobacco is therefore quite easy.
Expensive, unless you grow your own.
This seems to be a viable solution, grow tobacco and water extract the nicotine.
What you suggest is fascinating though !
Stand up for Australia. <3 .au !

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