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, July 5th, 2019 at 11:15pm
@eaze Vaping is indeed the future.
Smoke has carbon, and is responsible for most lung problems resulting from combustion.
I suggest investing in a GOOD herb vape, at least $100-200 vape.
The others simply combust the herbs.
So many ppl dislike vaping bcuz they tried a bad device.
Friday, July 5th, 2019 at 3:44pm
@Kelpalots @DJColonelCorn A meta-study (I think around 2012) estimated that at the time ~17,000 people/year (in the US) died from complications arising out of internal gastrointestinal bleeding events thought to have been caused by NSAIDs.
(Thanks to Lightning on Disqus for this)
Yes, @Kelpalots, they do
Tuesday, July 2nd, 2019 at 6:11am
@KnowNicotine Vaping, whether done by a teen human or adult, has been shown to be practically harmless. While crying "Save The Children" they banned e-cigs, but not tobacco, in San Francisco recently. Saving the teens from the awful vape. Yeah. They also claim adults do not like flavors. Sure.
Tuesday, July 2nd, 2019 at 6:07am
@KnowNicotine Not happy with this teaser.
It's about, and labelled as, the "teen vaping 'epidemic'".
I'd rather my teen vape than smoke and get disease.
This is not why I donated. This 'teen epidemic' is their excuse to ban vaping.
"Save The Children!" they cry. When it's really about taxes.
Sunday, June 30th, 2019 at 6:30pm
"and from online retail..." .. how, exactly, well the enforce THIS I wonder....
Sunday, June 30th, 2019 at 12:38am
@Kpascuch My old home town has a lot to learn.
First came the flavor ban, now an outright ban on all e-cigs.
I can't believe at this stage of the game we're going backwards.
After all the progress we've made.
My DOCTOR even, has finally decided she approves of VAPING as she can see results https://t.co/OUcWPEelfn
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Sunday, June 30th, 2019 at 12:32am
@Kpascuch Sad.
I was just in Oakland, California.
They couldn't sell me vape liquid.
Of course, the tobacco was readily available.
As an ex-smoker I find that insulting. https://t.co/UAvfpOmJYO
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Thursday, May 23rd, 2019 at 7:56am
@KnowNicotine @Biebert @ThirdLineFilms @JenniBiebertMKE @JimiJakeShaw uh.... all of California isn't like what you saw... next time, come up North and see the redwoods !
All the best, Aaron. <3

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