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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