Let Freedom Zyn
Let freedom ryng: On Thursday, the Food and Drug Administration (FDA) authorized the marketing of 20 Zyn nicotine pouch products, allowing them to be legally sold by tobacco retailers nationwide (barring any additional state and local restrictions).
Fellow Zyn users might find the news that the sale of their daily fix is now officially legal somewhat surprising given that it’s already readily available at almost every gas station and tobacconist in America.
The fact is that the sellers of Zyn and countless other nicotine pouches, vape products, and other tobacco substitutes, have been operating in a darkly shaded gray regulatory environment for years.
The 2009 Family Smoking Prevention and Tobacco Control Act requires that “new tobacco products” not on the market as of 2007 receive “pre-market product authorization” from the FDA before they can be legally sold.
That requirement effectively meant that all vapes, heated tobacco products, nicotine pouches, and other new substitutes for traditional combustible cigarettes and cigars needed the agency’s approval before they were legally allowed to be sold.
Much to the chagrin of both the sellers of these products and anti-nicotine groups, the FDA has been exceedingly slow at creating a regulatory process for granting that pre-market authorization.
The FDA’s foot-dragging eventually prompted a lawsuit from anti-nicotine groups, which in turn promoted federal courts to set some deadlines. New tobacco product makers had to submit pre-market authorization applications to the FDA by September 2020 and those products needed to receive that authorization by September 2021 in order to be sold legally.
Receiving the FDA’s pre-market authorization turned out to be a high bar. Companies hoping to sell their innovative, stimulative, flavorful wares must show to the agency’s satisfaction that the legal availability of their product makes people less likely to consume tobacco products they’re currently using, without encouraging non-users to start.
Individual flavors and nicotine levels also require separate FDA approvals. (The 20 Zyn products approved by the agency yesterday cover ten of the brand’s flavors offered in the three- and six-milligram nicotine doses.)
The result was that the September 2021 deadline came and went without the agency granting pre-market authorization to almost all manufacturers who’d applied for it.
At the same time, the agency had not explicitly denied the vast majority of those applications either.
This left Zyn, Juul, and your local vape shop in the uncomfortable position of selling products that lacked explicit legal FDA approval but had yet to be explicitly denied that approval by the agency.
It’s only been the agency’s lack of resources and discretion that’s stopped every non-authorized product from being pulled from store shelves and sellers hit with heavy fines.
Republicans in Congress have pointed out the absurdity of the current regulatory environment where illegal vape products are being sold just miles from the FDA’s own headquarters.
Yesterday’s decision by the FDA will allow the makers of Zyn (Phillip Morris International subsidiary Swedish Match) to sleep more soundly at night—provided they haven’t consumed too much of their own product right before bedtime.
Tik as I do, not as I
Article from Reason.com
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