FDA Continues to Issue (Pointless) Warning Letters

The Food & Drug Administration has issued another batch of warning letters to various small vape companies.

This marks the second batch of warning letters sent to manufacturers by the FDA, even after little to no actions were taken over the previous batch.

While the first round of warning letters exclusively targeted companies within the United States, the majority of these latest letters were sent to Chinese manufacturers with no known addresses in the US.

“None of these products need to exist, but it is important to note that 4 of the 5 warning letters went to companies in China offering products online for worldwide shipping, not U.S. manufacturers or importers,” tweeted Greg Conley, the Director of Legislative & External Affairs for American Vapor Manufacturers.

The Latest Batch of Warning Letters

The most recent warning letters have shared a number of similarities with the previous ones issued.

The agency highlighted the fact that these products are blatantly marketed to the underage population. This is by far one of the most common motives for any of the agency’s recent activity when it comes to attempting to further regulate the market.

The majority of the products in question boast designs that replicate popular toys and other youthful designs. These include products that “look like toys and youth-appealing electronics like glow sticks, Nintendo Game Boy, and walkie-talkies.”

The latest batch of warning letters was sent to:

“The designs of these products are an utterly flagrant attempt to target kids,” said Brian King, the Director of the FDA’s Center for Tobacco Products. “It’s a hard sell to suggest that adults using e-cigarettes with the goal of quitting smoking need a cartoon character emblazoned across the front of the product in order to do so successfully.”

Despite these bold words, it appears there is little that the FDA can actually do to prevent these companies from operating, especially given the fact that they are well outside of the agency’s jurisdiction.

Some of these companies have already been previously warned by the FDA. It is fair to say that two consecutive warning letters will most likely not be enough to sway these manufacturers from their practices.

This raises the question of why the FDA is even undertaking these actions.

There is speculation that the FDA is simply attempting to throw its weight in the eyes of the media, despite having no power to actually enforce these letters.

If true, this is obviously an attempt to save the agency’s face amidst the shambolic premarket tobacco application (PMTA) process that has been a hotbed of both praising and damning from news outlets over the past few years.

Previous Warning Letters

In a similar case, the FDA requested the help of the Department of Justice in issuing several warning letters to six small manufacturers on October 18, 2022.

Unlike this latest batch of warning letters, these companies were all found within the United States.

“Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” said Brian King. “We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”

The companies to be targeted in this first round of warning letters are as follows:

Morin Enterprises Inc. doing business as E-Cig Crib in the District of Minnesota
Soul Vapor LLC in the Southern District of West Virginia
Super Vape’z LLC in the Western District of Washington
Vapor Craft LLC in the Middle District of Georgia
Lucky’s Convenience & Tobacco LLC doing business as Lucky’s Vape & Smoke Shop in the District of Kansas
Seditious Vapours LLC doing business as Butt Out in the District of Arizona

Pointless, But Better Than Flavor Bans

While these warning letters may be all but pointless, the idea of banning products that are explicitly targeting the underage market is not the worst idea the FDA has come up with in recent times.

It certainly applies more heavily to the lower age range of those susceptible to this type of marketing, which should be the priority of the FDA, rather than products that have appreciable properties for smoking cessation.

Flavored vape products, on the other hand, offer a huge number of positives to the adult-use population. And yet, the agency has been on a crusade against these products despite their benefits.

The argument that flavored products only appeal to the youth population is, at best, a very weak one and ignores one of the biggest draw factors of adults looking to quit smoking.

If the FDA were serious about reducing the appeal of vaping to the underage population, the products that are the focus of these warning letters would be their highest priority until the market is completely free of them.

Of course, this would mean the FDA needs to undertake more than simple empty threats like the letters issued. This is particularly true in regard to the manufacturers that are within the United States.

In Summary

The Food & Drug Administration has issued yet another round of warning letters to various small vape manufacturers both inside and outside of the United States. These letters have condemned the production of vape products that are explicitly marketed toward the underage population.

This type of prohibition is arguably only beneficial when it comes to protecting the youth population, unlike flavor bans.

However, given the fact that the majority of these are Chinese companies that are well outside of the agency’s jurisdiction, this can be seen as more of a publicity stunt than a positive action.