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November 16, 2022

FDA Issues (More) Meaningless Warning Letters

The FDA has issued warning letters to five manufacturers for selling vape products that supposedly “target youth.” Four of the cited companies are located in China, and apparently have no U.S. addresses. One has been warned before for selling the very same product—with no consequences.

“The FDA is committed to keeping tobacco products out of the hands of our nation’s youth,” said FDA Center for Tobacco Products Director Brian King. “The agency will continue to hold companies accountable for illegally selling e-cigarettes, particularly those that shamelessly target youth.”

FDA doesn’t regulate Chinese manufacturers, so why warn them?

The vape devices named in the warning letters are all novelty products designed to look similar to toys (and popsicles), or have cartoon images imprinted on them. They are not popular or widely available products. But the FDA occasionally decides to issue meaningless warnings to novelty product manufacturers in order to encourage lazy reporters to play up the agency’s fearsome enforcement actions.

The FDA includes photos in their warning letters (see below)—neatly labeled “Exhibit A” and “Exhibit B”—so manufacturers can fully appreciate how children might be confused and attracted to their products. As a side benefit, FDA beat reporters can include the warning letter images in their outraged stories.

Since 2018, the FDA has warned manufacturers for selling novelty e-liquid bottles, wristwatch and fidget spinner vapes, and once issued a warning to an online Chinese seller of pure nicotine, a highly dangerous product most people didn’t know was available for sale until the FDA publicized it with a press release.

In August, the agency warned a Florida manufacturer of low-strength nicotine gummies—a unique product barely anyone knew existed. FDA Commissioner Robert Califf described the little-known candies as a “public health crisis just waiting to happen among our nation’s youth.” The product may have been discontinued before the FDA issued its press release.

Companies in China—like those cited today—manufacture products for sale around the world, not just in the United States. The FDA cannot enforce its rules for U.S. manufacturers against Chinese companies, or against retailers in other countries. But sending meaningless warning letters and issuing indignant press releases is a cost-effective and painless substitute for enforcing the millions of marketing denial orders (MDOs) it has issued to small American manufacturers, especially since some of those companies decide to fight back in court.

FDA won’t allow adult marketing but is outraged at 90s nostalgia

One of the companies named today, Wizvapor, received a warning for selling vaping products shaped like the 1990s-era handheld gaming device the Nintendo Game Boy, along with vapes shaped like a pager (look it up) and a tiny walkie-talkie.

According to the FDA’s press release, Wizvapor’s novelty vapes are “likely to promote use of the product by youth by imitating children’s toys and gaming products.” But would children in 2022 even recognize a Game Boy? The handheld Nintendo device launched in 1989, and would probably appeal more to nostalgic 45-year-olds than today’s teenagers.

It’s worth noting that the FDA warned Wizvapor previously for selling the very same product. Apparently the Chinese company ignored the mighty U.S. agency in 2020. Now they’ll understand the frightening consequences of blowing off an FDA warning: you get another one.

The manufacturers were also warned for selling products that have not received FDA authorization through the premarket tobacco application (PMTA) process. But that took a back seat today in the FDA’s public communications, which were squarely focused on the “child-appealing” imagery.

“The designs of these products are an utterly flagrant attempt to target kids,” said CTP director King. “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.”

Maybe so, but King’s outrage is a little misplaced. He should know better than anyone that American vaping product sellers aren’t allowed—under FDA rules—to market their wares as smoking cessation products. They aren’t even allowed to say they’re safer than cigarettes, or that they don’t emit smoke, or that they’re a good alternative.

As long as the FDA criminalizes adult marketing that accurately describes e-cigarettes as better choices for people who smoke, King and his agency can look forward to sending many more meaningless warning letters. Which is probably just fine with them.

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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John Hastings
John Hastings
18 days ago

The point you guys are apparently missing is this is a shot over the bow for manufacturers. The FDA will now begin going after manufacturers. Real ones next time. I hope vape industry insiders take this and Prop 31 as dire warnings enforcement is coming. Stop buying the false notion the FDA isn’t enforcing. They are. Bigly.

John Hastings
John Hastings
17 days ago
Reply to  Jim McDonald

As you said Jim, the major companies have been receiving warning letters for years now. That’s a warning. But there are companies who aren’t taking it seriously because the general consensus has been that they won’t start enforcing. This last stunt by the FDA is showing those doubters that they ARE enforcing. Do you have any idea how much it costs to legally destroy nicotine products you cannot sell or give away??? Vaping 360 ought to do an article on just that subject. How much LEGAL disposal costs, and what’s involved.