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.