The US Food and Drug Administration has authorized the sale of Vuse e-cigarette products in the past few days. Although only tobacco-flavored products have been authorized, some recent developments have emerged today. The U.S. Food and Drug Administration (FDA) responded to Triton Distribution’s October 6 emergency suspension motion, which required the suspension of the FDA’s Marketing Denial Order (MDO).

When the court considered Triton's application for review, the suspension order could allow Triton to continue to sell its flavored e-cigarette products (although the FDA has objected to this). The legal company name of Triton Distribution is Wages and White Lion Investments, LLC. The company is located in Richardson, Texas. It produces e-liquid under its own brand and produces it for other manufacturers under contract. In the PMTA submitted by Triton, some of the brands rejected by the FDA include Suicide Bunny, Boiler Maker, Vape Hooligan, Chewy Clouds and Teleos. In response to Triton’s emergency motion submitted to the Fifth Circuit Court of Appeals on October 12, FDA’s Justice Department lawyers stated: “E-cigarette use by children and adolescents is common, and the supply of flavors such as sweets and fruits has contributed to this. In this epidemic, these flavors are used to entice about 90% of underage users.” The FDA said that in view of clear evidence that flavored e-cigarette products can make teenagers addicted, under the Tobacco Control Law, the petitioner had to pass Strong and reliable counterproductive evidence can meet public health standards, but Triton Distribution did not provide such reliable evidence. However, the FDA did not provide any evidence that it is the taste that attracts young people to smoke e-cigarettes.

The FDA only asserts this based on the universality of use. They did not provide evidence that if there were no non-tobacco-flavored products, teenagers would stop smoking. The US Food and Drug Administration also did not provide "product-specific evidence" to prove that Triton's e-liquid is currently used by teenagers. The FDA just said that 85% of young people start to use flavored products, which seems to be the reason to eliminate products that millions of adults like.

The logic of the US Food and Drug Administration seems to be that since some teenagers use these products, they obviously cannot be sold to adults in a responsible manner. This logic is not self-consistent.

The agency knows from the results of the National Youth Tobacco Survey in 2021 that only 7.5% of school-age smokers use open-system products like Triton’s e-liquid, or 0.7% of all adolescents. In addition, flavored e-liquid is an overwhelming preference of adult smokers who use open system products to quit smoking

Excluding Turning Point Brands, so far, at least eight applications for review have been submitted to the Federal Court.

Since 2018, the FDA has been calling the growth of youth smoking an "epidemic", and it issued industry PMTA guidelines in 2019. However, it was not until August 26, 2021, the same day it began to issue MDOs for flavored smoking products, that the FDA publicly announced that manufacturers must provide evidence of "specific products" and that each product submitted "must be certified There are sufficient benefits for adult smokers to overcome the risks to young people.” Prior to this, the FDA had stated that the submitted PMTA could use existing, non-specific product data to illustrate the value of flavoring products. This is the "bait and conversion" that Turning Point Brands mentioned in the court documents. In response to Triton’s motion, the U.S. Food and Drug Administration’s attorneys pointed out that the court cannot force the U.S. Food and Drug Administration to authorize Triton’s products, nor can it force the agency to issue a suspension order to allow these products to continue to be sold on the market. . (Except for Vuse Solo, all current e-cigarette products are only on the market because of the FDA's enforcement discretion.

They did say that Triton has the right to seek judicial review of the FDA's denial order, and that if the petitioner wins, the FDA will reconsider the application based on the opinion of this court. Triton’s urgent motion requires the court to make a decision before October 15, so we may still see more news about the case before the weekend. After the U.S. Food and Drug Administration revoked the MDO for hundreds of Turning Point Brands (TPB) e-liquids, the company filed a voluntary withdrawal of the review of the Sixth Circuit Court of Appeals. The court approved the motion today and rejected the petition. If the FDA rejects its PMTA again (and now begins to review it again), TPB can appeal in the future, but now its products can be sold, perhaps more confident than any other e-cigarette products currently on the market. The FDA said in its cancellation letter, “In view of the unusual circumstances, the agency has no intention to initiate enforcement actions against the product under review. If it decides to enforce the law, it will first issue a warning letter to the company.”

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