FDA and Triton Argue in Court Filings

After yesterday’s news that the FDA has authorized one vaping product to be sold—and only in a tobacco flavor—the independent industry’s efforts to challenge the agency on legal grounds become more important. As of today, there are some updates to report.

FDA responds to Triton Distribution’s emergency motion for a stay

The FDA has responded to Triton Distribution’s Oct. 6 emergency motion for a stay of the agency’s Marketing Denial Order (MDO). A stay could allow Triton to continue selling its flavored vaping products while the court considers Triton’s petition for review (although the FDA disputes that).

Triton Distribution’s legal company name is Wages and White Lion Investments, LLC. The company is located in Richardson, Texas, and manufactures e-liquid under its own brand names, and under contract for other manufacturers. Some of the brands denied by the FDA in Triton’s PMTA submissions include Suicide Bunny, Boiler Maker, Vape Hooligan, Chewy Clouds, and Teleos.

In its response to Triton’s emergency motion, filed Oct. 12 in the 5th Circuit Court of Appeals, the FDA’s Justice Department lawyers argue that “there is an epidemic of e-cigarette use by children and adolescents, and that the epidemic is fueled by the availability of flavors such as candy and fruit, which are used to initiate approximately 90% of underage users.”

Therefore, says the FDA, “In light of the clear evidence that flavored e-cigarettes attract youth to an addictive product, FDA determined that the [Tobacco Control Act’s] public-health standard would be satisfied only by robust and reliable evidence of countervailing benefits. FDA concluded that petitioner had not presented such reliable evidence.”

But the FDA offers no evidence that it is the flavors that attract youth to vaping. The agency merely asserts that it is so, based on prevalence of use. They offer no proof that teenage vaping would cease without the existence of non-tobacco flavored products. Nor does the FDA offer “product-specific evidence” that Triton’s e-liquids currently are used by youth.

The agency merely states that 85 percent of youth begin vaping with flavored products, as though that is justification for eliminating products that millions of adults prefer. The FDA’s logic seems to be that since some teenagers use these products, they obviously cannot be marketed responsibly to adults.

The agency knows from 2021 National Youth Tobacco Survey results that open-system products like Triton’s e-liquids are used by just 7.5 percent of school-age vapers—or 0.7 percent of all youth. It also knows that flavored e-liquids are the overwhelming preference of adult vapers who quit smoking using open-system products.

The FDA has been calling the growth of teen vaping an “epidemic” since 2018, and it published industry PMTA guidance in 2019. But it wasn’t until Aug. 26, 2021—the same date it began issuing MDOs for flavored vaping products—that the agency publicly announced that manufacturers must provide “product-specific” evidence that each product submitted “to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”

Until that point, the agency had indicated that PMTA submissions could use existing, non-product-specific data to illustrate that flavored products had value. This is the "bait and switch" referred to in Turning Point Brands' court filings.

The FDA’s Justice Department lawyers note in their response to Triton's motion that the court cannot force the FDA to authorize Triton’s products or compel the agency to allow them to remain on the market by issuing a stay. (All current vaping products, except the Vuse Solo, only remain on the market because of FDA enforcement discretion.) They do say that Triton “is entitled to seek judicial review of the FDA denial order, and, if petitioner were to prevail, FDA would reconsider the application in accordance with this Court’s opinion.”

Triton’s emergency motion asks the court to decide by Oct. 15, so we may still see more news on this case before the weekend.

October 14th update: Triton responds to the FDA

In its Oct. 14 response to the FDA filing, Triton notes that while a stay issued by the court doesn't make Triton immune from FDA enforcement, it would return Triton's products to the pre-MDO status quo—meaning the company's products would be among the FDA's lowest priorities for use of its enforcement discretion. "A stay of the MDO would thus provide a practical, real-world remedy to Triton," says the company.

Triton also provides legal precedent for requiring the FDA to provide notice before changing its PMTA requirements. Notice is required, says Triton, "not only on formal regulations issued by an agency, but also the 'other public statements by the agency'." This is important because the FDA claims that its previous statements about acceptable evidence supporting flavored products came in guidance and not formal rules.

In fact, there was no formal PMTA Rule in place when Triton's PMTA was denied. FDA did not publish its final PMTA Rule until Oct. 4, 2021—more than five years after the Deeming Rule that established FDA authority over vaping products took effect!

As for FDA's denial of Triton's (and hundreds of other companies') PMTAs because they provided no "product-specific" scientific evidence that their flavored e-liquids would escape youth use, Triton explains that youth aren't using their products now because the company takes precautions to keep them out of underage hands.

Triton says it "markets its products only through age-gated specialty shops and websites requiring age verification, and only markets to existing users of cigarettes and vaping products—points that FDA utterly ignored....Unlike the products FDA did approve [Vuse Solo], because of these efforts, Triton’s brands are not identified as among those used by youth. FDA’s MDO was arbitrary and capricious because it relied on generalized data without considering alternative, conflicting, or individualized information specific to Triton or its products that contradicted FDA’s preconceived notions."

Generalized explanations for PMTA denials "given to all applicants with flavored products with no individualized consideration are not a 'hallmark of good government'...but a blatant violation of the [Administrative Procedure Act] and the rights of individual applicants."

Turning Point Brands voluntarily drops its petition for review

After the FDA rescinded its MDO for hundreds of Turning Point Brands (TPB) e-liquids, the company moved to voluntarily dismiss its petition for review by the 6th Circuit Court of Appeals. The court today granted the motion and dismissed the petition.

TPB can appeal later if the FDA denies its PMTAs (which are now back under review) again, but for now its products can be sold—perhaps with more confidence than any other vaping products currently on the market. The FDA said in its rescission letter that, “in light of the unusual circumstances,” the agency has no intention of initiating enforcement actions against the products under review, and would first issue a warning letter to the company if it decided to enforce.

TPB received an MDO covering 490 of its products on Sept. 14, and filed a petition for review with the Sixth U.S. Circuit Court of Appeals on Sept. 23. Manufacturers have 30 days after receiving an MDO to file petitions for review with a federal circuit court of appeals or an administrative appeal with the FDA. TPB filed its emergency motion for a stay on Sept. 30.

More MDO challenges filed in 5th Circuit Court of Appeals

Since our last update on Oct. 8, at least three more vape manufacturers have filed petitions for federal court reviews of their MDOs. All three were filed on Oct. 11 in the 5th Circuit Court of Appeals in New Orleans:

Not counting Turning Point Brands, at least eight petitions for review have been filed so far in federal court. Only Triton Distribution is known to have filed an emergency motion for a stay. It is possible additional petitions or motions have been filed that haven’t yet been publicly released.

RJ Reynolds Vuse Solo flavors receive MDOs

While it’s not exactly breaking news (we reported it yesterday), it may be significant that the FDA issued MDOs for Vuse Solo cartridges in flavors other than tobacco. (The Vuse Solo menthol flavor is still under review, according to the FDA.)

If Reynolds decides to pursue judicial review of its MDOs, the FDA and Justice Department could face a more well-equipped foe than the independent manufacturers it has squared off with so far in court. On the other hand, Reynolds may save its legal powder for a fight over its much more popular (and effective) Vuse Alto, a pod vape that owns a big chunk of c-store/gas station market share.

The FDA has not updated itspublic MDO list since Sept. 22 (not even to add RJ Reynolds), and none of the manufacturers on the public list have received an MDO since Sept. 17 (63 companies are not publicly listed because, the FDA says, their PMTAs were for products not currently being marketed).

The FDA has so far issued MDOs to 323 vape manufacturers (324 if you add RJ Reynolds). On Oct. 7 the FDA issued warning letters to 20 companies for selling products that have received MDOs.