Appeals Court Splits Decision on Myblu MDO Appeal

A federal appeals court today split its decision on myblu vaping products, granting manufacturer Fontem US’s petition for review of the FDA’s marketing denial for the myblu device and tobacco-flavored refill pods, but rejecting the company’s petition for myblu pods in some flavors other than tobacco.

On April 8, 2022, the FDA issued marketing denial orders (MDOs) for the myblu device, several tobacco-flavored refill pods, and an unknown number of pods in other flavors, which were not named in the MDO because they were not currently being marketed (and considered by the FDA to be confidential). (The appeal did not include the myblu menthol refill, which did not receive an MDO until last month, and will have to be appealed separately, if Fontem chooses to do so.)

Fontem US filed a petition for review in the U.S. Circuit Court of Appeals for the District of Columbia Circuit on May 6, 2022. Oral arguments were heard by the court on Jan. 25, 2023.

Today, in a unanimous decision by a three-judge panel, the court found that the FDA, in its marketing denial order (MDO) for the myblu device and tobacco-flavored refill pods, did not “undertake the analysis required for a denial on public health grounds.” Rather, said the court, the agency merely “identified five highly technical deficiencies,” but never explained “how the deficiencies relate to the overall public health consequences of Fontem’s unflavored products.”

(Weirdly, the decision, written by Judge Neomi Rao, consistently describes the myblu tobacco-flavored pods as “unflavored”—apparently reflecting the judge’s (or the whole court’s) mistaken belief that e-liquid naturally tastes like tobacco. All myblu tobacco-flavored products are mixed with artificial tobacco flavoring; the company doesn't sell unflavored products. Propylene glycol and vegetable glycerin (mixed with low levels of nicotine) have no real flavor to speak of.)

The court chided the agency for attempting a shortcut around the “holistic analysis” required to show whether an individual product is “appropriate for the protection of public health” without uniform product standards the FDA has declined to create. Without defined product standards, said the court, the agency must explain its reasoning thoroughly for each marketing denial.

“Under its statutory authority, the FDA may impose requirements to eliminate or reduce “harmful components of the product”; to govern the “construction, components, ingredients, additives, constituents, … and properties” of a tobacco product; to require the “testing” of tobacco products; and to require the results of such tests to meet certain standards,” wrote Judge Rao. “The failure to meet such a standard would be a ground for denying an application, and no public health balancing would be necessary. But because the FDA has not promulgated such regulations and instead has chosen to evaluate Fontem’s application on public health grounds, it must consider all the relevant public health considerations, including the benefits of the product.”

As for the myblu products in non-tobacco flavors, the court trusted the FDA’s judgment that flavored vapes “have significant appeal to youth and are associated with youth initiation of such products,” and that Fontem did not provide robust evidence proving that flavored products met the required public health standard. It was similar reasoning as was employed by a previous D.C. Circuit panel to reject MDO appeals by four small manufacturers last year.

Fontem US now has two options if it chooses to pursue its MDO appeal for its non-tobacco pods: petition the circuit court for an en banc rehearing (with all active judges on the court rehearing the case), or appeal to the Supreme Court. The company can certainly afford to pursue further appeals—Fontem is a subsidiary of Imperial Brands (the former Imperial Tobacco)—but it isn’t known whether it will.

Dozens of vaping manufacturers have challenged FDA marketing denial orders in court. Notably, a decision is expected soon in the en banc rehearing of Triton Distribution’s MDO appeal.