On Monday, a unanimous panel of the Fourth Circuit Court of Appeals in the United States rejected Avail Vapor's request to invalidate the marketing denial order (MDO) issued by the Food and Drug Administration for its electronic cigarettes.
On Monday, Circuit Judge J. Harvie Wilkinson wrote that Avail, by focusing on procedural objections rather than FDA protections for public health, "encourages us to ignore the forest for the trees." Circuit Judges Diana Gribbon Motz and Albert Diaz joined Wilkinson in his opinion.
According to a copy of the ruling obtained by Vapor Voice, the court rejected all of Avail's arguments, including the claim that the FDA's review of its pre-market tobacco product application (PMTA) was arbitrary and capricious.
We believe that Avail's remaining argument holds no value, which is that the FDA acted arbitrarily and capriciously when reviewing the applicant's PMTA," the decision stated. "The FDA does not allow young people to view e-cigarettes as another Baby Ruth or Milky Way, only to find themselves addicted to nicotine in a secretive manner. This is hardly insignificant.
The main complaint of Avail is that the FDA has imposed a new "comparative efficacy" standard that requires applicants to prove through certain long-term studies that their fruit and dessert-flavored products are more effective in promoting smoking cessation than tobacco-flavored products.
Avail complained that the adoption of the standard did not provide an explanation to applicants nor consider their vested interests. Avail also raised substantial objections, arguing that the FDA's implementation of the comparative effectiveness standard exceeded its statutory authority under the TCA.
Firstly, Avail attempted to connect certain forms of evidence and types of research in the rapidly growing area of FDA regulations. Secondly, the decision noted that Avail encouraged us to focus solely on the trees and ignore the forest when it comes to the key procedures. "Avail essentially asserts that the FDA is willing to consider certain forms of evidence, explicitly stating that it requests the FDA to accept such evidence as meeting the legal requirements, even if the FDA finds the evidence unsatisfactory," the decision stated.
According to the decision, Avail also submitted a marketing plan to its PMTA which outlines measures to prevent underage use. These measures include using "non-descriptive and non-characteristic names" to label its flavored e-liquids, which cannot identify the product flavor, to prevent attracting young people.
The agency has denied Avail's application for flavored electronic cigarettes, citing that the product poses a serious risk to teenagers without sufficient offsetting benefits for adults. The decision states that the agency will uphold its ruling and reject Avail's request for a review.
The judge explicitly stated that he disagreed with the decision of the 11th Circuit Court of Appeals to postpone the FDA's issuance of the MDO to Bidi Vapor. Insiders familiar with the Avail lawsuit indicate that applying for a rehearing before the Supreme Court would be a strong case.
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