Memos recently submitted to the U.S. Court of Appeals for the 3rd Circuit show that the Food and Drug Administration’s Center for Tobacco Products (CTP) allowed its director, Brian King, to reverse a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. The new documents were made available to Logic after it had filed its motion for a stay of its marketing denial order (MDO) for its menthol vaping products.
Attorneys for Logic, which is represented by Troutman Pepper, stated that the new documents reveal the “extraordinary fact that CTP’s Office of Science (OS) reversed its science-based recommendation to issue marketing granted orders for Logic’s premarket tobacco product applications (PMTAs) for its menthol-flavored electronic nicotine-delivery systems (ENDS) after receiving pressure from the new CTP director and his office, the Office of Center Director (OCD).”
Logic attorneys claim the company is entitled to a stay of the agency’s MDO for the Logic menthol products because the OCD overruled the OS’ initial recommendations to approve Logic’s products based upon its “science-based evaluation” of Logic’s submission. However, because the OCD said in the memos that menthol as a category would be “treated disfavorably,” Logic is asking the court to recognize that the agency’s actions of “basing product-specific decisions” on “unpromulgated, across-the-board policies” that were never subject to notice-and-comment rulemaking is “arbitrary and capricious.”
In the first memorandum, dated Oct. 25, the OS explains that it evaluated Logic’s PMTAs, including its product-specific evidence, and concluded that authorization of the marketing of Logic’s menthol-flavored ENDS was appropriate for the protection of public health. However, the memo shows that the OS changed course after the new CTP director and the OCD, to whom the OS reports, concluded that menthol-flavored ENDS should be treated as a “disfavored” product category despite the evidence to the contrary.
The second memorandum reiterates the same policy shift and suggests that meetings were held to address the concerns of OS staff regarding the appropriateness of the decision-making process behind the denial of Logic’s menthol PMTAs. The OS also had concerns that the new OCD approach would eliminate all nontobacco-flavored ENDS products.
Earlier this week, a unanimous panel of the United States Court of Appeals for the 4th Circuit denied Avail Vapor’s petition to have its MDO invalidated. Avail also argued that the FDA’s review process for PMTAs, although not specifically menthol, were arbitrary and capricious.
The U.S. Court of Appeals for the 11th Circuit stayed an MDO issued by the FDA to Bidi Vapor earlier this year, which also argued the agency’s rulemaking was arbitrary and capricious.
These two rulings were all made before the release of the Logic documents. Industry experts suggest that this revelation of FDA memos could be “game changing” for industry lawsuits.
