Logic's Mint E-Cigarette Approval Revoked by FDA Center Director Despite Scientists' Advice

Recently, according to the third circuit memorandum of the United States Court of Appeals, lawyers for Logic company alleged that the director of the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA), Brian King, allowed for the dismissal of recommendations from FDA scientists and revoked the market approval for Logic Technology's menthol electronic cigarette products.

A motion has been filed with Logic Corporation to suspend the marketing injunction (MDO) against its menthol e-cigarette products, and new documents have been provided to the company.

According to lawyers from Troutman Pepper, new documents being reviewed by Vapor Voice reveal an unusual fact: the Center for Tobacco Products' (CTP) Office of Science (OS) revoked its science-based recommendations for the marketing authorization order of Logic's mint-flavored electronic cigarette (ENDS) prior to its pre-market tobacco product application (PMTA) being approved, after pressure from the new CTP director and the Office of Compliance and Enforcement's (OCE) center director.

According to Logic's lawyer, the company claims the right to retain their mint-flavored product in the MDO of the institution because the Office of the Center Director (OCD) overturned the Office of Science's (OS) approval of Logic's "science-based assessment" and preliminary recommendation for their product. However, the memorandum states that mint is classified as a product that will be "disfavored", and Logic is seeking court recognition that the institution's actions, based on an "unpublished, comprehensive policy" and "product-specific decisions" that were not subject to notice or comment rules, were "arbitrary and capricious".

In the October 25 memo, the operating system stated that it evaluated Logic Company's pre-market tobacco product application (PMTA), including its product-specific evidence, and concluded that the authorization of marketing Logic's menthol-flavored ENDS is appropriate for protecting public health (APPH). However, the memo reveals that the operating system only changed course after the director of the new Center for Tobacco Products (CTP) and the Office of Center Director (OCD) reached the conclusion that menthol-flavored ENDS should be considered a "disfavored" product category despite conflicting evidence, as reported by the Office of Science (OS).

The OS memorandum stated, "From a policy perspective, at the time, OS believed that as long as menthol cigarettes were still on the market, menthol-flavored ENDS could directly replace them, providing a less harmful alternative for smokers of menthol cigarettes. Compared to non-menthol smokers, they were less likely to successfully quit smoking.

According to OS, this suggests that there are potential benefits in increasing usage and transition opportunities, and evidence specific to certain products suggests that even ENDS products that are no greater than tobacco-flavored could have a greater potential for smoking cessation or significant reduction in smoking.

Subsequently, OCD raised questions about OS's recommendations, including the adequacy and relevance of scientific literature regarding the differing preferences of adult menthol smokers for menthol, ultimately indicating possible behavioral changes. OCD also highlighted concerns about the significant appeal of menthol to young people. As of July 2022, the decision on Logic PMTA was still pending when CTP transitioned to Brian King as the new center director.

According to a memorandum, OS shared their views with the newly appointed center director and openly discussed various topics including literature, clinical studies related to Logic, usage risks, and potential post-marketing requirements. Following the meeting, a senior scientific consultant specializing in OCD shared their perspective with OS, highlighting the significant risks to young people and the lack of evidence supporting the practical difference between using tobacco flavoring versus menthol flavoring. As a result, the approach to menthol flavoring should be the same as other flavorings, only approving products if evidence shows that the benefits of menthol flavoring outweigh the risks to young people. This led OS to change their direction and their approval of Logic marketing.

The second memo restated the same policy shift and suggested convening a meeting to address concerns raised by operating system personnel about the appropriateness of the decision-making process behind the refusal of Logic peppermint PMTA. The operating system also expressed concern that the new OCD method would eliminate all ENDS products that do not contain tobacco flavors.