In connection with FDA Commissioner Scott Gottleib’s July 2017 announcement regarding a new comprehensive nicotine strategy, the FDA gave manufacturers an extension to comply with certain deadlines under the Deeming Regulations. The extension governed all premarket review submissions for newly-deemed products and “applie[d] only to compliance deadlines relating to . . . substantial equivalence exemption requests (SE EX requests), substantial equivalence reports (SE reports), and premarket tobacco product applications (PMTAs).”
A contingent of anti-tobacco advocacy and public health groups has now filed a Complaint challenging these extensions. The case is American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.), and the Complaint forwards three counts regarding the FDA Guidance that granted the extension:
- Count I: “The Guidance Is Ultra Vires and Unconstitutional;”
- Count II: “The Guidance Violates the APA’s Requirements for Notice-and-Comment Rulemaking;” and
- Count III: “The Guidance is Arbitrary and Capricious.”
In short, the Plaintiffs contend that the Tobacco Control Act leaves the FDA no authority to grant the deadline extensions and, further, that the FDA’s action amounts to an abdication of duty in violation of the pertinent statutes as well as the “Take Care Clause,” found in Article II, § 3 of the U.S. Constitution. Plaintiffs further attack the procedure by which the FDA issued the Guidance, and the reasonableness of the Guidance itself, under the Administrative Procedure Act.
The case remains in its early stages, having only been filed on March 27, 2018. It will be interesting to see how the FDA responds, including how it addresses the Plaintiffs’ standing to file the suit. Normally standing is substantially more difficult to establish where, as here, the plaintiff is not the subject of the challenged government action.
We will monitor for further updates.