In an August 2017 Guidance, the FDA gave companies an extension to comply with certain deadlines for premarket review submissions, including “substantial equivalence exemption requests (SE EX requests), substantial equivalence reports (SE reports), and premarket tobacco product applications (PMTAs).”

As discussed before in this blog, a contingent of anti-tobacco advocacy and public-health groups challenged the August 2017 Guidance in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.). The Plaintiffs contend that the FDA’s deadline extensions are unlawful under the “Take Care Clause” of Article II, § 3 of the Constitution and under the Administrative Procedure Act, 5 U.S.C. § 551, et seq.

The Plaintiffs moved for summary judgment on their claims. The FDA also moved for summary judgment, as well as to dismiss the Plaintiffs’ claims. On March 26, 2019, the Court issued a Letter Order based on the FDA’s recent modification of the August 2017 Guidance, as reflected in a March 13 Draft Guidance.

As noted in the Court’s Letter Order,

“Most recently, ‘on March 13, 2019, the FDA published draft guidance that, if finalized, would modify the August 2017 Guidance challenged in this case.’ If finalized, the Draft Guidance would, inter alia, ‘modify the policy of deferred enforcement’ for ‘most flavored e-cigarette products’ and ‘prioritize enforcement of the premarket review requirement’ against most flavored e-cigarette products and all e-cigarette products ‘targeted to minors or likely to promote use . . . by minors.’ Defendants noted that ‘[t]he FDA is accepting public comments on the draft guidance for a 30-day period that closes on April 15, 2019,’ and, ‘[i]f finalized, the agency has proposed that the revisions to its compliance policy take effect 30 days after the publication of a final guidance document.’”

In other words, the March 2019 Draft Guidance (if finalized in substantially the same form) would expose many companies to enforcement action based on the sale and distribution of flavored ENDS (other than tobacco-, mint-, or menthol-flavored) and flavored cigars that are presently on the market and, subject to the August 2017 Guidance, were expected to remain on the market into 2021 or 2022 at least.

Based on the FDA’s March 2019 Draft Guidance, the Court denied the parties’ motions without prejudice and subject “to renewal following the FDA’s finalization, or rejection of the Draft Guidance.” The Court observed the following, with respect to the March 2019 Draft Guidance’s effect on the Plaintiffs’ claims:

“[G]iven that the Draft Guidance, if finalized, will supplant the 2017 Guidance—the focus of Plaintiffs’ claims in this lawsuit—and perhaps necessitate an amendment to Plaintiffs’ Complaint, it is premature and would be neither efficient nor a wise allocation of resources to consider Plaintiffs’ Motion for Summary Judgment at this time, when the very guidance that Plaintiffs’ challenge is subject to possible imminent revision.

And the following, with respect to the effect on the FDA’s defenses: “Defendants’ justiciability arguments cannot fairly be considered in a vacuum, when the object of Plaintiffs’ grievances is in flux.”

The Court “caution[ed] . . . that the purpose of this Order is to suspend a ruling on the issues raised by the parties until such time that any decision regarding the revision of the 2017 Guidance has been made, with the expectation that this will be done in the very near future.” The Court would, however, revisit the Order “[s]hould the process become more prolonged” or if it were “determine[d] that the Defendants’ actions [were] for the purpose of delay, rather than to substantively re-evaluate the current Guidance.”

Thus, the Court also ordered that “the parties shall submit a status report every month, beginning on May 15, 2019, informing [the Court] of the status of the proposed revision of the Guidance.”


Obviously, there could be profound effects on the sale and distribution of flavored ENDS (other than tobacco-, mint-, or menthol-flavored) and flavored cigars, depending upon what ultimately comes of the March 2019 Draft Guidance and the litigation in American Academy of Pediatrics.

We will continue to monitor for further updates.