Synopsis

Fresh Farms E-liquid is a manufacturer of e-liquids for electronic cigarettes. On September 3 and Sept 5, 2020, Fresh Farms submitted 22 Premarket Tobacco Product Applications (PMTA) to the U.S. Food and Drug Administration (FDA). On January 4, 2021, FDA issued a Refuse-to-Accept (RTA) action against Fresh Farms’ PMTAs. Fresh Farms challenged the administrative decision on February 3, 2021, in the 9th Circuit. Fresh Farms sought 1) review of the RTA and decision to not grant filing dates for correcting deficiencies, and 2) a judgment that FDA’s decision was arbitrary, capricious, abuse of discretion, and otherwise not in accordance with the law. 

Why It Matters for Public Health

E-cigarettes, and especially flavored e-liquids, are very popular among consumers but especially popular among youth and young adults. FDA non-action against products otherwise lacking marketing-granted authorization permitted these products to remain available for users – including minors, despite federal, state, and local laws regulating the minimum age for sale of such products. FDA action against the manufacturers of flavored e-liquids is informed, in part, by the agency and public health objective of reducing towards eliminating e-cigarette use among youth and young adults.

Background

The Tobacco Control Act requires “new tobacco products,” defined as those that were commercially marketed after February 15, 2007, to go through a premarket review process and receive affirmative marketing orders before being sold in the U.S. In 2016, FDA deemed that electronic cigarette (“e-cigarettes”) and e-liquids were within its regulatory jurisdiction under the Tobacco Control Act, which amended the Food, Drug, and Cosmetic Act. E-cigarettes and e-liquids had been on-market for several years already, and in light of enforcement difficulties resulting therefrom FDA granted a grace period for on-market products before manufacturers would need to submit PMTAs. Following some parallel administrative and court action the deadline for PMTA submissions of this type was set for September 9, 2020 – with final decisions issued by September 9, 2021 for the majority of products (with the one-year between continuing the grace period).

Administrative Proceedings

On September 3 and Sept 5, 2020, Fresh Farms submitted 22 Premarket Tobacco Product Applications (PMTA) to the U.S. Food and Drug Administration (FDA). On January 4, 2021, FDA issued a Refuse-to-Accept (RTA) action against Fresh Farms’ PMTAs, citing that the PMTAs do not meet the regulatory requirements to permit substantive review in accordance with 21 CFR 1105.10(a)(3), (7), (10); and 21 CFR 25.15(a), 25.40(a). FDA, summarily, issued a marketing denial order unless/until Fresh Farms resubmitted new PMTAs that comported to the requirements of Sec. 910(b)(1) of the Food, Drug, and Cosmetics Act.

Proceedings in the Ninth Circuit Court of Appeals

Multiple mediation conferences were scheduled and occurred, utilizing the Circuit Court’s Mediation Program. The Program is designed to facilitate settlement while appeals are pending. As of November, 2021, mediation conferences continue to be scheduled; the Court has asked for a Petitioner Brief by 11/29/2021 and a Reply Brief by 12/29/2021.

Litigation Status

This dispute is ongoing and no final decision has yet been reached.