Court Grants FDA’s Request for Extension of Premarket Review Submission Deadline for Deemed Tobacco Products in Light of COVID-19; Agency Issues New Round of Warning Letters to CBD Retailers

Jonathan A. Havens
Published April 24, 2020

On April 23, 2020, the U.S. District Court for the District of Maryland granted the U.S. Food and Drug Administration’s (FDA or the Agency) request for an extension of the submission deadline for certain deemed tobacco product premarket review applications. FDA requested the extension on March 30, 2020, citing the “extraordinary circumstances” of the COVID-19 outbreak for the delay. The new deadline for applications for premarket review for deemed e-cigarettes, cigars, and other new tobacco products is September 9, 2020.

As we previously discussed here, here, and here, on July 28, 2017, FDA announced a comprehensive plan to overhaul the Agency’s tobacco regulatory efforts. Under this plan, the deadline for marketing applications for non-combusted products such as electronic nicotine delivery systems (ENDS) or e-cigarettes was August 8, 2022. However, the U.S. District Court for the District of Maryland moved this deadline up significantly by order to May 12, 2020. This latest 120-day extension, which FDA requested “[s]olely as a result of the pandemic and these exceptional and unforeseen circumstances” gives manufacturers even more time to prepare marketing applications for relevant products.

FDA requested the extension after receiving feedback from the tobacco industry, in which stakeholders expressed concern over meeting the May 2020 deadline in light of COVID-19 related laboratory disruptions, facility closures, and travel restrictions. FDA also noted that a number of Center for Tobacco Products (CTP) employees have been deployed to assist with COVID-19 efforts as part of the Public Health Service, and thus the Agency has fewer personnel available than usual for premarket application review.

At the same time, however, FDA stressed that it remains committed to prioritizing enforcement of e-cigarette products that appeal to minors, a policy which the Agency announced via guidance in January 2020 (discussed here). FDA began enforcing the guidance in early February 2020 and has since conducted over 2,300 inspections of brick-and-mortar shops and online retailers, and has issued 40 Warning Letters related to the same. Although the Agency has suspended physical inspections in light of the COVID-19 pandemic, FDA remains “committed to implementing the enforcement priorities outlined in the January 2020 guidance,” meaning retailers and manufacturers should make efforts to comply, if they have not done so already.

Also on April 23, 2020, FDA announced that it had issued two new Warning Letters to cannabidiol (CBD) firms for making claims related to CBD use in treating opioid use disorders and other serious medical conditions. The Warning Letters (here and here) are consistent with FDA’s prior CBD enforcement efforts, which have targeted companies that make particularly aggressive health claims (discussed here). FDA separately issued two Warning Letters earlier this month to CBD companies claiming to treat COVID-19 symptoms (here and here).

These enforcement measures follow the Agency’s March 2020 update and its report to Congress on its efforts to define a regulatory approach for CBD products. Both the update and the report (which the Agency was required to provide under the language of the Further Consolidated Appropriations Act) emphasize that FDA still has concerns about the potential safety risks of using CBD and about problems related to a number of currently marketed CBD consumer products under FDA jurisdiction, including delta-9 tetrahydrocannabinol (THC) contamination and suspect marketing practices. Notably, however, FDA stated in its report that it is “actively considering potential pathways for certain CBD products to be marketed as dietary supplement . . . and we are actively evaluating potential rulemaking to allow CBD in dietary supplements.” While this is a significant step for the Agency, it remains to be seen what the parameters of such rulemaking (if any) might looks like. FDA also did not provide any sort of timeline for either making a decision on whether to undertake rulemaking or, if it does decide to promulgate a rule, when that would happen. 

FDA announced in its recent CBD update that it was re-opening indefinitely the public docket initially established for its May 2019 public hearing, with the goal of gaining additional scientific data on CBD. Interested stakeholders should submit any relevant information to the Agency to help inform its regulatory treatment of CBD going forward.

We will continue to closely monitor this space as FDA’s regulatory approaches to ENDS and CBD products evolve. In the meantime, if you have questions regarding an issue raised in this post, please contact the authors or the attorney at the firm with whom you are regularly in contact.

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