On January 2, 2020, the FDA issued guidance concerning its enforcement priorities for electronic nicotine delivery systems (“ENDS”) and other deemed products on the market lacking premarket authorization (the “Guidance”). Just over a month later, the Comptroller of the State of Maryland has announced that the State will increase its enforcement against certain flavored ENDS products. The State purports to shore up a “loophole” in the FDA’s Guidance.
The FDA’s Enforcement Priorities
As this blog reported, the Guidance announced the FDA’s intent to prioritize enforcement against:
- “[a]ny flavored, cartridge-based ENDS products (except for tobacco- or menthol-flavored products;”
- “[a]ll other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access;”
- “[a]ny ENDS products targeted to, or whose marketing is likely to promote use by, minors;” and
- “any ENDS product that is offered for sale after May 12, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application).”
While the FDA’s enforcement policy categorically targeted cartridge-based ENDS products with flavors other than tobacco or menthol, it did not prioritize enforcement against “any non-cartridge-based flavored ENDS products for enforcement where the manufacturer is taking adequate measures to prevent minors’ access to these products.” Thus, the Guidance did not categorically prioritize enforcement against disposable ENDS with flavors other than tobacco or menthol.
The FDA stated that “youth overwhelmingly prefer cartridge-based ENDS products,” and the FDA sought to “strike an appropriate balance between preventing youth access to ENDS products and maintaining availability of potentially less harmful options for current adult smokers who have transitioned or wish to transition completely away from combusted tobacco products.”
On February 10, 2020, Maryland Comptroller Peter Franchot responded that the State would “take more aggressive action” by prohibiting cartridge-based ENDS products with flavors other than tobacco or menthol, as well as disposable ENDS with flavors other than tobacco or menthol. According to a press release from the Comptroller’s office, the FDA’s Guidance left a “loophole” for “flavored disposable e-cigarettes, which are growing in popularity among youngsters.”
The same day, the Comptroller’s Field Enforcement Division issued a Bulletin (the “Bulletin”) to the effect that wholesalers and retailers must cease all sales and marketing of cartridge-based and disposable ENDS products containing flavors other than tobacco or menthol. Specifically, “[t]he Comptroller’s Field Enforcement Division is prioritizing its enforcement actions against . . . cartridge-based and disposable [ENDS] with flavors other than tobacco or menthol.” The Bulletin says that these are the “products most widely used by children.”
The Bulletin cites Md. Bus. Reg. § 16.7-207(a)(5), which allows the Executive Director of the Alcohol and Tobacco Commission to deny an ENDS license application, reprimand an ENDS licensee, or suspend or revoke an ENDS license, if the applicant/licensee “violates federal, State, or local law regarding the sale of electronic smoking devices.” The Comptroller and the Field Enforcement Division appear to be invoking federal law, insofar as ENDS products are being sold without FDA marketing orders.
This is a significant development for ENDS manufacturers that are complying with FDA guidance. The FDA has balanced its enforcement policies, but States such as Maryland may move to enforce where the FDA has determined it best to hold off. Time will tell how or if other States follow Maryland’s example.