Photo of Zie Alere

Zie is an associate in the firm’s Regulatory Investigations, Strategy + Enforcement Practice Group. He assists in developing effective strategies to help deter or mitigate the risk of enforcement actions and litigation. As a summer associate, Zie drafted compliance guidelines, worked on pro bono matters, and created analytical memoranda.

This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory bills would create a mechanism for states to bar the sale of products that are not FDA-authorized or subject to a pending premarket application. Like state cigarette directories implemented in connection with the tobacco Master Settlement Agreement, these directories would specify which vapor products are permitted to be sold in the state.

In December, the U.S. Food and Drug Administration (FDA) issued warning letters to online retailers for reportedly selling unauthorized e-cigarette products. Consistent with the Center for Tobacco Products’ (CTP) recent focus, the letters target unauthorized products, which FDA states are particularly appealing to youth — including Lost Mary, Funky Republic/Funky Lands, and Elf Bar/EB Design. These warning letters follow FDA’s recent issuance of civil money penalty complaints against 25 brick-and-mortar retailers for failing to comply with prior warning letters. Those civil money penalty complaints, which we previously discussed here, continued the agency’s approach of seeking the maximum penalty approved by law.

Kentucky

Russell Coleman (R), a Louisville attorney and former federal prosecutor, prevailed over Pamela Stevenson (D), member of the Kentucky House of Representatives, for District 43. Coleman will take over from departing attorney general (AG) Daniel Cameron (R), who was unsuccessful in running for governor against incumbent Andy Beshear (D). Such an outcome suggests that prevailing political headwinds affect AGs differently — despite their overt party affiliations. Coleman will take over the AG post in December.

As a result of a legal challenge by the Oregon Cannabis Industry Alliance and cannabis cultivators in Oregon, the Oregon Health Authority’s (OHA) aspergillus fungus testing rule for marijuana, marijuana products, and industrial hemp concentrates and extracts has been withdrawn, and 2,500 pounds of marijuana plus 65,000 units of infused pre-rolls that failed aspergillus testing were released from administrative hold.

In September, the U.S. Food and Drug Administration (FDA) issued two new rounds of warning letters to online retailers, manufacturers, and distributors for reportedly selling or distributing unauthorized e-cigarette products. Notably, FDA’s most recent letters target several popular disposable flavored products, including Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech, which FDA states are particularly appealing to youth. FDA also sought civil money penalties against 22 retailers for failing to comply with prior warning letters and, for the first time, sought the maximum penalty allowed by law.