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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.

On April 2, three advocacy organizations filed a complaint in the U.S. District Court for the Northern District of California seeking an order directing the U.S. Food and Drug Administration (“FDA”) to promulgate its already-proposed rule banning menthol as a characterizing flavor in combustible cigarettes. The case comes as FDA has missed several internal deadlines for promulgating a final rule on the topic.Continue Reading Advocacy Organizations Sue FDA Over Delay in Menthol Cigarette Ban

We recently reported that several state legislatures are considering bills to establish vapor product directories this year—namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar bills have been introduced in Arizona, Hawaii, Iowa, Nebraska, New York, South Carolina, South Dakota, Vermont, Washington, West Virginia. Additionally, a bill in Oklahoma would update the state’s existing directory framework to be consistent with the proposals of these recent bills. The directories would allow states to prohibit the sale of vapor products that are not authorized by the U.S. Food & Drug Administration (FDA) or subject to a pending premarket application. Like the proposals discussed in our previous coverage, these bills are intended to reduce the proliferation of illicit vapor products. Continue Reading More States Consider Establishing Vapor Product Directories

In early January, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Wages & White Lion Investments, L.L.C. v. U.S. Food & Drug Administration, held that the U.S. Food and Drug Administration’s (FDA) marketing denial order (MDO) of petitioner’s premarket tobacco applications (PMTAs) violated the Administrative Procedure Act (APA).Continue Reading En Banc Fifth Circuit Solidifies Circuit Split on Flavored ENDS Product MDOs

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.Continue Reading Multiple States Consider Establishing Vapor Product Directories

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.

Continue Reading FDA Maintains Heightened Enforcement Against Sellers of Illegal E-Cigarettes

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.Continue Reading FDA Ramps Up Enforcement Against Flavored Disposable E-Cigarettes as External Pressures Mount