As discussed in our earlier post, the U.S. Food and Drug Administration’s (FDA) new draft guidance on flavored electronic nicotine delivery system (ENDS) products represents a meaningful effort to provide additional clarity about the Agency’s evidentiary expectations for premarket tobacco product applications (PMTAs). That clarity is welcome. At the same time, the draft guidance
On July 24, 2023, Keller and Heckman Partners Eric Gotting and Azim Chowdhury, along with co-counsel, on behalf of members of the Electronic Nicotine Delivery Systems (ENDS) industry[i], filed an amicus brief with the Supreme Court of the United States (SCOTUS) in support of petitioners in Loper Bright Enterprises v. Raimondo[ii]
Beyond the Food and Drug Administration (FDA) and Tobacco Control Act requirements that now apply to deemed tobacco products, manufacturers and retailers of vapor products, and particularly e-liquids, also face stringent environmental and waste management regulations and compliance issues that are significantly more complex than those faced by cigarette and traditional tobacco product companies. This
