Compliance

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We recently discussed the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products’ (CTP) strategic plan intended to guide CTP’s activity for the next five years. On the same day, CTP released its annual regulation and policy guidance agenda, which “outlines rules and guidance documents that are in development or planned for development.” Below, we discuss CTP’s current priorities for new regulations. CTP’s policy agenda is important because it identifies the areas CTP views as most in need of regulation or guidance, and the key actions it plans to take in those areas.

Recently, NJOY LLC filed a complaint in the U.S. District Court for the Central District of California against more than 30 foreign and domestic defendants that manufacture, market, distribute, and sell tobacco products in an (indirect) effort to force them to comply with federal and state laws. R.J. Reynolds Tobacco Company and R.J. Reynolds Vapor Company (collectively, RJR) also recently filed a complaint with the U.S. International Trade Commission (ITC) against more than 25 foreign and domestic manufacturers, distributors, and retailers (collectively, the respondents) that seeks to prevent the import and resale of certain tobacco products. These lawsuits serve as two examples of how industry is trying to take independent legal action to target allegedly noncompliant actors and force them to comply with applicable law.

As we previously reported, most states authorize direct-to-consumer (DTC) shipments of wine if the shipper has obtained the correct license, but this area of law has continued to evolve through litigation. Recently, the Virginia Court of Appeals decided a case involving whether an out-of-state online wine retailer (the retailer) was required to maintain multiple licenses for multiple out-of-state locations. This case should be of interest to any multistate wineries, breweries, or retailers selling and shipping wine or beer to consumers.

The Oregon Legislature’s 2023 regular session kicked off with a bang for the tobacco industry when House Bill 2128 (HB2128) was introduced at the request of Attorney General Ellen Rosenblum who also happens to the be president-elect of the National Association of Attorneys General. If passed, HB2128 would replace Oregon’s escrow deposit system, applicable to tobacco product manufacturers that are nonparticipating manufacturers (NPMs) under the Master Settlement Agreement (MSA), with an equity assessment. While HB2128 was only recently introduced and has a number of hurdles to overcome before it becomes law, we are not aware of any other state that has made a similar proposal to retroactively change escrow deposit systems for NPMs. Thus, HB2128 is worth monitoring, not only for its potential impact to Oregon NPMs, but also to see whether similar legislation will be introduced in other states.

As discussed here, on October 19, the Fifth Circuit Court of Appeals in Community Financial Services Association of America Ltd. (CFSA) v. Consumer Financial Protection Bureau (CFPB) held that the CFPB’s funding mechanism violates the appropriations clause because the CFPB does not receive its funding from annual congressional appropriations like most executive agencies, but…

In October 2022, the U.S. Food and Drug Administration (FDA) announced that the Department of Justice (DOJ), on its behalf, filed complaints against six electronic nicotine delivery system (ENDS) companies in federal district courts, seeking permanent injunctions. These cases are important because they mark the first time the FDA has litigated against companies to enforce…

The Senate recently passed the Medical Marijuana and Cannabidiol Research Expansion Act (the Act) by a voice vote after the House of Representatives passed the bill with strong bipartisan support (325-95) last July. The Act is the first stand-alone marijuana legislation passed in decades and, according to some news sources, President Biden will likely…

On August 2, 2021 and March 3, 2022 we reported on Executive Order 14036 (E.O. 14036) and the subsequent Treasury report entitled, “Competition in the Markets for Beer, Wine, and Spirits” (Report), which, among other things, directed the Alcohol and Tobacco Tax and Trade Bureau (TTB) to consider: (1) initiating a rulemaking to…

Several Washington breweries and beer distributors filed suit in federal court against the Oregon Liquor and Cannabis Commission, the State Attorney General, and the Governor. The out-of-state breweries are challenging Oregon laws that (1) allow resident breweries to sell, ship, and deliver beer directly to Oregon consumers with a direct shipper permit, but only allow…

In a recent press release, the Federal Trade Commission (FTC) issued its second e-cigarette report, analyzing domestic sales and marketing trends for the years 2019 and 2020. While FTC has issued a similar report for cigarettes and smokeless tobacco products since 1967 and 1987, respectively, it only recently decided to analyze this type…