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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.

Continue Reading ENDS Companies Take Legal Action Against Allegedly Noncompliant Competitors

On June 8, more than 50 members of Congress signed a letter addressed to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, expressing concerns over FDA’s delays in reviewing pending Premarket Tobacco Product Applications (PMTAs) and its failure to remove unauthorized products from the market. The letter strongly urges “FDA to (1) expeditiously complete review of remaining e-cigarette PMTAs; (2) follow the science on the risks flavored [e-cigarettes] pose to youth and deny PMTAs for all non-tobacco flavored e-cigarettes, including menthol flavored products; and (3) increase enforcement actions against companies that make, distribute, and sell flavored products without a marketing order, especially products with a significant market share, or products that are most popular with youth.” The letter also requests that FDA respond to several questions by June 23, as summarized below (as of the date of this blog post, we are not aware of any FDA response).Continue Reading Congress Urges FDA to Complete Its Review of E-Cigarette Applications

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…

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 determining whether the commerce clause of the U.S. Constitution prohibits a state’s taxation of a remote seller, the U.S. Supreme Court for decades has upheld a tax if (1) there is a substantial nexus between the taxing state and the taxpayer; (2) the tax is fairly apportioned; (3) the tax does not discriminate against…

On July 5, the U.S. District Court for the District of Columbia ruled that the decision of the Food and Drug Administration (FDA) to “deem” premium cigars subject to the same federal law as other tobacco products like cigarettes was “arbitrary and capricious.” In reaching this conclusion, Judge Amit Mehta relied heavily on industry comments…

On March 31, a New York federal court dismissed a proposed securities class-action lawsuit filed against Binance, the world’s largest cryptocurrency exchange. The lawsuit, one of a host of similar actions brought against cryptocurrency exchanges in 2020, was filed by token buyers who purchased cryptocurrency on Binance’s platform.

The plaintiffs asserted that Binance had violated…

In the Agricultural Improvement Act of 2018 (also known as the 2018 Farm Bill), did Congress authorize hemp producers to handle “hot” hemp — cannabis byproducts that surpass the legal limit of delta-9 tetrahydrocannabinols (THC) — during the hemp production process? Or does such material remain a Schedule I controlled substance subject to U.S. Drug…

The Department of Justice has loosened restrictions on the use of agency guidance documents to establish violations of underlying legal requirements in enforcement actions and other litigation. According to a memorandum by Attorney General Garland, DOJ attorneys may now “rely on relevant guidance documents in any appropriate and lawful circumstances, including when a guidance document…