Regulatory Litigation

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Washington Attorney General (AG) Bob Ferguson prevailed in his lawsuit against a plastic surgery practice, Allure Esthetic, and its owner, Dr. Javad A. Sajan (collectively, the company), alleging violations of the federal Consumer Review Fairness Act (CRFA), based upon the company’s practice of requiring patients to sign nondisclosure agreements (NDAs) that prohibited them from posting negative online reviews. The District Court granted the AG’s motion for summary judgment (in part) and found the company liable for violations of the CRFA. Damages will be decided at a later date.

In August 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia partially vacated a Food and Drug Administration (FDA) rule that had “deemed” premium cigars subject to the Federal Food, Drug, and Cosmetic Act (FDCA), known as the “Deeming Rule.” This decision exempted premium cigars from FDA’s tobacco product authorities. In September 2023, however, FDA appealed, and the U.S. Circuit Court of Appeals for the D.C. Circuit is currently weighing the matter. So, what would it take for FDA to succeed on appeal, and what is at stake for the premium cigar industry?

The Massachusetts Supreme Judicial Court (SJC) recently upheld, in a unanimous decision, the town of Brookline’s ordinance banning the sale of tobacco and e-cigarette products to anyone born after Jan. 1, 2000 (the Tobacco Sales Ban). Brookline is the first U.S. locality to impose a tobacco sales ban based on a specific date.

This article was originally published on February 14, 2024 in Reuters and Westlaw Today. It is republished here with permission.

As we discussed in part three of this series, “Navigating the Complexities of Regulatory Data Incident Investigations,” when an organization is the subject of regulatory data incident investigations, it must navigate a tangled regulatory web. Extricating itself from that web is the ultimate goal. But what form does that take?

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.

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).

On March 9, New York Attorney General Letisha James filed a complaint against leading cryptocurrency exchange KuCoin, alleging violations of the Martin Act, which prevents security sales fraud. AG James claimed that Ethereum — the second-largest cryptocurrency by market capitalization — is a security in the first regulator-initiated court claim.

A lawsuit stemming from the collapse of multibillion-dollar cryptocurrency exchange FTX seeks to recover a billion dollars from FTX’s founder and former CEO Sam Bankman-Fried, along with 11 paid endorsers, including Tom Brady, Naomi Osaka, Kevin O’Leary, Gisele Bündchen, Larry David, and Steph Curry. The plaintiffs allege the defendants were involved in a…

In a prior update, we discussed the ongoing legal challenges to the U.S. Food and Drug Administration’s (FDA) March 2020 rule on a graphic-warning requirement for cigarettes. Initially slated to take effect June 18, 2021, the rule would require 11 new textual, health warning statements accompanied by color, “photorealistic” images displayed on the top…