Federal Enforcement

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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.

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).

The Federal Communications Commission (FCC) recently amended requirements concerning artificial or prerecorded voice calls, effective July 20.[1] See Proposed 47 C.F.R. § 64.1200. Notably, the FCC amended requirements concerning prerecorded noncommercial and nontelemarketing commercial calls by (1) placing a cap on the number of calls to up to three calls within a consecutive 30-day period, unless the caller has obtained prior express consent, and (2) requiring callers to provide specific opt-out mechanisms.

The Department of Defense (DOD) wants to make it easier for companies with innovative solutions, such as startups, to bid on and receive federal government contracts. As such, DOD recently proposed a Defense Federal Acquisition Regulations (DFARS) amendment to implement provisions of the 2022 and 2023 National Defense Authorization Acts, which provide DOD with the authority to acquire “innovative commercial products and commercial services” under general solicitations using a new, more streamlined competitive selection process called a “commercial solution opening” (CSO). The amendment will add a new subpart to DFARs Part 212 at 212.7X. DOD expects the proposed process to reduce transaction costs for both private and public sectors, which it hopes will encourage smaller companies with innovative ideas and proven solutions to take part in the federal government contracting marketplace.

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…

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…

This article was originally published on August 19, 2022 in Reuters and is republished here with permission.

Companies today face increased risks from numerous regulatory bodies at the municipal, state, and federal levels. As we discussed in our previous article, “Preparing Companies for a New Day in Multistate AG Investigations,” sophisticated regulators —…