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

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

Introduction

On April 29, Aerojet Rocketdyne Holdings Inc. (Aerojet) settled claims by whistleblower Brain Markus for a reported $9 million after the second day of a jury trial.[1] This is the second recent settlement under the False Claims Act (FCA) relating to alleged misrepresentations about a company’s cybersecurity practices and systems in connection with

With the House Committee on Oversight and Reform and the Senate Committee on the Judiciary raising concerns over agencies’ FOIA compliance, the U.S. Department of Justice has responded with FOIA guidelines and related testimony before the Senate Committee on the Judiciary.

The past two months have seen Congress and the U.S. Department of Justice (DOJ)

On March 16, Senator Elizabeth Warren and Representative Mondaire Jones introduced the Prohibiting Anticompetitive Mergers Act in the Senate and the House. The bill provides the Federal Trade Commission (FTC) and Department of Justice (DOJ) with the authority to reject what they refer to as the most “anticompetitive” mergers without requiring a court order, aligning

As we previously reported, Executive Order 14036 (E.O. 14036) required the Treasury secretary, who oversees the Alcohol and Tobacco Tax and Trade Bureau (TTB), to issue a report to the White House Competition Council (the Council) chair, assessing the current market structure and conditions of competition in the U.S. alcohol market.

In response to

On January 24, Assistant Attorney General of the Antitrust Division Jonathan Kanter delivered remarks to the New York State Bar Association Antitrust Section. In his speech, Kanter expressed serious concerns over the recent increase in the concentration of industries and decrease in competition. Kanter believes that the “only way” to continue promoting competition is by

On October 6, Deputy Attorney General Lisa O. Monaco announced the creation of a National Cryptocurrency Enforcement Team (NCET) to handle criminal misuses of cryptocurrency. According to the press release, NCET will focus specifically on crimes committed in virtual currency exchanges, mixing and tumbling services, and money launderers. The team’s additional duties will include

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