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The Food and Drug Administration (FDA) recently issued first-of-its kind draft guidance for investigational new drug (IND) applications involving psychedelic drugs. Citing the rise in interest in exploring the potential therapeutic benefits of psychedelic drugs, FDA indicated its receptiveness to allowing researchers to investigate exactly how useful psychedelics are at treating psychological disorders, such as depression, post-traumatic stress disorder (PTSD), substance abuse, anxiety, and other conditions. While the guidance is not geared toward trials intended to support marketing applications, the agency’s attention to this topic may herald a new wave of associated investigations.Continue Reading FDA Issues Draft Guidance for Clinical Investigations of Psychedelic Drugs

Under the sponsorship of Representatives Morgan Griffith (R-VA) and Angie Craig (D-MN), congressional lawmakers recently renewed their effort to force the Food and Drug Administration’s (FDA) hand in regulating cannabidiol (CBD) products. The two proposed bills would require FDA to do what it stated in early 2023 it could not do: regulate CBD and other hemp-derived foods and dietary supplements under existing Food, Drug, and Cosmetic Act (FDCA) pathways.
Continue Reading New Congressional Bills Seek to Advance FDA CBD Product Regulation

The Virginia General Assembly recently passed — in both chambers — a bill to regulate delta-8 THC products in the commonwealth. The bill now awaits the governor’s signature. Governor Youngkin and the Republican-controlled House of Delegates have prioritized the control of these novel hemp-derived products over legislation to legalize the retail sale of adult-use marijuana, which will no longer begin in 2024.Continue Reading Virginia General Assembly Passes Bill to Regulate Delta-8 THC

On February 9, Attorney General William Tong sued five Connecticut retailers for violating the state’s Unfair Trade Practices Act (UTPA) by selling allegedly illegal delta-8 tetrahydrocannabinol (THC) products, many of which mimicked snack foods and candies popular among youth.Continue Reading Connecticut AG Sues Retailers for Illegal Delta-8 THC Product Sales

U.S.-based international trade group Cashmere and Camel Hair Manufacturers Institute (CCMI) recently filed a lawsuit against global online marketplace Etsy, Inc. in U.S. District Court for the District of Massachusetts for allegedly advertising and marketing third-party counterfeit cashmere products through its platform. CCMI claimed Etsy violated the Lanham Act; Massachusetts’ false advertising law; common law prohibitions on unfair competition; and Massachusetts’ Anti-Dilution Statute. CCMI also brought a novel civil claim that Etsy conspired with the fake cashmere suppliers.Continue Reading Etsy Targeted Over Sale of Counterfeit Products

Published in Law360 on January 10, 2023. © Copyright 2022, Portfolio Media, Inc., publisher of Law360. Reprinted here with permission.

In late November, the New Mexico attorney general announced a lawsuit[1] in the Santa Fe County First Judicial District Court against Philip Morris USA Inc., R.J. Reynolds and other signatories to the tobacco master settlement agreement alleging their violation of the MSA and various state and common laws due to their withholding of payments to the state.Continue Reading Parsing the New Wave of State Tobacco Settlement Suits

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 November 3, Judge Gary L. Sharpe of the U.S. District Court for the Northern District of New York issued a preliminary injunction, blocking cannabis regulators from issuing marijuana retail licenses for five geographic regions across the state, while a constitutional challenge to the program proceeds.
Continue Reading Federal Judge Finds NY Cannabis Residency Rules Likely Unconstitutional and Discriminatory Against Out-of-State Applicants