Elizabeth Gustafson

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Elizabeth Gustafson has extensive experience with intellectual property and trademark litigation, antitrust, internal and government investigations, and breach of contract claims.

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The U.S. Food and Drug Administration (FDA) recently released new guidance on sourcing and product quality to companies conducting clinical research related to the development of human drugs involving cannabis or cannabis-derived compounds. The agency’s nonbinding recommendations highlight potential opportunities for clinical researchers and sponsors of investigational new drugs after the 2018 Farm Bill significantly altered the regulatory landscape applicable to cannabis products.…

Continue Reading FDA Releases Guidance on Clinical Research into Cannabis-Derived Drugs

Cannabis: In Focus

  • FDA Rejects Citizen Petitions, Declines To Regulate CBD as a Dietary Supplement
  • Ninth Circuit Affirms Dismissal of Cannabis Company’s RICO Claims
  • Tenth Circuit Holds that 2018 Farm Bill Doesn’t Create Private Cause of Action for Hemp Farmers
  • US Virgin Islands Legalizes Recreational Cannabis

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Continue Reading Cannabis Legal Report—Week of January 30, 2023

Earlier this month, the medical journal Pediatrics published a new study analyzing reports of accidental child exposure to cannabis edibles from 2017 – 2022, finding that the number of young children accidentally ingesting cannabis in the United States has increased consistently and significantly over the past five years. According to the study, children, especially those under age five, are at particular risk as they may not be able to distinguish between copycat tetrahydrocannabinol (THC) products and the well-known treats they resemble.

As we’ve written elsewhere, states impose strict restrictions on underage access to cannabis products in the licensed marketplace and generally prohibit marketing cannabis products to minors. The study’s findings emphasize the risks posed by copycat THC products and echo concerns raised by the U.S. Food and Drug Administration (FDA) in a 2022 consumer alert. The agency noted many “edible products are designed to mimic the appearance of well-known branded foods by using similar brand names, logos, or pictures on their packaging. These copycats are easily mistaken for popular, well-recognized foods that appeal to children.” As the FDA detailed, “accidental ingestion of these products can lead to serious adverse events, especially in children.”…

Continue Reading Preventing Accidental Exposure of Illicit Cannabis Products to Underage Consumers

Cannabis: In Focus

  • New York City Attempts to Crack Down on Illicit Cannabis Market
  • Connecticut Launches Recreational Cannabis Sales, With More States Expected to Follow in 2023
  • Psilocybin State Updates
  • FDA Issues Three New Warning Letters to CBD Product Manufacturers Alleging COVID-19 Benefits
  • Congressional Research Service: Cannabis Banking and the Federal Reserve

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Continue Reading Cannabis Legal Report—Week of January 23, 2023

A December 2022 survey from Data for Progress reports that American voters, regardless of political affiliation, support federal cannabis legalization. Specifically, 75% of Democrats, 67% of independents, and 52% of Republicans agreed that cannabis should be legalized at the federal level.

Data for Progress also asked about two equity policies enacted as part of New…

Cannabis: In Focus

  • Election Round-up: Two States Approve, Three Reject Adult-Use Cannabis Referendums
  • Northern District of New York Rules on Dormant Commerce Clause and Adult-Use Retail Licenses in New York
  • Kansas Federal Court Dismisses Hemp Seizure Suit
  • Federal Court Dismisses Florida Lawsuit Seeking Gun Rights for Medical Cannabis Patients

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Continue Reading Cannabis Legal Report – Week of November 14, 2022

Cannabis: In Focus

  • Federal Court Allows State To Import Cannabis-Related Paraphernalia
  • Biden Announces Pardons of Federal Convictions for Simple Cannabis Possession and a Plan To Review the Current Schedule Status for Cannabis
  • California Struggles To Tame Thriving Illicit Market

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Continue Reading Cannabis Legal Report – Week of October 17, 2022

Cannabis: In Focus

  • Cannabis Testing Companies Facing State Regulatory Scrutiny in Nevada and Florida
  • FDA Appoints Former State Cannabis Policy Regulator as New Cannabis Advisor
  • DOJ Responds to Florida Lawsuit Challenging Federal Regulations Regarding Firearm Purchases by Medical Cannabis Patients

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Continue Reading Cannabis Legal Report­­ – Week of October 3, 2022

A California state appeals court affirmed a bong maker’s win in a suit alleging it violated California’s Proposition 65 (Prop. 65) by failing to warn consumers that its products expose them to marijuana smoke that could cause cancer or reproductive harm.

Prop. 65 is a California initiative approved by voters in 1986 and enacted into law as the Safe Drinking Water and Toxic Enforcement Act that same year. The law prohibits knowingly and intentionally causing exposure to substances, including cannabis smoke and delta-9-tetrahydrocannabinol (THC), that are known to the state to cause cancer or reproductive harm, without first providing a clear and reasonable warning. California maintains a list of substances that trigger Prop. 65 warnings. To comply with Prop. 65, businesses must provide consumers with a compliant warning, unless they can ensure that their product does not expose consumers to a listed substance at levels that may cause cancer or reproductive harm.

Plaintiff-appellant Environmental Health Advocates, Inc. (EHA) filed a private enforcement action against Sream, Inc. (Sream) on November 12, 2020, alleging Sream violated Prop. 65 when Sream failed to provide a warning that their water pipe products—more commonly known as bongs—exposed consumers to marijuana smoke. EHA’s enforcement action sought “injunctive relief against Sream, from manufacturing, importing, selling, and/or distributing the products without a clear and reasonable warning.”…

Continue Reading California State Appeals Court Affirms Bong Maker’s Win in Prop. 65 Suit