Minor Cannabinoids: Exploring the Science, Legality, & Opportunities
The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing...more
Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...more
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...more
What You Need To Know In A Minute Or Less - The current industry trend “beauty from within” refers to a focus on wellness—namely physical, mental, and lifestyle—and its impact on beauty. Oral supplements that consumers can...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more
Following the social isolation and public health concerns associated with the COVID-19 pandemic, many Americans reevaluated their health and wellness priorities, creating new opportunities for food systems companies to...more
In the world of healthy food and beverages, a crucial first step towards bringing a new product to the crowded U.S. market is identifying and understanding the regulatory authorities that oversee your product. This is not...more
On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC). FDA has previously sent warning letters to...more
Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more
On July 14, 2021, Senate Majority Leader Chuck Schumer, together with Senate Finance Committee Chair Ron Wyden and Senator Cory Booker, released a discussion draft of the Cannabis Administration and Opportunity Act (the...more
[co-author: Richa Patel, Summer Associate] The July 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses fluid trademarks and the Cannabis Administration and Opportunity Act. Plus, check out the answer key...more
In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for promotional materials that allegedly...more
Over the past few months, federal courts throughout the country have stayed litigation challenging the labeling of products infused or made with cannabidiol, better known as CBD. These courts, acknowledging that labeling and...more
Federal food-labeling laws preempt state laws that impose requirements different from or in addition to those established by federal law. In some cases, the FDA has spoken directly to a labeling issue by regulation, and if...more
Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more
Hemp production, unlike much of the farming industry, has not declined due to COVID-19. Meanwhile, certain CBD companies have wasted no time in making unsubstantiated claims related to COVID-19. In turn, FDA and FTC...more
On April 1, 2020, FDA issued a guidance document instructing companies on how to notify the agency of a permanent discontinuance or interruption of manufacturing of certain products pursuant to Section 506C of the FDCA (21...more
From severe shortages in medical masks and ventilation equipment worldwide to the curious “toilet paper desert” in America, COVID-19 is creating temporary and long-term disruptions in the availability of both highly...more
The Food and Drug Administration (FDA) has announced plans to consider the impact of influencers and payment disclosures on the prescription drug market with a pair of new studies....more
The cannabidiol (CBD) industry has been on the receiving end of over a half dozen new consumer class actions in recent weeks, which is likely only the beginning for the emerging industry....more
On the heels of the U.S. Food and Drug Administration’s (FDA) recent declarations regarding the safety of products containing cannabidiol (CBD), several companies have been hit with class action lawsuits alleging that that...more
Within the last two months, three class action lawsuits have been filed in federal courts against companies that sell ingestible products containing cannabidiol (CBD), a chemical compound found in the cannabis plant, alleging...more
As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court’s holding that the Secretary lacked the...more
Cannabidiol (CBD) – a non-psychoactive component of cannabis with numerous claimed health benefits – has steadily grown in popularity in recent years. This upward trajectory went into overdrive with the passage of the...more