Tag Archives: FDA

Will the United States Attorney General, via the U.S. Drug Enforcement Administration (“DEA”) follow the recent recommendation of the U.S. Department of Health and Human Services (“HHS”) to reschedule cannabis to Schedule III? The plain language in the United States Controlled Substances Act (the “CSA”) compels DEA to do so, but there is speculation that the DEA could disregard the last week’s historic HHS Recommendation because of the Attorney General’s limited duty under Section 811(d)(1) of the CSA.… More

In light of the August 30, 2023 historic recommendation from the U.S. Department of Health and Human Services (HHS) to reschedule cannabis to Schedule III, a multidisciplinary group of attorneys from Foley Hoag’s nationwide Cannabis practice provides the following outlook and analysis of what’s next:

Rescheduling Q&A

1)    What happened?

The U.S. Department of Health and Human Services (HHS) made a recommendation to the U.S.… More

The Food and Drug Administration (FDA) held a stakeholder call on May 25, 2023 to provide additional information related to the agency’s January 26 announcement that it believes a new regulatory framework for cannabidiol (CBD) products is needed. FDA has regulatory authority over a variety of products (including food, drugs, medical devices, dietary supplements, cosmetics, and tobacco products) but as we explained previously, FDA has identified risks associated with the use of CBD in certain products that it does not believe it can effectively manage under its current regulatory authorities.… More

The U.S. Drug Enforcement Agency (“DEA”) identified this week that it considers certain types of novel cannabinoids to be federally illegal schedule I substances, even if they were derived from hemp.

As many are aware, the legality of hemp-derived products often spurs more questions than answers. Moreover, intoxicating cannabinoids are not alone in that regard, as the U.S. Food & Drug Administration (“FDA”) just recently concluded that existing regulatory frameworks for foods and supplements are not appropriate for cannabidiol (CBD),… More

As the number of adult-use states continues to grow—with New York, New Jersey, Connecticut, Rhode Island, and Vermont recently joining the ranks—the scrutiny of cannabis-related advertising has grown with it.  In recent years, state and federal regulators have made it clear that cannabis claims are a priority, especially claims stating or implying a health benefit.  Most of the attention to date has been on CBD products and claims, but as THC products hit the shelves in more and more states,… More

More than two years have passed since hemp-derived cannabidiol (CBD) was legalized in the United States under the Agriculture Improvement Act of 2018 (also known as the “Farm Bill”).

The Food and Drug Administration (FDA) has been exploring  potential regulatory pathways for CBD but it has yet to engage in rulemaking or issue guidance that would provide a clear framework under which FDA could maintain oversight over CBD to ensure that its use in a range of products is safe.… More

The U.S. Food and Drug Administration (“FDA”) currently takes the position that cannabidiol (CBD) and other cannibinoids cannot be used in dietary supplements and food because of statutory provisions under the Federal Food, Drug, and Cosmetic Act (“FDCA”) that prohibit the sale of products containing an ingredient treated as a drug or involved in clinical trials. Since CBD was the subject of clinical investigations that led to the approval of the drug Epidiolex® (cannabidiol),… More

On Friday, May 31, 2019 the U.S. Food and Drug Administration (“FDA” or “Agency”) held the widely anticipated hearing on scientific data and information about products containing cannabis or cannabis-derived compounds, including cannabidiol (“CBD”). This is the first public hearing since legalization of hemp in the 2018 Farm Bill. The Agency heard from approximately 140 speakers from diverse industries including, academia, agriculture, consumers, health professionals, and manufacturing companies who offered various perspectives on the safety of cannabis-derived compounds and CBD.… More

With the opening of the East Coast’s first marijuana retailer just days away, consumers in Massachusetts may soon begin seeing advertisements promoting all manner of cannabis products, services, and establishments.  The state’s Cannabis Control Commission has drafted regulationsthat place restrictions on marijuana advertising, but even with those restrictions, there is still plenty of opportunity for retailers and product manufacturers to promote cannabis to consumers, particularly online and on mobile apps,… More