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
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more
On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that U.S. Secretary of HHS Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore closing the GRAS...more
The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more
On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS Secretary Robert F. Kennedy has directed the Food and Drug Administration (FDA or Agency) “to take steps to explore potential...more
On March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), in a seismic shift, announced that the U.S. Food and Drug Administration (“FDA”) would “explore potential...more
Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more
2025 will be a transformational year for the beverage and food industry, which has already been dramatically impacted by shifting market trends and profound policy changes. Here are the top five topics influencing the...more
U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced on March 10, 2025, that he directed the acting commissioner of the U.S. Food and Drug Administration (FDA) to explore potential...more
The policy statement aims to bring more rapid action on personnel and management decisions and empowers HHS and each of its offices and subagencies to promulgate or rescind certain rules without a period of notice and comment...more
We previously reported on the FDA’s laboratory-developed test (LDT) rule published on May 6, 2024, which classifies LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This shift marks the end...more
Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional - On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Even with the expected rescheduling of cannabis from a Schedule I drug to a Schedule III drug, it will take more for it to be eligible for interstate commerce. Marijuana would remain subject to provisions of the Food,...more
Baker Donelson recently published Anticipating SCOTUS Ruling on Chevron Deference – What to Know and Five Ways to Prepare explaining the United States Supreme Court's upcoming ruling which is expected to impact the regulatory...more
On May 16, 2024, the U.S. Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to reclassify marijuana from Schedule I to Schedule III under the federal Controlled Substances Act (“CSA”) and...more
On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug. The NPRM, which was published in...more
Moving marijuana under the Controlled Substances Act (“CSA”) from Schedule I to Schedule III will bring celebrated changes to the beleaguered state-sanctioned cannabis industries currently operating in 37 states, but will...more
On May 16, the Drug Enforcement Administration (“DEA“) published its 92-page notice of proposed rulemaking (“NPRM“) to move marijuana from schedule 1 on the Controlled Substances Act (“CSA”) to schedule 3 (ironically, the...more
In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more