GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage the risks of cannabidiol...more
Supporters of hemp-derived cannabidiol (CBD) who hoped the Food and Drug Administration would adopt a more progressive view of CBD were disappointed when FDA Chief Robert Califf recently testified that FDA does not consider...more
Schmidt v. Schmidt, Kirifides & Rassias, Pa. C. (WCAB); No: 1039 C.D. 2021; filed Nov. 14, 2023; Judge Covey - In this case, the claimant, an attorney, sustained a work injury on April 14, 2017, while loading files into 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
The FDA held a “stakeholders” call on May 25 to present information on how it reached its present stance concerning CBD and to answer a few questions. FDA’s presentation included its assessment of survey data concluding that...more
The Food and Drug Administration (FDA) has asked Congress to help develop a “cross-agency strategy” for creating a “new regulatory pathway” for CBD. In short, FDA states a “new regulatory pathway” is needed for CBD before...more
FDA Rejects Citizen Petitions, Declines To Regulate CBD as a Dietary Supplement - The U.S. Food and Drug Administration (FDA) announced its conclusion that a new regulatory pathway for cannabidiol (CBD) is needed on...more
In an official statement last week, the U.S. Food and Drug Administration (FDA) announced its conclusion that the existing regulatory framework for foods and dietary supplements is not appropriate for the regulation of...more
On January 26, the Food and Drug Administration essentially threw up its hands and announced that Congress needs to create a new regulatory pathway for cannabidiol (CBD) products because the existing pathways are inadequate...more
Creating further confusion and uncertainty in the hemp derived cannabidiol (CBD) markets, the FDA has determined that the existing regulatory frameworks for food and supplements are not appropriate for CBD....more
Many of us following the ever expanding cannabis industry in the United States have seen more and more CBD-infused food and drink products hitting the market and becoming readily available for consumers. There are CBD...more
Earlier today, May 4, 2022, the FDA issued warning letters to five companies selling products that contain delta-8 tetrahydrocannabinol (Delta-8 THC). Several of the companies also manufactured products containing...more
Hemp was federally legalized nearly four years ago. Since then, the industry has dealt with constantly changing rules, despite being in regulatory purgatory due to snail-paced progress from the U.S. Food & Drug Administration...more
The New York State Office of Cannabis Management (OCM) has announced regulations concerning the manufacturing and labeling of cannabinoid hemp products, and the availability of an online portal to facilitate required state...more
While we enter a new season this week, the same cannot be said for the FDA which, on November 16, reiterated that its approach to regulating the cannabidiol (CBD) industry will be “the same as it ever was”—a regulatory...more
On Wednesday, October 6, 2021, California Governor Gavin Newsom signed into law Assembly Bill 45 (AB-45) that “prohibit[s] restrictions on the sale of dietary supplements, food, beverages, cosmetics, or pet food that include...more
In this webinar, we’ll discuss what we know about FDA regulation of cannabis and cannabis-derived products and look at trends in recent FDA enforcement over CBD products. Topics include: - Pathways for FDA...more
The global cannabidiol (CBD) market size is expected to reach USD 13.4 billion by 2028. And yet a large part of that market—CBD-infused food, beverages, and dietary supplements—consists of unlawful sales. This article...more
FDA maintained its position that CBD in any form is subject to the drug preclusion language in the federal Food Drug and Cosmetic Act via objection letters posted regarding New Dietary Ingredient Notifications (NDIN) filed by...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
Welcome to our weekly roundup of CBD and hemp-related legal and regulatory news: CBD - Iowa Court of Appeals upholds state’s view of CBD as controlled substance - The Iowa Appeals Court sided with the Marion Civil...more
Move over CBD, there are new cannabinoids in town. CBD has been the most sought-after and utilized hemp-derived cannabinoid in consumer products, but due in part to technological advances, various other hemp-derived...more
On May 19, 2021, Senators Rand Paul (R-KY), Ron Wyden (D-OR), and Jeff Merkley (D-OR) introduced the Hemp Access and Consumer Safety Act of 2021 (SB 1698), which would address long-standing regulatory uncertainty facing...more