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 6 – Mitigating Class Action Exposure
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Podcast: Is the Dietary Supplement Regulatory Framework Working? - Diagnosing Health Care
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Business Divorces in the Food and Supplements Space
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - FDA Regulated Natural Products: Leveraging IP and Regulatory Requirements to Maximize Possible Return on Investment
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
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
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
On April 28th join INCBA's foremost thought leaders and impactful cannabis industry professionals for our INCBA Hemp Symposium. Featuring legal experts and regulators with an overview of what to expect from regulations to...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
The U.S. Food and Drug Administration (FDA) announced the conclusion of an internal working group that cannabidiol (CBD) will require a new regulatory pathway. The FDA explicitly denied three citizen petitions urging the...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
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, Senators Chuck Schumer (D-NY), Ron Wyden (D-OR), and Cory Booker (D-NJ) released the discussion draft of historic federal cannabis legalization legislation, the Cannabis Administration and Opportunity Act...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
US Senators Ron Wyden (D-Ore.), Rand Paul (R-Ky.), and Jeff Merkley (D-Ore.) introduced legislation on May 21 to ensure hemp-derived cannabidiol (CBD) is regulated by the US Food and Drug Administration (FDA) like other...more
On March 22, 2021, the U.S. Food and Drug Administration (FDA) issued warning letters to two companies, Honest Globe Inc. and Biolyte Laboratories LLC, for selling products labeled as containing cannabidiol (CBD) in ways that...more
On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...more
Cannabis is a rapidly growing industry; in 2019, overall sales of cannabis products legal under state law were estimated to be worth $13.6 billion, with an expected increase to $29.7 billion by 2025. While marijuana remains a...more
In late October, the New York State Department of Health (“DOH”) announced the release of the state’s long-awaited cannabidiol (“CBD”) guidelines. Reversing the state’s ban from last year on the sale of hemp-derived...more
Tell me if you’ve heard this one before – the regulatory issues surrounding CBD will be completely resolved after a certain “legislative fix” is passed. Remember all of the articles in December 2018 declaring CBD legal after...more
On Tuesday, July 21, 2020, the U.S. Food and Drug Administration (FDA) released a new draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The draft guidance is intended to...more
The cannabidiol (“CBD”) consumer product marketplace is booming. And, while FDA has maintained its position that CBD, even hemp-derived CBD, may not be included as an ingredient in conventional foods or dietary supplements,...more
The Council for Responsible Nutrition (CRN) submitted a citizen petition to the Food and Drug Administration (FDA) requesting that FDA: FDA exercise its statutory authority to establish a regulation under which...more
Contaminants injurious to health All licensing states regulate the presence of contaminants injurious to health in marijuana products. Illinois requires the Department of Agriculture to establish standards for microbial,...more
As cannabis products become legal in more and more states, commercial interest grows in protecting the trademarks associated with those products. The United States Patent and Trademark Office has maintained its refusal to...more
CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping. ...more
Lately, products containing CBD (from beer to skin cream to oils that can be diffused and vaped) seem to be all the rage. Why are CBD products suddenly turning up everywhere (your local Sheetz convenience store for...more