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
Medical Device Legal News with Sam Bernstein: Episode 8
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
The Food and Drug Administration (FDA) regulates the marketing of dietary supplements, over-the-counter (OTC) drugs, cosmetics, medical devices, foods, infant formula, pet foods/supplements, and even e-cigarettes. However,...more
LEGISLATION, REGULATIONS & STANDARDS - FDA to Push Back Enforcement of Certain MoCRA Requirements - The U.S. Food and Drug Administration (FDA) has announced that it intends to delay enforcement of cosmetic product...more
The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done...more
CSPI: Performance Enhancer Supplements Aren’t What They Seem - Manufacturers need to start by including the advertised ingredients - Double-Dog Dare You - Would you eat something called Rauvolfia vomitoria? No? Of...more
While we know the old adage chicken soup “cures” the common cold, decades of federal Food Drug Administration (FDA) enforcement have taught the industry that selling food as a “cure” renders it subject to criminal...more
On December 20, 2022, amidst a flurry of end-of-year activity on Capitol Hill, the Federal Trade Commission’s (FTC) Bureau of Consumer Protection issued a major update of its over two-decades-old guidance titled “Dietary...more
Just in time for your health-focused new year’s resolutions, the FTC released an updated guide for marketers: The Health Products Compliance Guidance. This guide last issued in 1998 under a more narrow title, focusing on...more
The Federal Trade Commission (FTC) announced its Health Products Compliance Guidance on December 20, 2022. The 2022 guidance updates and replaces the FTC’s 1998 guidance, Dietary Supplements: An Advertising Guide for...more
Made-in-USA Shootout Leads to Jury Trial, $3.1 Million Judgment Novelty glassware manufacturer weaponizes FTC guidance against rival - Is Half Bulletproof Really a Thing? For the uninitiated, the shot glass in...more
NAD Won’t Rename Supplement Maker - Innovix Pharma loses on product claims but gets to keep its calling card. Nerding Out - Aside from the intricacies of advertising, advertising law, and the disputes engendered...more
Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...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
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
The dietary supplement and personal care product space continued to see enforcement on false CBD, COVID, and fertility claims as well as related litigation involving “germ-killing” claims on hand sanitizers and wipes. Messy...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 (the “Act”), which generally provides a legal pathway for certain hemp-derived...more
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries. This month, someone moved someone’s smoked...more
Naughty With Nature - Last week, the FDA issued two warning letters to companies selling drugs where CBD is listed as an ingredient on the label. The FDA’s “naughty list” of companies manufacturing CBD-ingredient drugs is...more
The March 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses fair use cases for photographs and three recent developments in the cannabis space. We also highlight recent accolades earned by Sterne Kessler's...more
Sean Combs Opens New Front in War Against GBG Sean John - Accuses majority holder of using election-related trademarks to sell goods - Puffy Prologue - The lawsuit between Sean John Combs (AKA Puff Daddy, AKA P. Diddy, AKA...more
It is no surprise that four in five Americans (86 percent) reportedly take dietary supplements to improve their overall health. Now more than ever, health consciousness is at the forefront – we are focused on improving our...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
The Federal Trade Commission (“FTC”) has joined the U.S. Food and Drug Administration (“the “FDA”) in enforcing laws related to marketing CBD products. The FDA has historically issued warning letters and pursued companies...more