Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
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
Turns Out That Goldfish "No Artificial Flavors or Preservatives" Claim Was a Red Herring, New York Federal Court Says - A federal court in the Southern District of New York found that Veronika Ward, the plaintiff in a...more
Initial Attempt at Pinning Presence of PFAS in Coca-Cola Juice Drink as False Advertising Fizzes Out - The U.S. District Court for the Southern District of New York dismissed a plaintiff's initial complaint against...more
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
Among recent trends in consumer product false advertising class actions has been the rise in cases alleging false advertising for products touting ingredients as “all natural” or “100% natural.” These lawsuits often point to...more
MASSACHUSETTS - First Circuit Holds Putative Class Action Claims Alleging Deceptive Practices In Labeling of Lactase Product As Dietary Supplement Instead Of Drug When Product Claimed To Treat Lactose Intolerance...more
FTC Warns Influencers That Disclosures Miss the Sweet Spot - The Federal Trade Commission (FTC) continues to be very clear that policing the failure to disclose material connections by influencers when posting social media...more
In This Case, What You Can't See in Fact Is Not There: FTC Takes Down the Makers of the Invisible COVID Mask - After what has seemed like a lull in both diagnosed COVID cases and the enforcement variety—both the virus and...more
On Aug. 14, the Ninth Circuit issued its decision in Nacarino v. Kashi Co., providing some much-needed clarity to the FDA’s protein labeling requirements. The decision dealt with two separate cases from the Northern District...more
On August 14, 2023, a panel of judges for the United State Court of Appeals for the Ninth Circuit issued a published opinion affirming dismissal of two complaints alleging that food product labels advertising the amount of...more
Our weekly roundup aims to keep our readers up to date on recent notable rulings in the food & consumer packaged goods space. Darlene Hollins, et al. v. Walmart, Inc., et al., No. 21-56031 (9th Cir. – May 11, 2023): The...more
FTC Lays Out Some AI Ad Essentials - But specific guidance isn’t here yet, so...let’s be careful out there....more
In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices. A summary of the noteworthy...more
In December 2022, the the Federal Trade Commission published new guidance regarding representations about the benefits and safety of health-related products: Health Products Compliance Guidance. Federal Trade Commission...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
Does anyone remember the 1980’s song, “Freeze-Frame” by The J. Geils Band? A new year, a new Untitled Letter issued by the Food and Drug Administration’s Office of Prescription Drug Promotion to a prescription drug company....more
2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more
On August 31, 2020, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent a Warning Letter to the sponsor of a drug for a violative direct-to-consumer (DTC) radio advertisement.1 The radio...more
Advertising during a global pandemic and social justice movement triggers an increased level of regulatory risk and reputational harm. Regulators moved quickly to interrupt bad actors that took immediate advantage of...more
In response to the outbreak of COVID-19, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued several new warning letters to companies claiming their products prevent, treat or cure the novel...more
Part of a New Joint Initiative with FTC to Deter Anti-Competitive Practices, Including False or Misleading Comparisons - On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more
The cannabidiol (CBD) industry has been on the receiving end of over a half dozen new consumer class actions in recent weeks, which is likely only the beginning for the emerging industry....more
Shook Takes the Pulse of General Counsel on Maturation of Global Cannabis Market - More than half of in-house counsel surveyed in a new white paper by Shook, Hardy & Bacon plan to increase legal spending in the next two...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Plan to “Advance Plant, Animal Biotechnology Innovation” - U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has issued a statement announcing the...more
Introduction. On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not to dismiss her lawsuit against Jelly Belly Co. (“Jelly Belly”)...more
FDA’s final guidance expresses its view that the phrase “evaporated cane juice” is false and misleading. “Evaporated cane juice” has become a popular ingredient in everything from yogurt to cookies, attracting consumers...more