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
After years of rulemaking with impassioned input from food producers, industry stakeholders, and consumer groups, on December 27, 2024, the Food and Drug Administration (FDA or Agency) published a final rule titled “Food...more
The U.S. Food and Drug Administration (FDA) has announced a final rule updating the definition of the nutrient content claim “healthy.” To qualify as “healthy” under the updated definition, food products must contain a...more
On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more
Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...more
Healthy food and beverage (“F&B”) companies frequently use social media to advertise. When used appropriately, social media campaigns can be incredibly effective tools to help emerging F&B companies reach target consumers,...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Draft Guidance Seeks to Minimize Allergen Cross-Contact, Undeclared Allergens - The U.S. Food and Drug Administration (FDA) has issued updated draft guidance to help food...more
The American Conference Institute is hosting its first West Coast Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in Santa Monica on September 28-29, 2023! This conference comes just in time to...more
FTC’s New Health Products Guidance...more
LEGISLATION, REGULATIONS & STANDARDS - Evaluation of FDA Human Foods Program Finds Culture of “Constant Turmoil” - An independent review commissioned by the U.S. Food and Drug Administration (FDA) of the Human Foods Program...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....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
Hemp and marijuana both come from the cannabis sativa plant but as a result of the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”), cannabis sativa with a THC content of less than 0.3% was removed from the federal...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
Products containing hemp-derived cannabidiol ("CBD") have become incredibly popular in the United States, with new product brands entering the market seemingly every day. Consumer demand and public interest in those products...more
On Sept. 10, 2019, the Federal Trade Commission (FTC) issued warning letters to three undisclosed companies regarding their marketing claims on cannabidiol (CBD) products. The FTC claimed that each company made various...more
House Panel Questions FDA Officials on Food-Recall Audit - One day after the U.S. Food and Drug Administration (FDA) issued draft guidance on proposals to expedite product warnings and recalls, FDA and other health officials...more
Part 1: Current Trends and Ingredient Claims - Class-action lawsuits involving the false advertising of food products continue to be one of the most active areas in class litigation. Originally published in Update...more
What do the Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), Federal Drug Administration (FDA), Department of Agriculture (USDA), and Environmental Protection Agency (EPA) have in common? Each is, of...more
Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more
The year 2014 saw some important developments in the area of intellectual property law. A number of intellectual property-related issues even made national headlines. Who can forget the public debate over the rightful...more
On January 5, 2015 Judge Kimberly Mueller of the Eastern District of California denied Honest Tea’s motion to dismiss a case involving accusations that the company misled consumers about the antioxidant content of one of its...more
On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more
The Supreme Court issued a unanimous decision last week in Pom Wonderful LLC v. Coca-Cola Co., a case pitting the false advertising provisions of the Lanham Act against the beverage labeling standards of the federal Food Drug...more
On June 12, 2014, the United States Supreme Court issued its decision in POM Wonderful LLC v. Coca-Cola Co., No. 12-761, which confirms that federal false advertising claims can be brought against false or misleading...more