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
On October 1, 2024, the U.S. Food and Drug Administration (FDA or the Agency) implemented its unified Human Foods Program (HFP). The Agency established the HFP – which represented the single largest reorganization in FDA’s...more
Functional foods designed to promote relaxation, better sleep, and improved mood have exploded in popularity, and chocolate is increasingly the delivery method of choice. Calming confections featuring ingredients like...more
The regulatory landscape for consumer-packaged goods (CPG) brands is shifting, with artificial food dyes emerging as a central focus of both state and federal scrutiny. Recent actions by the federal and state governments,...more
Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by...more
Food laws and regulations are evolving rapidly — you and your team must prepare now to navigate the changes and anticipate what’s next on the horizon. ACI's virtual Food Law and Regulation Boot Camp will equip you with the...more
The authors were thinking of the Beatles’ 1963 song, “Not a Second Time,” when we read the latest Warning Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion. The company received a Warning...more
FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree...more
When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more
As 4/20 approaches, the cannabis industry is aflame with trends and opportunities that extend beyond traditional boundaries. Recent insights reveal a dynamic shift in consumer behavior and consumption methods, offering an...more
This (bad) pun of the 1974 Carly Simon song, “Haven’t Got Time for the Pain,” came to mind when we read the Food and Drug Administration’s Office of Prescription Drug Promotion’s (“OPDP”) first Notice of Violation of 2025....more
Celebrity Endorsements - As companies continue to seek effective advertising strategies, celebrity endorsements remain a powerful tool, particularly in reaching broad and receptive audiences through social media platforms....more
Attend ACI’s 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products to stay ahead of the latest environmental and sustainability developments impacting cosmetics and personal care products...more
The Super Bowl is not just the biggest game of the year for football fans, but it is also one of advertising’s biggest nights. Therefore, the FDA lawyers at Polsinelli were not only tuned in to root for the Kansas City Chiefs...more
In the past couple of weeks, I have been contacted by a few major news outlets about the legality of “THC beverages“. While it sounds like you can only find these products in a state-licensed cannabis dispensary, reporters...more
On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more
Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more
Late last month, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued its fourth Untitled Letter of the year to AbbVie, Inc. OPDP uses Untitled Letters to inform drug companies and...more
On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more
Attend ACI’s 8th Advanced Summit on Food Law – Regulation, Compliance and Litigation and obtain the tools and techniques you need to meet the legal and regulatory challenges which the food industry is now facing as well as...more
It’s that time of year again—Ad Law Symposium is back! Please join us in DC for this highly anticipated event focused on providing you with the information you need to promote your brand with confidence. Combining the...more
In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...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
Buried within the thousands of pages of the Consolidated Appropriations Act of 2023 is the most significant statutory expansion to the U.S. Food and Drug Administration’s (FDA) authority over cosmetics since 1938...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
If you’re marketing any pharmaceutical or medical device, the Food and Drug Administration (FDA) has its eye on you. More accurately, the FDA has its eye on your website and social media, checking to see what you’re claiming...more