News & Analysis as of

Federal Trade Commission (FTC) Regulatory Requirements Food and Drug Administration (FDA)

Husch Blackwell LLP

Chocolate Therapy: The Legal Limits of Mood and Sleep Claims in Functional Foods

Husch Blackwell LLP on

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

American Conference Institute (ACI)

[Virtual Conference] Food Law and Regulation Boot Camp - July 22nd - 23rd, 8:15 am - 2:00 pm CST

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

American Conference Institute (ACI)

[Event] 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products - March 27th - 28th, New York,...

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

Polsinelli

Monday Morning (Advertising) Quarterback – Unprecedented Hims & Hers Super Bowl Ad Has Legislators Concerned

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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

Perkins Coie

Q4 2024: Food and CPG Legal Trends

Perkins Coie on

We are pleased to share our Q4 Food and Consumer Packaged Goods (CPG) Legal Trends report. This report is a bite-size version of our annual year in review, providing timely insights on legal trends in the space. In Q4 of...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Foley & Lardner LLP

Federal Circuit Says Proper Orange Book-Listed Patent Must Claim Active Ingredient

Foley & Lardner LLP on

In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more

Stinson LLP

Trump's First 100 Days: Business Litigation

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Banks and other regulated entities have frequently challenged Biden-era rulemakings in court. The incoming administration may change the trajectory of these cases, as Trump has promised to stop agency overreach....more

Skadden, Arps, Slate, Meagher & Flom LLP

The FTC Challenges Companies’ Allegedly Improper Orange Book Patent Listings

The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

American Conference Institute (ACI)

[Event] 8th Advanced Summit on Food Law - April 30th - May 1st, Chicago, IL

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

Venable LLP

[Event] 10th Advertising Law Symposium - March 21st, Washington, DC

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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

Gardner Law

FDA Regulatory, Compliance, and Privacy Due Diligence — Finding Your Goldilocks Zone

Gardner Law on

When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more

Perkins Coie

Cannabis Legal Report - July 2023

Perkins Coie on

FDA and FTC Issue Cease and Desist Letters to Companies Selling Delta-8 Edibles - On July 5, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) jointly sent cease and desist letters to six companies...more

Mintz - Health Care Viewpoints

Recent Developments Signal Headwinds for Homeopathic Drug Products

Homeopathic drugs have an unusual status in the United States. On the one hand, they are incorporated into the Federal Food, Drug, and Cosmetic Act (FD&C Act) within the definition of “drug,” which specifically includes...more

Jones Day

Food, Drugs, Cosmetics, and Devices: Federal Regulatory Focus Areas in 2023

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In Short - The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more

Butler Snow LLP

Half-Baked: An Overview of Current Cannabinoid Laws & Regulations

Butler Snow LLP on

Over 50 years ago President Nixon declared a “War on Drugs,” leaving housewives over the country proclaiming marijuana to be the devil’s lettuce and urging sweet Billy to steer clear of the gateway drug...more

American Conference Institute (ACI)

[Event] Legal, Regulatory & Compliance Forum on Dietary Supplements - June 29th - 30th, New York, NY

American Conference Institute in collaboration with the Council for Responsible Nutrition (CRN) are excited to welcome you back to New York for the “return to live” reunion that the dietary supplements industry has been...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Bodman

The ABCs of CBD and Hemp: A Primer

Bodman on

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

BCLP

Fast Growing CBD Market Continues To Create Regulatory Challenges and Litigation Opportunity

BCLP on

CBD and CBD-containing products are ubiquitous, yet there is significant misunderstanding about their regulatory status. CBD is cannabidiol, one of more than a hundred different active compounds that can be derived from the...more

American Conference Institute (ACI)

[Virtual Event] Food Law – Regulation, Compliance and Litigation - May 12th - 13th, 8:15 am - 3:45 pm CDT

The food industry’s most comprehensive legal and regulatory conference, Food Law – Regulation, Compliance and Litigation, is returning this spring in a unique, interactive virtual format. Key stakeholders will discuss how to...more

Jones Day

Vital Signs: Digital Health Law Update | Summer 2020

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Note From the Editors - With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l February 2020

LEGISLATION, REGULATIONS & STANDARDS - Virginia Law Limiting Use of “Milk” Advances - Following a vote in the Virginia House Agriculture Subcommittee, the state’s House of Delegates will reportedly consider a bill that...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l November 2019

LEGISLATION, REGULATIONS & STANDARDS - USDA Issues Interim Rule On Hemp Production - The U.S. Department of Agriculture (USDA) has issued an interim final rule “specifying the rules and regulations to produce hemp.” The...more

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