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Federal Food Drug and Cosmetic Act (FFDCA) Manufacturers Marketing

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

Troutman Pepper Locke

What’s at Stake for the Premium Cigar Industry as DC Circuit Considers FDA Appeal?

Troutman Pepper Locke on

In August 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia partially vacated a Food and Drug Administration (FDA) rule that had “deemed” premium cigars subject to the Federal Food, Drug, and...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

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

Husch Blackwell LLP

Legal Insights for Manufacturing: Outlook for 2024

Husch Blackwell LLP on

Our downloadable report, Legal Insights for Manufacturing, explores how the business, legal, and regulatory framework is evolving—and will evolve—to address the large generational shifts taking place. This year, our report...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

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

Cozen O'Connor

Bipartisan AG Coalition Calls for FDA Regulation of Non-Tobacco Nicotine Products

Cozen O'Connor on

A bipartisan coalition of AGs from 27 states, the District of Columbia, and three territories has called on the FDA to deny marketing authorization for non-tobacco nicotine products (NTNs) which are currently marketed without...more

Alston & Bird

Bringing Dietary Supplements to Market: Key Requirements and Best Practices

Alston & Bird on

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

Womble Bond Dickinson

Insight into Medical Foods and the Scope of FDA Regulation

Womble Bond Dickinson on

The FDA has issued warning letters to manufacturers of products marketed as medical foods to treat a range of medical conditions, including fibromyalgia, autoimmune disorders, irritable bowel syndrome, arthritis, asthma,...more

Epstein Becker & Green

Federal Courts Say They Will Decide Cases Against CBD Product Manufacturers When the Smoke Clears

Epstein Becker & Green on

The cannabidiol (“CBD”) consumer product marketplace is booming. And, while FDA has maintained its position that CBD, even hemp-derived CBD, may not be included as an ingredient in conventional foods or dietary supplements,...more

Seyfarth Shaw LLP

Seyfarth on CBD – February 2020 Update

Seyfarth Shaw LLP on

CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping. ...more

Bradley Arant Boult Cummings LLP

The Beginning of the End or the End of the Beginning? The FDA Issues 15 New Warning Letters to CBD Companies - Cannabis Industry...

The U.S. Food and Drug Administration (FDA) sent a shot across the bow of the cannabidiol (CBD) industry on November 25. The FDA disclosed that it issued warning letters to 15 companies “for illegally selling products...more

Bradley Arant Boult Cummings LLP

Labeling and Advertising Risks for CBD Companies - Cannabis Industry News Alert

Cannabidiol (CBD) – a non-psychoactive component of cannabis with numerous claimed health benefits – has steadily grown in popularity in recent years. This upward trajectory went into overdrive with the passage of the...more

Butler Snow LLP

Express Preemption of Consumer Protection Actions: Preventing a Patchwork of State Drug and Device Regulations

Butler Snow LLP on

The Supremacy Clause of the United States Constitution declares federal law to be the “supreme Law of the Land.” Thus, when federal law and state law conflict, the state law is “preempted,” or rendered without effect. Under...more

Nutter McClennen & Fish LLP

Product Liability: 2017 Year in Review

Massachusetts state and federal courts issued a number of important product liability decisions in 2017. The Product Liability and Toxic Tort Litigation Group at Nutter recently reviewed these cases. Highlighted below are...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | October 2017

The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more

Morgan Lewis

Center for Veterinary Medicine Releases New Guidance

Morgan Lewis on

The center makes no bones about dog and cat food health claims. If you have been down a pet food aisle recently, you may have noticed dog and cat foods that claim to treat various conditions, such as claims to treat...more

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