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Food and Drug Administration (FDA) Marketing Manufacturers

Holland & Knight LLP

Red Flags Over Red 40: Heightened Regulatory Scrutiny on Use of Artificial Food Dyes

Holland & Knight LLP on

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

Troutman Pepper Locke

Supreme Court Says Affected Retailers May Challenge ENDS Manufacturer’s Marketing Denial Orders

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On June 20, the Supreme Court concluded that marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA) can be challenged not only by the applicants (typically, the manufacturer or importer of the...more

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

Perkins Coie

Psychoactive Kratom Draws Continued Scrutiny and Legal Action

Perkins Coie on

In recent years, plaintiffs have increasingly set their sights on kratom, a controversial botanical supplement, as a target for litigation. With at least 15 putative class-action cases filed in the past year alone, this...more

Stradling Yocca Carlson & Rauth

Vegan Collagen and the Law: Clean Beauty Claims Face Legal Scrutiny, but Courts Urge Common Sense

Clean Beauty Legal Risks Clean beauty claims have become the current "flavor of the month" for consumer class action lawsuits, particularly in California, New York, Florida, and Texas, where plaintiff's bar activity is...more

Gardner Law

FDA Guidance for Labeling Plant-based Products

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The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is...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

Troutman Pepper Locke

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

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In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

Mintz - Health Care Viewpoints

FDA Rolls Out Innovative New Designation Programs in Response to Congressional Mandates

Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and...more

Troutman Pepper Locke

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

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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

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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

Husch Blackwell LLP

MoCRA: Updates to FDA Safety Substantiation Requirements

Husch Blackwell LLP on

As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article, in our continuing series of posts diving into...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - July 2023 #2

LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Update on Sesame Allergen Labeling - The U.S. Food and Drug Administration (FDA) has released an FDA Voices “Catching Up with Califf” update that addresses the practice...more

Arnall Golden Gregory LLP

FDA Tries to Keep Up: FDA Publishes Two New Items Related to Artificial Intelligence

FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more

MoFo Life Sciences

FDA Clarifies The Human Factors Or Usability Information To Include In A Device Marketing Submission

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If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing device?...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

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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

Alston & Bird

Food & Beverage Digest - April 2021

Alston & Bird on

Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries. This month, someone moved someone’s smoked...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

BCLP

FDA Labeling Guidance: Making Structure/Function Claims for Dietary Supplements

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Dietary supplement manufacturers seeking to explain and market their products must carefully craft statements on supplement labels to ensure compliance with the Food and Drug Administration’s (“FDA’s”) regulations regarding...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

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