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Regulatory Oversight Product Labels Food and Drug Administration (FDA)

McGuireWoods LLP

Retailers at Risk: FDA Issues Advisory on Recreational Nitrous Oxide Products

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On June 4, 2025, the U.S. Food and Drug Administration issued a public advisory urging consumers not to inhale nitrous oxide (N2O) from commercial dispensers, including canisters, tanks and portable chargers. The advisory...more

Alston & Bird

FDA Seeks to Reform Approach to Regulation of Ingredients Used in Animal Food

Alston & Bird on

With the memorandum of understanding between the Food and Drug Administration (FDA) and the Association of Animal Feed Control Officials (AAFCO) set to expire, the FDA is proposing an alternative path to market for the...more

Dickinson Wright

Look Before You Leap – Early Determination of Product Classification and Regulatory Pathway for FDA-Regulated Products

Dickinson Wright on

Originally published in Healthcare Michigan, Volume 41,  No. 4 - The Food and Drug Administration (FDA) regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary...more

Alston & Bird

New Law Provides Food & Beverage Industry Protection Against Lawsuits Challenging “Healthy” Claims During Ongoing FDA Rulemaking

Alston & Bird on

Our Food & Beverage Team reports good news for the industry: product labels can follow either the Food and Drug Administration’s current version or any new version of a rule defining “healthy.”...more

Alston & Bird

FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

Alston & Bird on

Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved or conditionally approved...more

Troutman Pepper Locke

TTB Seeking Public Input on Potential Alcoholic Beverage Labeling Changes

Troutman Pepper Locke on

As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more

K&L Gates LLP

An Overview of the US Food and Drug Administration's Legislative Goals (Part I)

K&L Gates LLP on

In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more

Epstein Becker & Green

Unpacking Averages: Using NLP to Assess FDA’s Compliance with Notice and Comment in Guidance Development

Introduction - Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA...more

Foley Hoag LLP

Congress Adds Some Teeth to FDA’s Authority to Regulate Cosmetics

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The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more

Foley Hoag LLP

New Intended Use Rule Finalized

Foley Hoag LLP on

On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more

Hogan Lovells

FDA to test voluntary “healthy” symbols through consumer research

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has recently signaled its continued interest in developing a voluntary “healthy” symbol for packaged foods as a representation of the nutrient content claim....more

Hogan Lovells

FDA signals uptick in enforcement with market sweep on depression claims

Hogan Lovells on

On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...more

Bass, Berry & Sims PLC

FDA Increases Scrutiny of CBD Companies for Marketing and Labeling Practices

Bass, Berry & Sims PLC on

As the market for hemp-based products booms, many investors are grappling with (and consumers unaware of) the grey area within which hemp products­­ are being commercialized across the country. Increasing demand for...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

Carlton Fields

Court Stays CBD Class Action Until FDA Rolls Out Regulation

Carlton Fields on

A class action lawsuit alleging that Green Roads of Florida LLC misrepresented the amount of CBD contained in various products has been stayed pursuant to the primary jurisdiction doctrine because the plaintiffs’ claims...more

Stinson LLP

CBD Industry Experiences Wave of New Consumer Lawsuits

Stinson LLP on

The cannabidiol (CBD) industry has been on the receiving end of over a half dozen new consumer class actions in recent weeks, which is likely only the beginning for the emerging industry....more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

Brooks Pierce

What is Hemp? Is It Even Legal?

Brooks Pierce on

Hemp and cannabidiol (CBD) products are dominating the airwaves and the marketplace, and North Carolina has been at the forefront, ranking sixth in the nation in acres of hemp produced in 2018. Many predict that the market...more

Seyfarth Shaw LLP

CBD is Everywhere – But Where Does the FDA Stand?

Seyfarth Shaw LLP on

Seyfarth Synopsis: CBD is “thriving” in the current regulatory environment, but is it doing so illegally? As former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb opined last week, “the CBD craze is...more

Steptoe & Johnson PLLC

CBD Industry Must Prepare For FDA Regulation

On May 31, 2019, the Food & Drug Administration (“FDA”) held its first public hearing on regulating the processing, dispensing, and ingesting of Cannabidiol (“CBD”). The FDA’s Deputy Commissioner, Dr. Amy Abernethy, noted...more

Mintz - Consumer Product Safety Viewpoints

Cannabis-Derived Ingredients in FDA-Regulated Products: More Questions than Answers at FDA’s May 2019 Public Hearing

As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a public hearing “to obtain scientific data and information about the safety,...more

Knobbe Martens

A Joint Crackdown from the FTC and FDA on Medical Treatment Claims from CBD Companies

Knobbe Martens on

The Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA) jointly sent warning letters on April 3, 2019 to companies that advertise and sell cannabidiol (CBD) containing products via internet...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l April 2019

FDA Announces Next Steps in Cannabis Regulation - The U.S. Food and Drug Administration (FDA) has announced that it will take a number of steps to advance its consideration for the potential regulatory framework for...more

McDermott Will & Emery

FDA Announces Public Hearing on Products Containing Cannabis or Cannabis-Derived Compounds

On May 31, 2019, the Food and Drug Administration (FDA) will hold a public hearing on cannabis products. The hearing seeks to obtain scientific data on cannabis and cannabis-derived compounds, along with additional...more

Holland & Knight LLP

FDA Issues Statement on Cannabis Regulation and Announces Public Hearing

Holland & Knight LLP on

On April 2, 2019, FDA outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction...more

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