News & Analysis as of

Food and Drug Administration (FDA) Federal Food Drug and Cosmetic Act (FFDCA) Food Manufacturers

Akin Gump Strauss Hauer & Feld LLP

Citizen Petition Calls on FDA to Rethink Refined Carbs

Last week, former Food and Drug Administration (FDA) Commissioner David Kessler submitted a citizen petition urging FDA to revoke the generally recognized as safe (GRAS) status of refined carbohydrates used in industrial food...more

McDermott Will & Schulte

Bye-bye, bright dyes: Strategies for responding to FDA’s synthetic food dye phase-out

On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a plan to phase out petroleum-based synthetic dyes from the US food supply by the end of 2026,...more

Kelley Drye & Warren LLP

MAHA Movement Continues to Invite Significant Change for Food Regulation at Federal and State Levels

Robert F. Kennedy Jr. promised big changes as Secretary of the Department of Health & Human Services, the sweeping agency that oversees FDA, NIH, CDC, and other divisions and agencies. Five months into his tenure, he has...more

Morrison & Foerster LLP

FDA Targets 52 “Obsolete” Food Standards of Identity for Revocation

On July 17, 2025, FDA announced several rulemakings aimed at modernizing its standards of identity (SOIs) for food products – regulations that define what a food must contain and how it must be made to lawfully bear a...more

Holland & Knight LLP

Recent FDA Actions Pose Big Changes and Questions for Health and Food Industries

Holland & Knight LLP on

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more

Holland & Knight LLP

FDA Initiates New Post-Market Review Framework for Food Chemicals

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) has announced a new initiative to systematically review the safety of chemicals already in the nation's food supply....more

Shook, Hardy & Bacon L.L.P.

FDA, HHS Announce Measures to Phase Out Petroleum-Based Dyes in Food

The U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) have announced actions to phase out petroleum-based synthetic dyes from foods in the U.S. food supply. In a news release, FDA said...more

Alston & Bird

For Your Consumption – March 2025: Always Reading the Tea Leaves

Alston & Bird on

In the March edition of For Your Consumption, our food & beverage digest of court cases and litigation trends affecting the food, beverage, agribusiness, and cosmetics industries, there’s nothing natural about beavers’ anal...more

Husch Blackwell LLP

Eliminating the GRAS “Loophole”: Implications for Functional Foods and Beverages

Husch Blackwell LLP on

On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that U.S. Secretary of HHS Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore closing the GRAS...more

Venable LLP

Exploring the Future of GRAS: HHS’s Recent Directive and Its Potential Impact on the Food Industry

Venable LLP on

On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS Secretary Robert F. Kennedy has directed the Food and Drug Administration (FDA or Agency) “to take steps to explore potential...more

Epstein Becker & Green

The End of the Self-Affirmed GRAS Pathway?

Epstein Becker & Green on

On March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), in a seismic shift, announced that the U.S. Food and Drug Administration (“FDA”) would “explore potential...more

Morgan Lewis - Well Done

The Future of Artificial Colors in the US Food Supply Is Not So Bright

Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more

ArentFox Schiff

Five Key Topics for Beverage and Food Companies in 2025

ArentFox Schiff on

2025 will be a transformational year for the beverage and food industry, which has already been dramatically impacted by shifting market trends and profound policy changes. Here are the top five topics influencing the...more

Holland & Knight LLP

HHS Explores Stronger FDA Oversight for Food Ingredients

Holland & Knight LLP on

U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced on March 10, 2025, that he directed the acting commissioner of the U.S. Food and Drug Administration (FDA) to explore potential...more

Husch Blackwell LLP

Say Goodbye to the Red Dye: Legal Implications Following the FDA’s Recent Ban

Husch Blackwell LLP on

On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...more

Foster Garvey PC

FDA Revoking Authorization for Use of Red No. 3 in Food and Ingested Drugs

Foster Garvey PC on

On January 15, 2025, the Food and Drug Administration (FDA) amended its color additive regulations by revoking its authorization for use in food and ingested medications of FD&C Red No. 3 (Red No. 3), a synthetic red dye....more

K&L Gates LLP

FDA Revokes Authorization for the Use of Red Dye No. 3 in Food and Ingestible Drugs

K&L Gates LLP on

On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingestible drugs. This ban...more

Venable LLP

Red Dye No. 3 Ban at FDA and What's Next

Venable LLP on

On January 15, 2025, the Food and Drug Administration (FDA or Agency) issued an order to revoke the authorization for the use of FD&C Red No. 3 (Red No. 3) in food and ingested drugs in response to a 2022 color additive...more

Clark Hill PLC

Red Dye No 3: Old Data Induces New Ban

Clark Hill PLC on

On January 16, 2025 the federal Food and Drug Administration (FDA) issued notice requiring manufacturers to reformulate their products removing Red Dye No. 3 by January 15, 2027 for food (21 CFR §74.303) and January 18, 2028...more

Davis Wright Tremaine LLP

FDA's Definition of "Healthy" … Updated Just in Time for New Year's Resolutions

After years of talk, the U.S. Food and Drug Administration in mid-December 2024 at last finalized an updated definition of the implied nutrient content claim "healthy." The original definition of "healthy" dates back to the...more

Hogan Lovells

FDA Issues Final “Healthy” Rule

Hogan Lovells on

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued its long-awaited final rule updating the requirements for when the term “healthy” can be used as an implied nutrient content claim in food labeling. ...more

McDermott Will & Schulte

FDA’s Fresh Take on Use of “Healthy” in Food Labeling

On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’” The rule revises regulations that govern when food...more

K&L Gates LLP

Obtaining Clearances Through FDA's Food Contact Notification Program

K&L Gates LLP on

The US Food and Drug Administration’s (FDA) formal regulation of food packaging began in 1958 with the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. Since that time, the FDA has employed various...more

Holland & Knight LLP

Ninth Circuit Holds That California Food-Labeling Law Is Not Preempted by Federal Law

Holland & Knight LLP on

In 1990, Congress enacted the Nutrition Labeling and Education Act (NELA) as an amendment to the Food, Drug and Cosmetic Act (FDCA). Among other things, NELA 1) provided for modernization and standardization of the familiar...more

Foley & Lardner LLP

My Healthy Food Product is Ready to Go to Market – What About its Packaging?

Foley & Lardner LLP on

After formulating an exciting new healthy food or beverage, the packaging it comes in may feel like an afterthought.  It should not be.   Food packaging has become an increasingly hot topic among federal and state regulators,...more

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