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Proposed Rules Regulatory Requirements Food and Drug Administration (FDA)

ArentFox Schiff

FDA and USDA Seek Public Input to Help Define ‘Ultra-Processed Foods’ as Part of MAHA Campaign

ArentFox Schiff on

On July 23, the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced a coordinated initiative to address health risks associated with so-called “ultra-processed foods.”...more

Akin Gump Strauss Hauer & Feld LLP

FDA, HHS and USDA Serve Up Ultra-Processed Food RFI

On July 25, the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA), unveiled the highly anticipated joint request...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

Holland & Knight LLP

Out with the Old: FDA to Revoke 52 Standards of Identity – What Food Companies Need to Know

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The U.S. Food and Drug Administration (FDA) announced a final rule on July 16, 2025, revoking 52 standards of identity (SOIs) for food products that it deems obsolete. The FDA currently maintains more than 250 SOIs, and this...more

Womble Bond Dickinson

An Increasing Regulatory Maze for Nontraditional Meat Products

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As this blog has previously covered, various states have passed laws prohibiting plant-based products from being labeled like traditional meat products. A recent Oklahoma law bans using terms like beef, chicken, or bacon to...more

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

Hogan Lovells

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate...

Hogan Lovells on

On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more

Alston & Bird

Health Care Week in Review | Trump Administration Releases FY 2026 Budget Proposal; CMS Launches Oversight Initiative on Medicaid...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Mayer Brown

HHS and FDA Announce Plans to Phase out Synthetic Food Dyes

Mayer Brown on

On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a series of steps intended to eliminate all petroleum-based synthetic dyes from the US food...more

Environmental General Counsel PC

CalRecycle Releases New EPR Packaging Regulations: Imminent Compliance, New Exclusions, and Deferred Eco-Modulation Implementation

A lot is going on in the extended producer responsibility (“EPR”) packaging world this month.  Maryland and Washington became the sixth and seventh states respectively to enact EPR packaging laws.  And this week, just a...more

Hogan Lovells

HHS & FDA Request Public Comment to Inform Agency’s Infant Formula Nutrient Review

Hogan Lovells on

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) are requesting public comment on nutrient requirements for infant formulas intended for healthy, full-term infants. FDA’s...more

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Hogan Lovells

HHS and FDA Announce Plans to Phase Out Certified Colors

Hogan Lovells on

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced a series of measures to phase out all certified colors from the nation’s food supply by the end...more

Smart & Biggar

Health Canada publishes Guide to the precision regulating authorities under the Food and Drugs Act

Smart & Biggar on

In March 2025,  Health Canada published a Guide to the precision regulating authorities under the Food and Drugs Act. The Guide sets out the principles, policies, considerations and standards that Health Canada should follow...more

Davis Wright Tremaine LLP

Flurry of Activity from FDA in the First Four Months of 2025

It is an understatement to say the last four months have been a whirlwind. Cabinet confirmations, executive orders, policy changes, and more, including some developments that impact (or that will impact) the food industry...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Seeks To Remove Petroleum-Based Dyes From US Food Supply

On April 22, 2025, Secretary of Health and Human Services Robert F. Kennedy Jr. and Commissioner of the Food and Drug Administration (FDA) Dr. Martin Makary announced that FDA is taking actions to remove petroleum-based dyes...more

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more

Baker Donelson

What Food and Beverage Manufacturers Should Be Considering With HHS Secretary Kennedy at the Reins

Baker Donelson on

Human Health and Services (HHS) Secretary Robert F. Kennedy Jr. has instructed the Food and Drug Administration (FDA) to revisit and consider rulemaking regarding its Generally Recognized as Safe (GRAS) notification and...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Second Quarter of 2025 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

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

MoFo Life Sciences

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

MoFo Life Sciences on

On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more

DLA Piper

Food and Beverage News and Trends - March 2025 #2

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. Secretary Kennedy takes first steps to eliminate GRAS exception. Health and...more

Beveridge & Diamond PC

GRAS Self-Affirmation for Food Ingredients – To Be or Not to Be?

Beveridge & Diamond PC on

Key Takeaways - What Happened: HHS Secretary Kennedy directed FDA to consider removing the current self-affirmation pathway for determining that a food ingredient is Generally Recognized as Safe (GRAS)....more

Akin Gump Strauss Hauer & Feld LLP

Is Self-Affirming GRAS Off the Menu?

United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...more

Foley & Lardner LLP

Make Food “Healthy” Again: FDA’s Resolution for a Healthier 2025

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) began 2025 with a resolution to make food “healthy” again by announcing a trio of new final and proposed rules that are intended to make it easier for consumers to identify healthy...more

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