News & Analysis as of

Regulatory Requirements Food Safety Regulatory Reform

Shook, Hardy & Bacon L.L.P.

Think Tank Argues for Closing GRAS Loophole

U.S. policymakers should consider reforms to close loopholes surrounding Generally Recognized as Safe (GRAS) substances, according to an issue brief from the America First Policy Institute. The report recommends against...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

Morgan Lewis - Well Done

Food for Thought Implications of FDAs New Chemical Review Program

The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more systematic review process”...more

Arnall Golden Gregory LLP

Wind of Change: FDA Commissioner Makary Outlines His Vision for FDA

In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law...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

Beveridge & Diamond PC

FDA Food Chemical Regulation After the MAHA Executive Order

Beveridge & Diamond PC on

Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive FD&C Red Dye No. 3 in food after January 15, 2027. This was the latest example of...more

Morrison & Foerster LLP

FDA Seeks to Phase Out Synthetic Color Additives

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a major initiative to voluntarily phase out “petroleum-based synthetic dyes” (i.e., synthetic...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

Morgan Lewis

HHS Signals GRAS Reform: How Food Manufacturers Can Prepare Now

Morgan Lewis on

Ingredient suppliers and food manufacturers face an uncertain supply chain landscape in which “generally recognized as safe” (GRAS) self-determinations may be more closely scrutinized. The US Department of Health and Human...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA at the Start of the Trump Administration: A Cheat Sheet

There has been a flurry of activity at the Food and Drug Administration (FDA) since the start of the Trump administration. Day-to-day operations at FDA are already significantly altered, and we expect the trickle-down effects...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

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

DLA Piper

Food and Beverage News and Trends - March 2025 #2

DLA Piper on

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

Jones Day

FDA Directed to Explore Elimination of Food Additive "Loophole"

Jones Day on

Secretary Kennedy seeks to enhance FDA's oversight of food additives by eliminating a pathway that allows new ingredients to be introduced into the U.S. food supply without premarket notification to or approval by FDA....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

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

Cozen O'Connor

FDA Bans Red Dye No. 3 in Food and Ingested Drugs: What Manufacturers Should Know

Cozen O'Connor on

On January 16, 2025, the Food and Drug Administration (FDA) issued an order banning FD&C Red No.3 in food and ingested drugs.1 Food and ingested drug manufacturers who use Red No. 3 have until January 15, 2027, or January 18,...more

Shook, Hardy & Bacon L.L.P.

FDA Publishes Front-of-Pack Regulation, Bans Red Dye No. 3

The U.S. Food and Drug Administration (FDA) has published a proposed front-of-package nutrition label, the "Nutrition Info box," that would give consumers readily visible information about the "Low," "Med" or "High" levels of...more

Hogan Lovells

FDA releases Closer to Zero: An action plan to reduce exposure to toxic elements in children’s foods

Hogan Lovells on

The U.S. Food and Drug Administration recently announced a new initiative called Closer to Zero, which is an action plan that identifies steps the agency will take over the next three years (and beyond) to reduce exposure to...more

Hogan Lovells

New EU regulation defines “Food Safety Culture”

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The European Union (EU) recently adopted a regulation requiring food business operators to establish and provide evidence of an appropriate food safety culture and detailing the steps they must take to satisfy this...more

Hogan Lovells

Reminder: Compliance date for new FDA requirements for fermented and hydrolyzed “gluten-free” foods

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The 13 August 2021 compliance date for the U.S. Food and Drug Administration’s (FDA) final rule establishing recordkeeping requirements for foods bearing “gluten-free” claims that are fermented, hydrolyzed, or contain...more

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