News & Analysis as of

GRAS Food and Drug Administration (FDA)

Holland & Knight LLP

HHS Announces Actions to Phase Out Use of Food Additives

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The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) on April 22, 2025, announced their intent to phase out the use of certain food additives, including petrochemical-based dyes,...more

Baker Donelson

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

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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

Husch Blackwell LLP

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

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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

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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

American Conference Institute (ACI)

[Event] 9th Advanced Summit on Food Law Regulation, Compliance and Litigation - April 29th - 30th, Chicago, IL

Attend ACI’s 9th Advanced Summit on Food Law Regulation, Compliance and Litigation to connect and reconvene with industry leaders and acquire invaluable insights to surmount the latest challenges facing the food industry....more

ArentFox Schiff

RFK Jr. Takes Aim at GRAS Self-Affirmation Process

ArentFox Schiff on

On March 10, the US Department of Health and Human Services (HHS) announced that newly confirmed HHS Secretary Robert F. Kennedy Jr. has directed acting US Food and Drug Administration (FDA) Commissioner Dr. Sara Brenner to...more

Latham & Watkins LLP

HHS Directs FDA to Explore Rulemaking to Increase Oversight of Food Ingredients

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On March 10, 2025, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced in a press release that he has directed the Food and Drug Administration (FDA) to explore rulemaking to implement a...more

Ice Miller

RFK Jr. Calls to End the Self-Affirming GRAS “Loophole”

Ice Miller on

Through an Order that the Secretary of the U.S. Department of Health and Human Services (HHS) Robert F. Kennedy Jr. (RFK) called an act of “radical transparency,” the U.S. Food and Drug Administration (FDA) has been directed...more

Holland & Knight LLP

HHS Explores Stronger FDA Oversight for Food Ingredients

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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

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

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

Holland & Knight LLP

Holland & Knight Health Dose: March 11, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Skadden, Arps, Slate, Meagher & Flom LLP

Gauging the Likelihood of Trump Administration FDA Reforms

Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have featured opinions from...more

Venable LLP

FDA's Proposed Interim Animal Food Ingredient Consultation process - will the GRAS be Greener post-AAFCO Ingredient Definition...

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As of October 1, 2024, the Association of American Feed Control Official's (AAFCO) Annual Official Publication is no longer definitive as to which feed additives are FDA-approved or, otherwise, have been determined to be...more

DLA Piper

Food and Beverage News and Trends - December 2024

DLA Piper on

On November 21, the FDA sent its proposed rule on front of package (FOP) nutrition labels to the White House Office of Management and Budget (OMB). FOP labeling has been prioritized by the agency as part of a National...more

Venable LLP

New Center for Veterinary Medicine Final Guidance: Will AAFCO Animal Feed Ingredient Definitions Continue to Be a Safe Harbor for...

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The FDA Center for Veterinary Medicine released the Final Guidance for Industry today for its enforcement policy for AAFCO-defined animal feed ingredients. The big news is that FDA will no longer be reviewing the annual list...more

Husch Blackwell LLP

FDA Allows Longstanding MOU with AAFCO To Expire

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On August 2, 2024, the Association of American Feed Control Officials (“AAFCO”) announced that its Memorandum of Understanding 225-07-7001 (the “MOU”) with the U.S. Food and Drug Administration (“FDA”) outlining the AAFCO...more

Rivkin Radler LLP

The Case of ‘Gas Station Heroin’

Rivkin Radler LLP on

Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale? If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and...more

Foley & Lardner LLP

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

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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

McDermott Will & Emery

Don’t Assume Nonalcoholic Beverage Ingredients Are OK for Alcoholic Beverages

As we enter 2024, more and more brands are joining the nonalcoholic beverage space. An increasing variety of nonalcoholic, single-serve, ready-to-drink beverages are marketing the innovative use of indigenous botanicals,...more

Foley & Lardner LLP

Bringing a New Healthy Food Ingredient to Market: Understanding the Regulatory Pathways

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Whether formulating a new food or developing a novel ingredient, a critical first step is understanding the regulatory framework for bringing a new ingredient (or a food containing a new ingredient) to the market.  This...more

Husch Blackwell LLP

The Future of Functional Foods

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Following the social isolation and public health concerns associated with the COVID-19 pandemic, many Americans reevaluated their health and wellness priorities, creating new opportunities for food systems companies to...more

Sheppard Mullin Richter & Hampton LLP

FDA Moves to End Use of Brominated Vegetable Oil in Food

Within a month of California becoming the first state in the nation to ban manufacturing with, selling, or distributing food items that contain brominated vegetable oil (BVO), FDA has proposed to revoke the regulation...more

Perkins Coie

FDA Releases Public Inventory of Unapproved Food Additives

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The U.S. Food and Drug Administration (FDA) released a public inventory on July 12, 2023, of certain food ingredients that the agency has determined are unsafe because they are unapproved food additives that are not Generally...more

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