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GRAS Federal Food Drug and Cosmetic Act (FFDCA)

Akin Gump Strauss Hauer & Feld LLP

A New Recipe for GRAS? FDA’s Proposed Mandatory GRAS Notification Rule, BHA RFI and Congressional Reform Bills

It is no exaggeration to say that the past year has seen the most significant push to reform the U.S. Food and Drug Administration’s (FDA) generally recognized as safe (GRAS) process in more than two decades (see our prior...more

DLA Piper

Food and Beverage News and Trends - February 2026

DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. FDA releases 2026 deliverables for Human Foods Program. On January 23, the Food...more

The Food Lawyers ®

FDA’s Focus on Self-Affirmed GRAS: Regulatory Recalibration and Practical Implications

The Food Lawyers ® on

The U.S. Food and Drug Administration (FDA) has signaled renewed regulatory focus on the long-standing practice of “self-affirmed” GRAS determinations....more

Epstein Becker & Green

Eliminating the GRAS Pathway: An Update

Epstein Becker & Green on

Legislation introduced in the U.S. Senate in November, informally called the “Better FDA Act of 2025,” is perhaps a bit misleading. While it involves the Food and Drug Administration (“FDA”), the full title of S....more

Venable LLP

Prepare for FDA Proposal to Require Mandatory GRAS Notices

Venable LLP on

On December 1, the U.S. Food and Drug Administration (FDA) sent its proposed Generally Recognized as Safe (GRAS) rule, which is expected to mandate submission of GRAS notices for human and animal food substances, to the...more

Wiley Rein LLP

Reforming GRAS: Digesting the Proposed “Better Food Disclosure Act” (S. 3122)

Wiley Rein LLP on

Senator Roger Marshall (R-KS) introduced much-anticipated legislation this month that seeks to reform the process by which “generally recognized as safe” (GRAS) substances are assessed by the U.S. Food and Drug Administration...more

Hogan Lovells

Senator Marshall Introduces GRAS Reform Bill

Hogan Lovells on

On November 6, 2025, Senator Roger Marshall (R-KS) introduced the “Better Food Disclosure Act of 2025”, also known as the “Better FDA Act of 2025” (S. 3122) which would reform the Generally Recognized as Safe (“GRAS”) legal...more

Epstein Becker & Green

A Step Closer to the Proposed End of the Self-Affirmed GRAS Pathway

Epstein Becker & Green on

As EBG previously reported, on March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), announced that the U.S. Food and Drug Administration (the “FDA”) is exploring...more

Morrison & Foerster LLP

MAHA Strategy Report Signals Potential Changes for U.S. Food Policy and Regulation

On September 9, 2025, the Make America Healthy Again Commission published the “Make Our Children Healthy Again Strategy Report”. The Report sets out more than 120 actions to reshape U.S. food policy and regulation,...more

Venable LLP

FDA Announces Notice of Proposed Rulemaking to Eliminate Self-Affirmed GRAS and Revise GRAS Review Criteria

Venable LLP on

Last week, the Office of Information and Regulatory Affairs released the spring 2025 edition of the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). This semiannual publication outlines the...more

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

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

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

FDA Allows Longstanding MOU with AAFCO To Expire

Husch Blackwell LLP on

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?

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

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

Husch Blackwell LLP on

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

Perkins Coie

FDA Releases Public Inventory of Unapproved Food Additives

Perkins Coie on

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

Hogan Lovells

Homeopathic drug product makers warned to follow FDA premarket and GMP rules

Hogan Lovells on

Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against homeopathic products that it...more

Vicente LLP

High-THC Hemp Edibles Are Dangerous and Potentially Deadly: A Cautionary Tale in Minnesota

Vicente LLP on

On December 5, 2022, the Minnesota Board of Pharmacy filed a lawsuit against three affiliated Minnesota hemp companies seeking condemnation and destruction of several million dollars worth of gummy edibles. Ironically named...more

Hogan Lovells

FDA issues notable new round of warning letters involving foods with added CBD

Hogan Lovells on

On November 16, 2022, the United States Food and Drug Administration (FDA) issued Warning Letters to five companies that market food and beverage products containing cannabidiol (CBD). FDA takes the position that the...more

Vicente LLP

FDA Enforcement Action Targeted at Hemp-Derived Delta-8 Products

Vicente LLP on

On May 4, 2022, the FDA issued five warning letters to companies for selling products containing hemp-derived Delta-8 THC. Notably, this is the first time the FDA has issued warning letters specifically for Delta-8 products....more

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