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Regulatory Requirements Public Health Food Safety

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

Downey Brand LLP

Court Overturns Prop 65 Acrylamide Warning

Downey Brand LLP on

On May 2, a federal district court in Sacramento permanently enjoined the Prop 65 warning for acrylamide in food, finding it to be unconstitutional. At issue in the case, California Chamber of Commerce v. Bonta (E.D. Cal. No....more

Bergeson & Campbell, P.C.

NSF Announces PFAS-Free Certification for Nonfood Compounds and Food Equipment Materials 

On March 24, 2025, NSF announced the release of NSF Certification Guideline 537: PFAS-Free Products for Nonfood Compounds and Food Equipment Materials (NSF 537). The press release states that to be certified, nonfood compound...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

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....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

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

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

Cooley LLP

FDA Publishes Rule Updating ‘Healthy’ Nutrient Content Claim

Cooley LLP on

On December 27, 2024, the US Food and Drug Administration (FDA) published its final rule to update the definition for “healthy” claims on food labels. The new rule uses current nutrition science to both expand and restrict...more

Hogan Lovells

FDA Finalizes Two Food Allergen-Related Guidance Documents

Hogan Lovells on

On January 6, 2025, FDA published two final guidance documents related to food allergens: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and...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

EU bans BPA in Food Contact Materials: what does it mean for industry?

Hogan Lovells on

Jacqueline Mailly and Anastasia Vernikou of Hogan Lovells and Grégoire Paquet outline the details of the EU regulation introducing a ban on Bisphenol A (BPA) in food contact materials and its implications for industry. On 20...more

DLA Piper

FDA Bans Red Dye No. 3 Under the Delaney Clause

DLA Piper on

The US Food and Drug Administration (FDA) has revoked its authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3. Issued on January 15, 2025, the ban will go into effect for food (including dietary...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

Ropes & Gray LLP on

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

McGuireWoods LLP

FDA Bans Red Dye No. 3 in Food and Drugs, Sets Deadlines for Manufacturers to Reformulate

McGuireWoods LLP on

On Jan. 15, 2025, the U.S. Food and Drug Administration revoked its authorization for the use of Red Dye No. 3 in food and ingested medications. Red Dye No. 3, chemically known as erythrosine, is a synthetic color additive...more

Husch Blackwell LLP

FDA Bans the Use of Red No. 3 in Food and Ingested Drugs

Husch Blackwell LLP on

On January 16, the U.S. Food and Drug Administration (FDA) announced that it is revoking the authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The dye is commonly used in...more

DLA Piper

FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling

DLA Piper on

The US Food and Drug Administration (FDA) has released its proposed rule on front-of-package (FOP) nutrition labeling. Announced on January 14, 2025, the proposed rule would add a requirement to include an informational box...more

Womble Bond Dickinson

FDA Sets Action Levels For Lead

Womble Bond Dickinson on

A year ago, the FDA issued draft guidance for lead levels in baby foods. In the year since the FDA issued its draft guidance for lead levels in baby food, two states, California and Maryland, have adopted laws which require...more

Morrison & Foerster LLP

FDA Issues Action Levels for Lead in Baby Food

On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more

DLA Piper

FDA Issues Updated Final Rule for "Healthy" Labeling

DLA Piper on

The US Food and Drug Administration (FDA) released the final rule providing new criteria for when foods may be labeled with the nutrient content claim “healthy.” This rule, released on December 19, 2024, has been a priority...more

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