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Regulatory Reform › Rulemaking Process › Public Health

Holland & Knight LLP

Food and Chemical Update: FDA Unveils Data-Driven Assessment Tool to Rank Food Chemicals

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) is overhauling its approach to post-market oversight of food chemicals, marked by the proposed rollout of a new Post-Market Assessment Prioritization Tool. The FDA first announced...more

Morgan Lewis - As Prescribed

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Morgan Lewis - As Prescribed on

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

Morgan Lewis - Well Done

Food for Thought Implications of FDAs New Chemical Review Program

Morgan Lewis - Well Done on

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

White & Case LLP

EPA Partially Rolls Back PFAS Drinking Water Rule

White & Case LLP on

On May 14, 2025, the U.S. Environmental Protection Agency (EPA) announced that it plans to retain the current drinking water standards for two per- and polyfluoroalkyl substances (PFAS), i.e., perfluorooctanoic acid (PFOA)...more

ArentFox Schiff

Tennessee Passes Law That Requires ‘Best Science Available’ for PFAS Regulations

ArentFox Schiff on

Tennessee lawmakers are setting a new precedent in chemical regulation, including per- and polyfluoroalkyl substances (PFAS), by signing into law an industry-backed bill that requires the use of the “best science available”...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

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

Faegre Drinker Biddle & Reath LLP

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

Faegre Drinker Biddle & Reath LLP on

On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more

Stinson LLP

Minnesota Announces PFAS Rulemaking

Stinson LLP on

Minnesota has begun enacting substantive rules and standards for per- and polyfluoroalkyl substances (PFAS). In May, Minnesota enacted a PFAS statute that defines PFAS, creates a reporting requirement, and bans sale or...more

Hogan Lovells

New EU regulation defines “Food Safety Culture”

Hogan Lovells on

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

Stoel Rives LLP

Bunn’s “Renewal Plan” will Overhaul Oil & Gas Regulation in California Starting Next Year

Stoel Rives LLP on

On October 8, the California Department of Conservation (“DOC”) released a Renewal Plan for Oil and Gas Regulation (“Renewal Plan”) to revamp its regulatory program.  The goal of the Renewal Plan is to continue the DOC’s...more

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