News & Analysis as of

Rulemaking Process Regulatory Requirements Public Health

Mitchell, Williams, Selig, Gates & Woodyard,...

PM 2.5/Clean Air Act: Environmental Organizations Joint Letter to U.S. EPA Opposing Revisiting NAAQS

One hundred environmental organizations transmitted an April 21st letter to the United States Environmental Protection Agency (“EPA”) Administrator asking that the federal agency: …maintain and promptly implement a vital,...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

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

Troutman Pepper Locke

Federal Appellate Court Agrees that FDA Cannot Regulate “Premium Cigars”

Troutman Pepper Locke on

Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium...more

K&L Gates LLP

FDA Proposes Front-of-Package Labeling Requirements

K&L Gates LLP on

On 14 January 2024, the US Food and Drug Administration (FDA) issued a proposed rule to be published on 16 January, which, if finalized, will require a front-of-package (FOP) nutrition label on most packaged foods. This FOP...more

Husch Blackwell LLP

California’s Proposition 65 Short-Form Warnings Now in Effect

Husch Blackwell LLP on

California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a notice of proposed amendments to Proposition 65 in October 2023 that significantly modify the information businesses are required to provide in...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

Shook, Hardy & Bacon L.L.P.

FDA Announces Final Rule Updating Definition of "Healthy" Nutrient Content Claim - Food and Beverage Litigation and Regulatory...

The U.S. Food and Drug Administration (FDA) has announced a final rule updating the definition of the nutrient content claim “healthy.” To qualify as “healthy” under the updated definition, food products must contain a...more

Harris Beach Murtha PLLC

EPA Designates Two PFAS Substances as CERCLA Hazardous Substances

On April 19, 2024, just nine days after finalizing the first-ever national, legally enforceable drinking water standard for six individual per-and polyfluoroalkyl substances (PFAS), the Agency designated PFOA and PFOS, two...more

Downey Brand LLP

EPA outlines key PFAS regulatory developments on the horizon

Downey Brand LLP on

During the early stages of the Biden administration, efforts to regulate per- and poly-fluoroalkyl substances, aka “PFAS,” were largely piecemeal and driven by various proposals in Congress. Last month, however, the U.S....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

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l February 2020 #3

LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Guidance on Intentional Adulteration - The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional...more

King & Spalding

Emerging Regulation, Enforcement, and Litigation Involving Ethylene Oxide, a Critical Substance for Sterilizing Medical Products...

King & Spalding on

Ethylene oxide (“EtO”), one of the most widely used and effective substances for sterilizing medical products and devices, has come under intense scrutiny by the Environmental Protection Agency (“EPA”), the Food and Drug...more

Hogan Lovells

FDA Releases Third and Final Installment of Draft Guidance for FSMA Intentional Adulteration Rule

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”)....more

Stinson LLP

Minnesota Joins Intensifying Hunt for PFAS

Stinson LLP on

State and federal agencies continue to step up efforts to identify and regulate sources of per- and polyfluoroalkyl substances (PFAS), a group of man-made, environmentally persistent chemicals used in a wide range of consumer...more

Hogan Lovells

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

Hogan Lovells on

The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization Act (FSMA)....more

Seyfarth Shaw LLP

Cosmetics, Hemp, and CBD: Legislative and Regulatory Update

Seyfarth Shaw LLP on

Seyfarth Synopsis: Through a reintroduced House bill, Congress is taking strides to push for cosmetic regulation reform and, separately, through the SAFE Act, it is seeking to establish a safe harbor for financial...more

Hogan Lovells

FDA Issues Final Rule on Front-of-Pack Calorie Disclosures Used for Vending Machine Labeling Compliance

Hogan Lovells on

The Food and Drug Administration (FDA) issued a final rule to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to comply with the vending machine calorie labeling requirements. The...more

Hogan Lovells

The Use of an Alternate Name for Potassium Chloride in Food Labeling: Guidance for Industry

Hogan Lovells on

Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more

Hogan Lovells

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

Hogan Lovells on

On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally...more

23 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide