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Rulemaking Process Public Health

Bergeson & Campbell, P.C.

EPA Denies TSCA Section 21 Petition Concerning Prohibition of Hydrogen Fluoride in Domestic Oil Manufacturing

As reported in our February 14, 2025, blog item, on February 11, 2025, community and environmental groups submitted a petition under Section 21 of the Toxic Substances Control Act (TSCA) to the U.S. Environmental Protection...more

Venable LLP

U.S. EPA Delineates PFAS Plans

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The U.S. Environmental Protection Agency (EPA) issued a press release on April 28 setting forth its “first, not the last” statement regarding “major” actions and initiatives it intends to undertake to address human health and...more

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

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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?

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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

Venable LLP

Regulatory Freeze: FDA Pushes Back Effective Date of "Healthy" Nutrient Content Claim Rule

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On February 25, the Food and Drug Administration (FDA) announced a delay in the effective date for its final rule updating the criteria to use the "healthy" nutrient content claim on food labeling....more

Ice Miller

FDA Final Rule for “Healthy” Nutrient Content Claims Effective Date Looms but Rule’s Future Is Uncertain

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After years of rulemaking with impassioned input from food producers, industry stakeholders, and consumer groups, on December 27, 2024, the Food and Drug Administration (FDA or Agency) published a final rule titled “Food...more

Mintz - Health Care Viewpoints

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more

Troutman Pepper Locke

FDA Withdraws Proposed Bans on Menthol Cigarettes and Flavored Cigars

Troutman Pepper Locke on

In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be...more

Troutman Pepper Locke

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

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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

King & Spalding

FDA Releases Proposed Front-of-Package Nutrition Labeling Rule

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On January 16, 2025, the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) nutrition labeling (“proposed rule”)....more

K&L Gates LLP

FDA Proposes Front-of-Package Labeling Requirements

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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

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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

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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

Holland & Knight LLP

EPA Imposes More Stringent Lead Paint Dust Requirements

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In response to a decision by the U.S. Court of Appeals for the Ninth Circuit finding that the U.S. Environmental Protection Agency's (EPA) updates to its lead paint hazard standards were deficient because they improperly took...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

Polsinelli

October PFAS Regulatory Update

Polsinelli on

In October 2023, the United States Environmental Protection Agency (EPA) finalized two separate but analogous rulemakings – one under the Toxic Substances Control Act (TSCA), and one under the Emergency Planning and Community...more

Akin Gump Strauss Hauer & Feld LLP

FDA’s Proposed Rule on Laboratory Developed Tests: One Small Change to Regulatory Language That Would Mark a Giant Leap in Lab...

On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more

Stinson LLP

Minnesota Announces PFAS Rulemaking

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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

ArentFox Schiff

Environmental Justice Update: Louisiana Decision Upholds Use of EPA Emergency Powers

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Louisiana has been at the center of the Biden Administration’s prioritization of environmental justice (EJ) issues. In United States v. Denka Performance Elastomer, the Eastern District of Louisiana granted a motion by the...more

Holland & Knight LLP

The D.C. Circuit Overrules EPA on Regulating Perchlorate

Holland & Knight LLP on

The U.S. Court of Appeals for the District of Columbia Circuit has the latest word in the long-running saga concerning regulation of the contaminant perchlorate in its decision dated May 9, 2023, when it ruled the U.S....more

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