News & Analysis as of

Regulatory Requirements Proposed Rules Public Health

White & Case LLP

EPA Partially Rolls Back PFAS Drinking Water Rule

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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

Troutman Pepper Locke

PFAS Regulatory Landscape Update — The Message? Stay Tuned.

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The Environmental Protection Agency (EPA) has announced several actions in recent weeks that shed light on the Trump administration’s approach to PFAS regulation....more

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Morgan Lewis - Well Done

Proposed Nutrition and Allergen Labeling Changes for Alcoholic Beverages: Key Takeaways

The Alcohol and Tobacco Tax and Trade Bureau (TTB) has published a pair of proposed rules that if finalized could significantly reshape alcohol beverage labeling in the United States. In a move aimed at improving transparency...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

DLA Piper

Food and Beverage News and Trends - March 2025 #2

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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

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

Goldberg Segalla

Update RE: EPA’s Proposed PFAS Rule Comment Period

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In 2024, the EPA proposed a PFAS rule with a January 17, 2025, comment deadline in response to questions from the industry regarding the effective date of supplier notifications for mixtures or trade name products containing...more

Blake, Cassels & Graydon LLP

Santé Canada propose un règlement visant à atténuer les pénuries de drogues et d’instruments médicaux

Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...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

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

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

Williams Mullen

EPA Proposing to Expand Toxic Release Inventory Reporting Relating to PFAS

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Since late 2019, EPA has successfully added certain perfluoroalkyl substances (PFAS) to the toxic release inventory (TRI) list of chemicals subject to reporting under section 313 of the Emergency Planning and Community...more

DLA Piper

Maine DEP Proposes Currently Unavoidable Use Procedures for PFAS in Products Law

DLA Piper on

Maine’s Department of Environmental Protection (DEP) recently published a proposed rule prescribing procedures and criteria for determining Currently Unavoidable Uses (CUU) of intentionally added per- and polyfluoroalkyl...more

Troutman Pepper Locke

FDA Proposes Limiting Nicotine Levels in Cigarettes and Certain Other Combusted Tobacco Products

Troutman Pepper Locke on

On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products....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

MoFo Life Sciences

Front-of-pack, Front-of-mind

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On Tuesday, FDA proposed a rule that would require a front-of-pack mini nutrition label on most packaged foods by 2028. This is yet another effort by FDA to make it easier for consumers to determine which foods are “healthy”...more

Paul Hastings LLP

PFAS Legislative & Regulatory Developments Fourth Quarter 2024

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Per- and polyfluoroalkyl substances (PFAS) are a large class of synthetically created organic chemical compounds that have been at the forefront of complex environmental and legal issues in recent years. While many PFAS...more

Jones Day

HHS Announces Upcoming Federal Strategies to Enhance Cybersecurity for Health Care and Public Health Sectors

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The Department of Health and Human Services ("HHS") has released a concept paper outlining its new cybersecurity strategies for the health care sector, identifying cybersecurity priorities, potential future regulations and...more

Hogan Lovells

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

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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

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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

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

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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

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