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Final Rules Proposed Rules Food and Drug Administration (FDA)

Akin Gump Strauss Hauer & Feld LLP

FDA Grants Three Natural Food Additive Petitions

On May 9, 2025, the U.S. Food and Drug Administration (FDA) granted three color additive petitions, approving two new colorings and expanding one existing approval. These approvals come after the agency’s announcement last...more

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

Hogan Lovells on

The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

MoFo Life Sciences

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

MoFo Life Sciences on

On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....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

Akin Gump Strauss Hauer & Feld LLP

Is Self-Affirming GRAS Off the Menu?

United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...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

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

Axinn, Veltrop & Harkrider LLP

Pounding the Compounders: FDA’s “No Compound” Lists

Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...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

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

Holland & Knight LLP

FDA's New Year, New Rules: Labeling for Healthier Choices

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) is taking a stronger approach toward supporting health goals in 2025 and beyond by setting the tone and releasing a number of regulatory actions aimed at enhancing consumer health...more

Wiley Rein LLP

FDA’s Catch-Up Plan on Cosmetics Faces Likely Regulatory Delays with Change in Administrations

Wiley Rein LLP on

The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA): •Standardized test methods to detect...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024 #4

This Week in Washington: HHS announces reorganization of health technology offices; House recesses early because of an inability to pass appropriations bills; Senate Finance Committee chairman introduces legislation to...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024 #3

This Week in Washington: House Rules Committee to consider FY2025 Agriculture-FDA and Related Agencies funding bill amendments; MedPAC releases July 2024 data book on Medicare program spending; National drug shortages fall to...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024 #2

This Week in Washington: House Appropriations Committee marks up FY2025 Labor-HHS-Education and the Agriculture- FDA and Related Agencies funding bills; Senate Appropriations Committee marks up FY2025 Agriculture-FDA and...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024

This Week in Washington: House Ways and Means Committee marks up healthcare bills related to new technologies and coverage for weight loss drugs; CMS releases CY2025 Home Health and End-Stage Renal Disease PPS proposed rules;...more

McGuireWoods Consulting

Washington Healthcare Update - June 2024 #3

This Week in Washington: CBO releases analysis of health insurance rates; Senate Finance Committee Chairman releases draft legislation concerning labor and delivery unit closures; House Oversight and Accountability Committee...more

McGuireWoods Consulting

Washington Healthcare Update - June 2024 #2

This Week in Washington: House Energy and Commerce Committee marks up 13 healthcare bills; House Energy and Commerce Committee Subcommittee on Health holds hearing on CMMI; CMS announces it will recalculate MA Star Ratings....more

McGuireWoods Consulting

Washington Healthcare Update - June 2024

This Week in Washington: Senate Finance Committee Chairman sends letters concerning healthcare cybersecurity measures; House Energy and Commerce Committee Oversight and Investigations Subcommittee holds hearing on 340B...more

McGuireWoods Consulting

Washington Healthcare Update - May 2024 #4

This Week in Washington: Senate Finance Committee releases draft proposal outline concerning GME program; Senate HELP Committee marks up seven healthcare bills; NIH issues first-of-its-kind policy proposal to promote equal...more

McGuireWoods Consulting

Washington Healthcare Update - May 2024 #3

This Week in Washington: House appropriators release FY2025 topline appropriations levels; Senate Finance Committee releases white paper on Medicare physician payment reforms; House Energy and Commerce Committee Subcommittee...more

McGuireWoods Consulting

Washington Healthcare Update - May 2024 #2

This Week in Washington: House Ways and Means Committee marks up telehealth legislation; CMS extends state Medicaid unwinding flexibilities; Senate HELP Committee ranking member releases white paper outlining possible NIH...more

Quarles & Brady LLP

FDA Publishes Final Rule on Regulation of Lab-Developed Tests

Quarles & Brady LLP on

On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

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