News & Analysis as of

Labeling Final Rules

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

Cooley LLP

FDA Publishes Rule Updating ‘Healthy’ Nutrient Content Claim

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On December 27, 2024, the US Food and Drug Administration (FDA) published its final rule to update the definition for “healthy” claims on food labels. The new rule uses current nutrition science to both expand and restrict...more

ArentFox Schiff

Prop 65 Roundup - January 2025

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What Food Product Companies Need to Know About the New Proposition 65 Warning Requirements - On December 6, 2024, the Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements Proposition...more

Nutter McClennen & Fish LLP

Beverage Breakdown (January 2025)

Welcome to Nutter's Beverage Breakdown, a periodic legal update on developments related to the alcohol beverage industry, including industry news, federal and state updates, and more. We look forward to sharing our insights...more

Holland & Knight LLP

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

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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

Skadden, Arps, Slate, Meagher & Flom LLP

The Commercial Potential – and Practical Challenges – of Marketing OTC Drugs With ‘Additional Conditions for Nonprescription Use’

The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some drugs that are currently available only with a prescription to switch to OTC where a...more

Davis Wright Tremaine LLP

FDA's Definition of "Healthy" … Updated Just in Time for New Year's Resolutions

After years of talk, the U.S. Food and Drug Administration in mid-December 2024 at last finalized an updated definition of the implied nutrient content claim "healthy." The original definition of "healthy" dates back to the...more

Morgan Lewis - As Prescribed

Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule

The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug products by allowing the approval of a nonprescription drug product with an “Additional Condition...more

Venable LLP

FDA to Study Presence of Metals in Tampons: What to Know

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On September 10, the Food and Drug Administration (FDA) Biocompatibility and Toxicology Program published a statement announcing its intention to commission an independent literature review and internal bench laboratory study...more

King & Spalding

LDT Final Rule: Shifting the LDT Battlefield

King & Spalding on

On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more

Perkins Coie

USDA Issues Final Rule on Voluntary “Product of USA” Claims

Perkins Coie on

On March 18, USDA’s Food Safety and Inspection Service (FSIS) published its Final Rule on Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims (Final Rule). The Final Rule covers meat, poultry, and egg...more

Butler Snow LLP

Organic Overhaul: USDA’s New Rule Beefs Up Organic Product Regulation for the First Time in Three Decades

Butler Snow LLP on

The USDA’s wide-sweeping regulatory update may affect your company, even if it is only a small ingredient in the multi-billion dollar organic foods supply chain.   On January 18, 2023, the USDA National Organic Program...more

King & Spalding

Federal Trade Commission Issues New “Made In USA” Regulations

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Creates New Enforcement Tools And Applies The Rule To Labels “Appearing In All Contexts” (i.e., On Product Packaging Or Online) - On July 1, 2021, the Federal Trade Commission (“FTC”) approved a final rule to implement new...more

Cozen O'Connor

The Legality of Cannabidiol and Concerns Regarding False Advertising

Cozen O'Connor on

The legality of marijuana (also known as cannabis) has been a popular topic in recent years with thirty states and the District of Columbia having laws that legalize marijuana in some form. However, under federal law,...more

Womble Bond Dickinson

EPA Extends Compliance Deadlines for Formaldehyde Emission Standards in Composite Wood Products

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On September 26, 2017, EPA published a final rule in the federal register extending the compliance deadlines in its Formaldehyde Emission Standards for Composite Wood Products as follows...more

Akin Gump Strauss Hauer & Feld LLP

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

Williams Mullen

Environmental Notes - August 2016

Williams Mullen on

Time to Pay More: EPA Increases Maximum Civil Penalties - Remember the days when the maximum civil penalty EPA could assess for a violation of environmental law was $25,000 per day? Those days disappeared 26 years ago...more

Morgan Lewis

EPA Issues Final Rule Implementing Formaldehyde Emission Standards

Morgan Lewis on

Final rule seeks to reduce exposure to formaldehyde vapors by establishing emission standards and labeling requirements for certain wood products. Six years after the passage of the Formaldehyde Emission Standards for...more

Knobbe Martens

FDA Issues Final Rule on Use of Symbols in Labeling

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The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

Davis Wright Tremaine LLP

FDA Extends Menu Labeling Compliance Date

On July 9, 2015, the U.S. Food and Drug Administration (FDA) announced that it is extending the date for compliance with its menu labeling requirements by one year. Under the new timeframe, businesses covered by the menu...more

Bergeson & Campbell, P.C.

USDA Issues Final Rule Amending Voluntary Labeling Program For Biobased Products

On June 15, 2015, the U.S. Department of Agriculture (USDA) issued final amendments to the regulations concerning the Voluntary Labeling Program for Biobased Products. The rule is intended to incorporate statutory amendments...more

Bergeson & Campbell, P.C.

U.S. OSHA HCS 2012 Deadline Less Than Two Weeks Away

On March 26, 2012, OSHA issued a final rule modifying its HCS to conform to the United Nations' Globally Harmonized System of Classification and Labeling of Chemicals (GHS), Revision 3. In the final rule, OSHA drastically...more

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