News & Analysis as of

Labeling Final Rules Food and Drug Administration (FDA)

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

Cooley LLP on

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

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

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

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

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

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

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

Knobbe Martens

FDA Issues Final Rule on Use of Symbols in Labeling

Knobbe Martens on

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

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