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Food and Drug Administration (FDA) › Final Rules › Advertising

Saul Ewing LLP

Marketing Risk in the Age of Wellness: When Are Food Claims Misbranding?

Saul Ewing LLP on

On October 1, 2024, the U.S. Food and Drug Administration (FDA or the Agency) implemented its unified Human Foods Program (HFP). The Agency established the HFP – which represented the single largest reorganization in FDA’s...more

Ervin Cohen & Jessup LLP

FDA Webinar on the Updated Criteria for Making a “Healthy” Claim

Ervin Cohen & Jessup LLP on

On April 10, 2025, the FDA held a public webinar on the updated criteria for companies to use the “healthy” nutrient content claim. This webinar tracked the final rule issued on December 27, 2024....more

Ice Miller

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

Ice Miller on

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

BakerHostetler

Federal Court Blocks FDA’s Graphic Cigarette Warning Rule: The Limits of Regulatory Authority

BakerHostetler on

On Monday, a federal judge from the Eastern District of Texas, Judge J. Campbell Barker, ruled that the U.S. Food and Drug Administration (FDA) exceeded its authority under the Tobacco Control Act by requiring cigarette...more

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

King & Spalding

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

King & Spalding on

Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more

Venable LLP

The Major Statement: FDA's Recent Q&A Guidance and Rulemaking on Direct-to-Consumer Prescription Drug Advertisements and the...

Venable LLP on

On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more

Foley Hoag LLP

FDA’s Major Statement: The Agency’s Recent Direct-to-Consumer CCN Final Rule, Q&A Guidance and Enforcement Trends

Foley Hoag LLP on

On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more

Foley & Lardner LLP

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

Foley & Lardner LLP on

In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more

Morgan Lewis - As Prescribed

FDA Publishes Final Rule on Direct-to-Consumer Advertising Statements of Risk

Morgan Lewis - As Prescribed on

FDA issued the final rule Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format (Final Rule) on...more

Arnall Golden Gregory LLP

Proceed at Your Own Risk: FDA Issues Final Rule Requiring New Warnings for Cigarette Packages and Advertisements

Arnall Golden Gregory LLP on

In a world where the Coronavirus has taken over all of our day-to-day lives, other parts of the Food and Drug Administration continue to focus on initiatives that “promote greater public understanding [of the] negative health...more

Wilson Sonsini Goodrich & Rosati

Administration Again Attempts to Lower Drug Prices

Wilson Sonsini Goodrich & Rosati on

In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more

Holland & Knight LLP

Healthcare Law Update: July 2019

Holland & Knight LLP on

CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more

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