Regulatory Oversight, Food and Drug Administration (FDA), Labeling

Say Goodbye to the Red Dye: Legal Implications Following the FDA’s Recent Ban

Husch Blackwell LLP on 2/13/2025

On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...more

TTB Seeking Public Input on Potential Alcoholic Beverage Labeling Changes

Troutman Pepper Locke on 2/8/2024

As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more

Same As It Ever Was: FDA Reiterates That CBD Cannot Be Included in Food or Dietary Supplements

Bradley Arant Boult Cummings LLP on 12/1/2021

While we enter a new season this week, the same cannot be said for the FDA which, on November 16, reiterated that its approach to regulating the cannabidiol (CBD) industry will be “the same as it ever was”—a regulatory...more

FDA Solicits Feedback to Create Consistent Process for Labeling Devices

Faegre Drinker Biddle & Reath LLP on 6/11/2021

The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20,...more

FDA Warns of Risk of Failure in Stryker STAR Ankle Replacement Devices

Searcy Denney Scarola Barnhart & Shipley on 4/28/2021

The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers of a “higher than expected risk” of failure in Stryker Scandinavian Total Ankle Replacement (STAR) devices. According to the FDA, the...more

[Event] Rx Drug Advertising and Promotion Executive Think Tank – Embrace this New Era of Advertising with Creative and...

American Conference Institute (ACI) on 11/6/2019

ACI is delighted to present our inaugural Think Tank on Rx Drug Advertising and Promotion. Attend this intimate and in-depth symposium where the “who’s who” of pharmaceutical advertising and promotion will gather to discuss...more

FDA Considering Changes to Regulation of CBD Products - Agency Holds Public Hearing on Cannabis to Gather Input from Stakeholders,...

Holland & Knight LLP on 6/7/2019

• With the dramatic expansion of CBD products in the market, the U.S. Food and Drug Administration (FDA) is reviewing whether its current regulatory framework is appropriate, and if not, what modifications are needed. • The...more

FDA Silent on CBD Regulation at Cosmetics Conference, But Legislation May Be Imminent

Mintz on 4/1/2019

Regulation of cannabidiol (CBD) was a hot topic on Day 1 of ACI’s Cosmetics & Personal Care Products conference on March 28, 2019. Attendees asked many questions about legitimate uses of and claims for CBD, but definite...more

Working Together: FDA Releases Final Guidance on Interoperability

Hogan Lovells on 10/3/2017

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more

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