Regulatory Oversight, Regulatory Requirements, Federal Food Drug and Cosmetic Act (FFDCA)

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

Morrison & Foerster LLP on 6/18/2025

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

FDA Food Chemical Regulation: Understanding Pesticide Action Levels

Beveridge & Diamond PC on 5/9/2025

The U.S. Food and Drug Administration’s (FDA) March 2025 publication of its new “Chemical Contaminants Transparency Tool” spotlighted a lesser-known aspect of FDA’s regulation of pesticide residues on food: action levels....more

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

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

IR Global on 1/14/2025

In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on 10/2/2023

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

Quarles & Brady LLP on 8/23/2023

On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

Special Report - 2022 FDA Year in Review

McDermott Will & Schulte on 2/6/2023

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

FDA Public Meeting: Horizontal Approaches to Food Standards of Identity Modernization

Hogan Lovells on 10/11/2019

On September 27, 2019 the U.S. Food and Drug Administration (FDA) hosted a public meeting to gather information from stakeholders on changes the agency could make to existing standards of identity (SOIs), particularly changes...more

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

Akerman LLP - Health Law Rx on 8/26/2019

At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies. President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more

FDA Deauthorizes Seven Synthetic Flavorings and Adjuvants as Food Additives

Hogan Lovells on 10/30/2018

On October 9, 2018, the U.S. Food and Drug Administration (FDA) issued a final rule revoking authorization for seven synthetic flavorings and adjuvants as food additives. Notably, FDA’s rigorous scientific analysis determined...more

Regulatory Oversight › Regulatory Requirements › Federal Food Drug and Cosmetic Act (FFDCA)

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