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Food and Drug Administration (FDA) Regulatory Requirements Food & Drug Regulations

Epstein Becker & Green

Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast

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Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special...more

Holland & Knight LLP

Out with the Old: FDA to Revoke 52 Standards of Identity – What Food Companies Need to Know

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The U.S. Food and Drug Administration (FDA) announced a final rule on July 16, 2025, revoking 52 standards of identity (SOIs) for food products that it deems obsolete. The FDA currently maintains more than 250 SOIs, and this...more

Akin Gump Strauss Hauer & Feld LLP

FDA Adds a Dose of Clarity to the NDIN Process

Recently, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification...more

Morrison & Foerster LLP

FDA Seeks to Phase Out Synthetic Color Additives

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a major initiative to voluntarily phase out “petroleum-based synthetic dyes” (i.e., synthetic...more

DLA Piper

Food and Beverage News and Trends - February 2025

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New Trump Administration tariffs on Canada, Mexico, and China. On February 1, 2025, President Donald Trump signed three Executive Orders instituting sweeping new tariffs on all goods imported from Canada, Mexico, and China,...more

DLA Piper

FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling

DLA Piper on

The US Food and Drug Administration (FDA) has released its proposed rule on front-of-package (FOP) nutrition labeling. Announced on January 14, 2025, the proposed rule would add a requirement to include an informational box...more

DLA Piper

Certain DSCSA Deadline Extensions Set to Eclipse in 2025

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The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion...more

DLA Piper

Food and Beverage News and Trends - January 2025

DLA Piper on

FDA issues final guidance on lead in baby food. FDA has issued its Final Guidance on Action Levels for Lead in Processed Food Intended for Babies and Young Children as part of its Closer to Zero initiative to reduce dietary...more

Troutman Pepper Locke

Vape Companies Challenge Iowa’s New Vape Directory Law

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On December 17, 2024, Iowans for Alternatives to Smoking & Tobacco, Inc., Global Source Distribution, LLC, and others filed a complaint and motion for a preliminary injunction in federal district court against the Iowa...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - November 2024 #2

FDA Releases Guidance for Voluntary Qualified Importer Program - The U.S. Food and Drug Administration (FDA) has released guidance with revisions to the Food Safety Modernization Act Voluntary Qualified Importer Program...more

Quarles & Brady LLP

FDA Issues Broad Exemptions from DSCSA Enhanced Drug Distribution Security Requirements

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On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by section 582(g) of the Food,...more

Husch Blackwell LLP

Developing a Regulatory Compliance Checklist for Ketamine-Assisted Therapy

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Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more

Quarles & Brady LLP

Drug Supply Chain Security Act Compliance Extended But Trading Partners Should Still Prepare Now

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On Friday, August 25th, the Food and Drug Administration (“FDA”) issued a guidance document extending the November 27, 2023 enforcement deadline for drug and device manufacturers, wholesale distributors, dispensers, and...more

Quarles & Brady LLP

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

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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

Polsinelli

Triaging Health Risks in the Cosmetic World: FDA Says Let’s Start with Tattoo Inks

Polsinelli on

Last month, the FDA’s Office of Cosmetics and Colors issued a Draft Guidance encouraging tattoo ink manufacturers and distributors to recognize situations in which these products may become contaminated with microorganisms,...more

Jones Day

Food, Drugs, Cosmetics, and Devices: Federal Regulatory Focus Areas in 2023

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In Short - The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

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On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - March 2022

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

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