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From Caffeine To 'Healthy' Labeling, FDA Sets Year-End Agenda For US Food Supply

TUESDAY, June 30, 2026 — The U.S. Food and Drug Administration (FDA) has announced the food supply issues it seeks to tackle by year’s end. The FDA’s Human Food Program aims to pre...

FDA Issues Draft Guidance Clarifying Use of Form FDA 3542

FDA’s Human Foods Program Releases Updated 2026 Guidance Agenda

FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Su...

On June 18, 2026, the Food and Drug Administration (“FDA”) announced the submission of a proposed collection of information to the Office of Management and Budget (“OMB”) pertainin...

FDA warns four importers about safety verification failures

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...

FDA steps up import enforcement action on infant formula, cantaloupes and seafood

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.Re...

FDA cites four importers for verification failures involving produce, dairy ingredients

As part of its enforcement activities, the U.S. Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view u...

At the Half: No Free Kicks in FDA’s 2026 Enforcement

As the World Cup has captured the attention of viewers around the globe, so has the Food and Drug Administration (FDA) when it comes to taking enforcement action against regulated...

<![CDATA[FDA Pauses Release of New CRL’s Following Citizen’s Petition ]]>

Following Infant Formula Incidents, FDA Urges Manufacturers to Implement Stronger, Substantive Supplier Oversight

The letter to industry was issued in response to the botulism outbreaks linked to Nara Organics and ByHeart formulas, which identified Clostridia in the whole milk powder ingredien...

FDA warns Florida supplement maker about sanitation and allergen risks

As part of its enforcement activities, the U.S. Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view u...

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of ex...

FDA warns six importers in five states for food safety failures tied to tea, produce and sauces

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...

<![CDATA[The Industry’s Communication and Engagement with FDA]]>

FDA cites three companies for failing to verify safety of a variety of imported products

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...

FDA Proposes Long-Awaited Rule to Require Foreign Tobacco Manufacturers to Register Establishments and List Products

On June 26, 2026, the U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP), announced a proposed rule titled “Establishment Registration and Product Listing f...

<![CDATA[FDA's Timeline for DTC Prescription Drug Ad Oversight]]>

FDA halts release of new drug rejection letters while working to formalize policy

The FDA has paused a controversial policy of releasing letters describing its rationale for rejecting drugs, Fierce Biotech has learned, following a citizen’s petition from an unna...

<![CDATA[FDA Sends CRL to Cingulate for CTx-1301]]>

Federal Court Sets June 30 Deadline for FDA Response to PFAS-in-Food Citizen Petition

The Food and Drug Administration (FDA) now faces a June 30, 2026, deadline to issue a final response to a citizen petition seeking enforceable per- and polyfluorinated alkyl substa...

The Battle over Flavor: FDA Wins This Round!

By Esther Petrikovsky & Andrew J. Hull —

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Datroway]]>

FDA Releases Response Letter Denying Request to Set Temporary PFAS Tolerances

<![CDATA[FDA Expands Enhertu in Early HER2-Positive Breast Cancer]]>