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FDA Issues Draft Guidance Clarifying Use of Form FDA 3542

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 Issues Guidance on Protein Quality Testing for Infant Formula

The guidance was developed to help manufacturers and laboratories in the design, conduct, evaluation, and reporting of Protein Efficiency Ratio (PER) studies.

New guidance for infant manufacturers available

The FDA has issued final guidance for manufacturers of infant formula and laboratories conducting testing on infant formula. The guidance was developed to help manufacturers and la...

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’s Human Foods Program Releases Updated 2026 Guidance Agenda

FDA Issues Final Guidance for Content of Human Factors Information in Medical Device Submissions

By Adrienne R. Lenz, Principal Medical Device Regulation Expert —

FDA Human Foods Program Updates 2026 Guidance Agenda to Include ‘Healthy’ Claim, Caffeine Labeling

The guidance agenda lists topics that the program is considering for possible guidance documents or revisions to existing guidance documents, spanning Food Chemical Safety, Dietary...

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of ex...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 Supports Grouping Several Phthalates for Cumulative Risk Assessment

FDA published a literature review on the eight phthalates currently approved for food contact uses to determine whether they should be considered chemically and/or pharmacologicall...

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...

GRAS, additives, chemicals: Who should hold the authority?

-- OPINION --State leadership vs. a patchwork of regulations sums up of the controversy over the “FRESH Act” in a single phrase.Due to its controversial provisions on federal food...

<![CDATA[New FDA Draft Guidance Targets Gene Therapy Submission Burden by Allowing Use of Existing CMC and Scientific...

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...

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 Calls On Infant Formula Industry to Safeguard Against Contaminants Introduced Through Supply Chains

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...

Codex Moves to Adopt Standardized Precautionary Allergen Labeling, Kicks UPFs Can Down the Road

During the 49th Meeting of the Codex Committee on Food Labeling (CCFL49), guidelines on risk-based precautionary allergen labeling, labeling for multipack foods, and emergency flex...

2026 Regulatory Agenda Released – Updates Information Regarding GRAS Rulemaking

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...

The Battle over Flavor: FDA Wins This Round!

By Esther Petrikovsky & Andrew J. Hull —

FDA Releases Response Letter Denying Request to Set Temporary PFAS Tolerances

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 scientists flag concerns with peptides, the trendy molecules RFK Jr. supports

Documents reviewing the research on peptides note lack of good evidence of efficacy or safety. Yet an FDA panel will consider easing access to them later this month.