FDA

FDA Warning Letter to The Father's Table, LLC

The FDA issued a warning letter to The Father's Table, LLC, for serious violations of Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food regulations. The inspection found Listeria monocytogenes in the facility, rendering ready-to-eat food products adulterated.

FDA Warning Letter to Black Sheep Egg Company

The FDA issued a warning letter to Black Sheep Egg Company, LLC, following an inspection that detected Salmonella in environmental samples from their shell egg processing facility. The company is cited for insanitary conditions and violations of the Shell Egg regulation, rendering their products adulterated.

FDA Import Alert: GLP-1 Receptor Agonist Bulk Drug Substances

The FDA has issued Import Alert #66-80, placing Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances on Detention Without Physical Examination. This action is due to concerns that these substances, used in compounding, may be adulterated and not meet current good manufacturing practice (CGMP) requirements.

FDA Import Alert 16-120: Detention of Non-Compliant Fish Products

The FDA has updated Import Alert 16-120, revising guidance for field personnel regarding the detention without physical examination (DWPE) of fish and fishery products from foreign processors not in compliance with the Seafood HACCP regulation. The update includes changes to the title, reason for alert, and guidance sections, incorporating foreign remote regulatory assessments as a compliance verification method.

FDA Import Alert 98-06: New Tobacco Products Detained Without Authorization

The FDA has updated Import Alert 98-06, which detains new tobacco products lacking required marketing authorization. This revision clarifies guidance and agency contacts, noting that ENDS products are now covered under a separate alert (98-07). Manufacturers and importers must ensure proper authorization to avoid detention.

Savannah Bee Company Recalls BBQ Sauce Due to Undeclared Allergens

Savannah Bee Company is recalling its Honey BBQ Sauce-Mustard due to undeclared wheat and soy allergens. The recall was initiated after a customer reported mislabeled products containing the 'Honey BBQ Sauce-Sweet' ingredients. Consumers are urged to dispose of the product and seek a refund.

FDA Draft Guidance on Medical Gases Certification Process

The FDA has issued draft guidance for industry on the certification process for designated medical gases. This guidance explains the certification process and annual reporting requirements, aiming to reduce regulatory burden for the medical gas industry. Comments are due by April 13, 2026.

FDA Guidance: Plausible Mechanism Framework for Individualized Genetic Therapies

The FDA has issued draft guidance outlining a plausible mechanism framework for developing individualized genetic therapies. This framework provides recommendations for generating substantial evidence of effectiveness and safety for these novel treatments. The comment period for this draft guidance closes on April 27, 2026.

FDA Draft Guidance Q&A on Food Traceability Records

The FDA has issued draft guidance in a Q&A format to help industry understand the requirements for additional traceability records for certain foods, as established by a final rule in 2022. Comments on this draft guidance are due by May 21, 2026.

FDA Guidance on Antimicrobial Drug Durations for Food Animals

The FDA's Center for Veterinary Medicine has issued guidance for sponsors of new animal drug applications concerning medically important antimicrobial drugs used in food-producing animals. The guidance aims to facilitate voluntary changes to define durations of use for these drugs to mitigate antimicrobial resistance.