FDA regulatory updates

FDA regulatory updates, recalls, guidance, notices, food additive items, labeling actions, and compliance signals for F&B operators.

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Recent FDA documents

126 public records

Determination of Regulatory Review Period for Purposes of Patent Extension; UNLOXCYT

April 16, 2026 · Health and Human Services Department, Food and Drug Administration

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for UNLOXCYT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to...

Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples

June 22, 2026 · Health and Human Services Department, Food and Drug Administration

The Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples into class II (special controls). The special controls that apply to the...

Oscar Bobo: Final Debarment Order

May 15, 2026 · Health and Human Services Department, Food and Drug Administration

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Oscar Bobo for a period of 5 years from importing or offering for import any drug into the United States. FDA bases...

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples

May 6, 2026 · Health and Human Services Department, Food and Drug Administration

The Food and Drug Administration (FDA) is classifying the device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples into class II (special controls). The special controls that apply to the device type are identified...

NHTSA Automated Vehicle Safety Public Meeting: March 2026

February 9, 2026 · Transportation Department, National Highway Traffic Safety Administration

The National Highway Traffic Safety Administration (NHTSA) will hold a public meeting on March 10, 2026. The event will provide updates and insights into ongoing vehicle automation activities across NHTSA. The meeting will be held in-person and will feature...

Listing of Color Additives Exempt From Certification; Beetroot Red

February 6, 2026 · Health and Human Services Department, Food and Drug Administration

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of beetroot red for the coloring of human foods generally, at levels consistent with current good manufacturing practice, except in products...

Listing of Color Additives Exempt From Certification; Spirulina Extract

February 6, 2026 · Health and Human Services Department, Food and Drug Administration

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded use of spirulina (Arthrospira platensis) extract as a color additive in human foods generally (except for infant formula, certain foods subject...

Ballester Hermanos Realiza un Retiro por Contenido No Declarado de Soya y Leche en Pearl Milling Company Original Pancake & Waffles (MEZCLA PARA PANQUEQUES Y WAFFLES) Complete 5.99oz (170GR) Distribuido en Puerto Rico

June 4, 2026 · FDA

Ballester Hermanos está retirando un número limitado de bolsas de 5.99 OZ (170GR) de PEARL MILLING COMPANY ORIGINAL PANCAKE & WAFFLES (MEZCLA PARA PANQUEQUES Y WAFFLES) COMPLETE debido a la presencia no declarada de leche y soya. Las personas con alergia...

Nassar Investments Recalls Malazi Tahina Due to Salmonella Contamination

May 18, 2026 · FDA

RALEIGH, NC – MAY 19, 2026 – Nassar Investments is recalling Malazi Tahina, 1Kg bottle EXP: 30/12/2026 UPC 6 224011 088244 due to a contamination of Salmonella. Salmonella, an organism which can cause serious and sometimes fatal infections in young children,...

Certain cheese products recalled due to listeria monocytogenes

April 8, 2026 · International

The affected products are being recalled from the marketplace due to possible Listeria monocytogenes contamination. List of Sobeys banners: Atlantic: Coop, Foodland, Sobeys Ontario: Foodland, IGA, Safeway, Sobeys Western Canada: IGA, Safeway,...

Butylated Hydroxytoluene (BHT); Request for Information

May 13, 2026 · Health and Human Services Department, Food and Drug Administration

The Food and Drug Administration (FDA or we) is requesting information on the current uses and safety data for butylated hydroxytoluene (BHT) in human food and as a food contact substance. We are requesting this information as part of our systematic process...

Contains undeclared colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).

March 11, 2026 · FDA

Reason: Contains undeclared colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake). | Product: Premium Food Bubble Gum, packed in 2.5 oz clear flexible plastic packaging, all lots and codes. Sold in unit case of 30 LB. | Classification: Class II | Status: Ongoing