FDA

Happening in September: FDA, Stop Foodborne Illness Final Food Safety Culture Series 2 Webinar

Mon, 24 Aug 2026 10:13:01 -0400

The event will explore whether organizational investment in food safety culture has made a tangible impact on outcomes. FDA has also posted video recordings of past Food Safety Culture webinars and whitepapers summarizing each webinar.

Alfalfa Sprouts Contaminated With Both E. coli, Salmonella Sicken 55 People in 15 States

Fri, 21 Aug 2026 15:01:44 -0400

Outbreak strains include STEC serotypes O26:H11, O103:H25, and O168:H8 and one strain of Salmonella Agona. Some people were infected with more than one outbreak strain. The implicated products were distributed by Everything Sprouts LLC of Minneapolis, Minnesota.

FDA’s Listeria Prevention Public Meeting: Experts Debate Zero Tolerance, Emphasize Environmental Monitoring and Fundamental Controls

hendersonb@bnpmedia.com (Bailee Henderson) — Fri, 21 Aug 2026 12:36:43 -0400

Participants argued that reductions in listeriosis will require implementation of fundamental preventive controls, true “seek and destroy” efforts, and risk-based approaches. Dose-response models suggesting that low contamination may confer low risk were also discussed.

FDA's Proposed Mandatory GRAS Rule: What Food Safety Professionals Need to Know

Thu, 20 Aug 2026 05:00:00 -0400

FDA recently proposed the most significant changes to its GRAS framework since 1958. For companies managing ingredient compliance, the proposed mandatory filing obligations raise questions about statutory authority, agency capacity, and whether its design matches its stated objectives.

Trump to Nominate Dr. Heidi Overton for Next FDA Commissioner

Wed, 19 Aug 2026 09:07:17 -0400

As a public health and medical practitioner, Dr. Overton does not have a background in food policy or food safety, but has held roles in both Trump administrations. She will replace Dr. Marty Makary, who parted ways with the agency in May.

FDA Receives Color Additive Petitions for Three ‘Natural’ Food Dyes

Wed, 19 Aug 2026 08:37:31 -0400

Aligning with the agency’s priority of supporting agency in phasing out synthetic colorants from the food supply, the petitions seek expanded or new uses for gardenia (genipin) blue, safflower extract, and acetone-extracted carrot oil.

FDA Finalizes Guidance for Assessing Human Health Risks of Antimicrobial Use in Food-Producing Animals

Mon, 17 Aug 2026 10:33:19 -0400

Antimicrobial resistance (AMR) is recognized as a crucial threat to global public health. Antimicrobial use in animal agriculture can contribute to the emergence and spread of increasingly drug-resistant foodborne pathogens, impacting human medicine.

Congress Urged to Prevent FDA Traceability Rule Delay, Which Could Have Helped Cyclospora Outbreak Investigation

Fri, 14 Aug 2026 05:00:00 -0400

The appropriations bill for FY 2026 prohibits FDA from using federal funds to implement FSMA 204 before the delayed July 2028 compliance date. Earlier implementation of the Traceability Rule could have enabled faster, more effective response to the ongoing cyclosporiasis outbreak linked to Taylor Farms lettuce.

FDA Finalizes FSMA Preventive Controls Guidance for Fresh-Cut Produce

Tue, 11 Aug 2026 12:01:40 -0400

The resource provides recommendations and examples for implementing FSMA Preventive Controls for Human Foods Rule requirements to control known or reasonably foreseeable biological hazards in fresh-cut produce.

The Future of Self-Affirmed GRAS: Balancing Innovation, Transparency, and Food Safety

Tue, 11 Aug 2026 11:17:32 -0400

The self-affirmed GRAS pathway has supported innovation in the food industry for decades by allowing companies to bring new ingredients to market based on robust scientific evidence. As FDA considers changing this pathway, manufacturers should understand both the criticisms driving the debate and the steps they can take to prepare for potential regulatory change.

FDA, USDA Submit ‘Ultra-Processed Foods’ Definition for Final Review

hendersonb@bnpmedia.com (Bailee Henderson) — Mon, 10 Aug 2026 13:34:49 -0400

Federally defining UPFs could allow U.S. regulatory agencies to pursue specific policies for the category. The importance of processing versus nutrient content and formulation in causing diet-related chronic diseases, as well as the value of defining UPFs, has been heavily debated.

FDA Proposes Mandatory GRAS Notifications for Ingredients Introduced to U.S. Food Supply

hendersonb@bnpmedia.com (Bailee Henderson) — Mon, 10 Aug 2026 12:18:39 -0400

Importantly, the proposal would not establish a premarket review and approval process for GRAS substances. Companies could still independently conclude that a substance is GRAS and market it while FDA evaluates the notice.

Regulatory Updates: GRAS Proposed Rule Clears OMB Review; FDA Sends UPF Whitepaper to OIRA

Tue, 04 Aug 2026 15:18:00 -0400

Two topics of increasing regulatory scrutiny—the "Generally Recognized as Safe" (GRAS) rule and a federal definition of ultra-processed food (UPFs)—have seen some movement at the U.S. Government's Office of Management and Budget, signaling progress on the Trump administration's food policy agenda.

FDA Announces FY 2027 VQIP, TPP User Fee Rates

Thu, 30 Jul 2026 14:02:05 -0400

FDA has announced the fiscal year (FY) 2027 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP).

FDA to Centralize Administrative Functions, Generalize Inspectors

Wed, 29 Jul 2026 20:20:40 -0400

The notice formalizes proposed reorganization plans that surfaced in April 2025 amid the federal government-wide RIFs and the mass overhaul of HHS that occurred shortly after President Trump took office, spearheaded by DOGE.

FDA's Allergen Agenda Is Expanding: Thresholds, Gluten Cross-Contact, and What Food Companies Should Watch for Next

Tue, 28 Jul 2026 10:00:00 -0400

Companies making products containing allergens should pay close attention: FDA's approach to allergen regulation is actively evolving.

Taylor Farms Lettuce Cyclosporiasis Outbreak Expands to Nine States; CDC Reports Nearly 2,000 Cases, State Counts Exceed 10,000

hendersonb@bnpmedia.com (Bailee Henderson) — Fri, 24 Jul 2026 11:47:50 -0400

At least 1,947 people infected with Cyclospora who had exposure to Taco Bell have been reported in nine states. Michigan and Ohio are together reporting more than 10,000 cyclosporiasis cases. FDA is investigating three other outbreak clusters.

FDA Withdraws Authorizations for Two Obsolete Food Dye Uses

Wed, 22 Jul 2026 12:27:10 -0400

The authorized uses of Orange B in sausage casings and Citrus Red No. 2 on orange skins have been abandoned by industry.

FDA Lowers Brix Content for Orange Juice to Enable Manufacturers to Continue Using Florida Oranges

Mon, 20 Jul 2026 09:50:15 -0400

The Brix level for Florida oranges has been steadily declining over the past few decades due to severe weather and citrus greening, making it challenging to meet the original Standard of Identity (SOI) for pasteurized orange juice, which was established in 1963.

Recall Litigation and Regulatory Trends: Worrisome Changes Bring Similar Results—For Now

Mon, 20 Jul 2026 00:00:00 -0400

Given the headlines coming out of 2025, it would be reasonable to expect a shift in recall patterns in the food industry. Yet, looking past the headlines and into the numbers, 2025 remained remarkably consistent with the past decade of recall trends, in terms of count and cause.

FDA Says a Taco Bell Iceberg Lettuce Supplier is Source of Five-State Cyclosporiasis Outbreak

hendersonb@bnpmedia.com (Bailee Henderson) — Fri, 17 Jul 2026 08:08:21 -0400

The outbreak cluster includes more than 1,600 people in Indiana, Kentucky, Michigan, Ohio, and West Virginia. Outside of the outbreak cluster, Michigan and other parts of the U.S. continue to experience elevated rates of Cyclospora infections compared to previous years.

FDA Outlines Four Public Health Pillars, Reaffirms Food Priorities

Thu, 16 Jul 2026 16:34:07 -0400

Food-related priorities under the four pillars include post-market ingredient safety reviews, GRAS reform, food labeling modernization, and reducing dietary exposure to contaminants like toxic heavy metals.

U.S. Physicians Urge Regulatory Reform of FDA Dietary Supplement Oversight

Thu, 16 Jul 2026 05:00:00 -0400

Because dietary supplements are regulated by FDA as a subcategory of food, manufacturers are generally not required to demonstrate their safety or efficacy for pre-market approval. The American College of Physicians argues this allows adulterated and mislabeled products to enter the market.

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

hendersonb@bnpmedia.com (Bailee Henderson) — Mon, 13 Jul 2026 14:02:02 -0400

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 ingredient supply chain, as well as the global formula recall due to cereulide-contaminated arachidonic acid oil.

FDA Analyzes 15 Years of Mycotoxin Monitoring Data, Finds Low OTA Prevalence

Thu, 09 Jul 2026 05:00:00 -0400

The study represents the first publication of a large FDA dataset on ochratoxin A (OTA) occurrence in U.S. foods. OTA was detected above the limit of detection in 3.5 percent of all samples (which were targeted based on their susceptibility to contamination).

FDA Announces August Public Meeting on Foodborne Listeria monocytogenes Prevention

Wed, 08 Jul 2026 11:41:32 -0400

L. monocytogenes is the fourth-leading foodborne illness-related cause of death in the U.S. Despite continued efforts, listeriosis incidence rates have not declined, prompting FDA to launch a series of public engagements to discuss best practices for managing the pathogen.

FDA to Hire 2,200 Staffers as it Narrows Search for Commissioner, Names Produce Safety Director

hendersonb@bnpmedia.com (Bailee Henderson) — Tue, 30 Jun 2026 12:33:25 -0400

After losing more than 4,000 employees since the Trump Administration took office, FDA is in the process of hiring and re-hiring thousands. The agency is also close to choosing its next Commissioner and has selected a new Director of Produce Safety in the Human Foods Program’s Office of Microbiological Food Safety.

Small-Scale Produce Growers Share Perspectives on FDA’s Produce Safety Rule Exemptions

Tue, 30 Jun 2026 05:00:00 -0400

Researchers from Purdue University conducted focus groups with Indiana produce growers who qualified for exemptions from the Food Safety Modernization Act Produce Safety Rule, examining the beliefs and practical constraints that shape on-farm food safety practices.

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

Mon, 29 Jun 2026 14:11:23 -0400

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 Supplements, and Innovation; Microbiological Food Safety; and Nutrition.

CDC, FDA, USDA Collaboration Defines Framework for Classifying REP Strains, Identifies Strains of Concern

Fri, 26 Jun 2026 05:00:00 -0400

Reoccurring, emerging, and persisting (REP) strains cause foodborne illnesses over extended periods of time, rather than through isolated outbreaks. The REP framework was jointly developed by CDC, FDA, and USDA-FSIS through the Interagency Foodborne Outbreak Response Collaboration.