Tag Archives: FDA

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FDA Seeks Input on a New Method for Ranking Chemicals in Food for Post-market Assessments

By Food Safety Tech Staff
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The U.S. Food and Drug Administration (FDA) released for public comment its proposed method for ranking chemicals in the food supply. This method provides a transparent, systematic, and science-based approach to determine which chemicals the agency would prioritize for post-market assessments through the agency’s post-market chemical review program. It will allow the FDA to allocate resources more efficiently, ensuring that the agency focuses on food chemicals that may present the greatest potential public health risk, including risk to sensitive populations, and are of high public concern.

Determining if a chemical—either one intentionally added to food or a contaminant that is not intentionally added—needs to be further evaluated based on new information takes a structured and science-based approach to ensure that the FDA’s reviews are most protective of the health of consumers. The method released today uses Multi-Criteria Decision Analysis (MCDA) to determine a score for each chemical based on evaluating the information about a chemical against a pre-determined set of criteria. The method is similar in approach and criteria to one that the U.S. Environmental Protection Agency uses for prioritizing chemicals, but the FDA’s method takes into account factors specific to exposure from food and uses a scoring method similar to the FDA’s Risk Ranking Model for Traceability.

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FDA, USDA FSIS, CDC and States Collaborate on Outbreak Investigation of Listeria from Chicken Fettuccine Alfredo Meals

By Food Safety Tech Staff
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The U.S. Food & Drug Administration (FDA), U.S. Department of Agriculture Food Safety and Inspection Service (USDA FSIS), and Centers for Disease Control and Prevention (CDC), in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of Listeria monocytogenes infections linked to chicken fettuccine alfredo meals. Recalled product assembled at FreshRealm, Inc.’s San Clemente, California; Montezuma, Georgia; and Indianapolis, Indiana, manufacturing locations may be adulterated with the outbreak strain of Listeria monocytogenes.

As of June 18, 2025, a total of 17 cases have been reported from 13 states. Of the 11 people interviewed, 7 reported eating precooked meals, and 4 (57%) specifically reported eating chicken fettuccine alfredo. Of 17 people with information, 16 (94%) were hospitalized and there are 3 deaths attributed to listeriosis. There is one pregnancy associated illness in a mother that resulted in a fetal loss.

FDA has conducted a thorough investigation in response to this outbreak, including traceback of FDA-regulated ingredients within the assembled product. FDA used specific meal information reported by ill people, and collected by state officials and CDC, and firm records to trace FDA-regulated ingredients through the supply chain to the establishments where those were produced.  FSIS identified the outbreak strain in a routine sample of FreshRealm’s chicken fettuccine alfredo collected on March 19, 2025. This lot of product was not distributed into the food supply. FSIS also used purchase documentation to trace chicken fettuccine alfredo products purchased by two ill people to FreshRealm establishments. An additional two ill people verbally described chicken fettuccine alfredo products they purchased. FSIS identified products produced by FreshRealm that matched the descriptions during follow-up at the retail stores where they shopped.

FDA also initiated multiple inspections, including sample collection, at the manufacturers of some ingredients used to make the chicken fettuccine alfredo product.

Testing of the FDA-regulated ingredients collected to date is complete and the outbreak strain of Listeria was not found. FDA and FSIS have not yet determined a source of contamination for this product; however, both agencies are working closely with each other and CDC to continue to collect information to determine what additional steps are needed to protect public health.

On June 17, 2025, in response to this investigation, FreshRealm, Inc., recalled their pre-made chicken fettuccine alfredo products sold at Kroger and Walmart.

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Senator Tom Cotton Introduces Bill to Unify Food Safety Agencies

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Senator Tom Cotton (R-Arkansas) introduced the Study And Framework for Efficiency in Food Oversight and Organizational Design (SAFE FOOD) Act, legislation that would direct the Department of Agriculture to conduct a study on the consolidation of federal agencies that have a primary role in ensuring food safety into a single agency.

The Bill states that not later than 60 days after the date of enactment of this Act, the Secretary of Agriculture shall conduct a study on the consolidation of Federal agencies with a primary role in ensuring food safety in the United States (including the Food Safety and Inspection Service, the Food and Drug Administration, and Centers for Disease Control and Prevention) into a single agency.

Not later than 1 year after the date of enactment of this Act, the Secretary of Agriculture shall submit to the appropriate committees of Congress a report containing the results of the study; and any recommendations of the Secretary of Agriculture with respect to the consolidation.

Full text of the bill may be found here.

Beltway Beat

FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program

By Food Safety Tech Staff
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Under the new Nutrition Regulatory Science Program, the FDA and NIH will implement and accelerate a comprehensive nutrition research agenda that will provide critical information to inform effective food and nutrition policy actions to help make Americans’ food and diets healthier. The initiative will aim to answer questions such as:

  • How and why can ultra-processed foods harm people’s health?
  • How might certain food additives affect metabolic health and possibly contribute to chronic disease?
  • What is the role of maternal and infant dietary exposures on health outcomes across the lifespan, including autoimmune diseases?

Answering these questions and many others will enable effective policy development and help promote the radical transparency Americans deserve about the foods they are eating and how those foods can impact their health.

The FDA will provide its critical expertise in regulatory science and NIH will provide the infrastructure for the solicitation, review and management of scientific research. The initiative will bring together experts in many disciplines—including chronic disease, nutrition, toxicology, risk analysis, behavioral science, and chemistry—all with the goal to advance the gold standard of nutrition and food science.

The FDA and NIH will work together to develop a research agenda for the Nutrition Regulatory Science Program and are committed to ensuring all research conducted under the Program is fair, independent and free of conflicts of interest.

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FDA Approves Three Food Colors from Natural Sources

By Food Safety Tech Staff
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The U.S. Food and Drug Administration today announced it granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food.

The color additive petitions approved today are for:

  • Galdieria extract blue, a blue color derived from the unicellular red algae Galdieria sulphuraria. The FDA has approved the color additive for use in nonalcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, and whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives). The petition was submitted by the French company Fermentalg.
  • Butterfly pea flower extract, a blue color that can be used to achieve a range of shades including bright blues, intense purple, and natural greens. Produced through the water extraction of the dried flower petals of the butterfly pea plant, this color additive is already approved for use in sport drinks, fruit drinks, fruit and vegetable juices, alcoholic beverages, dairy drinks, ready to drink teas, nutritional beverages, gums, candy, coated nuts, ice creams, and yogurt. Today’s approval of a petition by St. Louis-based Sensient Colors LLC expands the approved use for coloring ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), plain corn chips, tortilla chips, and multigrain chips.
  • Calcium phosphate, a white color approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. The petition was filed by Innophos Inc. of Cranbury, New Jersey.

Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, section 721), color additives are subject to FDA approval to determine whether they are safe before they may be used in food. The FDA determines whether an additive is safe to use by considering the projected human dietary exposure to the color additive, the additive’s toxicological data, and other relevant information, such as published literature. Once the FDA approves a color additive petition, any manufacturer can use the coloring for the approved uses.

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FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

By Food Safety Tech Staff
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Today, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients. This change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.  “For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track,” said FDA Commissioner Martin A. Makary, M.D, M.P.H.

In addition, the FDA will evaluate the agency’s policies and practices for improvements to the foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight. These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry including lodging and transportation arrangements (taxi, limousine, and for-hire vehicle transit), to maintain the integrity of the oversight process.

The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. According to FDA, U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process. Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections.

Only in specific programs and cases are the FDA’s domestic inspections pre-announced to assure that appropriate records and personnel will be available during the inspection. But regulated companies do not have the authority to negotiate the day or time of the inspection— nor should foreign companies have the capability to do so either.

The FDA is authorized to take regulatory action against any firm that seeks to delay, deny, or limit an inspection, or refuses to permit entry for an unannounced drug or device inspection.

“The FDA’s rigorous, science-based global inspections of manufacturing facilities ensure that the food and drug products that enter the U.S. marketplace, and the homes of American consumers, are safe, trusted, and accessible,” said FDA Assistant Commissioner for Inspections and Investigations Michael Rogers. “These inspections provide real-time evidence and insights that are essential for making fact-based regulatory decisions to protect public health.”

The FDA’s global inspections generate real-time intelligence that strengthens enforcement. Every inspection goes through a classification assignment process to enable an appropriate regulatory response. Even inspections that yield a “No Action Indicated” provide important regulatory intelligence that strengthens the safety net for American consumers.

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FDA Releases the CORE 2023 Annual Report: Investigations of Foodborne Outbreaks and Adverse Events in FDA-Regulated Foods

By Food Safety Tech Staff
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Today, the U.S. Food and Drug Administration’s (FDA) Coordinated Outbreak Response & Evaluation (CORE) Network released its annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2023 calendar year.

The FDA’s CORE Network was established in 2011 with the mission to find, stop, and aid in the prevention of foodborne illness outbreaks. This is accomplished through disease surveillance, outbreak response, post-response activities, and collaboration with CDC, state and local public health agencies, and international public health partners. Every year, CORE evaluates and responds to numerous foodborne outbreaks and adverse events linked to FDA-regulated products.

In October 2024, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) reorganized into FDA’s Human Foods Program (HFP). With this change, CORE reorganized into the Office of Coordinated Outbreak Response, Evaluation, & Emergency Preparedness (CORE+EP). This report is for the 2023 calendar year and reflects the work that was conducted by CORE, CFSAN, and other respective FDA offices prior to the reorganization.

In 2023, CORE evaluated 69 incidents, responded to 25, and issued advisories for 10. These numbers remain similar to recent years, with 65 incidents evaluated, 28 responses, and 11 advisories issued in 2022. CORE investigations resulted in numerous public health actions, including recalls, public health advisories, a Warning Letter, FDA prevention strategies, and country-wide Import Alerts. These are further described in the report.

“CORE has also played a central role in developing and implementing key regulations, including the Final Rule for Traceability under the Food Safety Modernization Act (FSMA). CORE members are participants in the FDA Cyclospora Task Force focused on reducing the public health burden of foodborne illness caused by C. cayetanensis in produce. Additionally, our office actively works with food safety partners outside the agency to continue progress of the FDA-SENASICA-COFEPRIS Food Safety Partnership (FSP) with Mexico. These examples highlight just a few of the activities CORE engages in outside of outbreak and adverse event investigations. Dr. Stic Harris, CORE Network Director noted. I’m pleased to share with you some of CORE’s many achievements highlighted in the 2023 annual report.”

The 2023 annual report highlights a few noteworthy outbreaks: illnesses linked to toxins from morel mushrooms, lead linked to cinnamon in applesauce pouches, and Listeria monocytogenes linked to soft serve ice cream cups.

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HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Foods

By Food Safety Tech Staff
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In a room filled with MAHA Moms, the FDA Commissioner Marty Makary and HHS Secretary Robert F. Kennedy, Jr announced a series of new measures to phase out all petroleum-based synthetic dyes from the food supply.

“For too long, some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent,” said Robert F. Kennedy, Jr. “These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development. That era is coming to an end. We’re restoring gold-standard science, applying common sense, and beginning to earn back the public’s trust. And we’re doing it by working with industry to get these toxic dyes out of the foods our families eat every day.”

For over a decade, Europe has enforced strict regulations on synthetic dyes Since 2010, foods containing certain synthetic dyes in the EU must carry warning labels stating they “may have an adverse effect on activity and attention in children.” Many dyes commonly used in the U.S. are banned or tightly restricted in Europe, and manufacturers have responded by reformulating products with natural alternatives.

Many foods will need to be reformulated to remove synthetic dyes, including:

  • FRUIT LOOPS (RED 40, YELLOW 6, BLUE 1)
  • WELCH’S FRUIT SNACKS (RED 40, BLUE 1)
  • DORITOS (RED 40, YELLOW 5, YELLOW 6)
  • MOUNTAIN DEW (YELLOW 5)
  • POP TARTS (RED 40, YELLOW 6, BLUE 1)
  • MISSION SPINACH WRAPS (YELLOW 5, BLUE 1)
  • SUCKERS STRAWBERRY SPREAD (RED 40)
  • MT. OLIVE PICKLES (YELLOW 5)
  • NERDS GUMMY CLUSTERS (RED 40, YELLOW 5, BLUE 1)
  • MONSTER ENERGY BLUE HAWAIIAN (BLUE 1)

These are just a few examples-hundreds of familiar products will be affected.

The FDA is fast-tracking the review of calcium phosphate, Galdieria extract blue, gardenia blue, butterfly pea flower extract, and other natural alternatives to synthetic food dyes. The agency is also taking steps to issue guidance and provide regulatory flexibilities to industry.

The FDA is taking the following actions:

  1. Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
  2. Initiating the process to revoke authorization for two synthetic food colorings—Citrus Red No. 2 and Orange B—within the coming months.
  3. Working with industry to eliminate six remaining synthetic dyes—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—from the food supply by the end of next year.
  4. Authorizing four new natural color additives in the coming weeks, while also accelerating the review and approval of others.
  5. Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
  6. Requesting food companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required.

“Today, the FDA is asking food companies to substitute petrochemical dyes with natural ingredients for American children as they already do in Europe and Canada,” said FDA Commissioner Marty Makary, MD, MPH. “We have a new epidemic of childhood diabetes, obesity, depression, and ADHD. Given the growing concerns of doctors and parents about the potential role of petroleum-based food dyes, we should not be taking risks and do everything possible to safeguard the health of our children.”

In partnership with the NIH Nutrition Regulatory Science and Research Program, the FDA will enhance nutrition and food-related research to better inform regulatory decisions. This collaboration will strengthen the FDA’s ability to develop evidence-based food policies.

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FDA Shares Testing Results for PFAS in Bottled Water

By Food Safety Tech Staff
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The U.S. Food and Drug Administration (FDA) shared final results from their testing of domestic and imported bottled water collected at retail locations across the U.S. between 2023 and 2024 and analyzed for per- and polyfluoroalkyl substances (PFAS). The 197 samples included purified, artesian, spring, and mineral waters. Ten of the samples analyzed by the FDA had detectable levels of PFAS, none of which had levels that would have exceeded the maximum contaminant levels (MCLs) set by the Environmental Protection Agency (EPA) for PFAS if detected in public drinking water.

The FDA tested the bottled water samples for 18 types of PFAS, including the six PFAS for which EPA established MCLs in drinking water.  Of the ten samples with detectable PFAS levels, they detected a range of one to four different PFAS in each of the eight domestic bottled water samples, which were either purified or spring water, and a range of one to two different PFAS in each of the two imported bottled water samples, both of which were artesian water. Four of the PFAS detected were at levels below the EPA MCLs for PFAS in drinking water. Two of the PFAS detected do not have EPA MCLs established. The FDA has previously analyzed for PFAS in bottled water through a limited targeted survey (2016)and through the FDA’s Total Diet Study (TDS) samples. Results from the 2016 survey and TDS testing did not detect PFAS in bottled water samples.

Under section 410 of the Federal Food, Drug and Cosmetic Act (FD&C Act), when the EPA establishes new MCLs for public drinking water as part of a National Primary Drinking Water Regulation (NPDWR), the FDA is required to establish a standard of quality regulation for the same contaminants in bottled water, or make a finding that such a regulation is not necessary to protect the public health because the contaminant is not present in water used for bottled drinking water. If the FDA does not establish a regulation nor make a finding that such a regulation is not necessary, then the levels set by EPA’s NPDWR would be considered the applicable regulation for bottled water. The FDA can take action against bottled water that presents a safety concern even if there is no standard of quality for a contaminant.

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HHS Announces Transformation to Make America Healthy Again

By Food Safety Tech Staff
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The U.S. Department of Health and Human Services (HHS) announced a dramatic restructuring in accordance with President Trump’s Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.”

The restructuring will address this and serve multiple goals without impacting critical services. First, it will save taxpayers $1.8 billion per year through a reduction in workforce of about 10,000 full-time employees who are part of this most recent transformation. When combined with HHS’ other efforts, including early retirement and Fork in the Road, the restructuring results in a total downsizing from 82,000 to 62,000 full-time employees.

Secondly, it will streamline the functions of the Department. Currently, the 28 divisions of the HHS contain many redundant units. The restructuring plan will consolidate them into 15 new divisions, including a new Administration for a Healthy America, or AHA, and will centralize core functions such as Human Resources, Information Technology, Procurement, External Affairs, and Policy. Regional offices will be reduced from 10 to 5.

Third, the overhaul will implement the new HHS priority of ending America’s epidemic of chronic illness by focusing on safe, wholesome food, clean water, and the elimination of environmental toxins. These priorities will be reflected in the reorganization of HHS.

Finally, the restructuring will improve Americans’ experience with HHS by making the agency more responsive and efficient, while ensuring that Medicare, Medicaid, and other essential health services remain intact.

FDA will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. This reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors.

“We aren’t just reducing bureaucratic sprawl. We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic,” HHS Secretary Robert F. Kennedy, Jr. said. “This Department will do more – a lot more – at a lower cost to the taxpayer.”