A recent study published in the Journal of Food Protection has analyzed two decades of U.S. Food and Drug Administration (FDA) food product recall data, drawing conclusions from more than 35,000 individual product recalls from more than 10,000 recall events occurring between 2002 and mid-2023.

Product recalls were caused by contamination (i.e., allergens, microbiological, chemical, foreign objects, and undeclared food colors) in 91 percent of cases and by processing issues in the remaining 9 percent of cases. Processing issues were caused by Current Good Manufacturing Practice (cGMP) issues, HACCP issues, manufacturing problems, mislabeling or misbranding, improper refrigeration, and under-processing.

The vast majority—76 percent—of all 35,348 recalls were caused by microbiological contamination and allergens. Specifically, Listeria monocytogenes contamination was the most frequent cause of recalls (7,844 recalls), representing 22 percent of total recalls and 45 percent of microbiological contamination recalls. Salmonella caused 6,597 recalls, accounting for 18 percent of total recalls and 38 percent of microbiological recalls. Together, the two pathogens totaled 40 percent of all recalls.

Allergens represented 28 percent of all product recalls, mostly due to undeclared milk/whey (3,571 recalls, or 36 percent of allergen recalls), followed by eggs (1,405 or 14 percent), undeclared wheat (1,306 or 13 percent), and peanuts (1,226 or 12 percent). FDA classifies recalls as Class I, Class II, or Class III based on the potential severity of impact to public health. More than half of all recalls were Class I.

Listeria, Salmonella Represent 40 Percent of FDA Food and Beverage Recalls in Past 20 Years

FDA Human Foods Program Reveals Work Plans for 2025

FDA's Human Foods Program (HFP) has published a list of priority work it intends to deliver upon in Fiscal Year (FY) 2025. Under the newly reorganized HFP, which came into effect October 1, 2024, the agency's food regulatory work falls into three program areas: microbiological food safety, food chemical safety, and nutrition.

Microbiological Food Safety
FDA's microbiological food safety program area focuses on efforts to prevent or significantly reduce the incidence of foodborne illnesses from FDA-regulated foods. In FY 2025, the agency's work priorities in this area will include, among others:

• Finalizing an implementation plan and executing industry education programs for the Food Safety Modernization Act (FSMA) Final Rule on Preharvest Agricultural Water
• To support the implementation of the Food Traceability Final Rule (also known as FSMA 204), advancing traceability tools and other resources through a multi-pronged approach to educate and engage with industry
• Issuance of a final guidance for the FSMA Produce Safety Rule and development of resources to support compliance with other FSMA rules
• Integrating GenomeTrakr data from food and facility inspections and sampling by FDA and state partners into the U.S. Centers for Disease Control and Prevention's (CDC's) new outbreak surveillance platform, PN 2.0, and onboarding new labs to the GenomeTrakr Network
• In collaboration with federal and state partners, advancing the Highly Pathogenic Avian Influenza (HPAI) silo study to monitor the safety of dairy and milk products.

Food Chemical Safety
Using a risk management approach, FDA will focus its efforts in FY 2025 on enhancing its regulatory approach to food chemical safety and dietary supplement policy, and coordinating on regulatory and scientific issues for foods made through innovative technologies. Specific work priorities include, among others:

• Completing a review to identify efficiencies in FDA's current pre-market review processes for manufacturer submissions for food and color additives, food contact substances, and "generally recognized as safe" (GRAS) substances
• Redesigning the agency's framework for the post-market assessment of chemicals in food based on feedback received on its proposed systematic approach, and publishing an updated list of substances prioritized for re-assessment with projected timelines
• Issuance of a guidance under the Closer to Zero initiative to establish action levels for environmental contaminants in foods intended for infants and young children, including a final guidance on action levels for lead
• Issuance of the draft guidance for the FSMA Preventive Controls for Human Food Rule, specific to Chemical Hazards
• Expanding the use of new methods to better understand exposure to per- and polyfluoroalkyl substances (PFAS)
• Pursuing formal agreements with international regulatory counterparts to facilitate partnering on food chemical and innovation issues.

Nutrition
In the area of nutrition, FDA will focus its FY 2025 efforts on labeling and other initiatives to help consumers make more informed choices about the food they eat, and, for those who rely on certain critical foods as their sole source of nutrition, such as infant formula, working to make sure those products are safe, properly labeled, and nutritionally sound. A major focus will be increasing the resiliency of the U.S. infant formula market, including the publication of a long-term national strategy, which will help facilitate entry of new infant formula manufacturers to increase supply and mitigate future shortages, and will recommend necessary authorities to gain insight into the supply chain and risks for shortages.

Progressing the Human Foods Program
Although the newly reorganized HFP officially came into effect on October 1, significant work will continue through FY 2025 to fully operationalize the program. First, the FDA is prioritizing the hiring of permanent leadership for HFP offices. Once leadership is in place, HFP will develop and release a multi-year strategic plan. Read the full release of HFP FY 2025 deliverables here.

Once again, California has passed legislation that sets first-of-its kind food safety regulations in the U.S. Signed into law by Governor Gavin Newsom, California Assembly Bill 660 (AB 660) standardizes the use of "Best If Used By" and "Use By" dates on food labels, and prohibits the use of "Sell By" dates, marking the country's first mandatory food date labeling reforms.

Beginning July 1, 2026, companies selling food products in California must only use "Best If Used By" to indicate the date by which a product will reach its peak quality, and "Use By" to indicate the date by which a product's safety can no longer be guaranteed. The use of consumer-facing "Sell By" dates will be prohibited to reduce the chances of consumers confusing "Sell By" dates with quality or safety dates.

The use of any other ambiguous and inconsistent phrases like "Expires On" and "Freshest By" will also be eliminated.

AB 660 authorizes grocers to display "Packed On" labels on prepared food items, but they must also display the mandatory "Use By" or "Best If Used By" dates described in the legislation. Retained in the bill is the requirement limiting refrigerated shelf life to no more than 30 calendar days from packaging to consumption, except the time the product is maintained frozen, or the original safety date—whichever occurs first.

AB 660 was authored by Assemblymember Jacqui Irwin. The passage of her bill follows that of two other recent and unprecedented food safety acts in California, namely, the California Food Safety Act and the California School Food Safety Act, both authored by Assemblymember Jesse Gabriel, and both of which ban certain additives from foods under different circumstances.

California Passes Legislation Standardizing 'Best By' Dates on Food; Bans 'Sell By'

FDA Releases New Food Fraud Webpage

The U.S. Food and Drug Administration (FDA) has released a new website on economically motivated adulteration (EMA), including food fraud. The purpose of the website is to keep businesses and consumers informed on the latest food fraud developments.

The website includes links on how to report food fraud; examples of food adulteration; how food fraud is detected and monitored; enforcement and legal consequences, such as recalls, seizures, and import refusals; guidance documents to assist manufacturers and importers; and a list of import alerts.

EMA occurs when "someone intentionally leaves out, takes out, or substitutes a valuable ingredient or part of a food," according to FDA. EMA also occurs when a substance is added to a food to make it appear better or of greater value.

Food fraud is a common type of EMA that FDA investigates, but EMA also occurs with other products, including animal food and cosmetics. Some types of EMA are also misbranding violations. Estimating how frequently food fraud occurs or its exact economic impact can be challenging because food fraud is designed to avoid detection. Outside estimates by experts have found that food fraud affects 1 percent of the global food industry at a cost of approximately $10–$15 billion per year, although more recent expert estimates peg the cost as high as $40 billion per year.

Food fraud can also lead to major health issues and even death. Some examples include lead poisoning from adulterated spices and allergic reactions to a hidden or substituted ingredient that contains a small amount of just one food allergen.

Click here to visit FDA’s new EMA website.

FDA, in partnership with Purdue University and Indiana produce industry members, has begun a new, multi-year environmental study of Salmonella in the Southwest Indiana agricultural region. The study was prompted by multiple Salmonella outbreaks linked to cantaloupe grown in the area, and the research aims to assess risks related to how Salmonella is distributed and survives in Indiana's environment to identify and implement mitigation strategies.

Specifically, the study is being initiated following outbreaks linked to cantaloupe grown in Southwest Indiana where a specific source or route of contamination was not found, but other varieties of Salmonella were identified, some which were genetically similar to clinical, environmental, and food isolates collected in relation to the region over the last decade. These findings suggest that Salmonella is a reoccurring issue in the region and that multiple reservoirs for Salmonella may exist. The outbreak investigations have shown that that there are complex environmental survival, proliferation, and dispersal mechanisms of pathogens in this region that need to be better understood.

FDA will work in partnership with water quality, food safety, and agricultural experts from Purdue University and other agricultural stakeholders to form research teams that will collect and examine samples from the environment such as surface waters, soil, and dust. The team will also collect scat samples to assess the impact that animal intrusion and native wildlife may have on the growing environment. The study is intended to help FDA and the local growing community better understand the source of pathogens, their persistence, and how they transfer through the growing environment to help inform food safety practices.

Following Salmonella Outbreaks Linked to Indiana Cantaloupe, FDA and Purdue University Launch Environmental Study

Researchers from Osaka Metropolitan University in Japan have developed an antibody that can identify Campylobacter jejuni and inhibit its growth. This antibody could be an important step toward preventing, diagnosing, and treating infections caused by the foodborne pathogen.

The monoclonal antibody is able to detect C. jejuni by reacting to QcrC, a multiprotein complex expressed in pathogenic Campylobacter. As QcrC was found by the researchers in multiple C. jejuni strains, the antibody's reaction to the molecule is likely to be a highly reliable indicator of pathogenic C. jejuni. Additionally, because the antibody acts to suppress QcrC, which is involved in energy production for C. jejuni, the antibody has the potential to slow the bacteria's growth and decrease its pathogenicity.

Not only could the antibody be useful in the development of a simple detection system for the rapid identification of C. jejuni contamination in food, but it also has the potential to power medical treatments for C. jejuni infections, or could even provide the basis for a vaccine, according to the researchers.

Scientists Develop Antibody With Detection, Treatment Potential for Foodborne Campylobacter

Following a health assessment of brominated vegetable oil (BVO), Health Canada has revoked its authorization for use as a food additive. Health Canada is providing a transition period, ending August 30, 2025, to allow impacted products to be reformulated and relabeled, since the updated safety assessment did not find an immediate health concern with the current permitted use of BVO as a food additive.

Health Canada reviews the safety of permitted food additives when it receives a submission requesting an extension of use of an already permitted food additive, or when there is an emerging scientific development about the safety of an additive. The outcome of the updated safety assessment of BVO does not support its use as a food additive, and Health Canada did not receive any new safety information during the allotted comment period for the proposal to remove the chemical from the List of Permitted Food Additives.

Health Canada's decision follows the same decision made by the U.S. Food and Drug Administration in August 2024, when FDA revoked its authorization of the use of BVO in food due to studies showing the potential for adverse health effects to humans.

Canada Bans BVO as a Food Additive

The European Food Safety Authority (EFSA) has published new guidance on the submission of novel food applications, which will come into effect in February 2025. The guidance applies to all novel food applications, including those for cell-based foods and food ingredients.

The updated guidance reflects changes in the EU's legal framework for novel foods, which was originally implemented in 2018, taking into account the latest advances in food research and innovation, as well as the growing variety of novel food applications EFSA has received in recent years. Updates clarify definitions and data requirements for novel food applications, especially focusing on scientific areas where EFSA has noticed gaps in the past six years.

The guidance explains how to describe and identify novel foods, along with details on the production process, composition, specifications, and proposed uses. Applicants must also provide information on the food's expected consumption, history of use, and safety data, including how the body processes the food, toxicology, nutrition, and potential allergens. A supplemental administrative document outlines the practical steps for preparing and submitting an application.

EFSA has set a 9-month deadline to complete each risk assessment, although assessments could be paused or extended if more information is required from an applicant, and depending on the complexity and quality of the data submitted. The European Commission and the EU national authorities handle the final approval and marketing rules for approved novel foods.

EFSA Updates Guidance for Novel Food Applications

As a result of Operation OPSON 2024—an EU-wide coordinated effort targeting fraudulent and counterfeit foods—22,000 tons of food and 850,000 liters of beverages (mostly alcohol), totaling €91 million, were removed from the market.

Operation OPSON has been executed annually for the past 13 years. Led by Europol, other participants include the EU Directorate-General for Health and Food Safety (DG SANTE), the EU Directorate-General for Agriculture and Rural Development (DG-AGRI), national authorities from 29 European countries, and industry.

As a result of this year's Operation OPSON:

• 11 criminal networks were dismantled
• 104 arrest warrants were issued
• 184 search warrants were issued
• 278 people were reported to judicial authorities
• 5,821 checks and inspections were performed.

Food fraud trends recognized across Europe included the sale of expired food stolen from waste disposal companies, reintroduced to the market with reprinted expiration dates and new labels.

Additionally, olive oil and wines with a protected designation of origin (PDO) were the commodities most frequently counterfeited or fraudulently designated.

Across Europe, several notable arrests and seizure occurred. For example, in Spain, the Spanish Civil Guard, in collaboration with the Italian National Police and Europol, arrested four people who owned a canning company and seized approximately 120,000 cans of tuna and 45,000 liters of oil. These products were much lower quality than indicated on the label and were being sold at significantly lower price points than their competitors selling authentic goods. In another case, a Spanish pickle production company was investigated for selling products containing illegal chemicals like dyes and preservatives; 80 tons of product, much of which was already prepared for sale and consumption, were seized. The Spanish Civil Guard also acted against oil, ham, and cheese counterfeiters.

In Italy, the National Police's Anti-Adulteration and Public Health Units identified and seized approximately 42 tons of adulterated oil that was falsely labeled as Italian extra virgin olive oil, and was either ready for distribution or had already entered the market. Subsequently, officers searched warehouses and other locations, from which they seized 71 tons of oily substances and 623 liters of chlorophyll intended for the adulteration of oils. The total value of the seized items amounted to €900,000. Also in Italy, the National Police dismantled a criminal network dedicated to counterfeiting wines with a PDO or protected geographic indication (PGI), resulting in the seizure of 60,000 liters of counterfeit wine.

Moreover, an investigation led by the French National Police, in collaboration with the Italian National Police and the Swiss Federal Police, supported by Europol and Eurojust, led to the dismantling of a criminal network counterfeiting French PDO wines in Italy. The criminal network faked French red wine, which was forged in Italy and exported globally, charging up to €15,000 per bottle. The operation led to six arrests and seizures valued at €1.4 million, as well as the seizure of more than €100,000 in cash and documents.

In Sweden, the Swedish Food Agency, the Swedish Police, and other Swedish authorities worked together with EU officials to seize more than 600 tons of rice of a lower quality than was indicated on the label. Most of the rice was imported from countries outside the EU, primarily India and Pakistan.

€91 Million of Fraudulent Food Seized Through EU-Wide Operation in 2024

After 16 years as the staff lead for the Center for Produce Safety (CPS), Bonnie Fernandez-Fenaroli will be leaving the organization in mid-2025. She has served as the CPS Executive Director since 2008.

The Consumer Brands Association (CBA) has hired Melissa Hockstad to be the next head of the trade group, effective January 6, 2025. Hockstad joins Consumer Brands from her role as president and CEO of the American Cleaning Institute (ACI).

Arkansas Department of Agriculture Secretary Wes Ward will serve as the National Association of State Departments of Agriculture's (NASDA's) 2024–2025 President.

Erin Sigrist has joined FMI—The Food Industry Association as director of state government affairs.

Westfalia Fruit has appointed Chris Bush as Group CEO.

Former FDA Deputy Commissioner for Human Foods Frank Yiannas, M.P.H., has been appointed chief food safety advisor for Boar's Head Brand on an interim basis, effective October 4. In this role, Yiannas will help ensure the company meets standards of food safety and quality. Yiannas will also oversee the nationwide search for a chief food safety officer to succeed him.

Loma Systems has appointed Samantha Neves as its first global marketing director.

Sprague Pest Solutions has promoted Darren Van Steenwyk to Director of Regulatory and Compliance, and Ashley Roden has been named the new Technical Director. Sprague has also promoted Heather Mann to Operations Manager for the Portland, Oregon office, and Chant Martin to Operations Manager for the Seattle, Washington office.

Jarrett Foods has appointed Chantel Carrillo as its new quality assurance manager.

Cultivated meat company Meatable has hired Aris de Rijke, Ph.D. as the company's new chief technology officer.

Monogram Foods has hired Jessica Reese to join the executive team as the senior vice president of sales and business development.

Arjoon Bose was appointed as Bel Group's Chief Marketing and Digital Officer.

RESOURCES

FDA has released the third video in its "Importing FDA-Regulated Products" series. The new video provides an overview of the process for importing seafood, focusing on key regulatory requirements. It is designed to help importers, brokers, and foreign seafood producers better understand the steps involved in bringing safe and compliant seafood into the U.S.

Key topics covered in the video include:

• Regulatory requirements for importing seafood
• Information to provide to FDA during the import process
• What to expect during FDA's import review.

FDA must receive notification before seafood, or any food, is offered for import into the U.S. At the time of importation, FDA will verify compliance with applicable requirements. Seafood producers and importers must comply with seafood safety practices such as HACCP systems, Preventive Controls, and Good Manufacturing Practices (GMPs). Additional requirements such as Low Acid Canned Food and Acidified Food registration and listing and National Shellfish Sanitation Program (NSSP) requirements may also apply to some seafood products.

FDA also conducts field examinations and analyzes samples of seafood to ensure that they comply with applicable standards and/or labeling requirements. Additionally, FDA checks the import alert database to ensure that a manufacturer or product is not subject to detention without physical examination (DWPE) and listed on an import alert.

FDA Releases Video Detailing Requirements for Seafood Imports

The Illness Tracking in Travelers (ITIT) app provides a way for travelers to report daily health symptoms through a short questionnaire. The information gathered is then linked to location, climate, and air quality data. The research team analyzed data recorded through the app between April 2022 and July 2023, covering 470 trips taken by 609 travelers.

App data showed that people fall ill surprisingly often—on more than one-third of trips—while traveling abroad, with the majority of symptoms recorded being gastrointestinal (GI) issues. GI distress was reported on 19 percent of trips, and most frequently in travelers to Asia, but least frequently in travelers to Africa. Women experienced GI issues more commonly than men, either due to actually being more susceptible or because they were more thorough in recording data through the app.

The researchers are inviting more people to use the app—available in both the App Store and Google Play—as larger datasets would allow the researchers to run automated analysis using AI for early outbreak detection.

App Developed for People Traveling Abroad Could Enable Early Outbreak Detection