In a December 15, 2025 press release, the U.S. Food and Drug Administration reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best practices in recall implementation.
Last week, the FDA sent warning letters to several major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall. These warning letters highlight a concerning problem with recall effectiveness at the retail level. Last year, the FDA sent a similar warning letter to a retailer who failed to adequately remove recalled lead-contaminated WanaBana apple cinnamon fruit puree pouches from its store shelves.
In the weeks following the manufacturer’s voluntary recall of ByHeart infant formula products, FDA investigators and state and local partners checked retail stores across the U.S. over 4,000 times to ensure recalled product was not being made available to consumers. The investigation discovered recalled infant formula continued to be found on store shelves—for over three weeks in one case, in over 175 locations across 36 states. These warning letters highlight the critical responsibility that retailers have in effectuating a recall, particularly when dealing with products that pose serious health risks to our most vulnerable populations, such as infants.
The FDA has asked these retailers to respond to the warning letters within 15 days stating the specific steps they have taken to address any violations and prevent the recurrence of violations, or providing its reasoning and supporting information as to why the company believes it is not in violation of the law.
According to the FDA’s website, on September 30, 2025, the supplier of the affected pasta, Nate’s Fine Foods, Inc., expanded their recall of certain lots of pre-cooked pasta including fettucine, linguine, and farfalle (bowtie), after a sample of linguine pasta collected and tested by FreshRealm tested positive for Listeria monocytogenes.
On October 30, FDA updated the outbreak investigation stating the 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 prepared meals.
Since the last CDC case count update on September 25, 2025, a total of 7 new illnesses from 3 states have been reported, with 2 additional deaths reported. A total of 27 people infected with the outbreak strain of Listeria have been reported from 18 states. Of the 26 people with information available, 25 have been hospitalized and 6 deaths have been reported. One pregnancy-associated illness resulted in a fetal loss.
CDC and states are working to get information on whether sick people ate recalled food or if additional foods may be contaminated with Listeria monocytogenes.
FDA will continue to collaborate with federal and local partners and implicated firms and will provide updates as they become available.
Hormel Foods Corporation, a Tucker, Ga. establishment, is recalling approximately 256,185 pounds of canned beef stew product that may be contaminated with foreign material, specifically wood, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced May 28.
The problem was discovered after the establishment notified FSIS that they had received three consumer complaints reporting pieces of wood in the beef stew product.
There have been no confirmed reports of injury due to consumption of this product.
Food safety is an issue that is critical to millions of people’s health every year worldwide. Maintaining a high standard of hygiene is essential in preventing contamination and ensuring all people receive the safest quality food products every time. Inspections and audits are the key components to the industry’s effort to maintain these standards. These processes help identify potential risks and hazards, ensuring companies are compliant with regulatory requirements, and to ultimately protect all people’s health.
Audits and Inspections both verify the facility’s compliance with regulatory and procedural compliance, but in different ways. According to ISO definition, an audit is “systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.” An inspection is the “determination of conformity to specific requirements,” such as FDA or USDA regulations.
The Importance of Inspections and Audits
Inspections and audits are vital in the food industry for many reasons:
Preventing Foodborne Illnesses: Regular inspections and audits help the industry identify and mitigate risks that have the potential to lead to foodborne illnesses. This is a very crucial task in preventing outbreaks that can cause severe health issues and even fatalities.
Regulatory Compliance: The food industry is subject to stringent regulations set by governmental and international bodies. Inspections and audits help to ensure companies are complying with these regulations consistently, avoiding any legal penalties and maintaining consumer trust.
Quality Assurance: Inspections and audits help ensure food products meet quality standards also, which is very important and essential for companies maintaining brand reputation and customer satisfaction.
Risk Management: Identifying personal hazards and implementing corrective actions during inspections and audits helps the companies manage and reduce risks associated with food production and distribution.
Inspection Process
Food inspections and audits involve a thorough examination of facilities, processes, and products. The process typically includes the following steps:
Preparation: Inspectors will review relevant documents, any previous inspection reports, SOPs, and compliance records, to better understand the facility’s history and operations.
On-site Inspections: Inspectors will visit the facility in order to observe operations, interview staff, and inspect all equipment and outside premises.
Sampling and Testing: Samples of food products may be collected for laboratory testing to detect contaminants or verify compliance with safety and quality standards.
Documentation and Reporting: Inspectors will document their findings and provide a detailed report outlining any observations of non-conformances.
Follow-up: A follow-up inspection may be conducted to ensure all non-conformances have been closed and corrective actions have been implemented and the facility is compliant with all regulations.
Audit Process
Audits are systematic and independent examinations of records, processes, and systems to ensure compliance with specific standards. There are several types of audits in the food industry, including internal audits, supplier audits, and third-party audits. The audit process generally involves the following steps:
Planning: The audit scope, objectives, and criteria are defined. An audit plan is developed, detailing the audit schedule and then areas to be examined.
Execution: Auditors will review documents, conduct interviews, and observe operations to gather evidence. They assess compliance with regulatory requirements, industry standards, and company policies.
Analysis: Auditors analyze the evidence collected to identify areas of non-compliance, potential risks, and opportunities for improvement.
Reporting: A comprehensive audit report is prepared, highlighting findings, conclusions, and recommendations for corrective actions.
Follow-up: Auditors may conduct follow-up audits to verify all corrective actions have been implemented and compliance has been achieved.
Food Recalls
Food recalls are an integral part of the food safety system, initiated when a product is found to be contaminated or mislabeled. They are often the result of inspections and audits that identify serious issues. Here are a few notable statistics.
There were 547 Food and Drug Administration (FDA) food recalls in 2023, a five-year high for the industry and 19.6% more events than were recorded in 2022. FDA recalls are on track in 2024 to be consistent with 2023. U.S. Department of Agriculture (USDA) recalls also increased, rising 31% from 2022. The volume of units recalled also increased a more notable 132.8% from 2022 to 2023.
In 2023, 313 food products (224 from FDA, 89 from USDA) were recalled, over 1,100 people were sickened and 6 people died from foodborne illness recalls (based on data collected). The two largest recalls, lead-tainted applesauce sickened 519 children in 44 states, and Salmonella contaminated cantaloupe sickened over 400 people. CDC estimates 48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in the United States.
2% of all FDA recalls stemmed from undeclared allergens, a 27% increase from 2022. One reason for the increase in allergen recalls is as of Jan. 1, 2023, manufacturers had to disclose sesame in their foods. The most common undeclared allergens — wheat, shellfish, eggs, fish, peanuts, milk, tree nuts and soybeans — account for 90% of all food allergic reactions. Listeria was listed as second and Salmonella third for the most recalls.
Unsurprisingly, as the nation’s largest producer of food, California was found to be responsible for the largest share of all recalls. Over 16.3% of recalls originate from California products. Followed by New York at 8.1% and Texas at 6.5%. California customers are also most frequently affected by recalls. 39.8% of all recalls nationally impact residents in California, followed by New York at 36.4% and Pennsylvania at 35.8%.
The Role of Technology in Inspections and Audits
Advancements in technology have significantly enhanced the effectiveness of inspections and audits in the food industry. Some key innovations include:
Data Analytics: Big data analytics enable companies to identify trends and potential risks by analyzing large volumes of data from various source, such as inspection reports, consumer complaints, and laboratory results.
Blockchain: Blockchain technology provides a transparent and immutable record of the entire food supply chain, making it easier to trace the origin of products and detect potential issues quickly.
IoT Devices: Internet of Things (IoT) devices, such as sensors and RFID tags, provide real-time monitoring of conditions like temperature and humidity, ensuring that products are stored and transported under optimal conditions.
Mobile Inspection Tools: Mobile applications and digital platforms streamline the inspection process by allowing inspectors to record findings, take photos, and generate reports on-site, reducing paperwork and improving efficiency.
Inspections and audits are indispensable components of the food industry’s efforts to ensure safety, quality, and compliance. They play a crucial role in preventing foodborne illnesses, managing risks, and maintaining consumer trust. As the technology continues to advance with properly trained and calibrated auditors, the effectiveness and efficiency of inspections and audits will only improve, further safeguarding the food supply chain from the farm to the table.
By understanding the crucial role inspections and audits play, stakeholders in the food industry can better prepare to meet the high standards necessary to ensure that food products are safe for consumption. The continued evolution of these processes, bolstered by technological advancements, promises a safer future for consumers worldwide.
Recalls represent one of the largest threats to a food company’s profitability and reputation. In recent years, technology solutions such as cloud-based software have been introduced to better prepare and safeguard businesses.
According to the US Department of Agriculture, more than 300 food products were recalled last year, representing a significant 31% increase compared with 2022. The reasons behind recalls vary and include food containing contaminated items such as metal or plastic, exposure to pathogens and undeclared allergens on product labels. The Centers for Disease Control estimates that each year, roughly one in six Americans (or 48 million people) gets sick from foodborne diseases. Recalls represent one of the largest threats to a food company’s profitability and reputation. In recent years, technology solutions such as cloud-based software have been introduced to better prepare and safeguard businesses.
Supply Chain Connectivity
Despite advances in technology, many food manufacturers and processors still rely on manual tools and management across their supply chains. Manual systems can result in major issues during a crisis, including errors in inputting or updating data and miscommunication, such as being unable to quickly reach multiple vendors and suppliers at a given time.
Proper and comprehensive supply chain management is critical to food safety. In the instance of a recall, businesses must be able to quickly activate their recall management plan, disseminating important information both up and down the supply chain while documenting to meet certification and regulatory requirements. It’s key that all suppliers – local, national and international – demonstrate that they are compliant with all relevant food and market regulations. Product source information must also be tracked and searchable in records.
Robust and proactive document control can help an organization avoid recalls by quickly identifying risky suppliers or non-compliant ingredients.
Innovative Solutions Support Recalls
Several new technologies are being employed to support greater traceability and transparency across the food supply chain. With cybersecurity attacks now being a risk that can result in product recalls, more companies are investing in information security solutions to further protect their data. Certifications to standards such as ISO/IEC 27001, which has requirements for establishing, managing and maintaining an information security management system help businesses to demonstrate that they follow an international standard for managing security controls. This can provide an added level of assurance that cybersecurity risks have been identified and safeguarded.
Some companies are now using RFID to tag and track food items. QR codes and bar codes can be scanned on easily accessible devices such as smartphones and tablets, providing instant access to records to ensure traceability.
Cloud-based software also allows companies to manage complex and critical data more confidently. NSF TraQtion® is a new software solution that directs suppliers to an online portal to upload documents, complete questionnaires and communicate. Beyond supplier data, cloud-based software can also be used for recipe management and storage, tracking complaints, label compliance and setting company-wide standards. By simplifying and digitizing data, documents and records collection, leaders can instantly access information during audits and assessments, allowing for quick delivery when program documentation is requested or required.
If not properly and swiftly handled, a recall or outbreak can cost a business tens of thousands of dollars or more. By using cloud-based technology to put an easily accessible and implementable risk management plan in place, businesses can be better prepared for a food safety incident. Overall, software can minimize back-and-forth messaging, urgent data requests, meetings and calls by digitizing and streamlining both communication and documentation.
How to Select the Right Tech Solutions
When preparing for a potential recall, it’s important to be proactive. Start with identifying the pain points in the organization’s risk management plan and then see if there are tools that can be used to strengthen the plan and address its weaknesses. While some tools may require greater investment, this can pay off in the long run when you consider how detrimental recalls can be.
As we look at recalls and technology solutions, we must acknowledge that the requirement for full compliance to the Food Safety Modernization Act (FSMA) 204 rule is January 20, 2026. For those applicable, technology will play a major role in the FDA’s recordkeeping requirements and 24-hour turnaround of an electronic, sortable spreadsheet for traceability of products. In most cases, with larger-scale operations, this can only happen with the utilization of new and emerging software.
The goal of technology implementation is to create a more sustainable food system. With earlier identification and traceability of adulterated products, the removal and retrieval process from commerce will be faster and, in turn, should result in a decrease of incidents reducing illness and potential deaths.
Digital solutions will also help to fill the gaps for root cause investigations, thus more efficiently allowing for enhanced preventative actions and training to avoid recurrence. While onboarding of new technology can sometimes be costly, over time, the ROI of reduced recalls and product losses can increase revenue gains and negate the initial investment.
Food is a global commodity, and advancing technology and innovations in system processes can help move the supply chain forward in delivering safe, quality consumable products around the world. Now is the time to lead the industry forward for a safer, more sustainable future for both companies and consumers. We must invest in technology solutions within our food supply chain to continue advancing human and planet health.
On January 8, the FDA Coordinated Outbreak Response & Evaluation (CORE) Network released its first annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2022 calendar year.
In 2022, CORE evaluated 65 incidents, responded to 28 and issued advisories for 11. These numbers show a slight increase from 2021 when 59 incidents were evaluated with 19 responses and 10 advisories. The investigations in 2022 included E. coli, Cronobacter, hepatitis A virus, Listeria monocytogenes, and Salmonella which were linked to a variety of products, including produce, dairy and fish.
CORE investigations also resulted in numerous public health actions, including recalls, public health advisories, Warning Letters, FDA prevention strategies, a country-wide Import Alert and a Consent Decree. Outbreak advisories were issued for:
E. coli O157:H7 linked to packaged salads
Cronobacter linked to infant formula
Salmonella Senftenberg linked to peanut butter
Hepatitis A Virus linked to strawberries
Unknown contaminant linked to French Lentil and Leek Crumbles
Listeria monocytogenes linked to ice cream
Listeria monocytogenes linked to Brie and Camembert soft cheese products
E. coli O121 linked to frozen falafel
Salmonella Litchfield linked to seafood
Listeria monocytogenes linked to enoki mushrooms
Salmonella Typhimurium linked to sprouts
The 2022 annual report highlights noteworthy outbreaks from 2022, including Listeria monocytogenes linked to enoki mushrooms, Salmonella linked to cantaloupe and Salmonella linked to peanut butter.
Recall—it’s a word that strikes fear in the hearts of CEOs, food safety professionals and the general public. At the 2023 Food Safety Consortium, Roger Hancock, CEO of Recall InfoLink, joined Matt Regusci and Francine Shaw, co-hosts of the “Don’t Eat Poop” podcast, to discuss the challenges in handling food recalls and the importance of taking steps now to make the recall process faster and more efficient.
Hancock launched Recall InfoLink, a supply chain process management system, after spending 15 years leading food safety and quality at Albertson’s, where he managed roughly 250 recalls per year. His goal was to improve how companies manage recalls, making the process easier and faster, and ensuring that the right message gets to the right people at the right time.
“Faster is better,” said Hancock. “For a CEO, the brand isn’t as exposed in the media, the cost will be fairly low and liability contained. For the consumer, faster means maybe I didn’t buy it because it was already pulled from the shelves or, if I bought it, I took it out of my pantry before I ate it.”
When recalls happen slowly or over time, the problem isn’t typically with individual companies and how they perform the recall. “The problem is between companies,” said Hancock. “The bigger the recall, the more companies that get involved in passing data from place to place, and that tends to slow things down. And you can imagine a game of telephone where the message consistency changes and problems start to escalate.”
He seeks to solve this problem by building what he calls a “recall-ready community.” “Our concept is if preparedness is done as a community—or as a supply chain—then those gaps can be identified ahead of time,” said Hancock. “So, when everybody’s hair is on fire and a recall is happening, they’re not having to solve problems that they’ve already identified and solved…Every recall is unexpected and unplanned, so to make them fast and easy requires practice and being ready.”
During the conversation, Hancock shared the most challenging recall he was involved in during his 30-year career. “It was the first and only mad cow disease (BSE) recall in the U.S.,” he said. On December 23, 2002, Albertson’s found out that a BSE-positive cow was in its supply chain. “I spent from December 23 to end of January documenting the recall. It was nightmare,” said Hancock. “There was a lot of concern/fear about mad cow disease at the time and there was a cow that had tested positive for BSE in our supply chain. There were no protocols for how to handle it. There were no regulations around how to handle it. So, it was very complex.”
Hancock did point out that, despite the high number of food recalls happening every year, very few pose a risk to human health. “Most recalls remove products that have a problem or defect that isn’t really going to hurt anyone, but for business or compliance reasons probably needs to get out of the supply chain. So only a fraction of recalls that happen actually pose a risk to people,” he said.
This raised the question of recall fatigue and whether businesses and consumers have become complacent. “Some of our clients choose to notify their customers out of courtesy that they didn’t buy the recalled product. And what we find is that too many of those courtesy notifications end up creating a habit of, ‘I don’t need to look at this.’ So, there is a risk there. And as I’m listening to all of the focus on consumer notification, I worry about that same risk. As we think about consumer notification and even streamlining business communication, it takes a savvy person to know how to do it correctly, so that you don’t have unintended consequences of either people ignoring the notification or of creating a panic.”
Listen to the full episode here and join us October 20-22 at the 2024 Food Safety Consortium in Washington, DC.:
Last week, hundreds of food safety professionals, members of the FDA and USDA, and leaders in academia, food safety testing and cybersecurity met in Parsippany, New Jersey, for the 2023 Food Safety Consortium.
Keynote speaker Sandra Eskin, Deputy Undersecretary for Food Safety at USDA FSIS, and Erik Mettler, Assistant Commissioner for Partnerships and Policy in the FDA’s Office of Regulatory Affairs, opened the Consortium to discuss their agencies’ priorities for 2024 and took part in a town hall Q&A with attendees.
Sandra Eskin and Erik Mettler
In April, the USDA FSIS declared salmonella an adulterant in raw breaded chicken products. The agency is now reviewing comments and finalizing a framework for other poultry products and examining how to substantiate claims, such as “Pasture Raised,” “Grass Fed” and “Raised without Antibiotics.” Cell-cultured meat is another key focus for FSIS, and it is requiring labeling of “Cell Cultivated” on the packaging of these products.
Mettler discussed the “mass reorganization” of the FDA that is currently underway following the 2022 Reagan Udall report, noting that Jim Jones, the new Deputy Commissioner for Human Foods will have full control of policy and resources of the Human Foods program. A key focus will be risk management prioritization. Expect to see full reorganization in late summer or early fall of 2024.
Reorganization of the FDA’s Human Foods program was a hot topic that was also discussed in depth during Modernizing the U.S. Food Safety System with panelists Stephen Ostroff, former FDA commission, Barbara Kowalcyk, faculty at Georgetown University, and Bill Marler, food safety attorney with Marler Clark.
Session Highlights
This year, attendees had the opportunity to take part in full-day pre-conference workshops, including Food Safety Auditor Training with Trish Wester, president of the Association for Food Safety Auditing Professionals, and the Food Safety Culture Design Workshop with Gina Nicholson Kramer, Associate Director of Partnerships, Policy, & Learning at The Ohio State University, and Richard Fleming and Austin Welch of Sage Media.
Sessions during the two-day Consortium covered everything from data analytics to risk mitigation, grassroots food safety culture and recall trends.
Steven Gendel
Attendees were able to take part in a Panel Discussion with the Producer and Food Safety Experts Behind “Poisoned: The Dirty Truth About Your Food” Documentary with producer Kristin Lazure and featured members of the film, including Dr. Darin Detwiler, CEO of Detwiler Consulting Group, and professor at Northeastern University, attorney Bill Marler, and Brian Ronholm, director of food policy at Consumer Reports.
Steven Gendel spoke on regulatory guidance, thresholds and best practices for Allergen Advisory Labeling, followed by Tracie Sheehan of Mérieux Nutrisciences who presented Protecting Allergic Consumers through Audited and Validated Allergen Control Plans.
Food Safety and Cybersecurity panel discussion
Two sessions highlighted the growing threat of cyber attacks. Attendees gained valuable insights from Mark Wittrock, Assistant Director – Health, Food, and Agriculture Resilience Office of Health Security, U.S. Department of Homeland Security, in Re-Imagining Food Protection as a National Security Issue – DHS Perspective, and Scott Algeier of the Food-Ag ISAC, who led a panel discussion on Food Safety and Cybersecurity.
“We’d like to thank all of our attendees, speakers and sponsors for helping make this year’s Food Safety Consortium a success. Through discussion, sharing of knowledge and building industry connections, the food industry will be better prepared to tackle the biggest challenges facing food safety, ensuring a safer and more resilient food supply for consumers,” said Rick Biros, founder and program director of the Consortium and publisher of Food Safety Tech. “We look forward to welcoming everyone to next year’s program in Washington, DC.”
Save the Date: The 2024 Food Safety Consortium will take place October 20-22 in Washington, DC. The call for abstracts is now open.
About the Food Safety Consortium: Organized by Food Safety Tech, the Food Safety Consortium Conference, launched in 2012, is an educational and networking event that has food safety, food integrity and food defense as the foundation of its educational content. With a unique focus on science, technology, best practices and compliance, the “Consortium” features critical thinking topics that have been developed for both industry veterans and knowledgeable newcomers.
The USDA Food Safety and Inspection Service (FSIS) has launched a new feature on its website that enables software developers to access data on recalls and public health alerts through an application programming interface (API), allowing the public to access critical and timely public health information.
Currently, FSIS issues recall communications to alert consumers of potential food safety issues related to FSIS-regulated products. The API will act as a bridge, allowing software developers to leverage FSIS recall data to create new products for consumers or incorporate them into existing digital services and mobile apps. The agency’s recall and public health alert information continues to be publicly available through the FSIS website, Twitter, FoodSafety.gov, an RSS feed, and annual recall data summaries.
“Transparency, innovation, and collaboration are essential to public health,” said USDA Under Secretary for Food Safety Dr. Emilio Esteban. “By opening critical data through public APIs, third-party software developers will be able to expand the reach of our information among American consumers far beyond what FSIS could do on its own.”
Since January 2020, FSIS has migrated several applications from on-premises legacy software to cloud systems, including the FSIS public website in 2021. The cloud-based infrastructure for the website laid the foundation to build out the recall API. In addition to recall data, FSIS is working on APIs for other critical datasets.
For more information on how to use the FSIS’ recall API and other developer resources, visit the API webpage.
The FDA Center for Food Safety and Applied Nutrition (CFSAN) is hosting a free hybrid public meeting entitled “Modernizing Food and Drug Administration Recalls Listening Session” on September 29, 2023, from 9:00am-5:00pm ET.
Join the discussion on “Recalls Trends, Regulation and Lessons Learned,” a Panel Discussion with FDA at the Food Safety Consortium, October 16-18
The listening session will provide an opportunity for stakeholders to share information and feedback about topics related to recall modernization, for FDA-regulated products. The FDA is inviting comments from all interested stakeholders and has identified the following examples of topic categories of the type of information the agency is interested in obtaining:
General recall preparations / contingency planning
Creating successful recall strategies, including methods to reach underserved communities
Initiating a recall
Strategies for public warning, including press releases, social media, and other communication tools
Increasing efficiency and effectiveness of recall information exchange
Ensuring effective recalls
Terminating a recall
Strategies for reducing recall recurrence for similar situations
The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31, Rm. 1503A (the Great Room), Silver Spring, MD 20993. Virtual registration is also available.
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