The U.S. Food and Drug Administration (FDA) announced today it has updated the nutritional requirements a food must meet to use the claim “healthy” on the package, which includes criteria a food must meet to use the “healthy” claim on the package. The FDA also is exploring the development of a symbol to represent the claim “healthy” to make it easier to spot foods that can be the foundation of healthy eating patterns.
Updating the “Healthy” Definition on Food Packaging
The last time “healthy” was defined on packaging was in the 1990s. Based on the nutrition science and federal dietary guidelines at that time, the definition was solely focused on individual nutrients; for example, it included limits for saturated fat, total fat, cholesterol, and sodium and required a certain amount of beneficial nutrients like certain vitamins, minerals, fiber, and protein.
With a greater understanding of dietary patterns and their effects on health, and FDA recognizes that foods are made up of a variety of nutrients that work together as part of a healthy dietary pattern.
To be consistent with the latest nutrition science and federal dietary guidelines the updated definition of “healthy” requires that:
A food must contain a certain amount of a food group like fruits, vegetables, grains, protein foods, or dairy.
A food can’t contain too much saturated fat, sodium, or added sugars.
How the “Healthy” Claim Works
Placing a “healthy” claim on a food package is voluntary. If manufacturers choose to do it, their products must have the nutrient content required by the “healthy” definition. Manufacturers who choose to use the “healthy” claim can use the new criteria starting on February 25, 2025.
Here are some examples of what qualifies to use the “healthy” claim under the updated definition:
Nuts and seeds, olive oils, higher-fat fish, like salmon, and eggs would qualify as healthy because of their nutrient profile. They didn’t qualify under the previous definition.
Water. While water isn’t part of a food group, it is considered an optimal beverage by the Dietary Guidelines.
Here are some examples of what no longer qualifies to use the “healthy” claim under the updated definition:
Fortified white bread, highly sweetened yogurt, highly sweetened cereal.
FSMA requires FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. This control includes importation of food from facilities[1] that have been certified in accordance with FDA’s Accredited Third-Party Certification Program (also referred to as the Third-Party Program or TPP) (section 808 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384d)) and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications regulation (also referred to as the TPP regulation) (see 21 CFR part 1, subpart M), as well as other measures that support a high level of confidence in the safety and security of the food they import. Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.
The guidance document describes FDA’s policy regarding participation in FDA’s Voluntary Qualified Importer Program (VQIP) by importers of food for humans or animals. This document provides guidance on:
The benefits VQIP importers can expect to receive;
The eligibility criteria for VQIP participation;
Instructions for completing a VQIP application;
Conditions that may result in revocation of participation in VQIP; and
Criteria for VQIP reinstatement following revocation.
This guidance document is presented in question and answer format. This guidance document may be modified (in accordance with FDA’s good guidance practice regulation (21 CFR 10.115)) as VQIP is implemented and evaluated. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required. This guidance represents FDA’s current thinking regarding what will be considered for participation in VQIP and how VQIP will expedite entry of imports.
The pronouns “I,” “me,” “you,” and “your” are used in this guidance to refer to the importer who may want to participate in VQIP. “Agency” and the pronouns “we” and “our” are used to refer to FDA. The term “food” has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(f)), except that, for the purposes of VQIP, food does not include pesticides as defined in 7 U.S.C. 136(u).
Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1 and December 31, 2024.
The FDA will consider the registration of a food facility to be expired if a facility’s registration is not renewed by December 31, 2024. There is no fee associated with registration or renewal. Owners, operators, or agents in charge of food facilities must submit their renewal information electronically through their FDA Industry Systems (FIS) account, unless they have received a waiver that allows for paper submission.
Food facility registration is critical to helping the FDA identify the location and possible source of a foodborne illness outbreak or potential bioterrorism incident. Food facility registration requirements were initiated with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and amended by the FDA Food Safety Modernization Act (FSMA) in 2011. FSMA requires facilities to submit additional information to the FDA and to renew their registrations every other year.
The following resources are available to assist in the registration and renewal process:
Food facilities with questions can contact the Data Management Support Services: by phone 1- 240-247-8804; or by email at FURLS@fda.gov on U.S. Government business days (Monday to Friday, excluding U.S. government holidays) from 9:00 a.m. to 6:00 p.m. Eastern Time (see Federal Holidays (opm.gov) and Current Status (opm.gov).
The U.S. Food and Drug Administration’s reorganization implementation involving the creation of a unified Human Foods Program (HFP), adoption of a new model for its field operations and other significant modernization efforts are scheduled for Oct. 1, 2024, notably enhancing the agency’s ability to oversee and protect the human food supply and other products the FDA regulates.
Lead by Jim Jones, Deputy Commissioner for Human Foods at FDA, the reorganization establishes the HFP by realigning the functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, as well as key functions from the Office of Regulatory Affairs (ORA) under one program.
Additionally, the restructuring of ORA will enable the field operations unit to focus on inspections, investigations and imports as its core mission. The FDA is changing the name of ORA to the Office of Inspections and Investigations (OII) to better convey the organization’s role as the frontline of the FDA, which provides real time insights and science-based evidence necessary to ensure the safety and quality of products Americans depend on.
Jim Jones will Keynote the Food Safety Consortium Conference, October 20-22 in Washington DC. During this session Mr. Jones will delve into the agency’s recent reorganizational changes, key regulatory policy priorities, and commitment to stakeholder transparency. Doug Stearns, Deputy Associate Commissioner of Regulatory Affairs, will discuss how these changes will shape investigations and inspections for both domestic and foreign facilities. Attendees will gain valuable perspectives on regulatory shifts, emerging challenges, and collaborative opportunities shaping the landscape of food safety and compliance. Discover how the new Deputy Commissioner’s strategic vision will drive innovation, enhance public health outcomes, and foster trust within the food industry. Attendees will have the opportunity to gain deep insights into emerging challenges, innovative strategies, and collaborative approaches to advancing food safety.
Through product testing, the FDA has determined that the ground cinnamon products listed on their website contain elevated levels of lead and that prolonged exposure to these products may be unsafe. The FDA is advising consumers to throw away and not to buy these ground cinnamon products. The FDA has recommended that the firms voluntarily recall these products, with the exception of the MTCI cinnamon. According to the FDA’s website, the FDA has been unable to reach MTCI to share their findings and request that the company initiate a recall. No illnesses or adverse events have been reported to date in association with these products.
Following the October 2023 recall of cinnamon apple puree and applesauce products due to elevated lead levels linked to the cinnamon in those products and the concern for lead toxicity in children, the FDA initiated a targeted survey of ground cinnamon products from discount retail stores and analyzed the samples for lead and chromium.
Based on results from the survey, the FDA is recommending recalls of ground cinnamon from six distributors whose products had elevated lead levels ranging from 2.03 to 3.4 parts per million (ppm). These levels are significantly lower than the levels of lead associated with the ongoing investigation into ground cinnamon from Ecuador supplied by Negasmart to Austrofoods, the manufacturer of the apple puree and applesauce products, which were between 2,270 ppm to 5,110 ppm in the cinnamon.
FDA Actions
The FDA announced it is continuing its Toxic Elements monitoring program, which includes testing of a variety of foods including colored spices offered for sale in the U.S. According to their website, sampling at import has prevented some cinnamon with elevated lead levels from entering U.S. commerce; however, like all of FDA surveillance activities, these monitoring programs only evaluate a subset of the commodity being imported. FDA will follow-up on these findings as well as continue our activities at import to prevent unsafe cinnamon from reaching consumers in the U.S., including by adding firms and products to import alert where appropriate. Ultimately, FDA says, it is the responsibility of the manufacturers and the importers to ensure the safety of the products that enter into the U.S. market.
The FDA also sent a letter to all cinnamon manufacturers, processors, distributors, and facility operators in the U.S. reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including in ground cinnamon products. The FDA will continue to work with firms to ensure they are meeting their responsibilities under provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule.
According the the FDA’s website, Totally Cool, Inc. of Owings Mills, Maryland is recalling multiple brands of ice cream products, because they have the potential to be contaminated with Listeria monocytogenes. Products were distributed nationwide, and available in retail locations and direct delivery. No illnesses have been reported to date.
The brands involved were Abilyn’s Frozen Bakery, Amafruits, Chipwich, Cumberland Farms, Dolcezza Gelato, Friendly’s, Hershey’s Ice Cream, Jeni’s, LaSalle, Marco, Taharka Brothers, the Frozen Farmer and Yelloh. More than 65 products were recalled, including ice cream cakes and sandwiches, as well as sorbets, according to a list published by the FDA that includes expiration dates.
Totally Cool, Inc. has ceased the production and distribution of the affected products due to FDA sampling which discovered the presence of Listeria monocytogenes. The company continues its investigation and is taking preventive actions. No other products produced by Totally Cool, Inc. are impacted by this recall.
There is only one week left to submit your comments to the docket on the New Era of Smarter Food Safety. FDA is seeking feedback on topics discussed during the public meeting as well as specific questions they have identified in the topics for consideration document on FDA’s meeting page. FDA encourages anyone interested in submitting comments to
the docket, to please do so by the June 24, 2024 deadline. Comments can be submitted at www.regulations.gov [2] to docket number FDA-2024-N-1744.
The U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the White House announced the National Strategy for Reducing Food Loss and Waste and Recycling Organics as part of President Biden’s whole-of-government approach to tackle climate change, feed people, address environmental justice, and promote a circular economy.
According to the USDA’s press release, the strategy released on June 12 provides tangible goals that the U.S. government partners along with retailers and consumers can work toward to help further prevent the loss and waste of food, increase recycling of food and other organic materials to support a more circular economy for all, reduce greenhouse gas (GHG) emissions, save households and businesses money, and build cleaner, healthier communities.
“USDA is committed to reducing food loss and waste, facilitating many programs and activities to engage farmers, producers, communities and businesses in this collective effort,” said Agriculture Secretary Tom Vilsack. “This National Strategy charts a course to reduce our nation’s food loss and waste by 50% by 2030, and I am encouraged by the actions outlined for USDA and our federal partners. Everyone has a role to play in reducing food loss and waste, and I hope that these federal commitments will inspire and catalyze action in the private sector and communities around the U.S.”
“The FDA is committed to completing the actions outlined in the National Strategy that incentivize and encourage food loss and waste prevention and organics recycling,” said FDA Commissioner Robert M. Califf, M.D. “Along with the FDA, USDA and EPA efforts, U.S. consumers and retailers play an important role in meeting the National Strategy’s goal of reducing food loss and waste by 2030. As part of the release of this strategy, the FDA has made important resources available to guide, support, and accelerate their food loss and waste activities including the 2022 Food Code, Tips to Reduce Food Waste and the Food Loss and Waste Social Media Toolkit. We encourage all stakeholders to take advantage of these resources as we work together to reduce food loss and waste.”
The strategy drives progress toward the National Food Loss and Waste Reduction Goal to reduce the loss and waste of food by 50% by 2030.
The strategy highlights four objectives:
Objective 1: Prevent food loss.
Objective 2: Prevent food waste.
Objective 3: Increase the recycling rate for all organic waste.
Objective 4: Support policies that incentivize and encourage the prevention of food loss and waste and organics recycling.
For each objective, the strategy highlights actions that USDA, EPA, and FDA could take. Some of the priority USDA actions include:
* Investing $2.5 million from USDA’s National Institute of Food and Agriculture (NIFA) to rigorously test and measure the effectiveness of different consumer messages to encourage households to reduce food waste, in preparation for a National Wasted Food Prevention Campaign.
* Funding a new NIFA $1.5 million Center for Research, Behavioral Economics, and Extension on Food Loss and Waste to create meaningful momentum on food loss and waste prevention among land-grant universities, their partners and external stakeholders.
* Funding research and development on new food loss and waste innovations, such as innovative new packaging technology and cultivars to extend the shelf life of food and prevent loss.
* The Risk Management Agency (RMA) is working with farmers, crop insurance agents, and gleaning organizations to encourage the reduction of on-farm food loss.
The strategy also highlights the importance of public-private partnerships in reducing food loss and waste. On June 1, the three agencies renewed a Memorandum of Understanding (MOU) with the Food Waste Reduction Alliance (FWRA), which is comprised of the Consumer Brands Association, FMI – The Food Industry Association, and the National Restaurant Association. This public-private partnership will explore actions to reach industry sectors, through efforts such as targeted industry resources, tools, and guidance.
Additionally, USDA and EPA have been actively growing the U.S. Food Loss and Waste 2030 Champions pledge, through which food business have publicly committed to reducing food loss and waste by 50% by 2030 in their U.S. operations. 2030 Champions include industry giants such as Starbucks, Hilton, and Kroger.
The National Strategy builds on USDA’s prior work to reduce food loss and waste, including over $60 million in investments and activities that USDA has undertaken to reduce food loss and waste, including those announced in May.
For more information about Food Loss and Waste Reduction activities visit:
* USDA: Food Loss and Waste
* FDA: Food Loss and Waste
Learn more about The Impacts of Food Loss and Waste (FLW) and Food Donation at the Food Safety Consortium Conference, October 20-22 in Washington DC. This session will discuss how unique solutions such as thorough data tracking and predictive analytics in addition to a focus on food safety ultimately provides bottom-line benefits and positive community health outcomes. Presenters:
Al Baroudi, MS, Ph.D. Vice President, QA & Food Safety, The Cheesecake Factory Incorporated
Glenda Lewis, MSPH, Supervisory Consumer Safety Officer Director, Retail Food Protection Staff, U.S. Food and Drug Administration (FDA)
Minimizing the risk of contamination is a must if you work in food manufacturing. Accidentally including allergens in your products can cause harm to consumers, undermine your brand image, and lead to hefty lawsuits.
Even major food industry brands like McDonald’s fall foul of food safety laws from time to time. Recently, a man with a dairy allergy was allegedly served cheese in his Big Mac1, resulting in anaphylactic shock. This caused a large lawsuit and could damage the global food giant’s reputation.
You can take steps to stay in line with regulations and best practices by training your staff and implementing proper procedures. This will reduce the risk of human error and help you produce food that is both tasty and safe for consumers.
Food Safety Modernization Act
Most people think of food contamination as a thing of the past. However, 1 in 6 Americans2 fell ill due to foodborne diseases last year. This led to 128,000 hospitalizations and 3,000 deaths. The FDA’s Food Safety Modernization Act (FSMA) seeks to end this issue by bringing food manufacturing standards into the modern age. This means you may need to revise your approach to manufacturing to stay on the right side of changing guidelines. At its core, the FSMA includes:
Preventive Controls for Human Foods: Since 2015, food manufacturers have been required to produce a food safety plan. This plan should include key details like potential hazards and risk-mitigation strategies that are currently in place.
Third-Party Accreditation: Receiving a third-party authentication can keep you up to date with changing guidelines. Similarly, only working with suppliers who have been verified via third parties who work to ISO/IEC standards ensures that allergens don’t enter your facility from suppliers.
Preventing Intentional Adulteration: No employer wants to believe that their employees would intentionally harm consumers — but it does happen. The FSMA ruling against intentional adulteration means that you can seek support from the intelligence community if you suspect that a stakeholder is intentionally contaminating your supply.
These FSMA regulations aren’t exhaustive and should be seen as the bare minimum. You’ll still need to take proactive steps to improve communication on the food plant floor3 and should implement policies like proper labeling to keep contaminants and allergens separated.
Proper Labeling
If you’re producing food for public consumption, you must properly label your food. Failing to declare that allergens may enter a certain product will land you in legal trouble and will put consumers at risk. Rather than risking an allergic reaction, follow FDA labeling guidelines4 which include:
Clearly labeling the eight major allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans).
Including the source name of foods (for example, the source name of whey is milk, meaning your label should include “whey (milk)”).
Provide advisory statements like “may contain [allergen]” and “produced in a facility that also uses [allergen].”
Conduct regular testing and monitoring of products and processes to ensure that allergens have not entered the batch.
Taking these steps minimizes the risk of labeling errors and protects consumers. This is particularly important if you want to produce a product that is specifically allergen-free (for example, gluten-free or dairy-free). Failing to declare ingredients properly puts consumers at risk and will land you in hot legal water.
Segregating Allergens
Managing potential allergens is crucial if you work in a food manufacturing plant that produces multiple products. Failing to properly segregate allergens undermines your labeling system and increases the risk of cross-contamination between workstations.
You can minimize the risk of allergens entering the system by using simulations to improve business processes5. Virtual simulations are capable of generating scenarios that you may not have thought of but are likely to occur. You can also use constructive simulations to visualize what might happen should an allergen make its way into the supply. This is particularly important when onboarding new employees who may not understand the risk that allergens present to the food production process.
You can also use emerging technology to improve production6 and reduce the risk of contamination. For example, as your firm grows, you may want to invest in AI and advanced robotics. Robotics can react quickly to changing demand and are less likely to inadvertently spread allergens throughout your supply. This is particularly important when carrying out repetitive tasks, like filling pre-packaged sandwiches or seasoning foods. Automated robots can take care of these mundane tasks, leaving human workers to focus on more creative tasks.
Some food manufacturers, like Walmart, are also using blockchain technology to trace and track contamination. This can improve your crisis management plan7 and bolster operational resilience. Your crisis management team leader can tap into tech to improve communications and simulate potential breaches. This will help you practice your crisis management plan and will ensure that you’re able to pinpoint errors to learn from in the future.
Sanitation Procedures
Regularly sanitizing your workspace is crucial if you want to produce clean, allergen-free goods. This applies to your people, too, who may inadvertently bring allergens in with them when they arrive at work or move between stations.
However, you can’t expect regular handwashing to be enough. Instead, embrace the digital revolution and use data8 to clean up your production line. This will improve reporting and ensure that compliance guidelines are followed at all times. For example, if you suspect that your employees are not washing their hands thoroughly enough, you can use digital products to track employee handwashing and time folks while they apply hot, soapy water.
Digital tracking can also alert you to potentially unclean workstations. For example, if you work in a bakery and typically produce most of your dough before dawn, a digital program can track the contaminants that have entered the workspace in order to produce your bread or baked goods. This will alert you to potential allergen risks and ensure that any workstation that has used an ingredient like gluten is properly sanitized in a timely fashion.
Staff Training
Properly training your employees is key to minimizing contamination risk and staying on the right side of regulatory compliance laws. A proper approach to training will empower employees and help them understand the potential risks involved with food manufacturing.
However, proper training doesn’t mean that you should force your workers to sit through hours of PowerPoint. Instead, train smarter, not harder9 by conducting training that is:
Legitimate. Before asking folks to engage in further training, ask yourself whether or not you are qualified to speak on the subject. If not, consider bringing in a speaker who is well-respected in the food safety industry.
Authentic. Build a culture of trust and engagement at your workplace by working with speakers and programs that are accredited and up to date with compliance law. This will convince folks that your speakers are worth listening to and that your training programs are worth completing.
Engaging. Don’t force your employees to sit through lengthy seminars without an opportunity to engage. Instead, encourage participation by creating engaging training programs that help folks learn skills as they go.
Simplistic. Food safety can be complex. Cut through this complexity by giving folks simple, actionable steps to take. This will minimize the risk of folks forgetting your policies and will empower employees who want to improve safety at work.
These training principles are well-established in the food production and safety world. Even simple changes, like including a quiz or mock preparation test, will pique people’s interest and ensure that employees are engaged when receiving training. If you fail to run engaging, intelligent training, you put yourself at greater risk of contamination during production.
Conclusion
Following FDA guidelines should keep your consumers safe by minimizing the risk of an allergen entering your workspace. However, you’ll need to go above and beyond minimum requirements if you want to completely eliminate the risk of contamination. Get the ball rolling by embracing the digital revolution and using automation or robotics to handle more mundane tasks. This empowers employees and reduces the risk of human errors during production.
The U.S. House Committee on Oversight and Accountability will hold a hearing on April 11, 2024, tiled “Oversight of the Food and Drug Administration.” The hearing will examine the Oversight Committee’s ongoing investigations into the FDA response to several issues, including the infant formula crisis and food safety, drug shortages, facility inspections, hemp regulation, regulation of tobacco and nicotine products, and over-the-counter decongestants.
“The Oversight Committee has highlighted several crises occurring on the FDA’s watch which have negatively impacted the lives and health of American people and families. From a botched response to a nationwide infant formula crisis, failure to regulate safe tobacco products, failure to prepare for and address critical drug shortages, and more, we have identified how dysfunction at the FDA could be worsening many of these preventable crises. We will hold the Commissioner accountable for what the FDA is doing to address ongoing crises, how they are conducting inspections to prevent nationwide crises in the future, and how they intend to ensure the FDA is first and foremost protecting American consumers,” said Oversight Committee Chairman James Comer (R-Ky.).
The hearing will be livestreamed online on April 11 at 1:00pm ET.
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