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.
A universal truth in bustling cities and rural villages alike is that people want to know the food they are eating is safe. Brands tasked with ensuring food safety walk a line between meeting regulatory requirements and balancing resource constraints. It’s a delicate dance in both developing and established economies.
At the federal level, we typically see programs designed to ensure food safety relegated to the back burner. In the U.S., the FDA’s food program, a linchpin of food safety, has experienced its own challenges according to revelations from Stephen Ostroff. The two-term acting commissioner of the FDA has publicly revealed the internal struggles across various regulatory bodies both within the FDA and the U.S. regulatory system. Across the pond in the UK, efforts to modernize food safety and hygiene inspections have faced their own setbacks, including a lack of inspectors and poor cross-border coordination.
For nations at every stage of development, the road to food safety regulation is long and winding. Charting the way requires innovative solutions and collaborative effort on a global scale.
Challenges in Developing Countries
In developing countries, insufficient regulatory frameworks, a lack of enforcement, and the absence of modern technology and facilities for proper food handling and processing are major hurdles to ensuring broad food safety. We have seen time and again that efforts to improve food handling practices often result in short-lived change and challenges when scaling.
Beyond resource constraints, the prevalence of street vendors and local markets in the “informal sector,” which serve a significant portion of the population, typically lack oversight. A 2020 study published in the National Library of Medicine estimated that 2.5 billion people globally rely on street food for at least one meal daily, highlighting the importance of solving food safety concerns in this sector.
Food contamination also poses a serious threat. Microbiological pathogens including Salmonella, E. coli, Listeria, and chemical contaminants, can render food and water unsafe. According to a recent UN World Water Development Report, around 2 billion people globally don’t have access to clean and safe drinking water, and approximately 3.6 billion people — 46% of the world’s population — lack adequate sanitation services.
The FDA’s Funding Dilemma
While food safety in the U.S. isn’t as dire as developing countries, we face a different set of concerns. The FDA’s historically underfunded food program has lagged due to staffing shortages, leadership issues and limited resources. A recent 10% increase in funding is a step in the right direction, but critics argue it’s still not enough. Many believe the agency prioritizes drug and medicine oversight and is biased towards appointing leaders with medical backgrounds rather than food industry knowledge.
Beyond the lack of funding and internal infrastructure, there is a broader push to restructure the FDA altogether. The 100+ year old agency created by the passage of the 1906 Pure Food and Drugs Act, is beginning to show its age. Today, with limited staff and resources, the FDA struggles to inspect foreign food shipments and physically examines less than 1% of imported products. With consumer palettes increasingly favoring global delicacies, this nominal inspection rate underscores the need for increased funding and a more innovative approach to FDA strategies.
UK’s Tightrope Walk on Food Safety
Similarly, in the UK, where the Food Standards Agency (FSA) governs food safety, budgetary constraints and other industry concerns are causing setbacks as it attempts to modernize inspections. The FSA has expressed concern that local authorities do not have the resources to deliver food controls, with new data revealing that they are a long way off from meeting the required frequencies of interventions at lower-risk establishments. As a result, some outlets in England, Wales, and Northern Ireland have not been checked for years. Additionally, UK’s exit from the European Union (Brexit), adds another layer of complexity, with potential disruptions to regulatory frameworks and the need for new trade agreements.
A Cautiously Optimistic Outlook on Global Food Safety
The global food safety landscape is at a crossroads and headed for extinction if changes do not take place within the next decade. Initiatives such as capacity-building programs, training workshops, and public-private partnerships empower individuals and organizations with the knowledge and skills necessary to implement effective food safety practices, while the global exchange of digital food safety data increasingly levels the information playing field for brands and regulatory bodies alike.
Achieving global food safety requires a multi-stakeholder approach that recognizes the unique challenges faced by different nations and leverages the strengths of various stakeholders. By focusing on prevention, capacity building, collaboration, and innovation, we can work towards a future where everyone has access to safe and nutritious food. This journey will require sustained commitment from governments, international organizations, the private sector, and individuals to ensure a healthy and sustainable future for all. For those of us in the business of helping to ensure food safety by creating a more transparent global supply network and making regulatory compliance easier to navigate, we are cautiously optimistic in the future and believe in the industry’s ability to rise above the challenge.
James “Jim” Jones will serve as the FDA’s first Deputy Commissioner for Human Foods. Per the FDA’s announcement, Jones, in this new executive position will lead the charge in setting and advancing priorities for a proposed unified Human Foods Program (HFP). Program areas would include food safety, chemical safety and innovative food products, including those from new agricultural technologies, that will bolster the resilience of the U.S. food supply in the face of climate change and globalization, as well as nutrition to help reduce diet-related diseases and improve health equity. Jones is scheduled to begin at the FDA on September 24, 2023.
For more than 30 years, Jones has held various positions in the U.S. Environmental Protection Agency (EPA), stakeholder community and private industry where he has managed teams and provided strategic planning and thought leadership around issues related to chemical safety and sustainability in the environment. His work has focused on lessening the impact that chemicals and pollution have on the U.S. food supply. At the EPA, he was a principal architect of the 2016 overhaul of the Toxic Substances Control Act, the first update of that statute in more than 40 years. He was also responsible for decision-making related to the regulation of pesticides and commercial chemicals. He also led several national sustainability programs, including the EPA’s Environmental Preferable Purchasing Program and the Presidential Green Chemistry Awards Challenge. He is a seasoned leader whose experience managing change initiatives within the federal government will be invaluable as we continue to build a unified HFP.
“I’m delighted to welcome Jim to the FDA. His impressive career, extensive leadership experience, and passionate vision for the future of the Human Foods Program make him an ideal selection for this pivotal position,” said FDA Commissioner Robert M. Califf, M.D. “Our proposed reorganization is the largest undertaking of its kind in recent history for our agency. I’m confident that under Jim’s leadership, we will build a stronger organization that will be integrated with other components of the FDA and focused on keeping the foods we regulate safe and nutritious, while ensuring the agency remains on the cutting edge of the latest advancements in food science and nutrition. I’m looking forward to working with him when he joins us next month.”
Jones was an integral member of the Reagan-Udall Foundation’s Independent Expert Panel for Foods, which submitted a report in December 2022 on the operational evaluation of the FDA’s Human Foods Program. He holds a master’s degree in economics from the University of California at Santa Barbara and a bachelor’s degree in economics from the University of Maryland.
“Jim is among the most public-spirited and able government leaders I know. I cannot think of a better choice for this crucial role. In his 20 years in leadership positions at EPA, Jim demonstrated know-how to lead complex, science-based regulatory programs in a visionary and inclusive way. Jim knows food safety and the food system from his leadership of EPA’s pesticide program, and he knows the food safety and nutrition challenges FDA faces through his service on the Reagan-Udall Foundation Expert Panel,” said Mike Taylor, board member emeritus of STOP Foodborne Illness and former FDA Deputy Commissioner for Foods and Veterinary Medicine.
In the role of Deputy Commissioner for Human Foods, Jones will report directly to the FDA Commissioner. He will exercise decision-making authority over all HFP entities when the reorganization is in effect, including related Office of Regulatory Affairs (ORA) activities. He will provide executive leadership over the entire program as well as over resource allocation, risk-prioritization strategy, policy, and major response activities involving human foods. The leadership for Center for Food Safety and Applied Nutrition and Office of Food Policy and Response will report to Jones until the proposed HFP reorganization is implemented.
“I am very excited about the opportunity to serve as the first Deputy Commissioner for Human Foods at the FDA. I had the pleasure of serving on the expert panel that provided operational recommendations for the FDA’s foods-related activities, and I now look forward to helping the agency realize its vision for the proposed Human Foods Program, including carrying out important nutrition initiatives to improve the health of our country,” said Jones. “As a former pesticide regulator, I have a deep understanding of the unique needs of government programs involved in upholding safety of the U.S. food supply, as well as the important role that the agriculture community and state partners play in this paradigm. I am honored to serve the FDA and the country in this new capacity.”
Food safety and quality professionals can take advantage of three days of education, networking and panel discussions at the 11th Annual Food Safety Consortium, October 16-18 in Parsippany, New Jersey. This year’s event is co-located with the Cannabis Quality Conference and Food Defense Consortium.
Keynote Speakers: Erik P. Mettler, MPA, MPH, Assistant Commissioner for Partnerships and Policy, Office of Partnerships and Operational Policy, Office of Regulatory Affairs (ORA) at FDA, and Sandra Eskin, Deputy Undersecretary Food Safety, USDA, Food Safety & Inspection Service.
Following the keynote presentations, attendees can take part in a Town Hall Q&A with Mettler and Eskin, followed by a panel discussion on Modernizing the U.S. Food Safety System, featuring Stephen Ostroff. Former FDA Commissioner, Barbara Kowalcyk, Executive Director of the Center for Foodborne Illness Research and Prevention, and Bill Marler, Attorney with Food Safety Law Firm Marler Clark.
This year’s program includes four pre-conference workshops, taking place on Monday, October 16:
Food Safety Culture Design Workshop
CP-FS Credential Review Course
Food Safety Auditor Training
The Seed to Sale Safety Workshop
Days two and three feature panel discussions covering food safety culture, supply chain, recall patterns and succession planning, as well as breakout sessions on prevention, mitigation, control and regulation of key food safety hazards. Session highlights include:
Re-Imagining Food Protection as a National Security Issue – DHS Perspective, Presented by Mark Wittrock, Assistant Director – Health, Food, and Agriculture Resilience Office of Health Security, U.S. Department of Homeland Security.
The Rise of Previously Unforeseen Hazards, Presented by Tim Lombardo, EAS Consulting
Food Safety Supply Chain Management, Presented by Celso Pagutalan, ASR Group
Succession Planning for Food Safety Inspectors, Panelists: Gina Nicholson Kramer, April Bishop of TreeHouse Foods, Barbara Kowalcyk, Executive Director of the Center for Foodborne Illness Research and Prevention, Erik P. Mettler, MPA, MPH, Assistant Commissioner for Partnerships and Policy, Office of Regulatory Affairs (ORA) at FDA, Rance Baker of NEHA, and Jorge Hernandez of Wendy’s
Food Safety Culture: Creating a “Speak Up Culture,” Presented by Austin Welch, Sage Media
Risk Mitigation through Assessment, Testing, Monitoring and Compliance, Presented by Dr. Sandra Johnson, SGS North America
Recalls Trends, Regulation and Lessons Learned, Panelists: Erik P. Mettler, MPA, MPH, Assistant Commissioner for Partnerships and Policy, Office of Regulatory Affairs (ORA) at FDA, Shawn Stevens, attorney with the Food Industry Counsel, and Stephen Ostroff, M.D. former Acting FDA Commissioner.
Food Allergen Advisory Labeling, Presented by Dr. Steven Gendel
Don’t miss out on opportunities to network with other food safety and quality professionals during the opening night reception, networking lunches and coffee breaks.
Frank Yiannas, former FDA Deputy Commissioner for Food Policy and Response, has been appointed to Chipotle Mexican Grill’s Food Safety Advisory Council, a group of independent experts commissioned to ensure Chipotle’s food safety standards continue to evolve and serve as best practices for the restaurant industry.
Chipotle established the Food Safety Advisory Council in 2016 to complement the company’s internal food safety team in pursuit of continuous improvement and performance excellence. Yiannas joins fellow industry experts David Acheson, M.D., former FDA Associate Commissioner of Foods; Elisabeth Hagen, M.D., former USDA Under Secretary for Food Safety; Hal King, Ph.D., former CDC Research Scientist and Director of Food Safety with Chick-fil-A; and James Marsden, Ph. D., former Head of Food Safety at Chipotle and distinguished professor.
“In order to make sure our food safety culture and programs are as robust as possible, it’s critical to supplement our internal expertise with independent external guidance,” said Kerry Bridges, Vice President of Food Safety at Chipotle. “Frank’s vast experience with the FDA and other large brands will help guarantee Chipotle’s food safety standards continue to be best-in-class.”
Yiannas most recently served under two administrations as the Deputy Commissioner for Food Policy and Response at the FDA, a position he held from 2018 to 2023, after spending 30 years in leadership roles with Walmart and the Walt Disney Company.
Throughout his career, Yiannas has been recognized for his role in strengthening food safety standards in new and innovative ways, as well as building effective food safety management systems based on modern, science-based, and tech-enabled prevention principles.
“I’m delighted to join and collaborate with some of the nation’s foremost food safety authorities and serve on Chipotle’s Food Safety Advisory Council,” said Yiannas. “I look forward to lending my experience to a company committed to ‘cultivating a better world’ that benefits people and the planet.”
On March 24, the FDA announced that it intends to amend the standards of identity (SOIs) to permit the use of salt substitutes in foods for which salt is a required or optional ingredient. The proposed rule would provide manufacturers with flexibility and facilitate industry innovation to reduce sodium in standardized foods.
Currently, most FDA SOIs do not permit the use of salt substitutes. The proposed rule would use a “horizontal” approach for SOIs, under which a single rule would apply to multiple SOIs across several categories of standardized foods.
Specifically, the proposed rule would amend the 80 SOIs that specify salt as a required or an optional ingredient. Because these 80 SOIs are referenced in other SOIs, the FDA notes that 140 of the 250 SOIs currently established for a wide variety of foods could be affected.
The proposed rule does not list permitted salt substitutes but defines them as safe and suitable ingredients used to replace some or all of the added sodium chloride and that serve the functions of salt in food. The extent to which salt can be replaced depends on the ability of a salt substitute to replace the functions of salt in food without compromising food safety and the characteristics of the food.
The FDA is requesting comments on potential salt substitutes that may be used as a result of the new flexibility provided in this proposed rule. Comments can be submitted until 120 days after the date of publication in the Federal Register. Electronic comments can be submitted at Regulations.gov.
The FDA announced that it has begun a national search for a new Deputy Commissioner for Human Foods and has provided an update on its proposed restructuring of the agency’s Human Foods Program and Office of Regulatory Affairs (ORA).
The Deputy Commissioner for Human Foods will report directly to the FDA Commissioner. As part of its search criteria, the agency notes that it is focused on identifying a candidate that has the expertise to provide leadership over the FDA’s nutrition and food safety programs (including programs aimed at preventing and responding to chemical, microbial, and other hazards).
“The ideal candidate will have executive-level and real-world experience sufficient to lead the newly envisioned Human Foods Program and its vast remit. This individual will also have clear line of authority over the proposed Human Foods Program, which would include the existing components of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain human foods-related components of ORA,” said the FDA in its statement released on February 28.
In terms of the proposed restructuring of the Human Foods program, the Deputy Commissioner will be charged with setting strategic direction for food inspections and have authority over program resource allocation. To achieve these goals, the agency has started the process of:
Assessing specific functions of ORA, CFSAN and OFPR to be unified into a new Office of Integrated Food Safety Systems Partnerships that will engage with state, local, tribal, and territorial food safety regulatory partners. The assessment will also include how best to enhance connectivity with international food safety partnership programs.
Analyzing inspection and compliance functions that sit within both ORA and program offices across the agency to determine opportunities to streamline operations and clarify decision-making authority at each step of the inspection process as well as integrate new automation and information technology (IT) support. The new processes will enable ORA and program personnel to function as a multidisciplinary team, eliminating sequential steps, immediately bringing the best expertise to bear on the problem at hand, and speeding decisions.
Determining how best to empower the Deputy Commissioner for Human Foods and leaders of other programs, along with the Associate Commissioner for Regulatory Affairs, to oversee program and field resource allocation, including publicly mapping the budget to functional activities to provide clarity on resource allocation.
Ensuring seamless coordination across the FDA and state-operated food laboratory operations by evaluating the foods laboratory programs, including the relationships, roles, and responsibilities among CFSAN, CVM, ORA and state-operated laboratories.
Improving the FDA’s ability to conduct risk prioritization to deliver the highest public health benefit by performing an extensive evaluation of how the Human Foods Program accomplishes risk management, particularly risk prioritization, given the multitude of demands and the scarce resources, and how this can be used to guide dynamic work planning and resource allocation.
Planning for greater enterprise transformation of certain ORA IT functions, which will be coordinated with the FDA’s Office of Digital Transformation (ODT). This move builds on the existing project to create an enterprise-wide platform for managing inspections and compliance activities. ODT will drive upgrades to FDA-wide IT systems.
Evaluating training programs, including for FDA investigators, to see how they can best serve the needs of both the FDA, regulatory partners and regulated industry. This will include assessing whether some training functions or roles should be unified into the Human Foods Program and other product programs.
This vision will include moving cosmetics regulation and color certification functions out of CFSAN and into the Office of the Chief Scientist to better align the expertise of the agency’s cosmetics subject matter experts with the Chief Scientist and to leverage the FDA’s areas of expertise across the agency as it works to implement the Modernization of Cosmetics Regulation Act of 2022.
“Our proposal specifically tackles issues identified in two independent evaluations of our food programs, one conducted by the Reagan-Udall Foundation and an internal evaluation of the agency’s infant formula response. We’ve heard loud and clear that the current resource distribution and operational model between the FDA’s regulatory programs and field operations are siloed and there’s too much duplication. We intend to fix this and strengthen both the regulatory programs and field force,” said FDA Commissioner Robert M. Califf, M.D. “Both subject matter experts in the programs and the expertise of our investigators in the field will see more interaction as part of multidisciplinary teams that have clarity on who is in charge of making decisions.”
The FDA is seeking to finalize its proposal this Fall. It will then undergo a thorough review before advancing to Congress for a 30-day notification period where members may raise any concerns that the FDA may need to address. Afterwards, the FDA will issue a Federal Register Notice, provide notification to and engage, as needed, in negotiations with the Unions for impacted staff, prior to initiation of the new proposal. The FDA emphasized that it will continue to engage with stakeholders throughout this process.
On Thursday, March 2, 2023, at 1:00 pm (ET) the FDA is holding a webinar to discuss the recent draft guidance on lead action levels for foods intended for children less than two years of age. The draft guidance, titled “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry,” was issued in January. It covers the proposed action levels for lead in a wide range of commercial foods targeted to this population. These levels support the agency’s broader effort to reduce exposure to arsenic, lead, cadmium, and mercury from foods, and advance the agency’s Closer to Zero action plan goals.
During the webinar the FDA will provide an overview of the draft guidance and answer stakeholder questions. Featured speakers include Dr. Susan Mayne, Director, Center for Food Safety & Applied Nutrition (CFSAN), Dr. Conrad Choiniere, Director, Office of Analytics and Outreach, CFSAN, and Dr. Paul South, Director, Division of Plant Products and Beverages, Office of Food Safety, CFSAN.
Stakeholders can register for the webinar and submit questions or brief comments related to this draft guidance on the registration page. Questions or comments must be submitted by Thursday, February 9, 2023.
The webinar will be recorded and posted to the FDA website.
Frank Yiannas is stepping down from his position as FDA Deputy Commissioner for the Office of Food Policy and Response effective February 24. In his resignation letter, Yiannas cited concerns about the decentralized structure of the FDA foods program and urged the Commissioner to consider “creation of a more integrated operating structure and a fully empowered and experienced Deputy Commissioner for Foods, with direct oversight of those centers and offices responsible for human and animal foods.”
During his tenure, Yiannis oversaw several efforts to modernize and improve food safety, including issuing the FSMA Final Food Traceability Rule and a new, proposed Agricultural Water Standard.
During his tenure, Yiannis has taken an active role engaging regularly with both industry and consumer groups to advance food safety and the prevention of foodborne illness. We at Food Safety Tech thank him for his service to the FDA and American consumers.
For the past two years, Food Safety Tech, creator of the annual Food Safety Consortium conference, has been supporting FSQA professionals through its virtual Food Safety Tech Hazards Series.
Focused on the four core areas of food safety: detection, mitigation, control and regulation of risk, the series has addressed pathogens, pest control, and physical and chemical hazards facing the food industry.
The virtual conferences, which have attracted thousands of attendees, provide information on ongoing and emerging risks for both new and seasoned FSQA professionals, featuring speakers from industry, regulatory agencies and standards bodies.
In 2023, we are building on the popularity and success of these virtual events by expanding the Food Safety Tech Hazards Series to include two in-person events coming this spring and fall.
In 2022, salmonella– and listeria-related cases represented 37.4% of food and beverage product recalls, an uptick from 33.3% in 2021. “Food safety hazards continue to be a challenge for all aspects of the food industry from farm to fork.” said Rick Biros, president of Innovative Publishing Company, publisher of Food Safety Tech and director of the Food Safety Consortium conference. “The detection, mitigation and control of food safety hazards issues must be discussed among peers and best practices must be shared, something you can’t do virtually. The human connection is so important for conference attendees. Whether it’s a random connection over lunch, a one-on-one question with a speaker after a presentation or a seat next to a new friend in a learning session—connecting with others is what makes events so valuable. This year’s in-person events are designed to help facilitate this much needed critical thinking and sharing of best practices.”
“We look forward to bringing the Food Safety Tech Hazards series to an in-person audience in 2023,” said Inga Hansen, editor of Food Safety Tech. “This format will complement our virtual series and allow for the live discussion and networking that can only be achieved in person.”
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