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FDA Provides Update on Restructuring of Human Foods Program

By Food Safety Tech Staff
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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.

 

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FDA to Hold March 2 Webinar on Action Levels for Lead in Infant Food

By Food Safety Tech Staff
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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.

 

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From the Editor’s Desk

FDA Proposes Redesign of Human Foods Program

By Food Safety Tech Staff
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On January 31, Robert M. Califf, M.D., MACC, FDA Commissioner of Food and Drugs shared a proposal for a unified Human Foods Program that would combine the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and certain functions of the Office of Regulatory Affairs (ORA) under one leader.

The new model was proposed in response to the findings of an external evaluation of the FDA Foods program conducted by an expert panel of the Reagan-Udall Foundation and a separate internal review of the agency’s infant formula supply chain response completed last year.

The Reagan Udall evaluation identified several concerns, including lack of communication, lack of a clear vision and mission, lack of a clear, overarching leader, and siloed workers within the FDA’s Human Foods program. The panel also found that the FDA Human Foods program was ill defined with multiple agencies, including CFSAN, OFPR and OVA, working independently of each other, often with separate leadership and little sharing of information. It recommended creating a new Federal Food Administration under HHS that would operate parallel to, rather than under the auspices of, the FDA.

In his statement announcing the proposal for a more unified Human Foods program, Califf highlighted the issues identified by these independent reviews, including problems with the current culture, structure, resources, and authorities in the FDA Human Foods program.

“Today I am announcing a new, transformative vision for the FDA Human Foods Program. I am also announcing a transformative vision for the Office of Regulatory Affairs (ORA, the FDA’s field-based operations) to support the FDA organization as a whole. The proposed structures for both groups will have clear priorities that are focused on protecting and promoting a safe, nutritious U.S. food supply that more quickly adapts to an ever-changing and evolving environment,” said Califf.

The “Vision for a Reimagined Human Foods Program” includes the recommendation to create a Human Foods Program under a single leader who reports directly to the Commissioner. Under this plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), as well as certain functions of ORA will be unified into a new organization called the Human Foods Program.

“The FDA will conduct a competitive national search for a Deputy Commissioner for Human Foods, who will oversee the Program. The person in this position will report directly to me and will be charged with leading a unified Human Foods Program that keeps the foods we regulate safe and nutritious, while ensuring the agency remains on the cutting edge of the latest advancements in science, technology, and nutrition,” said Califf. “The Deputy Commissioner will have decision-making authority over policy, strategy, and regulatory program activities within the Human Foods Program, as well as resource allocation and risk-prioritization.”

Other key elements of the proposed new Human Foods Program include:

  • Creation of a Center for Excellence in Nutrition that prioritizes the agency’s ongoing efforts to help American consumers make more informed food choices, including by working with industry to offer healthier, more nutritious food products.
  • Establishment of an Office of Integrated Food Safety System Partnerships that will focus on elevating, coordinating and integrating the FDA’s food safety and response activities with state and local regulatory partners to more effectively meet the vision of an Integrated Food Safety System in the FDA Food Safety Modernization Act of 2011.

The proposed program would also include the establishment of a Human Foods Advisory Committee made up of external experts who will advise the agency on challenging and emerging issues in food safety, nutrition and innovative food technologies.

“Finally, there will be an emphasis on strengthening our enterprise information technology and analytical capabilities to fulfill the promise described in the New Era of Smarter Food Safety and support the improvement in workflow that will accompany these changes,” said Califf. “This area of focus will support the work of the Human Foods Program by enabling more facile communication, more efficient operations and enhanced empirical risk algorithms to guide the priorities of the program and the work in the field.”

To execute this new plan, the FDA has formed an Implementation and Change Management Group that will be charged with developing a detailed plan for implementation of the newly organized agency. “While details of this proposal continue to be developed, CFSAN, ORA, and OFPR will continue to operate under their current structures, with my direct oversight. I look forward to providing additional public updates by the end of February on our progress, organizational design and timeline,” said Califf.

 

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Expert Panel Recommends a New Federal Food Administration Separate from FDA

By Food Safety Tech Staff
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On December 6, the Independent Expert Panel for Human Foods submitted its Operational Evaluation of FDA’s Human Foods Program report to Dr. Robert Califf, FDA Commissioner for Food and Drugs. The evaluation and report, which addressed culture, structure/leadership, resources, and authorities, were facilitated by the Reagan-Udall Foundation at Dr. Califf’s request.

The panel, chaired by former Commissioner of Food and Drugs Dr. Jane Henney, highlighted several concerning findings in their report, including lack of communication, lack of a clear vision and mission, lack of a clear, overarching leader, and siloed workers within the FDA’s Human Foods program. Its recommendations to improve both food safety and nutrition in the U.S. included creating a new Federal Food Administration under HHS that would operate parallel to, rather than under the auspices of, the FDA.

Notably, the panel found that the FDA Human Foods program was ill defined with multiple agencies, including CFSAN, OFPR and OVA, working independently of each other, often with separate leadership and little sharing of information.

“The current structure of the FDA Human Foods Program reinforces duplicative or competing roles and responsibilities, siloed work, and inadequate internal and external engagement. This reality impedes the Human Foods Program move toward a prevention paradigm. While a change in structure cannot address all the challenges identified through this Human Foods Program review, changing the current organizational configuration will assist the Agency in advancing its mission,” the panel wrote.

In addition to Dr. Henney, the panel included Francisco Diez-Gonzalez, PhD, James Jones, Barbara Kowalcyk, PhD, Shiriki Kumanyika, PhD, MS, MPH, and John Taylor, JD. The team of researchers, former regulators, and process improvement specialists used a three-phase evaluation protocol consisting of information gathering, information synthesis and analysis, and report generation. The panel heard from more than 350 stakeholders through a two-day in-person stakeholder meeting, an online stakeholder public portal, and a series of interviews.

“We were honored to take on this challenge and worked diligently to propose changes to strengthen the operation of FDA’s Human Foods Program,” said Dr. Henney. “The report provides constructive recommendations that will take time to work through and implement, but we are confident the effort will benefit the health and safety of the American public.”

Read the full report here.

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FDA Announces Upcoming Webinars on Food Safety Culture and “Healthy” Food Labeling

By Food Safety Tech Staff
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The FDA has announced two upcoming webinars for food manufacturers and industry stakeholders. On Friday, October 21, 2022, at 1:00 pm ET, the FDA will provide an overview of its proposed rule to update the definition of “healthy” nutrient content claims for food products. The “healthy” claim acts as a quick signal on food package labels to identify foods that will help consumers build healthy eating patterns.

The FDA has proposed changes to the definition of “healthy” to align with current nutrition science, the Dietary Guidelines for Americans, 2020-2025 and the updated Nutrition Facts label. The guidance also includes the agency’s intent to exercise enforcement discretion with respect to the implied nutrient content claim “healthy” for foods that have a fat profile of predominantly monounsaturated and polyunsaturated fats, but do not meet the regulatory definition of “low fat,” and on foods that contain at least 10% of the daily value (DV) per reference amount customarily consumed of potassium or vitamin D.

Speakers include:

  • Janesia Robbs, Communications and Public Engagement Staff, FDA CFSAN
  • Dr. Claudine Kavanaugh, Director, Office of Nutrition and Food Labeling (ONFL), FDA CFSAN
  • Dr. Sarah Gebauer, Nutritionist, Nutrition Science Review Branch, ONFL, FDA CFSAN
  • Vincent DeJesus, Nutritionist, Nutrition Assessment & Evaluation Branch, ONFL, FDA CFSAN

Registration is required. Register here.

On Wednesday, October 26, from 12:00 pm to 1:00 pm ET, the FDA and Stop Foodborne Illness, a nonprofit public health organization, will be host their fifth collaborative webinar, titled “Rewards and Recognition Programs.” Guest speakers will share their experiences in establishing rewards programs that drive positive food safety culture. Speakers include:

  • Shawn Fear, Director of Quality, Conagra Brands
  • Danielle Richardson, Director of Food Safety, Conagra Brands
  • Lone Jespersen, Principal and Founder, Cultivate, SA
  • Donald Prater, Associate Commissioner for Imported Food Safety, FDA
  • Conrad Choiniere, PhD, Director of the Office of Analytics and Outreach, FDA Center for Food Safety and Applied Nutrition (CFSAN)
  • Vanessa Coffman, Director, Alliance to Stop Foodborne Illness, Stop Foodborne Illness

Those who would like to attend the webinar can register here.

 

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FDA Publishes Public Dashboard from Reportable Food Registry for Easier Analysis of Agency Data

By Food Safety Tech Staff
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FDA has published an interactive Reportable Food Registry (RFR) Data Dashboard to provide faster access to better data about hazards and dangerous food products. Called FDA-TRACK, the new RFR will be published annually, and contains 10 years of data (from September 2009–2019), encompassing 28 commodities and 20 food safety hazards. Users can interact with data points in an effort to obtain customized information. They can also change the graphs and charts, and view trends based on commodities, hazards and time frames.

The interactive dashboard provides more “access and transparency with state and local partners who use the data to better [their] workplan and determine how to target their own sampling assignments to concerns that are more common in their area, allows industry to educate themselves on trends and identify areas were additional good manufacturing practices and preventive controls could better prevent future outbreaks or contamination in their products; and offers a robust data set to researchers and others who are interested in studying the safety of our food system,” according to a CFSAN update.

The RFR was established by Congress to help FDA more effectively track patterns of food and feed adulteration. “Overall, this will be a more efficient, less resource-intensive process for FDA to provide data,” the agency stated.

When a company uncovers a food product that is hazardous, it must submit an RFR to the FDA using the electronic portal. This year the agency will launch a project that allows companies to export RFR data from their own business systems or from third party applications directly into the portal.

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FDA Publishes Long-Awaited Final Rule on Lab Accreditation

By Food Safety Tech Staff
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At long last FDA has issued its final rule for Laboratory Accreditation for Analyses of Foods (LAAF). The FSMA rule establishes a lab accreditation program for testing food in certain situations and applies only to accredited bodies and food testing labs that opt to participate in the program; these ABs and labs must fulfill certain eligibility requirements.

“The establishment of the LAAF program will improve the FDA’s capacity to protect U.S. consumers from unsafe food by improving the accuracy and reliability of certain food testing through the uniformity of standards and enhanced oversight of participating laboratories,” CFSAN states in a news release.

According to CFSAN, the LAAF will apply to testing that is:

  • “to support removal of a food from an import alert through successful consecutive testing requirements;
  • to support admission of an imported food detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act;
  • required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem (i.e., certain tests of shell eggs, sprouts, and bottled drinking water);
  • required by a directed food laboratory order, a new procedure being implemented in this final rule that will allow the FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances; and
  • conducted in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention order.”

The final rule will be published on the Federal Register on December 3.

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FDA Responds to Subcommittee Report on Toxic Metals in Baby Food

By Food Safety Tech Staff
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Following a report released nearly two weeks ago about the potential danger posed by toxic heavy metals found in baby foods manufactured by several major companies, FDA has issued a response. The report, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury”, was released by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy on February 4. The Subcommittee stated that FDA should require baby food manufacturers to test their finished products for toxic heavy metals and require any toxic heavy metals be reported on food labeling. It also stated that FDA should set maximum levels of toxic heavy metals allowed in baby foods.

“The FDA has been actively working on this issue using a risk-based approach to prioritize and target the agency’s efforts. Consumers should know that FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study,” the agency stated in a CFSAN update. “Further, the FDA also monitors baby food under the FDA’s compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food and through targeted sampling assignments.”

FDA cited its work in sampling infant rice cereal for arsenic, which it says has resulted in safer products on the market, along with its recent court order to stop a U.S. company from distributing adulterated juice that had potentially harmful levels of inorganic arsenic and patulin (a mycotoxin).

The CFSAN update, however, did not specifically address the companies or baby foods called out in the Subcommittee’s report.

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FDA to Conduct Remote Importer FSVP Inspections, Extends Comment Period for Lab Accreditation Proposed Rule

By Food Safety Tech Staff
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Today the FDA announced that it will begin requesting electronic records related to import records required under FSVP for Importers of Food for Humans and Animals. The agency is moving to remote inspections as a result of the COVID-19 pandemic. FDA stated that in “rare” instances it will onsite FSVP inspections—these situations include outbreaks.

“The FDA will immediately begin conducting a limited number of remote inspections, prioritizing the inspections of FSVP importers of food from foreign suppliers whose onsite food facility or farm inspections have been postponed due to COVID-19. The Agency is also planning to continue to conduct previously assigned routine and follow-up inspections remotely during this time. Importers subject to the remote inspections will be contacted by an FDA investigator who will explain the process for the remote inspection and make written requests for records.” – CFSAN Constituent Update

FDA has also extended the comment period for the Laboratory Accreditation Program Proposed Rule from April 6, 2020 to July 6, 2020.

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FDA’s Pesticide Analysis Finds Most Foods Tested Below EPA Tolerance Levels

By Food Safety Tech Staff
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Today FDA released the results of its yearly report on pesticide residues, and the good news is that of the 6504 samples taken, most of them were below EPA tolerance levels. As part of the Pesticide Residue Monitoring Program for FY 2017, FDA tested for 761 pesticides and industrial chemicals in domestic and imported foods for animals and humans. The following are some highlights of the FDA’s findings:

  • Percentage of foods compliant with federal standards
    • 96.2% of domestic human foods
    • 89.6% of imported human foods
    • 98.8% domestic animal foods
    • 94.4% imported animal foods
  • Percentage of food samples without pesticide residues
    • Milk and game meat: 100%
    • Shell egg: 87.5%
    • Honey: 77.3%
  • Percentage of food samples without glyphosate or glufosinate residues
  • Milk and eggs: 100%
  • Corn: 82.1%
  • Soybeans: 60%

“Ensuring the safety of the American food supply is a critical part of the work of the U.S. Food and Drug Administration. Our annual efforts to test both human and animal foods for pesticide residues in foods is important as we work to limit exposure to any pesticide residues that may be unsafe,” said Susan Mayne, Ph.D., director of FDA’s CFSAN, in an agency release. “We will continue to do this important monitoring work, taking action when appropriate, to help ensure our food supply remains among the safest in the world.”