Tag Archives: FDA

February 28, 2023

FDA Provides Update on Restructuring of Human Foods Program

By Food Safety Tech Staff

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.

February 5, 2023

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.

January 25, 2023

Frank Yiannas Announces Resignation from FDA

By Food Safety Tech Staff

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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.

January 10, 2023

From the Editor’s Desk

Food Safety Tech Hazards Series Expands to In-Person Events in 2023

By Food Safety Tech Staff

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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.”

Stay tuned for upcoming dates and registration.

December 20, 2022

Challenges and Best Practices in Developing a Strong Food Safety Culture

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On December 12, The FDA released a systematic review of the scientific literature on food safety culture (FSC), which identified barriers, as well as best practices, for organizations seeking to develop a stronger culture of food safety. The FDA noted that it will use this research to inform its continued efforts in support of food safety culture.

While food safety culture is defined in various ways in the literature, the review identified the most frequently cited definition of FSC as “the aggregation of the prevailing, relatively constant, learned, shared attitudes, values and beliefs contributing to the hygiene behaviors used within a particular food handling environment.” (Griffith, Livesey, and Clayton 2010).

Best practices for promoting FSC include:

Promoting FSC as a topmost goal of each member of the organization, not just a goal of a specific group within an organization.
Branding your commitment to FSC and promoting it everywhere. This includes displaying food safety messaging in break rooms, hallways, elevators, parking lots, or anywhere employees congregate so employees don’t forget it. In his book Food Safety Culture: Creating a Behavior-Based Food Safety Management System, Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response wrote that, “Messaging should be simple, communicate what the desired behavior is, be placed where the desired behavior should occur, and changed often enough to prevent desensitizing.”
Building your food safety messages on the concept of “we,” and clearly defining how employees’ job objectives align with food safety.
Promoting FSC not only within your organization, but also within your entire supply chain.

Challenges and barriers to a strong and effective FSC include:

Over-reliance on Food Safety Management Systems (FSMS). Because FSMSs do not address the human impact on food safety, they do not guarantee a good FSC. A combination of a well-elaborated FSMS and a favorable food safety climate is ideal.

Prioritization of Cost-saving and Money-earning. A commitment to food safety must take precedence over other objectives and cultures that compete for priority within an organization, including the culture of saving money.

Frequent Staff Turnover. Continuous turnover can be detrimental to key determinants of FSC, such as risk awareness and accountability.

Optimistic Bias. Reviewed studies found that some organizations or employees have an “illusion of invulnerability,” which may hinder effective implementation of food safety behaviors. Without perceiving a susceptibility to food contamination, people often resist a focus on it unless they can see the value.

Download the Food Safety Culture Systematic Literature Review.

December 12, 2022

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.

December 12, 2022

Food Safety Attorney

No Magic Bullets: Making Health Claims that Comply with FDA Regulations

By Jennifer Allen

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With increasing numbers of Americans paying closer attention to the contents of the food they eat, food manufacturers are understandably eager to publicize the health benefits of their products. The FDA allows food manufacturers to make health claims on food labels, but, perhaps not surprisingly, it is strict about how manufacturers make those claims, and all health claims require pre-approval.

First, what qualifies as a health claim? A health claim is any claim on a label or labeling that expressly or impliedly characterizes a relationship between a substance and a disease or health-related condition. The claim may state that increased consumption of a particular substance reduces certain disease risks, or it may state that decreased consumption reduces that risk. The former claim would be associated with a product high in a particular substance, the latter with a product low in a particular substance. A health claim may not state that the substance diagnoses, cures, mitigates, or treats disease. Only pre-approved drugs and medications may carry those claims.

The statement “Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis,” is an example of the former type of health claim. It connects consumption of a higher amount of a particular substance (calcium) with the reduced risk of a particular disease (osteoporosis). In contrast, the statement “Diets low in saturated fat may reduce the risk of heart disease” is an example of the latter type of health claim. Note that health claims are different from structure/function claims, which don’t reference a specific disease. The statement “Calcium builds strong bones” is a structure/function claim, a type of claim that does not require FDA pre-approval.

You can find the list of currently approved health claims in the regulations at 21 CFR 101, commonly referred to as Subpart E. As an example, if your product contains calcium and vitamin D, you would look to 21 CFR 101.72 for guidance on how to make a claim on your label that consuming more of these substances reduces the risk of osteoporosis. You would look to §101.75 for guidance on making a claim about reduced saturated fat and heart disease.

Disqualifying Substance Levels

But before you make any health claim, you must first ensure that your product doesn’t contain disqualifying levels of certain substances, namely fat, saturated fat, cholesterol, and sodium. You can find those levels in 21 CFR 101.14. The reason for that requirement is, health claims lead the consumer to believe that the product they are consuming is “healthy.” If, for example, your readymade meal product contains 2,500 mg of sodium, the FDA frowns on you marketing it as healthy, even if you’ve manufactured the meal with increased levels of vitamin D.

Key Criteria To Support “Healthy” Labeling

If your product passes the initial test above and meets the following criteria, you can make a health claim:

All your statements are consistent with the detailed and specific requirements in Subpart E;
Your claim is limited to describing the value of either decreased or increased consumption of the substance as part of a total dietary pattern;
Your claim is complete, truthful, and not misleading;
All the information is in one place, without intervening material. Note that in place of making a direct claim on the label, you may instead refer the consumer to another location, such as a website, for information about the claim. If you include a graphic image to portray the claim, it must be immediately adjacent to the verbal claim or reference statement;
The claim enables the consumer to comprehend the information and understand its relative significance in the context of a total daily diet; and
The particular substance is either low enough or high enough to justify the claim.

These six requirements can be summed up in the following statement: Don’t offer false promises to the consumer. Reduction of disease risk is a lifelong process. No single food or group of foods can work miracles. Consuming a low fat dessert product will probably not protect the consumer from heart disease if she routinely consumes it after enjoying a fast-food meal. Your health claim shouldn’t suggest in any way that it will. After all, you’re selling a food product, not a magic bullet.

November 15, 2022

Foodborne Illness Report Highlights High-Risk Food Categories

By Food Safety Tech Staff

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This month, the Interagency Food Safety Analytics Collaboration’s (IFSAC) released it newest annual report , “Foodborne illness source attribution estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States.” IFSAC is a collaboration between the CDC, FDA and USDA Food Safety and Inspection Service (FSIS).

The report was developed to help shape the priorities of the FDA, inform the creation of targeted interventions to reduce foodborne illnesses caused by these pathogens, inform stakeholders and improve regulatory agency’s to assess whether prevention measures are working.

The report identified 3,749 outbreaks that occurred from 1998 through 2020 and were confirmed or suspected to be caused by Salmonella, E. coli O157, or Listeria, including 192 outbreaks that were confirmed or suspected to be caused by multiple pathogens or serotypes.

The IFSAC excluded 96 of these outbreaks according to its pathogen-exclusion criteria, leaving 3,653 outbreaks. The agency further excluded 1,524 outbreaks without a confirmed or suspected implicated food, 836 outbreaks for which the food vehicle could not be assigned to one of the 17 food categories, and six that occurred in a U.S. territory.

The resulting dataset for the report included 1,287 outbreaks in which the confirmed or suspected implicated food or foods could be assigned to a single food category. These included 960 caused or suspected to be caused by Salmonella, 272 by E. coli O157 and 55 by Listeria. Outbreaks from 2016 through 2020 provide 71% of model-estimated illnesses used to calculate attribution for Salmonella, 67% for E. coli O157 and 62% for Listeria.

Salmonella illnesses came from a wide variety of foods, with more than 75% of illnesses attributed to seven food categories: Chicken, Fruits, Pork, Seeded Vegetables (such as tomatoes), Other Produce (such as fungi, herbs, nuts, and root vegetables), Beef and Turkey.

More than 80% of E. coli O157 illnesses were linked to Vegetable Row Crops (such as leafy greens) and Beef.

More than 75% of Listeria monocytogenes illnesses were linked to Dairy products, Fruits and Vegetable Row Crops, though the IFSAC noted that “the rarity of Listeria monocytogenes outbreaks makes these estimates less reliable than those for other pathogens.”

Attribution estimates for Campylobacter outbreaks were not included in this year’s report, though they have been included in the past. IFSAC said that this was “due to continued concerns about the limitations of using outbreak data to attribute Campylobacter illnesses to sources … these concerns are largely due to the outsized influence of outbreaks in certain foods that pose a high individual risk for Campylobacter infection but do not represent the risk to the general population.” For example, 91% of reported Campylobacter outbreaks related to dairy products were associated with unpasteurized milk, while 57% majority of chicken-related outbreaks were due to chicken liver products, which are not widely consumed.

November 7, 2022

FDA Submits Final FSMA Rule for Food Traceability

By Food Safety Tech Staff

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On November 7, the FDA sent the FSMA Final Rule: Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal Register (OFR).

The final rule includes a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). The FDA notes that while the proposed requirements only apply to those foods on the FTL, “they were designed to be suitable for all FDA-regulated food products. FDA would encourage the voluntary adoption of these practices industrywide.”

The final rule will become effective 60 days after it is published in the Federal Register, which the FDA anticipated would happen within one to two weeks. The compliance date for all persons subject to the recordkeeping requirements is two years after the effective date.

November 4, 2022

FDA Poised To Increase Color Certification Fees

By Food Safety Tech Staff

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On November 1, the FDA issued a proposed rule to amend the color additive regulations with a 10 cent per pound increase in color certification fees. If the rule is finalized, this would be the first increase since 2005 when the current schedule became effective.

In its announcement of the proposed rule, the FDA said the increase in fees is necessary to cover increased operating costs “in order to ensure the color certification program continues operating at the high level of quality and efficiency that industry expects.”

Under the Federal Food, Drug, and Cosmetic (FD&C) Act, certain color additives must be certified by the FDA for use in food, drugs, cosmetics and medical devices. The FDA analyzes samples from each batch of color additive received from a manufacturer to verify that it meets composition and purity specifications. Manufacturers pay fees, based on the weight of each batch, and these fees support the FDA’s color certification program.

Stakeholders can submit electronic comments on the proposed rule at http://www.regulations.gov or send written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2022-N-1635.

Disqualifying Substance Levels

Key Criteria To Support “Healthy” Labeling

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