Tag Archives: FDA

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Ask The Expert

Seeing the Forest Through the Trees: Advancing Integration in the U.S. Food Protection System

By Rick Biros
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Calls to integrate the regulatory oversight of the U.S. food system have been echoed for decades through studies, reports, and policy forums—yet meaningful change has remained elusive. While the FDA’s recent creation of the Office of Inspections and Investigations marks an important step toward more coordinated oversight, the USDA’s FSIS still lacks a parallel structure, and significant gaps persist across the broader food protection landscape.

From food safety and quality to food defense, food integrity, and physical and digital security, the farm to fork system continues to operate in silos. This fragmentation not only creates regulatory confusion for industry stakeholders but also fuels inconsistent enforcement and mixed messages for consumers potentially leading to negative public health impacts and loss of consumer trust due to confusing recall messages—exemplified by the widely cited disparity in how cheese and pepperoni pizzas are regulated by different federal agencies.

This topic will be discussed at the Food Safety Consortium conference in Alexandria VA., October 19-21. Panelists include Benjamin Reading, Ph.D. Interim Assistant Director, NC Agricultural Research Service (NCARS) Associate Professor & University Faculty Scholar, North Carolina State University and Jason Bashura, M.P.H., RS, a 25+ yrs. public health and food protection professional. Ben and Jason discuss the need for truly unified, risk-based U.S. food protection system in this 26 minute recorded webinar. To watch the video, click on the image below or this link: Watch the Webinar.

Ben and Jason discuss the need for truly unified, risk-based U.S. food protection system in this 26 minute recorded webinar

After watching the video, we invite you to take a quick 5 question survey on this topic. You can win a chance to receive a complimentary registration to the Food Safety Consortium by correctly identifying the number of times Jason says the two words “Food Protection” in the webinar. Click here to take the Survey.

The session at the Food Safety Consortium will convene leaders from regulatory agencies, industry, academia, and NGOs to explore the structural and operational challenges that continue to hinder integration. Through their collective insights, attendees will gain a deeper understanding of what a truly unified, risk-based food protection system could look like, why such a system is needed now more than ever, and how emerging solutions—both policy-based and practical—can help close longstanding gaps.

By moving beyond agency silos and outdated jurisdictional lines, this session challenges participants to rethink what it means to protect the food supply and to consider how collaboration can turn complexity into clarity. This is the next step in seeing the forest through the trees—and laying the groundwork for a smarter, more resilient food protection system.

The Food Safety Consortium, presented by Food Safety Tech and the American Frozen Food Institute (AFFI) will take place October 19-21, 2025, at the Crystal Gateway Marriott, Arlington VA directly across the Potomac River from  Washington, DC. The Program starts with several pre-conference workshops and training which leads into two full days of high-level panel discussions and educational presentations that will be sure to open your mind and expose you to a variety of topics, ideas and like-minded Food PROTECTION professionals who will be in attendance.

For a limited time, you can receive a 10% discount off registration by entering the discount code FoodProtection. Visit FoodSafetyConsortium.org

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Allergen Alley

FDA to Open Registration for the Virtual Public Meeting and Listening Sessions on Food Allergen Thresholds and Their Potential Applications

By Food Safety Tech Staff
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The FDA invites the public to attend a virtual public meeting on November 18, 2025 and listening sessions on November 19 – 20, 2025 regarding food allergen thresholds and their potential applications in the U.S. Recent scientific developments in food allergen thresholds have prompted the FDA to explore how these thresholds can improve food safety, enhance labeling practices and help consumers make more informed choices. The purpose of the public meeting and listening sessions is to discuss strategies for approaching food allergen thresholds to benefit public health.

During these events, there will be presentations to provide background on the food allergen landscape and risk-based food allergen thresholds. The two days of facilitated listening sessions (November 19 – 20, 2025) will offer participants the opportunity to provide feedback on the following topics:

  • Risk-based food allergen thresholds concepts,
  • Risk communications and labeling,
  • Potential applications of food allergen thresholds; and
  • Challenges with food allergen thresholds in the U.S.

Questions for consideration during the public meeting and listening sessions, should be submitted through the registration. Registration for the November 18, 2025 public meeting will remain open until the start of the meeting. In order to attend the listening sessions, participants are required to register by November 3, 2025. There will be a maximum number of participants for each session.

Beginning November 18, 2025, a Regulations.gov docket will open for comments related to the event topic. The FDA will provide future communications on the comments process and timeline.

Beltway Beat

Kyle Diamantas, Deputy Commissioner for Human Foods, FDA To Present at the Food Safety Consortium

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Donna Garren, Ph.D., Executive Vice President of Science & Policy at AFFI who co-chairs the Food Safety Consortium program committee confirmed that Kyle Diamantas, Deputy Commissioner for Human Foods, FDA will present at the Food Safety Consortium Conference, October 19-21 in Washington DC.

Mr. Diamantas will join Dr. Denise Eblen, Administrator, U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) in a plenary session called “Regulators in the Spotlight: FDA & USDA’s Vision for Safer Food.” They discuss FDA and FSIS’ vision for advancing food safety through science-based policymaking, enhanced surveillance, and streamlined regulatory frameworks.

Equally important, this session will emphasize the critical role of stakeholder engagement. Attendees will hear how industry leaders, state regulators, consumer advocates, and academic partners can actively participate in shaping policy—ensuring that new regulations are practical, effective, and rooted in collaboration.

Dr. Emilio Esteban, Chief Scientific Officer for Mérieux NutriSciences’ North America division, and Head of its Global Analytical Hub and former Undersecretary for Food Safety at USDA is the opening keynote speaker. The closing keynote speaker is Ricky Dickson, Author and Former CEO of Blue Bell Creameries.

The full program is available at FoodSafetyConsortium.org

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Beltway Beat

FDA Announces FY2026 User Fees for VQIP and TPP

By Food Safety Tech Staff
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The U.S. Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2026 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP).

The user fee rates are authorized by the FDA Food Safety Modernization Act (FSMA) and allow the agency to assess and collect fees to cover the FDA’s cost of administering these programs.

Voluntary Qualified Importer Program (VQIP)

VQIP is a voluntary fee-based program that offers importers who achieve and maintain a high level of control over the safety and security of their supply chains expedited review and importation of human and animal foods into the United States.

The FY2026 VQIP user fee supports program benefits from October 1, 2025, through September 30, 2026. Approved VQIP applicants must pay the user fee before October 1, 2025, to begin receiving benefits for FY 2026.

The FY 2026 VQIP User Fees are detailed in the Federal Register Notice announcing the FY 2026 VQIP User Fee Rates.

Direct questions regarding VQIP to the VQIP Importers Help Desk at 1-301-796-8745 or FSMAVQIP@fda.hhs.gov.

Accredited Third-Party Certification Program (TPP)

TPP is a voluntary program in which FDA recognizes “accreditation bodies” that may accredit third-party “certification bodies.” The certification bodies can conduct food safety audits and issue certifications of foreign food facilities. The FY 2026 TPP user fee rate will be effective on October 1, 2025, and will remain in effect through September 30, 2026.

Questions regarding TPP can be sent to FDAthirdpartyprogram@fda.hhs.gov.

The FY 2026 Third-Party Certification Fees are detailed in the Federal Register Notice announcing the FY2026 Third-Party Certification Program User Fee Rates.

You can also subscribe to receive updates about the U.S. Import programs policies and regulations by visiting the FDA Email Updates page and entering your email address.

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Beltway Beat

Update on Outbreak Investigation of Listeria monocytogenes: Ready-to-Eat Foods

By Food Safety Tech Staff
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The FDA and CDC, in collaboration with state and local partners, announced in a press release that they investigated illnesses in a multistate outbreak of Listeria monocytogenes infections linked to recalled Ready-to-Eat (RTE) foods, or products that do not need additional cooking, produced by Fresh & Ready Foods, LLC of San Fernando, CA.

The recalled products were identified by the “Use By” dates from 4/22/2025 to 5/19/2025 and include the following brand names:

  • Fresh & Ready Foods
  • City Point Market Fresh Food to Go
  • Fresh Take Crave Away

These products are no longer available for sale in stores.

CDC announced that the outbreak is over. CDC reports a total of 10 illnesses in two states. There has been a total of 10 hospitalizations and one death attributed to listeriosis.

FDA is working with Fresh & Ready Foods on corrective and preventive actions.

FDA’s outbreak investigation is complete.

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Beltway Beat

FDA Approves Gardenia (Genipin) Blue Color Additive

By Food Safety Tech Staff
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The U.S. Food and Drug Administration announced on July 14, 2025 that it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice. It is the fourth color derived from natural sources approved by the FDA for use in foods in the last two months.

Gardenia (genipin) blue is derived from the fruit of the gardenia, a flowering evergreen. The FDA has approved the color additive for use in sports drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, hard candy, and soft candy.

The three colors derived from natural sources approved in May were: galdieria extract blue, a blue colorant derived from the unicellular red algae Galdieria sulphuraria; calcium phosphate, a white powder; and butterfly pea flower extract, a blue color that can be used to achieve a range of shades including bright blues, intense purple, and natural greens.

Under section 721 of the Federal Food, Drug, and Cosmetic Act, color additives must be FDA-approved before they may be used in foods. The FDA determines whether a color additive is safe to use by considering the projected human dietary exposure to the color additive, the additive’s toxicological data, and other relevant information, such as published literature. Once the FDA approves a color additive, any manufacturer can use the coloring in accordance with the conditions of use.

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Beltway Beat

FDA Encourages Food Manufacturers to Accelerate Phasing Out the Use of FD&C Red No. 3 in Foods Before 2027 Deadline

By Food Safety Tech Staff
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On January 15, 2025, the U.S. Food and Drug Administration issued an order revoking the authorization for the use of FD&C Red No. 3 in foods, including dietary supplements (permitted under 21 Code of Federal Regulations (CFR) 74.303), and in ingested drugs (permitted under 21 CFR 74.1303). The final order stated that manufacturers who use FD&C Red No. 3 in foods and ingested drugs would have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products.

The FDA’s action to revoke the authorization for the use of FD&C Red No. 3 was based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a color additive if it has been found to induce cancer in humans or animals. The FDA determined that data presented in a 2022 color additive petition showed that FD&C Red No. 3 causes cancer in male laboratory rats when exposed to high levels.

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) announced a series of new measures to phase out all petroleum-based synthetic dyes, also known as color additives subject to certification, from the nation’s food supply. As part of this phase out, HHS and FDA requested food companies to remove FD&C Red No. 3 sooner than the 2027 deadline required by the final order. To support this goal, the FDA encourages food manufacturers to, as soon as is practicably possible, reformulate to stop using FD&C Red No. 3 in foods, including dietary supplements, with the goal of completing phase out before the January 15, 2027, deadline. The FDA believes that accelerating the phase out of the use of FD&C Red No. 3 in foods will help further the goal of Making America Healthy Again.

The FDA recognizes that substituting FD&C Red No. 3 used in foods, including dietary supplements, with other color additives may require the expanded use of authorized color additives and/or the development of new color additives. The FDA also recognizes the widespread interest in substituting FD&C Red No. 3 with color additives derived from other sources, including plants. Regardless of the source material, each color additive must meet the legal safety standard of a reasonable certainty of no harm under the intended conditions of use. The FDA evaluates data in a petition to ensure that the use of a color additive meets the legally required safety standard and issues a regulation prescribing safe conditions of use.  Information about color additive petitions is available on FDA’s website: Color Additive Petitions | FDA.

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Listeria
Ask The Expert

Listeria-related Regulations, FDA & USDA

By Bob Lijana
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Listeria

To enforce food safety regulations, FDA and USDA have a “zero tolerance” policy for Listeria monocytogenes (Lm) in certain foods. This means Lm must not be found in any 25-gram sample. According to FDA’s Compliance Policy Guide, legal action may be recommended if Lm is found in a ready-to-eat (RTE) food that allows Lm to grow. While the compliance guide is not legally binding, the finding of Lm in your facility could still lead to enforcement by FDA.

Do note that this is a regulatory policy. It does not mean that the typical healthy individual cannot tolerate Lm. Quite the contrary, as recognized by other countries (such as New Zealand, Canada, and the European Union), some foodstuffs are allowed up to 100 CFU/gm of Lm (although the EU tolerance is supposed to change to “not detectable in 25 gm” as of June 1, 2026). For some foods, Japan allows even higher levels. Because of these higher limits, some people believe that allowing some level of Lm in a food is a very practical approach.

That said, the USA does not. Any food company—big or small—can face public health warnings, safety alerts, product withdrawals, or recalls because of Lm. No one is exempt if something goes wrong with how food is handled or processed.

Unfortunately, even with past mistakes and costly recalls, Lm-related recalls still occur. Some recent examples:

  • July 2025: recall of over 350,000 lb of turkey bacon (Kraft Heinz—Oscar Mayer).
  • June 2025: recall of chicken alfredo meals; at least 16 people hospitalized; at least 2 deaths (FreshRealm–Kroger and Walmart).
  • May 2025: recall of nearly 90 vending machine sandwiches and other products; at least 10 people hospitalized (Fresh & Ready Foods).
  • Apr 2025: recall of nearly 2,000 cases of ready to eat celery sticks (Duda Farms).
  • Feb 2025: recall of frozen supplement shakes; 12 deaths (Lyons Magnus–Sysco).
  • Jan 2025: recall of 2,000,000 cases of doughnuts and pastries (FGF Brands–Dunkin).
  • Oct 2024: recall of 12,000,000 lb of pre-cooked meat and poultry (Bruce Pack).
  • Oct 2024: recall of 200 varieties of frozen waffles and pancakes (Treehouse Foods—Food Lion, Harris Teeter, Publix).
  • Aug 2024: recall of 7,200,000 lb of sliced deli meats; 10 deaths (Boars Head).
  • Feb 2024: recall of 50 different cheese products; 2 deaths (Rizo Lopez Foods—Albertson’s, Trader Joe’s).

Even if one disagrees with the scientific basis for a “zero-tolerance” approach, all regulations require an ongoing vigilance to Lm presence in the plant environment (and of course in the food). This includes non-regulatory food safety schemes such as SQF (Safe Quality Foods). The current SQF Code (which is being updated for 2026) includes a requirement for a risk-based environmental monitoring program for pathogen detection, sampling, and eradication. To help in this regard, both FDA (“draft guidance for industry”) and USDA (“compliance guideline”) have excellent technical guidance documents. These publicly-available resources cover the microbiological aspects of Lm, how to identify Lm, and how to assess risks in order to determine appropriate preventive and corrective actions.

Regulators also use DNA testing in their quest to find root sources of Lm. Whole genome sequencing (WGS) is like testing for one’s ancestry. Listeria samples can be categorized based on their genetic (DNA) makeup. With an extensive database (e.g., PulseNet) FDA may be able to link the DNA from a Lm environmental sample in a plant with the DNA from a blood sample from someone who has been hospitalized with listeriosis. If FDA can also determine that the food was purchased in the same state as the plant is located and/or that the hospitalized person said that they ate that specific food, then FDA can link everything together.

Food manufacturers need to be aware of how WGS can affect their operations. A publication on this topic provides useful perspective from FDA’s point of view and the manufacturer’s point of view. These do not always align.

Regulations help protect the public health. Use these regulations as guides to protect the food you make.

See the Related Articles below to read the series.

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Beltway Beat

Texas to put Warning Labels on Foods with any one of 44 Additives

By Food Safety Tech Staff
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Food Politics by Marion Nestle reported today that Texas Governor Greg Abbott has signed a bill authorizing warning labels on food products containing one or more of a long list of chemical additives. The list includes the color additives that the FDA has targeted, but also bleached and brominated flour, BHA and BHT, DATEM, Olestra, partially hydrogenated oil, and potassium bromate and iodate. The label reads:

WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United  Kingdom.

Food Politics added “what’s also stunning is how far this law goes beyond California’s law prohibiting red dye No. 3, and West Virginia’s law restricting seven dyes in schools.”

Obviously, Food companies cannot formulate products for individual states. To sell into Texas, companies with the 44 additives in their products will have to a) publish the warning label on their packaging b) get rid of these chemicals, c) lobby for a less restrictive federal law preempting state laws.

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Beltway Beat

Application for FY2026 Benefits in the VQIP Portal Due September 1

By Food Safety Tech Staff
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The application window for the Voluntary Qualified Importer Program (VQIP) portal for fiscal year FY 2026 benefits will close on September1, 2025. Submitting applications early ensures sufficient time for review and user fee processing. VQIP benefits will begin on October 1, 2025, contingent upon approval of the application and receipt of the user fee payment.

VQIP is a fee-based program that offers importers an opportunity to expedite the review and importation process of human and animal foods into the United States by demonstrating and maintaining control over the safety and security of their supply chains.

Prior to applying, it is essential to confirm that all foreign suppliers of the intended food imports under VQIP hold valid facility certifications issued by a certification body (CB) accredited under the FDA’s Accredited Third-Party Certification Program (TPP).

Importers or foreign suppliers seeking eligibility for VQIP should engage with an accredited CB under TPP to arrange for an audit meeting the criteria of a regulatory audit. It’s crucial to note that only the outcomes of a regulatory audit can ascertain eligibility for certification under TPP, as per the definitions outlined in 21 CFR 1.600(c) and 21 CFR 1.651.

Food importers interested in applying for VQIP benefits during FY 2026, visit:

Questions may be submitted to the VQIP Importers’ Help Desk via 1-301-796-8745 or via email to FSMAVQIP@fda.hhs.gov.