California Ag Network

Tag: FDA

  • FDA Issues Emergency Use Authorization for Generic Drug to Prevent New World Screwworm in Cattle

    FDA’s 14th EUA against NWS

    The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for the prevention of New World screwworm (NWS) infestations in cattle when administered within 24 hours of birth, at the time of castration or at the appearance of a wound Bimectin injection is not authorized for use in lactating dairy cows or in calves that will be processed for veal.

    Based on the available evidence, the FDA has concluded it is reasonable to believe that Bimectin injection may be effective for the prevention of Screwworm infections in certain cattle when used as authorized, and the known and potential benefits of the product outweigh its known and potential risks.

    “This authorization reflects the FDA’s commitment to expanding generic drug options against New World screwworm,” said Timothy Schell, Ph.D., director of the FDA’s Center for Veterinary Medicine. “By authorizing both generic and pioneer products, the Agency is ensuring producers aren’t dependent on a single manufacturer or product to protect their herds.”

    To maintain the continued safety of the food supply and avoid drug residues, it is critical that cattle producers carefully follow the 35-day slaughter withdrawal time and not administer this drug in lactating dairy cows and calves that will be processed for veal.

    Bimectin injection is a generic version of Ivomec, which was authorized in February 2026 for the prevention of NWS myiasis in cattle. The FDA previously approved Bimectin injection for the treatment and control of various parasites in cattle. This EUA is only for the Bimectin injection and does not authorize other dosage forms of Bimectin.

    Bimectin injection is available over the counter without a prescription. Cattle producers are responsible for using Bimectin injection in accordance with the product labeling and fact sheet.

    This EUA will be effective until it is revoked or the HHS Secretary terminates the declaration that the potential public health emergency presented by NWS justifies the emergency use authorization of animal drugs for NWS.

    Bimectin injection is sponsored by Bimeda Animal Health Ltd. based in Ireland.

  • Meat Institute: FDA Proposed GRAS Reforms Good First Step

    The Meat Institute said the proposed changes to the Food and Drug Administration’s (FDA) generally recognized as safe (GRAS) regulations are a good first step but it will continue to work with the Administration to ensure reforms protect food safety, foster innovation and maintain an affordable food supply.
    “The Meat Institute supports updating the GRAS framework in a way that strengthens consumer confidence while preserving a science-based, risk-based regulatory system,” said Meat Institute President and CEO Julie Anna Potts. “We will work closely with FDA and FSIS to ensure reforms continue to protect food safety, support innovation, and preserve affordable meat and poultry options for consumers.”
    “Consumers deserve confidence that the ingredients in their food have been rigorously evaluated for safety — and an updated GRAS process can deliver that transparency without disrupting an abundant, affordable food supply.
    “GRAS reform should improve transparency, establish a consistent national standard, while recognizing the unique regulatory framework that governs meat and poultry, where FSIS relies on FDA’s safety evaluations to approve substances as safe and suitable,” said Potts. “Close coordination between the two agencies is essential to consistent implementation.”
    The Meat Institute will provide comments during the comment period including the following priorities for regulators to consider:
    Practical timelines. New requirements should include adequate implementation time for manufacturers to comply.
    Preserving longstanding safe uses. Reform should not disturb ingredients with an established safety record.
    FDA-FSIS coordination. Close collaboration between the two agencies is critical to consistent implementation across the food supply.
    The Meat Institute warns that without thoughtful implementation, reform could delay new technologies and ingredients that improve food safety, extend shelf life, reduce food waste, and help manufacturers meet evolving consumer expectations.
    “The Meat Institute encourages HHS and FDA to pursue GRAS reform through a transparent, science-based, and collaborative approach that provides regulatory certainty for industry while protecting consumers,” said Potts.
    — Story contributed by the Meat Institute

  • California Citrus Mutual Welcomes FDA Update to Orange Juice Standard

    California Citrus Mutual (CCM) recently welcomed the U.S. Food and Drug Administration’s decision to update the federal standard of identity for pasteurized orange juice. The action marks the first significant revision to the standard in more than 60 years and takes effect Aug.19.

    Under the revised standard, orange juice will be permitted to contain up to 15% juice from mandarins and mandarin hybrids while still being labeled orange juice. The rule also adjusts the minimum sugar-content threshold, known as the Brix level, to reflect current growing conditions. Together, the changes bring the decades-old standard in line with today’s citrus industry and strengthen the domestic juice supply.

    The FDA reviewed consumer sensory data during its rulemaking process and concluded that the change will not alter how consumers perceive orange juice. The agency found the update preserves the taste and quality consumers expect while giving domestic producers greater flexibility and reducing reliance on imported juice.

    CCM supported the update through the FDA’s public rulemaking process, submitting comments in favor of the change and working with members of Congress to advance it. The petitions that prompted the rule were led by Florida’s citrus industry, whose growers have faced production challenges from disease and severe weather.

    “The California citrus industry thanks the FDA for updating the orange juice standard and allowing the blending of complementary citrus varieties,” said Jacob Villagomez, CCM Director of Governmental Affairs. “This decision supports domestic juice production, reduces reliance on imports, and ensures consumers continue receiving the quality and flavor they expect.”

    The change is expected to create new opportunities for California growers, who produce large volumes of mandarins and mandarin hybrids. California is predominantly a fresh-market supplier, and the higher blending allowance opens a stronger processing outlet for fruit that does not reach the fresh market. Mandarins have become an increasingly important part of California’s citrus production.

    CCM appreciates the FDA’s willingness to update a decades-old regulation through a science-based process that benefits growers, processors, and consumers alike. — Story contributed by California Citrus Mutual

  • Almond Hulls Receive GRAS Status from FDA

    Almond hulls were recently given Generally Recognized as Safe (GRAS) status by the FDA. This designation opens the door for them to be used in a variety of different food products, as they are high in fiber and phytonutrients. Almond Board of California CEO and President Clarice Turner spoke with Matthew Malcolm at California Ag Network to discuss this recent breakthrough and what it means for the almond industry. Watch this quick video and learn more in Pacific Nut Producer Magazine.

  • NMPF Releases Statement on the DAIRY PRIDE Act

    The National Milk Producers Federation (NMPF) released a statement supporting the reintroduction of the DAIRY PRIDE Act in the U.S. House of Representatives. Introduced by Reps. John Joyce (R-PA) and Josh Riley (D-NY), the act would deem food products that are making inaccurate claims about milk content “misbranded,” requiring the the U.S. Food and Drug Administration (FDA) to issue guidance for nationwide enforcement of these products within 90 days.

    NMPF President and CEO Gregg Doud expressed support for the DAIRY PRIDE Act, stating:

    “FDA’s continued failure to enforce its own rules on the proper labeling of plant-based alternative products is a public health problem, plain and simple. Milk and dairy products supply 13 essential nutrients, including three that continue to be identified as nutrients of public health concern: calcium, potassium, and vitamin D. But plant-based imitation products that are not nutritionally equivalent to real milk and do not deliver dairy’s unique nutrient package for too long have been allowed to imply to consumers that they are just like the real thing, creating a public health problem that FDA commissioners have acknowledged over the past decade.

    “The DAIRY PRIDE Act directs FDA to enforce dairy standards of identity, which were developed to promote honesty and protect consumers. Through the standards of identity, dairy terms, including “milk”, “cheese” and “yogurt,” have come to carry distinct meaning in the minds of consumers, with built-in expectations for nutritional values. By not enforcing these standards, FDA has allowed plant-based imitators to prey on consumers’ expectations while delivering nutritionally inferior products.

    “It’s high time FDA makes it easier for consumers to navigate the choices they face in the grocery aisles; the DAIRY PRIDE Act is an important step in the right direction. Dairy farmers and their cooperatives thank Reps. John Joyce and Josh Riley for their bipartisan leadership in finding solutions through this critical legislation.”

  • FDA Intends to Extend Compliance Date for FSMA Food Traceability Rule

    The U.S. Food and Drug Administration (FDA) has announced its intention to extend the compliance date for the Food Traceability Rule (the “final rule”) by 30 months. The FDA intends to extend the compliance date using appropriate procedures at a later time, including publishing a proposed rule in the Federal Register.

    The FDA remains committed to successful implementation of the full requirements of the final rule, as they will allow for faster identification and removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. Accordingly, the compliance date extension does not amend, nor do we intend to amend, the requirements of the final rule, which will improve food safety and protect public health. Instead, the compliance date extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.

    The final rule establishes additional traceability recordkeeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods on the Food Traceability List. The final rule requires a higher degree of coordination between members of the food industry than has been required in the past. Therefore, to achieve the full public health benefits of the final rule, all covered entities must be in compliance. Even those few entities who are well positioned to meet the final rule’s requirements by January 2026 have expressed concern about the timeline, in part because of their reliance on receiving accurate data from their supply chain partners, who are not similarly situated. Therefore, FDA intends to allow industry additional time, across all regulated sectors, to fully implement the final rule’s requirements.

    The FDA intends to use the extended time period to continue the agency’s work with stakeholders, including by participating in cross-sector dialogue to identify solutions to implementation challenges and by continuing to provide technical assistance, tools, and other resources to assist industry with implementation.

    The final rule applies to domestic and foreign entities producing food for U.S. consumption and was issued in 2022 in accordance with the FDA Food Safety Modernization Act.

  • Ensuring Effectiveness of Federal-State Milk Safety System While Bird Flu Impacts Dairies

    The U.S. Food & Drug Administration (FDA), alongside its federal and state partners, is continuing to take a stepwise approach to its scientific analysis of commercial milk safety during the first-of-its-kind detection of HPAI H5N1 in dairy cattle. While FDA’s initial assessment of the milk safety system continues to be affirmed by sampling and testing of retail dairy products, there remain a number of collective activities being undertaken to ensure the continued effectiveness of the federal-state milk safety system. The FDA will continue to follow a sound scientific process to inform the agency’s public health decisions related to food safety.

    FDA recently announced preliminary results of a study of 297 retail dairy samples, which were all found to be negative for viable virus. The FDA is today announcing that all final egg inoculation tests associated with this retail sampling study have been completed and were also found to be negative for viable HPAI H5N1 virus. These confirmatory test results mark the completion of our laboratory research efforts related to these 297 retail dairy samples. Additional sampling and other surveillance activities will continue.

    While FDA retail sampling test results to date are clear about the safety of the commercial milk supply and representative of real-world scenarios, additional scientific work is being undertaken to validate the criteria for pasteurization relative to the HPAI H5N1 virus and will include tests using pasteurization equipment typically used by milk processors. Today, we’d like to share more about our additional research efforts.

    The established pasteurization process set forth in federal regulation (21 CFR 1240.61) and the Pasteurized Milk Ordinance (PMO) provides specific temperature and time requirements for effective elimination of known pathogens in the milk supply. To further validate pasteurization effectiveness against this recently detected virus, the FDA previously noted it was testing samples of pooled raw milk routed for commercial processing to characterize potential virus levels that the pasteurization process must eliminate. Our pasteurization study is designed to better replicate real-world conditions to deliver the pasteurization treatment parameters set forth in the CFR and PMO, and to assess their effectiveness in inactivating HPAI H5N1 in bovine milk and other dairy products.

    The results from this study will help further the FDA’s understanding of pasteurization efficacy against anticipated concentrations of virus under real-world processing conditions. The pasteurization study is ongoing and we anticipate making preliminary results available in the near future.

    The agency is also announcing an additional $8 million is being made available to support its ongoing response activities to ensure the safety of the commercial milk supply. This funding will support the agency’s ability to validate pasteurization criteria, conduct surveillance at different points in the milk production system, bolster laboratory capacity and provide needed resources to train staff on biosecurity procedures.

    Additionally, these funds will help support HPAI H5N1 activities in partnership with state co-regulatory partners, who administer state programs as part of the federal/state milk safety system. It may also allow the FDA to partner with universities on critical research questions.

    To date, the totality of evidence – including studies on the effectiveness of pasteurization against multiple pathogens, recent studies on the effectiveness of pasteurization of HPAI H5N1 in eggs at lower temperatures than generally used in dairy products, negative retail sample results to date, and real-world evidence from the last 100 years of the PMO — continues to indicate that the commercial milk supply is safe.

    At the same time, the FDA also continues to advise against the consumption of raw milk (milk that has not been pasteurized). The FDA and CDC have long standing information regarding the increased risk of foodborne illness associated with numerous pathogens that may be present in raw milk. This increased risk exists for both humans and other animals that might drink raw milk. Additional guidance on raw milk and milk handling can be found on our website.

    FDA is committed to continuing to initiate, support, and collaborate on research and surveillance of milk production, processing, and pasteurization to further our public health goals.

  • FDA to Host Webinar on the FSMA Final Rule on Pre-Harvest Agricultural Water

    View on the FDA Website

    The U.S. Food & Drug Administration (FDA) will hold an informational webinar on Monday, May 20, 2024, 1-2pm ET on the recently released Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water (Agricultural Water Final Rule) issued under the FDA Food Safety Modernization Act (FSMA). The rule represents an important step towards enhancing the safety of produce, as agricultural water can be a major conduit for pathogens that can contaminate produce.

    During the webinar, the FDA will provide an overview of the final rule and answer pre-submitted questions as well as take live questions.

    The final rule replaces certain pre-harvest agricultural water requirements for covered produce (other than sprouts) in the 2015 produce safety rule with requirements for systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water. Specifically, this rule:

    • Establishes requirements for agricultural water assessments that evaluate a variety of factors that are key determinants of contamination risks associated with pre-harvest agricultural water; this includes an evaluation of the water system, water use practices, crop characteristics, environmental conditions, potential impacts on water from adjacent and nearby land, and other relevant factors;
    • Includes testing pre-harvest agricultural water as part of an assessment in certain circumstances;
    • Requires farms to implement effective mitigation measures within specific timeframes based on findings from their assessments. Hazards related to certain activities associated with adjacent and nearby land uses are subject to expedited mitigation; and
    • Adds new options for mitigation measures, providing farms with additional flexibility in responding to findings from their pre-harvest agricultural water assessments.

    The rule also finalizes the dates for compliance with the pre-harvest agricultural water requirements for non-sprout covered produce as follows:

    • For very small farms: 2 years, 9 months after the effective date of the final rule
    • For small farms: 1 year, 9 months after the effective date of the final rule
    • For all other farms: 9 months after the effective date of the final rule

    Register at: FSMA Final Rule on Pre-Harvest Agricultural Water Webinar

    The webinar is a virtual event. Registration will remain open until the day of the webinar. Attendees who wish to submit questions may do so during registration through May 15.

    The webinar will be recorded and posted to the meeting page.

    Additional Information

  • FDA Foods Coalition to Advocate for the Implementation of Proposed Redesign of Human Foods Program

    The FDA Foods Coalition was launched on Oct. 26th to advocate for a modernized, effective foods program at the U.S. Food and Drug Administration (FDA) focused on preventing foodborne illness outbreaks and other food safety risks, and decreasing diet-related chronic diseases. Made up of consumer advocates, food industry representatives, public health groups, and state and local regulators, the Coalition will educate policymakers, media and the public about improving the governance of the FDA Human Foods Program.

    The Coalition is supportive of FDA’s proposed redesign of the Human Foods Program and looks forward to working with Commissioner Robert Califf, M.D., and new Deputy Commissioner for Human Foods Jim Jones to implement these changes and facilitate greater transparency, accountability and meaningful stakeholder engagement.

    Many of the organizations in the diverse coalition began working together following FDA’s delayed response to the infant formula crisis and called on Commissioner Califf to appoint a leader empowered to address the fundamental problems plaguing the agency’s foods program. In response, Commissioner Califf ordered an external review of the program by the Reagan Udall Foundation, which concluded that the FDA’s culture, organizational structure, and governance model undermine its effectiveness. Earlier this year, Commissioner Califf announced plans to adopt many of those recommendations and recently appointed Jim Jones as deputy commissioner of its Human Foods Program.

    “Consumers depend on the FDA to be effectively organized and governed to prevent food safety risks and ensure our food is safe,” said Brian Ronholm, director of food policy at Consumer Reports and co-chair of the FDA Foods Coalition. “Commissioner Califf has proposed a redesign that will allow the Human Foods Program to carry out its critical mission and make the agency more accountable and transparent. Our coalition supports these changes and believes the implementation of them is critically important to all of the FDA’s food system stakeholders.”

    “Industry needs a strong, unified, and modernized FDA to facilitate innovation, growth, and the production of safe, nutritious foods that are accessible and affordable for all consumers,” said Roberta Wagner, senior vice president of regulatory and scientific affairs at the International Dairy Foods Association and co-chair of the FDA Foods Coalition. “The coalition will continue to advocate that FDA shift away from its traditional reactionary model to a modernized, prevention-oriented oversight model that aligns with industry’s immense efforts to ensure continual improvement and prevent problems from occurring, as exemplified by industry’s ongoing implementation of the Food Safety Modernization Act (FSMA). Industry values FDA’s oversight role in assuring companies produce safe food every day for American consumers, and we look forward to supporting the agency’s Human Foods Program through this coalition.”

    “FDA needs substantial additional resources to strengthen and improve its human food safety and nutrition programs.  Maximizing the value of such an investment will require stakeholders and the FDA to address the organizational, cultural, and policy challenges that confront food safety,” saidSteven Grossman, Executive Director of the Alliance for a Stronger FDA. “The FDA Foods Coalition is uniquely positioned to achieve this and is a natural complement to the Alliance’s efforts to increase funding.”

    In addition to Consumer Reports and the International Dairy Foods Association, the Coalition includes the American Frozen Food Institute, Association of Food and Drug Officials, Center for Science in the Public Interest, Consumer Brands Association, Consumer Federation of America, Environmental Defense Fund, Environmental Working Group, International Fresh Produce Association, Peanut and Tree Nut Processors Association, STOP Foodborne Illness, and Western Growers. The Coalition will continue its outreach to other stakeholders that align with this mission.

    The FDA Foods Coalition will work with the agency to ensure that FDA’s Human Foods Program:

    ●       Communicates, embraces and promotes a clear and compelling vision, mission and value statement.
    ●       Institutes an organizational structure with a single leader with a clear articulation of roles, responsibilities, and accountability and a culture that is well-equipped to sustain leadership transitions.
    ●       Establishes — through the new deputy commissioner position — a management system that fully integrates the Human Foods Program on policy, resource management, and field operations, and leads a program-wide transformation that prioritizes the shift to a public health prevention culture in both headquarters and field operations.
    ●       Develops and nurtures a culture where regulatory decision-making is focused on consumer safety and public health, rooted in scientific evidence and FDA’s legal framework, and occurs in a timely and predictable way.
    ●       Prioritizes meaningful stakeholder engagement and collaboration in regulatory priority setting and decision making based on science-driven and effective risk management principles, maximum transparency, and data sharing.
    ●       Establishes a stronger, more cooperative relationship with state, local, and tribal governments, including fulfilling the FSMA vision of a National Integrated Food Safety System.
    ●       Formulates an appropriations strategy that considers stakeholder input and includes a well-defined, prioritized agenda and clarity and transparency on how program funding would be allocated.

    ●       Has authority and resources to ensure that the agency’s Enterprise Modernization initiative meets the operational and data management needs of the Human Foods Program.

  • FDA Issues Guidance for Qualified Exempt Farms that Utilized Temporary Flexibilities During COVID-19

    The U.S. Food and Drug Administration will be transitioning away from its policy regarding flexibilities available to qualified exempt farms under the Produce Safety Rule during the COVID-19 Public Health Emergency (PHE).

    Under the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule, farms are eligible for a qualified exemption and associated modified requirements if they meet the below criteria:

    1. The average annual value of the farm’s direct sales of food to qualified end-users exceeded the average annual value of the farm’s food sales to all others during the previous three years. A qualified end-user is either (a) the consumer of the food (where the term consumer does not include a business) or (b) a restaurant or retail food establishment that is located in the same State or the same Indian reservation as the farm or not more than 275 miles away; and
    2. The farm’s food sales averaged less than $500,000 (adjusted for inflation) per year during the previous three years.

      During the COVID-19 PHE, state and local governments across the United States instituted public health orders, and some businesses took other mitigating efforts, that resulted in many restaurants, retail food establishments and schools significantly limiting their operations, leaving many farmers without their usual qualified end-user customers. In May 2020, the FDA issued temporary guidance regarding available flexibilities under which affected farmers could shift their sales away from qualified end-users while still being considered eligible for the qualified exemption, as long as they continued to meet the requirement that their average annual food sales during the previous three years totaled less than $500,000 (adjusted for inflation).Recently, the Department of Health and Human Services announced that it is planning for the COVID-19 PHE declaration to expire at the end of the day on May 11, 2023. Soon after HHS’ announcement, FDA announced that the temporary Qualified Exemption guidance (among others) would remain in effect until November 7, 2023. Today the FDA issued guidance to help explain how farms may transition from the temporary policy back to the qualified exempt criteria in the Produce Safety Rule.

      In the guidance, the FDA notes that the preamble to the Produce Safety Rule acknowledges that, under some circumstances, farms may have less than three years of records to support their eligibility for the qualified exemption, during which time the FDA would consider it reasonable for the farm to base their calculations on the records they have (such as records for the preceding one or two calendar years). For farms that have no records regarding direct sales to qualified end-users for any of the preceding three calendar years, but that meet the other criterion for the qualified exemption (average annual food sales for the previous three years less than $500,000), the FDA will restart the clock beginning January 1, 2024.

      This means that in 2024, farms should begin collecting data regarding their direct sales to qualified end-users as described in the first criterion above. In 2025, farms will be able to use their records from 2024, without averaging in other years, to demonstrate that they meet the criteria for the exemption. In 2026 and 2027, farms should be able to average their sales from the previous 2-3 years to demonstrate eligibility for the qualified exemption. Farms that fail to demonstrate eligibility will no longer have qualified exempt status and will need to come into compliance with the full requirements of the Produce Safety Rule unless another exemption applies.

      Farms that have questions about this transition process can contact their local Produce Safety Network representative or the FDA through the FSMA Technical Assistance Network.