LA Department of Public Health declares Hepatitis A Outbreak in Los Angeles County

By Food Safety Tech Staff
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In a Press Release, the Los Angeles County Department of Public Health has declared a community-wide outbreak of hepatitis A following a sustained increase in clinical cases and elevated virus levels detected in local wastewater. Public Health confirmed 165 hepatitis A cases in LA County since 2024, which is three times the number of cases reported in 2023.

Although unhoused individuals are at higher risk for contracting hepatitis A infection because they often have limited access to handwashing and toileting facilities, of the 29 hepatitis A cases confirmed to date in 2025, most have been among people without travel or housing risk factors. This increase in hepatitis A infections among people without risk factors has corresponded with recent increases in hepatitis A wastewater concentrations. “It is also important for residents to wash their hands with soap and water regularly and especially before eating and preparing food and after using the bathroom.”

While the risk to the general public remains low, community-wide protection actions are needed to ensure that transmission of hepatitis A is reduced.

“The ongoing increase in hepatitis A cases signals that quick action is needed to protect public health,” said Muntu Davis, MD, MPH, Los Angeles County Health Officer. “The hepatitis A vaccine is safe, effective, and offers long-term protection. Getting vaccinated is simple, and it’s one of the most important things you can do for your own health and the health of our entire community. It is also important for residents to wash their hands with soap and water regularly and especially before eating and preparing food and after using the bathroom.”

Public Health continues to monitor for and immediately investigate suspect hepatitis A cases and is working closely with healthcare providers to request that they remain vigilant for hepatitis A. Public Health is also working with organizations that serve people experiencing homelessness to educate the community about the increase in hepatitis A, encourage people to get vaccinated, and recommend those with symptoms of hepatitis A to seek medical care.

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FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program

By Food Safety Tech Staff
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Under the new Nutrition Regulatory Science Program, the FDA and NIH will implement and accelerate a comprehensive nutrition research agenda that will provide critical information to inform effective food and nutrition policy actions to help make Americans’ food and diets healthier. The initiative will aim to answer questions such as:

  • How and why can ultra-processed foods harm people’s health?
  • How might certain food additives affect metabolic health and possibly contribute to chronic disease?
  • What is the role of maternal and infant dietary exposures on health outcomes across the lifespan, including autoimmune diseases?

Answering these questions and many others will enable effective policy development and help promote the radical transparency Americans deserve about the foods they are eating and how those foods can impact their health.

The FDA will provide its critical expertise in regulatory science and NIH will provide the infrastructure for the solicitation, review and management of scientific research. The initiative will bring together experts in many disciplines—including chronic disease, nutrition, toxicology, risk analysis, behavioral science, and chemistry—all with the goal to advance the gold standard of nutrition and food science.

The FDA and NIH will work together to develop a research agenda for the Nutrition Regulatory Science Program and are committed to ensuring all research conducted under the Program is fair, independent and free of conflicts of interest.

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FDA Approves Three Food Colors from Natural Sources

By Food Safety Tech Staff
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The U.S. Food and Drug Administration today announced it granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food.

The color additive petitions approved today are for:

  • Galdieria extract blue, a blue color derived from the unicellular red algae Galdieria sulphuraria. The FDA has approved the color additive for use in nonalcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, and whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives). The petition was submitted by the French company Fermentalg.
  • 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. Produced through the water extraction of the dried flower petals of the butterfly pea plant, this color additive is already approved for use in sport drinks, fruit drinks, fruit and vegetable juices, alcoholic beverages, dairy drinks, ready to drink teas, nutritional beverages, gums, candy, coated nuts, ice creams, and yogurt. Today’s approval of a petition by St. Louis-based Sensient Colors LLC expands the approved use for coloring ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), plain corn chips, tortilla chips, and multigrain chips.
  • Calcium phosphate, a white color approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. The petition was filed by Innophos Inc. of Cranbury, New Jersey.

Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, section 721), color additives are subject to FDA approval to determine whether they are safe before they may be used in food. The FDA determines whether an 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 petition, any manufacturer can use the coloring for the approved uses.

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FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

By Food Safety Tech Staff
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Today, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients. This change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.  “For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track,” said FDA Commissioner Martin A. Makary, M.D, M.P.H.

In addition, the FDA will evaluate the agency’s policies and practices for improvements to the foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight. These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry including lodging and transportation arrangements (taxi, limousine, and for-hire vehicle transit), to maintain the integrity of the oversight process.

The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. According to FDA, U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process. Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections.

Only in specific programs and cases are the FDA’s domestic inspections pre-announced to assure that appropriate records and personnel will be available during the inspection. But regulated companies do not have the authority to negotiate the day or time of the inspection— nor should foreign companies have the capability to do so either.

The FDA is authorized to take regulatory action against any firm that seeks to delay, deny, or limit an inspection, or refuses to permit entry for an unannounced drug or device inspection.

“The FDA’s rigorous, science-based global inspections of manufacturing facilities ensure that the food and drug products that enter the U.S. marketplace, and the homes of American consumers, are safe, trusted, and accessible,” said FDA Assistant Commissioner for Inspections and Investigations Michael Rogers. “These inspections provide real-time evidence and insights that are essential for making fact-based regulatory decisions to protect public health.”

The FDA’s global inspections generate real-time intelligence that strengthens enforcement. Every inspection goes through a classification assignment process to enable an appropriate regulatory response. Even inspections that yield a “No Action Indicated” provide important regulatory intelligence that strengthens the safety net for American consumers.

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FDA Releases the CORE 2023 Annual Report: Investigations of Foodborne Outbreaks and Adverse Events in FDA-Regulated Foods

By Food Safety Tech Staff
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Today, the U.S. Food and Drug Administration’s (FDA) Coordinated Outbreak Response & Evaluation (CORE) Network released its annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2023 calendar year.

The FDA’s CORE Network was established in 2011 with the mission to find, stop, and aid in the prevention of foodborne illness outbreaks. This is accomplished through disease surveillance, outbreak response, post-response activities, and collaboration with CDC, state and local public health agencies, and international public health partners. Every year, CORE evaluates and responds to numerous foodborne outbreaks and adverse events linked to FDA-regulated products.

In October 2024, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) reorganized into FDA’s Human Foods Program (HFP). With this change, CORE reorganized into the Office of Coordinated Outbreak Response, Evaluation, & Emergency Preparedness (CORE+EP). This report is for the 2023 calendar year and reflects the work that was conducted by CORE, CFSAN, and other respective FDA offices prior to the reorganization.

In 2023, CORE evaluated 69 incidents, responded to 25, and issued advisories for 10. These numbers remain similar to recent years, with 65 incidents evaluated, 28 responses, and 11 advisories issued in 2022. CORE investigations resulted in numerous public health actions, including recalls, public health advisories, a Warning Letter, FDA prevention strategies, and country-wide Import Alerts. These are further described in the report.

“CORE has also played a central role in developing and implementing key regulations, including the Final Rule for Traceability under the Food Safety Modernization Act (FSMA). CORE members are participants in the FDA Cyclospora Task Force focused on reducing the public health burden of foodborne illness caused by C. cayetanensis in produce. Additionally, our office actively works with food safety partners outside the agency to continue progress of the FDA-SENASICA-COFEPRIS Food Safety Partnership (FSP) with Mexico. These examples highlight just a few of the activities CORE engages in outside of outbreak and adverse event investigations. Dr. Stic Harris, CORE Network Director noted. I’m pleased to share with you some of CORE’s many achievements highlighted in the 2023 annual report.”

The 2023 annual report highlights a few noteworthy outbreaks: illnesses linked to toxins from morel mushrooms, lead linked to cinnamon in applesauce pouches, and Listeria monocytogenes linked to soft serve ice cream cups.

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HHS Reinstates Some Laid Off FDA Staffers

By Food Safety Tech Staff
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The NY Times reported that Health and Human Services officials have reversed the decision to fire a few dozen scientists at the Food and Drug Administration’s food-safety labs, and say they are conducting a review to determine if other critical posts were cut. The H.H.S. spokesman said those employees called back had been inadvertently fired because of inaccurate job classification codes.

The decision to rehire specialists on outbreaks of food-related illnesses and those who study the safety of products like infant formula follows contradictory assertions made by Dr. Marty Makary, the F.D.A. commissioner, in media interviews this week. “I can tell you there were no cuts to scientists or inspectors,” Dr. Makary said Wednesday on CNN. In fact, scientists had been fired from several food and drug safety labs across the country, including in Puerto Rico, and from the veterinary division where bird flu safety work was underway.

About 40 employees at the Moffett Lab in Chicago and at a San Francisco-area lab are being offered their jobs back, the department spokesman said. Scientists in those labs studied a variety of aspects of food safety, from how chemicals and germs pass through food packaging to methods for keeping bacteria out of infant formula. Some scientists in Chicago reviewed the work and results of other labs to ensure that milk and seafood were safe.

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USDA FSIS Withdraws Proposed Salmonella Framework for Raw Poultry Products

By Food Safety Tech Staff
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FSIS announced in a Notice of Withdrawal on the Federal Register dated April 25, 2025 that it is withdrawing the “Salmonella Framework for Raw Poultry Products” proposed rule and proposed determination to allow the Agency to further assess its approach for addressing Salmonella illnesses associated with poultry products.

The Notice gave the background and in August 7, 2024, FSIS published a proposed rule and proposed determination in the Federal Register titled “Salmonella Framework for Raw Poultry Products” (89 FR 64678). The proposed framework was targeted at reducing Salmonella illnesses associated with poultry products.

The proposal announced FSIS’ proposed determination that raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey products contaminated with certain Salmonella levels and serotypes are adulterated as defined in the Poultry Products Inspection Act (PPIA) (21 U.S.C. 453 et seq.). FSIS proposed to establish final product standards based on these Salmonella levels and serotypes.

FSIS also proposed to revise the regulations in 9 CFR 381.65(g) that require that all poultry slaughter establishments develop, implement, and maintain written procedures to prevent contamination by enteric pathogens throughout the entire slaughter and dressing operation to clarify that these procedures must include a microbial monitoring program (MMP) that incorporates statistical process control (SPC) monitoring methods, to require sampling at rehang instead of pre-chill, and to require that all establishments conduct paired sampling at rehang and post-chill.

The Agency proposed to amend the recordkeeping requirements under 9 CFR 381.65(h) to require that establishments submit their microbial monitoring sampling results to FSIS electronically. FSIS had considered proposing to require that incoming flocks meet a predetermined target level for Salmonella at receiving. However, at the time the proposal was published, the research did not support the use of a threshold for test results at the receiving step and many small poultry producers and processors said that such an approach would impose an overwhelming burden on them.

Therefore, the proposed framework focused on a non-regulatory approach for reducing the Salmonella load on incoming birds. FSIS received 7,089 comments on the proposed framework during the comment period, which closed on January 17, 2025. Most of the comments were submitted as part of organized letter writing campaigns, while 1,415 were unique comment letters.

“The decision to withdraw the Salmonella Poultry framework sends the clear message that the Make America Healthy initiative does not care about the thousands of people who get sick from preventable foodborne Salmonella infections linked to poultry. The proposal was developed with robust stakeholder input and the decision to withdraw it was made before FSIS even had an opportunity to review the extensive docket.”  Sandra Eskin, CEO of Stop Foodborne Illness and former Deputy Under Secretary Food Safety, USDA, FSISFSIS received substantive comments from a variety of stakeholders that included poultry and meat industry trade associations, small poultry producer and processor trade associations, large and small poultry processing establishments, consumer advocacy organizations, members of academia, scientific and technical trade associations, diagnostic laboratory companies, foreign entities (government, poultry processors, and importers), law students, State Departments of Agriculture and State representatives, members of Congress, and a risk assessment firm.

The issues that generated the most comments, both positive and negative, included those associated with FSIS’ legal authority to propose the final product standards, the proposed Salmonella levels and serotypes for the final product standards, the proposed use of SPC monitoring, the scientific and technical information used to support the proposed framework, the potential economic impacts of the proposed framework, and the potential impact of the proposed framework on small poultry growers and processors. Several comments also suggested alternative approaches other than the proposed framework for addressing Salmonella illnesses associated with poultry products.

While FSIS continues to support the goal of reducing Salmonella illnesses associated with poultry products, the Agency believes that the comments have raised several important issues that warrant further consideration. Therefore, FSIS is withdrawing the “Salmonella Framework for Raw Poultry Products” proposed rule and proposed determination to allow the Agency to further assess its approach for addressing Salmonella illnesses associated with poultry products.

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HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Foods

By Food Safety Tech Staff
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In a room filled with MAHA Moms, the FDA Commissioner Marty Makary and HHS Secretary Robert F. Kennedy, Jr announced a series of new measures to phase out all petroleum-based synthetic dyes from the food supply.

“For too long, some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent,” said Robert F. Kennedy, Jr. “These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development. That era is coming to an end. We’re restoring gold-standard science, applying common sense, and beginning to earn back the public’s trust. And we’re doing it by working with industry to get these toxic dyes out of the foods our families eat every day.”

For over a decade, Europe has enforced strict regulations on synthetic dyes Since 2010, foods containing certain synthetic dyes in the EU must carry warning labels stating they “may have an adverse effect on activity and attention in children.” Many dyes commonly used in the U.S. are banned or tightly restricted in Europe, and manufacturers have responded by reformulating products with natural alternatives.

Many foods will need to be reformulated to remove synthetic dyes, including:

  • FRUIT LOOPS (RED 40, YELLOW 6, BLUE 1)
  • WELCH’S FRUIT SNACKS (RED 40, BLUE 1)
  • DORITOS (RED 40, YELLOW 5, YELLOW 6)
  • MOUNTAIN DEW (YELLOW 5)
  • POP TARTS (RED 40, YELLOW 6, BLUE 1)
  • MISSION SPINACH WRAPS (YELLOW 5, BLUE 1)
  • SUCKERS STRAWBERRY SPREAD (RED 40)
  • MT. OLIVE PICKLES (YELLOW 5)
  • NERDS GUMMY CLUSTERS (RED 40, YELLOW 5, BLUE 1)
  • MONSTER ENERGY BLUE HAWAIIAN (BLUE 1)

These are just a few examples-hundreds of familiar products will be affected.

The FDA is fast-tracking the review of calcium phosphate, Galdieria extract blue, gardenia blue, butterfly pea flower extract, and other natural alternatives to synthetic food dyes. The agency is also taking steps to issue guidance and provide regulatory flexibilities to industry.

The FDA is taking the following actions:

  1. Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
  2. Initiating the process to revoke authorization for two synthetic food colorings—Citrus Red No. 2 and Orange B—within the coming months.
  3. Working with industry to eliminate six remaining synthetic dyes—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—from the food supply by the end of next year.
  4. Authorizing four new natural color additives in the coming weeks, while also accelerating the review and approval of others.
  5. Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
  6. Requesting food companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required.

“Today, the FDA is asking food companies to substitute petrochemical dyes with natural ingredients for American children as they already do in Europe and Canada,” said FDA Commissioner Marty Makary, MD, MPH. “We have a new epidemic of childhood diabetes, obesity, depression, and ADHD. Given the growing concerns of doctors and parents about the potential role of petroleum-based food dyes, we should not be taking risks and do everything possible to safeguard the health of our children.”

In partnership with the NIH Nutrition Regulatory Science and Research Program, the FDA will enhance nutrition and food-related research to better inform regulatory decisions. This collaboration will strengthen the FDA’s ability to develop evidence-based food policies.

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Health Groups Urge FDA: Target Toxins, Preserve Safe Food Ingredients

By Food Safety Tech Staff
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The paper was developed in response to HHS Secretary Robert F. Kennedy, Jr.’s March 10 directive to the FDA to explore eliminating the “self-affirmed” Generally Recognized as Safe (GRAS) pathway, which allows companies to determine food ingredient safety without FDA review.

The white paper advocates for an alternative to the total elimination of the ‘Self-GRAS’ pathway, focusing instead on eliminating the most hazardous chemicals while preserving access to safe, beneficial ingredients. The paper and further background materials can be found here.

ANH’s white paper has been endorsed by a range of groups, including the Global Wellness Forum, the Organic Consumers Association, and the National Foundation for Integrative Medicine, with more groups continuing to sign on. It was also sent to RFK, Jr. and various members of relevant FDA and HHS committees, encouraging them to incorporate this common-sense plan into GRAS reform.

“We support Secretary Kennedy’s intention to remove the most toxic substances from our food supply,” said Jonathan Emord, J.D., ANH General Counsel and co-author of the white paper. However, the government should avoid complete elimination of Self-GRAS, which would create a massive regulatory bottleneck, potentially removing thousands of safe ingredients from the market along with those that are unsafe.”

The authors emphasize that their targeted approach is particularly well-suited to the current reality of reduced resources at the Department of Health and Human Services. “By focusing regulatory scrutiny on the small subset of ingredients with demonstrated safety concerns rather than attempting to review all 10,000+ self-affirmed ingredients, this strategy allows the FDA to efficiently protect public health even with limited staff and resources,” the white paper explains.

According to ANH, the GRAS designation was established under the Food Additive Amendment of 1958 to exempt well-established, demonstrably safe food ingredients from the FDA’s rigorous pre-market approval process. Companies have used this pathway to introduce ingredients into the food supply, including colors, preservatives, technological additives, and chemicals, most of which have not been thoroughly reviewed for safety or reassessed after decades of use. While these concerns are valid, the Self-GRAS pathway remains vital for introducing safe, innovative products without unnecessary regulatory burdens.

ANH’s proposed reforms draw important contrasts with the European regulatory approach to food additives, where only about 400 ingredients are currently permitted. The paper argues this may be overly cautious, potentially depriving consumers of healthy options.

“Our white paper defines a strategy for balanced GRAS reform while avoiding the EU model of extensive regulatory overreach in favor of freedom of choice,” said Robert Verkerk, Ph.D., ANH’s Executive & Scientific Director and white paper co-author.

The white paper proposes several key reforms:

  1. Targeted Approach to Unsafe Ingredients: Prioritize the removal of specific unsafe ingredients rather than requiring re-evaluation of all 10,000+ self-affirmed GRAS substances. The paper identifies potassium bromate, propylparaben, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), sodium benzoate, and brominated vegetable oil (BVO) as examples of additives that may be injurious due to their chronic toxicity.
  2. Public Transparency Register: Create a comprehensive online database of all GRAS determinations, enhancing accountability and consumer information. This would complement the FDA’s recently announced Chemical Contaminants Transparency Tool.
  3. Tiered Risk/Benefit Assessment: Implement a four-tier system that calibrates evidence requirements based on an ingredient’s history of use and safety profile. Substances with at least 30 years of safe use would face minimal requirements, while those with evidence of potential toxicity would require more robust safety data.
  4. “Safe Harbor” for Time-Tested Ingredients: Create a pathway for ingredients with a documented history of safe use for over 60 years, predating the 1958 Food Additive Amendment. These would be officially recognized by the FDA as “historically safe.”
  5. Appropriate Warning Requirements: When specific populations may be vulnerable to otherwise safe ingredients, warnings rather than outright bans should be required. The FDA would recognize such warnings as creating a presumption of safety for the ingredient.
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HHS Announces Transformation to Make America Healthy Again

By Food Safety Tech Staff
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The U.S. Department of Health and Human Services (HHS) announced a dramatic restructuring in accordance with President Trump’s Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.”

The restructuring will address this and serve multiple goals without impacting critical services. First, it will save taxpayers $1.8 billion per year through a reduction in workforce of about 10,000 full-time employees who are part of this most recent transformation. When combined with HHS’ other efforts, including early retirement and Fork in the Road, the restructuring results in a total downsizing from 82,000 to 62,000 full-time employees.

Secondly, it will streamline the functions of the Department. Currently, the 28 divisions of the HHS contain many redundant units. The restructuring plan will consolidate them into 15 new divisions, including a new Administration for a Healthy America, or AHA, and will centralize core functions such as Human Resources, Information Technology, Procurement, External Affairs, and Policy. Regional offices will be reduced from 10 to 5.

Third, the overhaul will implement the new HHS priority of ending America’s epidemic of chronic illness by focusing on safe, wholesome food, clean water, and the elimination of environmental toxins. These priorities will be reflected in the reorganization of HHS.

Finally, the restructuring will improve Americans’ experience with HHS by making the agency more responsive and efficient, while ensuring that Medicare, Medicaid, and other essential health services remain intact.

FDA will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. This reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors.

“We aren’t just reducing bureaucratic sprawl. We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic,” HHS Secretary Robert F. Kennedy, Jr. said. “This Department will do more – a lot more – at a lower cost to the taxpayer.”