Tag Archives: FDA

Beltway Beat

FDA Intends to Extend Compliance Date for Food Traceability Rule

By Food Safety Tech Staff
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The U.S. Food and Drug Administration (FDA) announced on its website that it intends 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 the requirements of the final rule. 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.

Food lab
Beltway Beat

HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods

By Food Safety Tech Staff
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Food lab

The U.S. Food and Drug Administration announced in a Press Release, the Chemical Contaminants Transparency Tool (CCT Tool), an online searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action levels, and guidance levels) that are used to evaluate potential health risks of contaminants in human foods. Chemical contaminants include a broad range of chemical substances that may be present in food and that have the potential to cause harm.

To protect public health and help industry market products that are safe for U.S. consumers, the FDA establishes or utilizes tolerances, action levels and guidance levels for some contaminants in food. These are levels above which the agency may find that a food may be unsafe but do not represent permissible levels of contamination. The FDA uses these levels to help minimize or prevent chemical hazards in food.

“Ideally there would be no contaminants in our food supply, but chemical contaminants may occur in food when they are present in the growing, storage or processing environments,” said Acting FDA Commissioner Sara Brenner, M.D., M.P.H. “Because many of the most nutritious foods can also contain contaminants, consumers should eat a variety of nutrient-dense foods across and within the main food groups of vegetables, fruits, grains, dairy and protein to help protect from possible exposure effects.”

The CCT Tool, which provides contaminant levels in one location for ease of searching, is one of the outcomes of the FDA’s initiative to modernize food chemical safety. The consolidated list includes the contaminant name, commodity, contaminant level type (e.g., action level, guidance level), level value and reference (e.g., Code of Federal Regulations, FDA Guidance for Industry). The list can also be filtered by contaminant type.

Baby Bottle
Beltway Beat

HHS, FDA Announce Operation Stork Speed

By Food Safety Tech Staff
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Baby Bottle

The FDA is announced in a Press Release a set of actions and initiatives focused on infant formula, called “Operation Stork Speed” such as beginning the nutrient review process and increasing testing for heavy metals and other contaminants. The agency is also encouraging companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients.

The FDA uses its authorities, both longstanding and newly granted, to uphold the safety, nutritional adequacy and resilience of infant formula and the infant formula supply. With Operation Stork Speed, the FDA is:

  • Starting the nutrient review required by law by issuing a Request for Information in the coming months to start the first comprehensive update and review of infant formula nutrients by the FDA since 1998
  • Increasing testing for heavy metals and other contaminants in infant formula and other foods children consume
  • Extending the personal importation policy
  • Encouraging companies to work with the FDA on any questions regarding increased transparency and clearer labeling
  • Communicating regularly with consumers and industry stakeholders as significant developments occur to ensure transparency, including information regarding nutrients and health outcomes
  • Collaborating with the National Institutes of Health and other scientific bodies to address priority scientific research gaps regarding short- and long-term health outcomes associated with formula feeding in infancy and childhood across the lifespan

“The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,” said HHS Secretary Robert F. Kennedy, Jr.

Vulto Creamery Cheese
Beltway Beat

FDA Provides Update on the Federal-State Milk Safety System

By Food Safety Tech Staff
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Vulto Creamery Cheese

The FDA is sharing interim results from its ongoing sampling of 60-day aged raw milk cheese. As of March 10, 2025, 110 samples of the planned 299 have been collected. Of those 110 samples, 96 were negative by PCR (meaning that H5N1 was not detected in the analyzed samples), and 14 are still in progress. Final results are expected later this spring.

In addition, the preview appearing in a published pre-print of the research funded by the FDA and New York State and conducted at Cornell University suggests that aging raw milk cheese for 60 days or longer is not effective at eliminating H5N1. The previewed findings also suggest that either heat treating raw milk to adequate parameters or manufacturing cheese at or below a pH of 5.0 could be effective at inactivating H5N1.

To read more about this research and to see recommendations for industry and consumers from the FDA, visit: Investigation of Avian Influenza A (H5N1) Virus in Dairy Cattle

Beltway Beat

RFK Jr Moves to Eliminate GRAS and Synthetic Dyes

By Food Safety Tech Staff
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HHS Secretary Robert F. Kennedy Jr. directed the acting FDA commissioner, to take steps to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway. According the HHS website, this will enhance the FDA’s oversight of ingredients considered to be GRAS.

“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” said Secretary Kennedy. “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”

Eliminating the self-affirmation process would require companies seeking to introduce new ingredients in foods to publicly notify the FDA of their intended use of such ingredients, along with underlying safety data, before they are introduced in the food supply.

“The FDA is committed to further safeguarding the food supply by ensuring the appropriate review of ingredients and substances that come into contact with food,” said Acting FDA Commissioner Sara Brenner, M.D., M.P.H. “The FDA will continue to follow our authorities and leverage our resources to protect the health of consumers to ensure that food is a vehicle for wellness.”

The statement said, HHS is committed to working with Congress to explore ways legislation can completely close the GRAS loophole.

Synthetic Dyes DOA

On Monday, in his first meeting with top executives from PepsiCo, W.K. Kellogg, General Mills and other large companies, Secretary Kennedy bluntly told them that a top priority would be eliminating artificial dyes from the nation’s food supply according to a NY Times article.

In a letter to it’s members, Melissa Hockstad the Consumer Brands Association’s President wrote “Decision time is imminent” According to the letter, Mr. Kennedy also warned food companies that they should anticipate significant change as a result of his quest for “getting the worst ingredients out” of food. And while Mr. Kennedy said in the meeting that he wanted to work with the industry, he also “made clear his intention to take action unless the industry is willing to be proactive with solutions,” according to the Hockstad letter.

Beltway Beat

FDA names Kyle Diamantas J.D. as new Acting Deputy Commissioner for Human Foods

By Food Safety Tech Staff
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U.S. Food and Drug Administration has announced food and beverage attorney Kyle Diamantas is the new acting deputy commissioner for human foods. He replaces Jim Jones, who resigned last week in protest of staffing cuts.

FDA’s leadership webpage was updated this week to include Mr. Diamantas and stated that as the Acting Deputy Commissioner for Human Foods, he leads the agency’s Human Foods Program, overseeing all FDA nutrition and food safety activities. In this role, Mr. Diamantas exercises authority over all Human Food Program entities and operations, including resource allocation, risk-prioritization strategy and decision making, policy initiatives, and major response activities involving human foods. Mr. Diamantas also oversees food resources in the agency’s Office of Inspections and Investigations.

As the FDA’s top food executive, Mr. Diamantas sets the strategic direction and operations for food policy in the U.S., while serving as a critical liaison between the agency, Department of Health and Human Services, and The White House. He also represents the agency on food activities and matters in dealings with foreign governments and international organizations.

Mr. Diamantas has extensive experience working with various federal and state agencies and policy makers, scientific organizations, consumer advocacy groups, and industry stakeholders. Prior to coming to FDA, Diamantas worked at the law firm Jones Day. He has wide-ranging experience on matters spanning regulatory, compliance, investigative, enforcement, rulemaking, and legislation. Mr. Diamantas holds a juris doctor from the University of Florida Levin College of Law and a bachelor’s in pre-law political science from the University of Central Florida.

The announcement appears to conflict HHS Secretary Robert F. Kennedy Jr’s pledge to shut the revolving door between industry and government. According to the website, Lawtally, prior to working at Jones Day, Diamantas was a senior associate at Baker, Donelson, Bearman, Caldwell & Berkowitz. He focused his practice on civil litigation and regulatory compliance, with an emphasis on United States Food and Drug Administration (FDA), United States Federal Trade Commission (FTC), and state equivalent regulatory and compliance issues and disputes.

He assisted in the representation of drug, device, cosmetic, dietary supplement, food, and consumer product manufacturers and supply chain participants on issues involving labeling, advertising, regulatory and quality compliance, and in transactions and litigation involving products and companies subject to FDA and FTC regulation.

 

FDA Logo
Beltway Beat

Sweeping FDA Cuts Hit Food Safety Staffer’s Inboxes

By Food Safety Tech Staff
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FDA Logo

The Guardian reported that the Trump administration’s effort to slash the size of the federal workforce reached the Food and Drug Administration this weekend, as recently hired employees who review the safety of food ingredients, medical devices and other products were fired. Probationary employees across the FDA received notices on Saturday evening that their jobs were being eliminated.

On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. CBS News obtained a letter that outlined the reasons that staff at the Department of Health and Human Services (HHS) were given for their firing.

“Unfortunately, the Agency finds that you are not fit for continued employment because your ability, knowledge and skills do not fit the Agency’s current needs, and your performance has not been adequate to justify further employment at the Agency,” said the letters.

This action lead to Jim Jones, FDA’s deputy commissioner for human foods, resigning from his post at the agency, in protest over sweeping staff cuts.  See Related Story.

The NY Times reported Robert F. Kennedy, Jr. the Head of HHS made his first address on Tuesday to employees of the Department of Health and Human Services. He said that a commission established by Trump to look into the rise of chronic disease in the United States would scrutinize the factors he has cited in the past: the childhood vaccine schedule, electromagnetic radiation, pesticides, ultra-processed foods, artificial food allergens, psychiatric drugs and microplastics. “Nothing is going to be off limits,” Kennedy said.

The recent cuts at FDA include staffers responsible for reviewing the safety of new food additives and ingredients, according to an FDA staffer familiar with the firings.

 

 

Jim Jones, FDA
Beltway Beat

Jim Jones resigns as FDA deputy commissioner for human foods

By Food Safety Tech Staff
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Jim Jones, FDA

Jim Jones, FDA’s deputy commissioner for human foods, has resigned from his post at the agency, according to multiple sources. The head of the food division at the US Food and Drug Administration has quit in protest over sweeping staff cuts that he warns will hamper the agency’s ability to protect public health.

Jim Jones, who joined the agency in September 2023, cited “indiscriminate” layoffs to 89 staff members, including key technical experts. In his resignation letter to the acting FDA commissioner, Sara Brenner, seen by Bloomberg News, Jones said the cuts would make it “fruitless” to continue in his role given the Trump administration’s “disdain for the very people” needed to implement food safety reforms.

According to Bloomberg News, the White House defended the staff changes, with press secretary Karoline Leavitt telling saying “bureaucrats” were resistant to implementing the president’s agenda. “President Trump is only interested in the best and most qualified people who are also willing to implement his America First Agenda on behalf of the American people,” Leavitt said in an email. “It’s not for everyone, and that’s okay.”

Jones was an integral member of the Reagan-Udall Foundation’s Independent Expert Panel for Foods, which submitted a report in December 2022 on the operational evaluation of the FDA’s Human Foods Program. He holds a master’s degree in economics from the University of California at Santa Barbara and a bachelor’s degree in economics from the University of Maryland.

In October of 2024, Jones lead the U.S. Food and Drug Administration’s reorganization implementation involving the creation of the unified Human Foods Program (HFP), adoption of a new model for its field operations and other significant modernization efforts, notably enhancing the agency’s ability to oversee and protect the human food supply and other products the FDA regulates.

photo credit: Rick Biros

Jones was the Keynote Speaker at the Food Safety Consortium Conference, October 2024 in Washington DC. in which he delved into the agency’s recent reorganizational changes, key regulatory policy priorities, and commitment to stakeholder transparency.

“I was looking forward to working to pursue the department’s agenda of improving the health of Americans by reducing diet-related chronic disease and risks from chemicals in food,” Jones wrote in his resignation letter.

 

Beltway Beat

Robert F. Kennedy Jr. Confirmed As Health and Human Services Secretary

By Food Safety Tech Staff
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The Senate confirmed Robert F. Kennedy Jr. as Health and Human Services secretary, putting a longtime critic of processed foods, big agriculture, vaccines and the medical establishment in charge of the nation’s vast and powerful health system.

Every Democrat voted against Kennedy, while Sen. Mitch McConnell, a polio survivor who had criticized the nominee’s questioning of vaccines, was the lone Republican no vote.

Mr. Kennedy is expected to be sworn in on Thursday afternoon to lead the federal Department of Health and Human Services, a sprawling agency with 13 operating divisions, including some — the Food and Drug Administration, the National Institutes of Health and the Centers for Disease Control and Prevention — that he has called corrupt.

The Consumer Brands Association, which represents makers of ultraprocessed foods, issued a pointed statement, reminding Mr. Kennedy that they are the nation’s largest manufacturing employer, and that they would like to see aspects of the status quo remain in place.

“The federal regulatory agencies within H.H.S. operate under a science and risk-based mandate, and it is critical that framework remains under the new administration,” said Sarah Gallo, the group’s senior vice president for federal affairs.

Beltway Beat

Food and Dietary Supplement Labeling: What Comes Next?

By Paula Brock, PhD, MSCI
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Labeling of food and dietary supplements in the United States involve several aspects and each must be approached with careful consideration. Regulatory, scientific, and business decisions need to be considered when working on labels’ mandatory elements and claims. The FDA released in December 2024 and January 2025 a few new proposed and final rules on several issues that will impact food and dietary supplement labeling. 1,2,3,4 However, it is unclear at this time whether these rules will be approved by the new federal administration. 5 Stay tuned into these topics over the next few months to obtain information on the final requirements.

Mandatory elements of the label declared on the principal display panel (or front-of-package) include the statement of identity and net content of the product. Other elements such as warnings might also be required depending on the product. One of the newly proposed rules by the FDA is the inclusion of an abbreviated version of the nutrition information (“Nutrition Info Box”) to be placed on the front of the package of most packaged foods. 1 If approved, companies will have 3 to 4 years (depending on business size) to implement the new label. Although editing a label is not very challenging, some companies might decide to reformulate the entire product in order to avoid a potential drop in sales. The nutrition info box will include clear information of product’s level as low, medium, or high of saturated fats, sodium, and added sugars on the front-of-package. In addition, the FDA released a draft guidance (nonbinding recommendations) on the statement of identity of plant-based foods. Coming up with the statement of identity of non-standardized foods can be tricky. This FDA guidance provides examples of how to name plant-based foods such as “soy-based cheddar cheese,” “chickpea and lentil-based fish sticks,” and “chia and flaxseed egg-less scramble.” This draft guidance is open to receive comments. The period for comments ends on May 7, 2025, and can be submitted online. 2

The other mandatory elements of the label are declared in the information panel. This is the panel located immediately to the right of the principal display panel and includes the Nutrition/Supplement Facts panel, the list of other ingredients (including allergen declaration), and the name and place of business. One of the FDA’s newly proposed rules that will impact the information panel if approved is the ban on Red No. 3 color additive. 3 Prohibiting the use FD&C Red No.3 will cause companies to reformulate their products. Food companies will have until January 15, 2027 to comply. Imported foods will also have to comply. This rule came into decision due to data that Red No.3 dye might induce cancer. The FDA also released a final guidance for industry regarding food allergen labeling. This guidance provides several new questions and answers on allergens such as shellfish and fish species as well as on allergen-free claims. Although this is a final guidance, comments can be submitted any time. 4

Claims are another important piece of the labeling. Claims inform consumers of the intended use of the product as well as add product marketability. However, as with the other components of the label, ensuring compliance with the correct claims wording and claims substantiation will keep companies out of trouble. The new FDA rule that will affect product claims if approved is on the term “healthy.” In December 2024, the FDA released a final rule on the eligibility for use of the term “healthy” as it relates to nutrient content claims in food and dietary supplements. This rule is set to be effective on February 25, 2025 with compliance until February 25, 2028. However, again it is unclear if this final rule will remain after the new federal administration. In general, the term “healthy” will only be allowed when products meet the criteria of containing a certain amount of healthy nutrients (i.e., fruits, vegetables, grains, fat-free and low-fat dairy and proteins) as well as staying under the limit for unhealthy nutrients including added sugars, saturated fat and sodium. 5

References

  1. FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods. Content current as of: 01/14/2025. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-proposes-requiring-glance-nutrition-information-front-packaged-foods
  2. S. Department of Health and Human Services – Food and Drug Administration – Human Foods Program. Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry – Draft Guidance. January 2025. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-labeling-plant-based-alternatives-animal-derived-foods
  3. FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs. January 15, 2025. Retrieved from https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs?utm_medium=email&utm_source=govdelivery
  4. Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5). January 2025. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-food-allergen-labeling-edition-5
  5. Federal Register. Food Labeling: Nutrient Content Claims; Definitions of Term “Healthy”. Final Rule. 12/27/2024. Retrieved from https://www.federalregister.gov/documents/2024/12/27/2024-29957/food-labeling-nutrient-content-claims-definition-of-term-healthy
  6. U.S. Department of Health and Human Services – Food and Drug Administration – Use of the term healthy on food labeling. Current as of: 01/16/2025. Retrieved from: https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/use-term-healthy-food-labeling
  7. White House – Presidential Actions. Regulatory Freeze Pending Review. January 20, 2025. Retrieved from https://www.whitehouse.gov/presidential-actions/2025/01/regulatory-freeze-pending-review/?utm_campaign=EAS&utm_medium=email&_hsenc=p2ANqtz-_HHp0nhlpXvYDyI9YOR-vQDb1SlAgnpQqVgmz8ThSBYafnpoq4dU9cxrRdWE-bzXjjg5QSK9cAKqt0pJyAXSmuO2JP-Yjk7A_ym9DL2xL6O49XJRI&_hsmi=343689829&utm_content=343689829&utm_source=hs_email