Tag Archives: FDA

Beltway Beat

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

By Food Safety Tech Staff
No Comments

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
No Comments
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
No Comments
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
No Comments

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
No Comments

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
Beltway Beat

RFK Jr. as Health Secretary? What the food industry expect.

By Food Safety Tech Staff, Rick Biros
No Comments

1/30/2025. Editor’s update of original article from 11/15/2024. Robert F. Kennedy Jr. battled his way through his second Senate confirmation hearing. According to the NY Times, Kennedy defended his views on vaccination during a raucous three-hour session on Thursday that featured shouting matches, angry accusations and a senator in tears, and also exposed the deep misgivings of a key Republican who could hold Mr. Kennedy’s future in his hands. The Senate hearings focused Mr. Kennedy’s views on vaccination did not touch on his food and agriculture ideas and plans.

Original article from 11/15/2024: According to the Wall Street Journal, President-elect Donald Trump is planning to nominate environmental lawyer Robert F. Kennedy Jr. to serve as Health and Human Services secretary. Kennedy’s nomination was not a surprise. Last month, Kennedy said Trump had promised him control of the department and its many subagencies, which include the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Centers for Medicare and Medicaid (CMS), and others. Trump himself pledged during the campaign to let Kennedy “go wild on health.”

To put things into context, the mission of the U.S. Department of Health and Human Services (HHS) according to it’s website is to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. FDA is an agency within the Department of Health and Human Services and consists of nine Center-level organizations and thirteen Headquarter (HQ) Offices including the newly reorganized Human Foods Program headed up by Jim Jones.

Kennedy’s website, Make America Healthy Again states that Kennedy has spent nearly 40 years fighting corrupt corporations and government agencies. During his tenure at RiverKeeper, he successfully sued dozens of municipalities to force compliance with the Clean Water Act. He won cases against corporate giants, including a suit against General Electric for toxic runoff from its corporate jet hangar and a court order against ExxonMobil mandating they clean up tens of millions of gallons of spilled oil in Brooklyn, NY. As of Dec 2022, the Monsanto lawsuits to which Kennedy has devoted much of the past decade have yielded $11 Billion for farmers, migrant workers, day laborers, and families exposed to the pesticide RoundUp.

If approved, what can the food industry expect from Kennedy?

According to Make America Healthy Again, Kennedy sees Big Pharma and Big Agriculture having an undue influence on what Americans eat and how they manage their health over time.

Kennedy says the public health establishment is too focused on infectious diseases and wants to redirect resources toward issues he characterizes as the chronic disease epidemic, including obesity, diabetes, autism and mental illnesses. He blames them on corporations including food producers using harmful pesticides and additives. He traces America’s high levels of chronic disease to the widespread availability of highly processed, non-nutritious food, which he blames in part on a broken agriculture policy.

Some of his food and agriculture ideas plans share the same pseudoscience as Kennedy’s views on vaccines. Kennedy recently posted on social media that the FDA had “waged a war on public health” by “aggressive suppression” of Americans’ access to raw milk, despite raw milk’s risk of causing life-threatening diarrheal diseases and now, bird flu,

Kennedy has labeled Trump’s fast food diet as “poison” and wants to reduce the amount of ultra-processed food in the American food supply. In recent interviews, Kennedy has suggested clearing out “entire departments” at FDA, including the Center for Food Safety and Applied Nutrition.

However, if Kennedy wants to restrict the use of already-approved food additives, he needs more resources — not fewer: The process involves rigorous reviews of data, issuing public warnings, and actively monitoring the food supply. If Kennedy succeeded in closing the food safety office, that would reduce the number of people who could be dedicated to the job.

The European culture regarding food additives is generally the additive needs to be proven safe before allowed into the supply chain. Conversely, FDA’s position for years has been the additive is allowed to be used unless it has been proven harmful. Two opposite ways of regulating. Kennedy’s position on additives might move the U.S. to be more like the E.U.

Other actions could be taken by the Trump administration to reduce the amount of ultra-processed food in the American food supply, but many of them would be taken outside of HHS. The US Department of Agriculture (USDA) sets the guidelines that govern school lunch programs, which means much of what children eat is determined by that agency; Trump has not yet nominated a USDA commissioner. The USDA is also primarily responsible for overseeing farming, another industry Kennedy has heavily criticized throughout his public career and pledged to target if he were to take a role in the federal government. He would likely need to work with the USDA to follow through.

One Agency?

Kennedy is correct that food safety regulation in the US is currently a mess, says David Acheson, President of TAG. Meat, poultry, and egg plants are inspected daily under the auspices of the USDA, while every other kind of food production facility — including the farms whose produce is responsible for most of the food-borne illness in the US and the nation’s countless other industrial food manufacturers — are inspected by FDA inspectors at most once a year.

It would make far more sense to unify these functions under one agency and harmonize the frequency of food production facility inspections so none are falling through the cracks. That is the kind of organizational shake-up that could actually make a difference.

The concept of one agency is not new according to Frank Yiannas, former Deputy Commissioner for Food Policy and Response at the U.S. Food and Drug Administration. Yiannas, in his closing keynote presentation at last month’s Food Safety Consortium Conference said the idea has been proposed by the Obama and the previous Trump administration, however, it requires Congress to approve the combination of the two agencies.

It remains to be seen what impact Kennedy’s proposals will have on the food industry but they bear little resemblance to those of prior Republican administrations, which have typically favored cutting regulations, not increasing them.

 

FDA Logo
Beltway Beat

Blumenthal, Smith, Booker, & Durbin Call Out FDA for Proposed Cuts to State & Local Food Safety Programs

By Food Safety Tech Staff
No Comments
FDA Logo

In a press release on U.S. Senator’s  Richard Blumenthal (D-CT) website, he and fellow Senators Tina Smith (D-MN), Cory Booker (D-NJ), and Dick Durbin (D-IL) wrote to Jim Jones, Deputy Commissioner for Human Foods at the Food and Drug Administration (FDA), seeking an explanation regarding the agency’s plans to significantly reduce funding for state and local food safety programs. These programs perform a majority of food inspections reported by the FDA, including processing facility inspections, produce safety inspections, and retail food inspections.

“We are concerned that these proposed cuts will undo years of progress toward establishing a truly integrated food safety system,” wrote the Senators. “State budgets across the country are already stretched thin, these cuts would deleteriously impact our nation’s food safety system as some state programs inevitably scale back or are eliminated completely.”

“While we appreciate that you may need to occasionally reallocate resources based on programmatic needs, we are concerned that the full impact of the proposed cuts to state and local programs has not been taken into account and that the agency has failed to fully consider alternative options,” the Senators continued.

The full text of the letter can be found here

 

FDA Logo
Beltway Beat

FDA bans red dye No. 3 from food and beverages

By Food Safety Tech Staff
No Comments
FDA Logo

The FDA announced today that it is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition. The petition requested the agency review whether the Delaney Clause applied and cited, among other data and information, two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat specific hormonal mechanism. The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.

The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals. This is not the first time the agency revoked an authorization based on the Delaney Clause. For example, in 2018, the FDA revoked the authorization for certain synthetic flavors based on the Delaney Clause in response to a food additive petition.

Food and beverage manufacturers who use FD&C Red No. 3 in their products will have until January 15, 2027 to reformulate their products. Other countries still currently allow for certain uses of FD&C Red No. 3 (called erythrosine in other countries). However, foods imported to the U.S. must comply with U.S. requirements.

Beltway Beat

FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods

By Food Safety Tech Staff
No Comments

The U.S. Food and Drug Administration is announcing an important step to provide nutrition information to consumers by proposing to require a front-of-package (FOP) nutrition label for most packaged foods. This proposal plays a key role in the agency’s nutrition priorities, which are part of a government-wide effort in combatting the nation’s chronic disease crisis. If finalized, the proposal would give consumers readily visible information about a food’s saturated fat, sodium and added sugars content—three nutrients directly linked with chronic diseases when consumed in excess.

The proposed FOP nutrition label, also referred to as the “Nutrition Info box,” provides information on saturated fat, sodium and added sugars content in a simple format showing whether the food has “Low,” “Med” or “High” levels of these nutrients. It complements the FDA’s iconic Nutrition Facts label, which gives consumers more detailed information about the nutrients in their food.

The proposed rule, if finalized, would require food manufacturers to add a Nutrition Info box to most packaged food products three years after the final rule’s effective date for businesses with $10 million or more in annual food sales and four years after the final rule’s effective date for businesses with less than $10 million in annual food sales.

Comments on the proposed rule can be submitted electronically to http://www.regulations.gov by May 16, 2025.

FDA Logo
Beltway Beat

FDA’s Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children

No Comments
FDA Logo

The Food and Drug Administration (FDA) announced on its website the availability of a final guidance for industry entitled “Action Levels for Lead in Processed Food Intended for Babies and Young Children.” The guidance establishes action levels for lead in certain processed foods intended for babies and young children less than 2 years old. The guidance is intended to set achievable action levels that will help further reduce lead in the food supply.

In accordance with § 109.6 (21 CFR 109.6), this guidance establishes the following action levels for lead in processed food intended for babies and young children less than 2 years old:

  • 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain- and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats
  • 20 ppb for single-ingredient root vegetables; and 20 ppb for dry infant cereals

Consistent with § 109.6(d), these action levels reflect levels of lead at which FDA may regard the food as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)). FDA said it intends to consider these action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case.