Tag Archives: FDA

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

By Food Safety Tech Staff
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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

 

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FDA bans red dye No. 3 from food and beverages

By Food Safety Tech Staff
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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
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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.

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

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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.

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FDA updates nutritional requirements a food must meet to use the claim “healthy” on the package

By Food Safety Tech Staff
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I.M. Healthy SoyNut Butter, recall

The U.S. Food and Drug Administration (FDA) announced today it has updated the nutritional requirements a food must meet to use the claim “healthy” on the package, which includes criteria a food must meet to use the “healthy” claim on the package. The FDA also is exploring the development of a symbol to represent the claim “healthy” to make it easier to spot foods that can be the foundation of healthy eating patterns.

Updating the “Healthy” Definition on Food Packaging

The last time “healthy” was defined on packaging was in the 1990s. Based on the nutrition science and federal dietary guidelines at that time, the definition was solely focused on individual nutrients; for example, it included limits for saturated fat, total fat, cholesterol, and sodium and required a certain amount of beneficial nutrients like certain vitamins, minerals, fiber, and protein.

With a greater understanding of dietary patterns and their effects on health, and FDA recognizes that foods are made up of a variety of nutrients that work together as part of a healthy dietary pattern.

To be consistent with the latest nutrition science and federal dietary guidelines the updated definition of “healthy” requires that:

  • A food must contain a certain amount of a food group like fruits, vegetables, grains, protein foods, or dairy.
  • A food can’t contain too much saturated fat, sodium, or added sugars.

How the “Healthy” Claim Works

Placing a “healthy” claim on a food package is voluntary. If manufacturers choose to do it, their products must have the nutrient content required by the “healthy” definition. Manufacturers who choose to use the “healthy” claim can use the new criteria starting on February 25, 2025.

Here are some examples of what qualifies to use the “healthy” claim under the updated definition:

  • Nuts and seeds, olive oils, higher-fat fish, like salmon, and eggs would qualify as healthy because of their nutrient profile. They didn’t qualify under the previous definition.
  • Water. While water isn’t part of a food group, it is considered an optimal beverage by the Dietary Guidelines.

Here are some examples of what no longer qualifies to use the “healthy” claim under the updated definition:

  • Fortified white bread, highly sweetened yogurt, highly sweetened cereal.

For more details, see Use of the Term Healthy on Food Labeling.

Beltway Beat

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

By Food Safety Tech Staff, Rick Biros
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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.

 

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FDA Publishes New Guidance Document for Voluntary Qualified Importer Program

By Food Safety Tech Staff
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FSMA requires FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.  This control includes importation of food from facilities[1] that have been certified in accordance with FDA’s Accredited Third-Party Certification Program (also referred to as the Third-Party Program or TPP) (section 808 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384d)) and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications regulation (also referred to as the TPP regulation) (see 21 CFR part 1, subpart M), as well as other measures that support a high level of confidence in the safety and security of the food they import.  Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.

The guidance document describes FDA’s policy regarding participation in FDA’s Voluntary Qualified Importer Program (VQIP) by importers of food for humans or animals.  This document provides guidance on:

  • The benefits VQIP importers can expect to receive;
  • The eligibility criteria for VQIP participation;
  • Instructions for completing a VQIP application;
  • Conditions that may result in revocation of participation in VQIP; and
  • Criteria for VQIP reinstatement following revocation.

This guidance document is presented in question and answer format.  This guidance document may be modified (in accordance with FDA’s good guidance practice regulation (21 CFR 10.115)) as VQIP is implemented and evaluated.  FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidance means that something is suggested or recommended, but not required.  This guidance represents FDA’s current thinking regarding what will be considered for participation in VQIP and how VQIP will expedite entry of imports.

The pronouns “I,” “me,” “you,” and “your” are used in this guidance to refer to the importer who may want to participate in VQIP.  “Agency” and the pronouns “we” and “our” are used to refer to FDA.  The term “food” has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(f)), except that, for the purposes of VQIP, food does not include pesticides as defined in 7 U.S.C. 136(u).

Download the Guidance

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FDA Reminds Animal and Human Food Facilities to Register or Renew their Food Facility Registration before December 31

By Food Safety Tech Staff
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Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1 and December 31, 2024.

The FDA will consider the registration of a food facility to be expired if a facility’s registration is not renewed by December 31, 2024. There is no fee associated with registration or renewal. Owners, operators, or agents in charge of food facilities must submit their renewal information electronically through their FDA Industry Systems (FIS) account, unless they have received a waiver that allows for paper submission.

Food facility registration is critical to helping the FDA identify the location and possible source of a foodborne illness outbreak or potential bioterrorism incident. Food facility registration requirements were initiated with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and amended by the FDA Food Safety Modernization Act (FSMA) in 2011. FSMA requires facilities to submit additional information to the FDA and to renew their registrations every other year.

The following resources are available to assist in the registration and renewal process:

FFR Renewal:

FFR Guidance:

FFR User Guides:

FIS User Guides:

Food facilities with questions can contact the Data Management Support Services: by phone 1- 240-247-8804; or by email at FURLS@fda.gov on U.S. Government business days (Monday to Friday, excluding U.S. government holidays) from 9:00 a.m. to 6:00 p.m. Eastern Time (see Federal Holidays (opm.gov) and Current Status (opm.gov).

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FDA’s new Human Foods Program (HFP) kick’s off October 1

By Food Safety Tech Staff
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The U.S. Food and Drug Administration’s reorganization implementation involving the creation of a unified Human Foods Program (HFP), adoption of a new model for its field operations and other significant modernization efforts are scheduled for Oct. 1, 2024, notably enhancing the agency’s ability to oversee and protect the human food supply and other products the FDA regulates.

Jim Jones, FDALead by Jim Jones, Deputy Commissioner for Human Foods at FDA, the reorganization establishes the HFP by realigning the functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, as well as key functions from the Office of Regulatory Affairs (ORA) under one program.

Additionally, the restructuring of ORA will enable the field operations unit to focus on inspections, investigations and imports as its core mission. The FDA is changing the name of ORA to the Office of Inspections and Investigations (OII) to better convey the organization’s role as the frontline of the FDA, which provides real time insights and science-based evidence necessary to ensure the safety and quality of products Americans depend on.

Jim Jones will Keynote the Food Safety Consortium Conference, October 20-22 in Washington DC. During this session Mr. Jones will delve into the agency’s recent reorganizational changes, key regulatory policy priorities, and commitment to stakeholder transparency. Doug Stearns, Deputy Associate Commissioner of Regulatory Affairs, will discuss how these changes will shape investigations and inspections for both domestic and foreign facilities. Attendees will gain valuable perspectives on regulatory shifts, emerging challenges, and collaborative opportunities shaping the landscape of food safety and compliance. Discover how the new Deputy Commissioner’s strategic vision will drive innovation, enhance public health outcomes, and foster trust within the food industry. Attendees will have the opportunity to gain deep insights into emerging challenges, innovative strategies, and collaborative approaches to advancing food safety.

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More Ground Cinnamon Products Added to FDA Public Health Alert Due to Presence of Elevated Levels of Lead

By Food Safety Tech Staff
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Through product testing, the FDA has determined that the ground cinnamon products listed on their website contain elevated levels of lead and that prolonged exposure to these products may be unsafe. The FDA is advising consumers to throw away and not to buy these ground cinnamon products. The FDA has recommended that the firms voluntarily recall these products, with the exception of the MTCI cinnamon. According to the FDA’s website, the FDA has been unable to reach MTCI to share their findings and request that the company initiate a recall. No illnesses or adverse events have been reported to date in association with these products.

Following the October 2023 recall of cinnamon apple puree and applesauce products due to elevated lead levels linked to the cinnamon in those products and the concern for lead toxicity in children, the FDA initiated a targeted survey of ground cinnamon products from discount retail stores and analyzed the samples for lead and chromium.

Based on results from the survey, the FDA is recommending recalls of ground cinnamon from six distributors whose products had elevated lead levels ranging from 2.03 to 3.4 parts per million (ppm). These levels are significantly lower than the levels of lead associated with the ongoing investigation into ground cinnamon from Ecuador supplied by Negasmart to Austrofoods, the manufacturer of the apple puree and applesauce products, which were between 2,270 ppm to 5,110 ppm in the cinnamon.

FDA Actions

The FDA announced it is continuing its Toxic Elements monitoring program, which includes testing of a variety of foods including colored spices offered for sale in the U.S. According to their website, sampling at import has prevented some cinnamon with elevated lead levels from entering U.S. commerce; however, like all of FDA surveillance activities, these monitoring programs only evaluate a subset of the commodity being imported. FDA will follow-up on these findings as well as continue our activities at import to prevent unsafe cinnamon from reaching consumers in the U.S., including by adding firms and products to import alert where appropriate. Ultimately, FDA says, it is the responsibility of the manufacturers and the importers to ensure the safety of the products that enter into the U.S. market.

The FDA also sent a letter to all cinnamon manufacturers, processors, distributors, and facility operators in the U.S. reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including in ground cinnamon products. The FDA will continue to work with firms to ensure they are meeting their responsibilities under provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule.