Tag Archives: infant formula

FDA Logo

FDA Releases Updated Compliance Program for Infant Formula

By Food Safety Tech Staff
No Comments
FDA Logo

The FDA has updated its infant formula compliance program for FDA investigators, laboratory analysts and compliance officers. The updates build on lessons learned over the last several years to elaborate on FDA’s approaches for inspections, sampling, laboratory analysis and imported infant formula products. For example, updates include instructions for annual environmental sampling of Cronobacter and Salmonella at powdered infant formula facilities and instruction for FDA notification should a sample test positive for Cronobacter or Salmonella, or if a sample is found to have nutrients that are above or below required levels per the agency’s infant formula regulation.

The compliance program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program.

Additional background on the risks associated with Salmonella and Cronobacter in infant formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, are also included in the updated compliance program.

Inspectors are directed to perform environmental sampling once a year at each domestic powder infant formula manufacturing facility during annual or compliance follow-up inspection for both Cronobacter and Salmonella analysis if there are no significant adverse supply-chain implications.

The Division of Field Programs and Guidance (DFPG) and ORA Critical Foods Coordination Team will prioritize the annual inspection schedule based on:

  • the facilities’ previous inspection results
  • number of consumer complaints since the last inspection
  • number of violative samples collected by FDA in the last twelve months
  • the previous environmental sampling results performed by FDA

Per the instructions, environmental sampling should focus on zone two sites near potential product exposure points in the process (i.e., transfer points, fluid bed, sifters, rotary valves, man doors into drying system, filling lines, blending equipment, raw material handling equipment, etc.) including any areas indicating water accumulation. Additional sampling should also be done from zone three sites which may suggest a route of contamination (i.e., doorways, traffic routes, etc.) to dry production areas, finished product or food contact surfaces. Zone one sites should not be swabbed as these zones can be hard to reach and may introduce contamination during swabbing of a closed system. Unless conditions observed indicate a possible route of contamination, FDA does not recommend swabbing zone four areas at a high frequency.

Inspectors are advised to collect between 100-300 environmental swabs for Cronobacter spp. and 100-300 environmental swabs for Salmonella spp. at each firm, depending upon the size of the facility.

Baby Bottle

Stratified Sampling Increases Cronobacter Identification in Infant Formula

By Food Safety Tech Staff
No Comments
Baby Bottle

A new study, published in the Journal of Food Protection, found that spacing out samples over time, called “stratified” sampling, is better at catching risky pathogens like Cronobacter in powdered products, such as infant formula, than randomly sampling from the product as it is being produced. In addition, the study found that that while taking more samples of a product generally increases the chance of catching the pathogen, there is a point after which it is unlikely that additional sampling will increase safety.

The new paper “Simulation Evaluation of Power of Sampling Plans to Detect Cronobacter in Powdered Infant Formula Production” used computer models to simulate sampling and testing finished formula, to determine the efficacy of current national and international guidelines for testing programs, and find solutions to improve detection of Cronobacter in these types of products.

All efforts were based on detecting a realistic hazard, here defined by testing samples from Cronobacter-contaminated batches produced in Europe in the 2010s, using the most current data available. The paper found that safety plans with 30 or more grab samples had a very high probability of detecting the hazard. And that there was a point of diminishing returns, such that very high sample numbers—for example, testing every can produced—would not be meaningfully more powerful.

“This shows that existing sampling and testing guidance is powerful, at least for the one hazard profile our team had access to for the study,” said project lead Matthew J. Stasiewicz of the University of Illinois Urbana-Champaign. “This also highlights the need for additional research and data-sharing efforts into patterns of contamination in current infant formula production, so that sampling and testing can be better matched to current needs.”

“In additional to analyzing scenarios we found relevant, we built a web app that allows industry stakeholders to simulate various sampling scenarios and gain deeper understanding of the effectiveness of sampling plans specific to their plants. With this knowledge, producers can proactively address risks and optimize current sampling practices,” added Minho Kim, lead author.

 

USDA Logo

USDA FSIS To Host Virtual Public Meeting on Cyclospora Cayetanensis in Produce

By Food Safety Tech Staff
No Comments
USDA Logo

The USDA Food Safety and Inspection Services (FSIS) and the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will be holding a virtual public meeting on August 30, 2023, from 11 a.m.-1 p.m. ET to discuss and vote to adopt NACMCF’s recent report on Cyclospora cayetanensis in produce. Written comments must be submitted by August 25, 2023. The committee will also provide an update on the Cronobacter spp. in powdered infant formula charge.

The report was requested by the FDA, as the agency seeks more information on the factors that can contribute to C. cayetanensis contamination of domestically grown and imported produce, as well as recommendations for developing an effective prevention and management strategy.

As the report highlighted, cyclosporiasis previously was associated with travel outside of the U.S. or consumption of contaminated imported foods. However, in recent years, the U.S. has seen an increase in cases and positive samples associated with produce, both as raw agricultural commodities, and fresh-cut produce, grown in the U.S. In the last three years, the number of cyclosporiasis cases has increased approximately 300%, often linked to fresh produce consumption, specifically leafy herbs and ready-to-eat salads.

Attendees must pre-register by Friday, August 25, 2023, to receive details on how to access the meeting. During pre-registration, attendees may also express interest in delivering comments during the meeting. Oral comments will be limited to three minutes per speaker. The agenda will be shared on the FSIS Events & Meetings page prior to the event.

 

FDA Logo

FDA CFSAN Announces Priority Guidances for Remainder of 2023

By Food Safety Tech Staff
No Comments
FDA Logo

Infant food safety, including new arsenic and cadmium action levels, are among the new priorities the FDA plans to address before the end of 2023. On July 6, the FDA Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2023.

The following guidance topics have been added to the 2023 agenda:

  • Draft Guidance on Dietary Supplement Master Files
  • Draft Guidance on Low-Moisture Ready to Eat Foods (including infant formula)
  • Draft Guidance on Action Levels for Arsenic in Food Intended for Babies and Young Children
  • Draft Guidance on Action Levels for Cadmium in Food Intended for Babies and Young Children
  • Amendment to the Menu Labeling Supplemental Guidance
  • Guidance on Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein.

Public comments on the list of human food and cosmetic guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA – 2021-N-0553.

The FDA’s list of guidance topics is just one of several resources that the Foods Program routinely shares with stakeholders and partners to inform them of agency priorities. Most proposed and final rules are on the “Unified Agenda of Regulatory and Deregulatory Actions,” which is published by the Office of Information and Regulatory Affairs in the Office of Management and Budget. The Unified Agenda is updated twice a year and reports planned actions by federal departments and agencies government wide. A list of those FDA regulations and guidance documents under Administration review is available on the Office of Management and Budget website.

 

Jennifer Allen
Food Safety Attorney

Protecting the Nation’s Tiniest Consumers

By Jennifer Allen
No Comments
Jennifer Allen

Does your company need to worry about regulations relating to foods designed for infants (considered to be anyone aged 0-12 months)? If you manufacture infant formula, then of course the answer is yes. But what if you manufacture baby food—those cute little jars of liquified goodness? Traditionally, those types of food haven’t been subject to any special FDA regulations. Manufacturers simply need to follow the regulations that govern all foods designed for consumption by humans of any age. That, however, is changing.

There is a growing push to limit, and ultimately eliminate, heavy metals, such as inorganic arsenic, lead, cadmium, and mercury, present in baby food. These elements are present in our food chain in amounts that are concerning to members of the U.S. Congress and other stakeholders because of modern manufacturing techniques, and they have an outsized effect on infant health.

Pending Legislation

On March 25, 2021, the Baby Food Safety Act was introduced in Congress. As of the time this article was written, it had not yet passed. If it passes, it will require manufacturers, within one year of its enactment, to reduce levels of inorganic arsenic in non-cereal foods to 10 ppb and in cereals to 15 ppb, levels of cadmium and lead to 5 ppb in non-cereals and 10 ppb in cereals, and levels of mercury to 2 ppb in non-cereals and cereals. Within three years of enactment, the Act requires that final regulatory levels be set that reduce these levels to an even lower amount. It also requires reevaluation of the current regulatory levels every five years thereafter.

But the Act would do much more than simply setting limits for heavy metals in baby food. It would also:

  • Add regulations to the Food Drug and Cosmetics Act requiring FDA to specifically regulate foods for consumers up to 36 months old
  • Require manufacturers to report levels of heavy metals biannually on their websites
  • Give FDA mandatory recall authority
  • Mandate creation of public awareness campaigns
  • Offer grants for farming research

Current FDA Actions

The FDA is already working to reduce heavy metals in baby foods. In August 2020, the FDA finalized guidance setting the limit for inorganic arsenic in baby rice cereals to 100 micrograms per kilogram. Fortunately, most manufacturers had already achieved those limits; sampling from 2018 showed that 76% of manufacturers were in compliance, up from 47% in 2014 and from just 36% between 2011 and 2013.

In early 2021, FDA launched an action plan to address heavy metals in foods consumed by infants and young children, called Closer to Zero. The overarching purpose of the plan is to gather data about heavy metal levels and then set tolerances for those substances, with the input from all stakeholders. Thus, the FDA has signaled its intent to act regardless of what Congress has in store.

More recently, the FDA issued draft guidance, titled “Action Levels for Lead in Food Intended for Babies and Young Children,” recommending that levels of lead be limited to 10 ppb in fruits, some vegetables, and yogurt, and to 20 ppb in root vegetables and dry cereal. The guidance is focused on processed foods, including foods served in jars, pouches, tubs, and boxes intended for children under two.

Whatever the ultimate outcome of these initial steps taken by Congress and FDA, one thing is clear: Concerns about heavy metals in the foods consumed by our tiniest citizens isn’t going away. So, if the product you manufacture or grow may be destined for a jar of baby food—even if you don’t think you manufacture baby food—it’s time to begin working to address the issue in your facilities and your fields.

FDA Logo

FDA Calls for Enhanced Powdered Infant Formula Safety Measures in Letter to Industry

By Food Safety Tech Staff
No Comments
FDA Logo

On March 8, the FDA sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of our infants.

The agency notes that since the 2022 infant formula recalls and resulting shortages, it has been working to improve the resiliency of the infant formula supply by issuing multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate products in the U.S. marketplace through the exercise of enforcement discretion. The FDA has also taken steps to enhance the safety of powdered infant formula through the development of a Cronobacter prevention strategy, enhanced inspectional activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate.

In addition, over the past two months, food safety staff have been meeting regularly with manufacturers to further develop the prevention strategy to help prevent Cronobacter illness associated with consumption of powdered infant formula. The letter sent to manufacturers reflects the information the agency gained through interactions with industry as well as the latest available science on improving the microbiological safety of powdered infant formula.

The FDA called on members of the infant formula industry to use the information in the letter to take prompt action to improve processes and programs for the protection of infants. In addition to this call to action, Congress recently added new requirements for manufacturers aimed at mitigating supply chain disruptions through mandatory shortage notifications and risk management plans.

 

Salmonella

National Advisory Committee Announces Public Meeting to Discuss Actions on Cronobacter, Cyclospora and Salmonella

No Comments
Salmonella

The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will hold a virtual public meeting on November 15 from 10:00 am to 12:00 pm ET to discuss work being advanced by the FDA on Cronobacter spp. in powdered infant formula. The Committee will also discuss updates under the Cyclospora cayetanensis subcommittee and vote on adopting the report: “Enhancing Salmonella Control in Poultry Products.”

NACMCF is an advisory committee, established by the USDA, that provides impartial, scientific advice and/or peer reviews to federal food safety agencies for use in the development of an integrated national food safety systems approach.

The meeting is intended to help the committee gain scientific insight regarding Cronobacter infections, including recommendations for how public health authorities can better protect public health, as well as recommendations for food safety management practices that the food industry can implement to enhance the safety of powdered infant formula.

The meeting will be held virtually using Zoom. Attendees must pre-register to receive a join link, dial-in number, access code and unique Attendee ID. Attendees who would like to deliver comments during the meeting must register by November 8, 2022. Attendees who do not plan to speak at the public meeting may register at any time up to the day of the meeting. The meeting agenda is available on the FSIS events page.

 

Gary Nowacki
FST Soapbox

It’s Time To Embrace Ingredient Agility

By Gary Nowacki
No Comments
Gary Nowacki

In a recent Politico report, critics blasted the U.S. Food and Drug Administration (FDA) for chronic failures, including instances of contaminated baby formula, outbreaks of contaminated produce and the agency’s institutional reticence to implement changes.[1] Compounding the situation is the most fragmented global supply chain in history, making it a particularly challenging time for food and beverage companies.

Ingredients are the building blocks of the supply chain, so when circumstances threaten their integrity and availability, the ripple effect can linger for weeks, months or even years. As the FDA’s limitations become more apparent and supply chain challenges persist, brands must take responsibility for foundational change that addresses and mitigates risks related to food-, beverage- and supplement-borne illness.

Food Safety and Supply Chain Issues Challenge CPGs

As the Politico coverage pointed out, high turnover at the top of FDA has contributed to the agency’s challenges: five different commissioners have led the FDA over the last three years. In addition to concerns with federal oversight, brands are still navigating a broken supply chain, which has taken a beating over the last few years. And while the damage has come from war, trade tariffs and shipping congestion, food safety also emerged as a culprit when the FDA announced a recall of some of the country’s most popular infant formula brands. In February, the agency announced it was investigating consumer complaints of bacterial infections in four infants who were hospitalized. This bacterial infection might have contributed to death in two cases.[2]

While the recall emerged as a catalyst for the U.S. formula shortage, it wasn’t the only factor. Import restraints and market concentration (four companies produce 90% of the formula sold [3]) contributed to this perfect storm that rocked an already strained supply chain. National out-of-stock rates peaked at 70% near the end of May, and regulators announced that they did not expect relief until July. [4]

In scenarios such as this, the best defense brands can employ is to build a diverse supplier base and agile ingredient supply chain. Relying on a limited number of ingredient suppliers is a risky strategy even under the best of market conditions. But when disaster strikes, it can cripple a manufacturer and grind production to a halt. For the sake of consumers, creating agility and resilience around ingredients and sourcing is critical.

Equally important to cultivating relationships with alternate suppliers is the ability to have quick access to critical data. A robust digital document management system that offers manufacturers a unified view of products, data and processes across the business and the supply chain can help brands ensure they have a resilient ingredients network able to withstand supply chain or ingredient-sourcing issues. CPGs can benefit from instant access to millions of supplier documents to help fast-track sourcing, formulation and recipe development as well as protect themselves from potential disaster.

Pandemic Uncertainty and New Legislation

As the pandemic ramped up in March 2020, the FDA announced it would pause most foreign food inspections.[5] Additionally, regulators moved to virtual audits to keep their inspectors safe from COVID. Recalls fell. The FDA reported 495 recalls in the fiscal year 2020 and 427 in 2021. By comparison, the agency reported 526 recalls in the fiscal year 2019.[6]

The drop in recalls could be attributed to the ongoing rollout of the Food Safety Modernization Act (FSMA), which strengthened food production safeguards. In addition, a proposed rule change to FSMA, Section 204, would enforce better recordkeeping and quicker recall responses. The introduction of the Formula Shortage Reporting Act of 2022, requiring immediate action from manufacturers when future disruptions to production occur, is another step toward stricter food standards.

If passed, Section 204 would require companies who process, pack or hold items on the food traceability list (FTL) to capture and store ingredient data for two years, and submit it within 24 hours of a recall.[7] Without a formal system of record in place to manage food production, tracing ingredients—where, when and from whom they came—is a difficult and complex challenge to solve. Human error, overseas suppliers, recalls and other constantly changing variables all must be tracked and monitored constantly. This diligence demands automation and collaboration at scale.

Collaboration via holistic networked platforms can facilitate that diligence by enabling global ingredients suppliers, CPG brands, co-manufacturers and packing companies to build safer, stronger and more modern supply chain networks. Today, the stakes of not having a modern supply chain and access to real-time ingredient data have grown exponentially beyond profit and competitive advantage to a whole new level of costing lives.

Nimble Access to Ingredient Data is Crucial

On May 27, U.S. Sen. Edward J. Markey, D-Massachusetts, introduced the “Ensuring Safe and Toxic Free Foods Act.” The bill, co-sponsored by Sens. Richard Blumenthal, D-Connecticut, and Elizabeth Warren, D-Massachusetts, would—among other things—strengthen the Substances Generally Recognized as Safe (GRAS) Rule, which allows companies to avoid pre-market approval for food chemicals.[8]

The bill would direct the FDA to revise the GRAS Rule to include provisions that:

  • Prohibit manufacturers from designating substances as safe without supplying proper notice and supporting information to the Secretary of Health and Human Services
  • Require safety information to be publicly available on the FDA website and subject to a 90-day public review period
  • Prohibit carcinogenic substances from receiving GRAS designation
  • Prohibit substances that show reproductive or developmental toxicity from receiving GRAS designation
  • Prohibit people with conflicts of interest from serving as experts in reviewing and evaluating scientific data regarding GRAS designations

Brands must have easy access to ingredient data to ensure compliance with the GRAS revisions as well as be proactive about food safety. Software that monitors threats and regulatory risks throughout the supply chain in real-time is essential to prevent both food safety issues and supply chain disruptions. These systems transform massive amounts of data into user-friendly, actionable insights for fast and effective risk management.

Food safety remains one of the gravest public health threats to consumers worldwide. The U.S. Centers for Disease Control and Prevention (CDC) insists that foodborne diseases cause 76 million illnesses in the U.S. annually, leading to 325,000 hospitalizations and 5,000 fatalities.[9]

With the FDA still struggling to regain the agency’s pre-pandemic diligence, it’s incumbent on manufacturers to double down on food safety. Digitization—evolving from paper to relevant, real-time data—is a critical component of the path forward to improve safety and increase ingredient agility.

Technology and automation help manufacturers and suppliers work better together, collaborate on ingredient data, move more quickly and problem solve together. In today’s modern supply chain, more CPGs are investing in partnerships to increase agility and gain more resilience over the shocks we’ve seen the past few years. More flexible and collaborative tools for engaging with global ingredient supplier networks can increase safety while improving bottom line efficiency.

References:

[1] Bottemiller Evich, H. (2022, April 8). The FDA’s Food Failure. Politico.

[2] U.S. Food & Drug Administration. (2022, May 12). Powdered Infant Formula Recall: What to Know.

[3] Muller, M. & Nyler, L. (2022, May 20). How US Baby Formula Monopolies Have Failed Families. Bloomberg.

[4] KHN. (2022, May 27). FDA Chief Suggests Stockpile Of Baby Formula Once Crisis Ends In July. Kaiser Health News.

[5] U.S. Food & Drug Administration. (2021, May). Resiliency Roadmap for FDA Inspectional Oversight.

[6] U.S. PIRG Education Fund. (2022, January 31). Food Recalls Decline in 2021, but That Doesn’t Mean Food is Safer.

[7] Govinfo.gov. (2022, June 13). Formula Shortage Reporting Act of 2022.

[8] Ensuring Safe and Toxic-Free Foods Act of 2022. (2022, May 27). Ensuring Safe and Toxic Free Foods Act.

[9] Centers for Disease Control and Prevention. (2018). Estimates of Foodborne Illness in the United States.