FDA has released an updated infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The program is designed to outline the agency’s approach for inspections, sample collection, sample analysis, and compliance as part of its effort to strengthen the safety, resiliency, and oversight of the formula industry.

In September 2022, FDA released its internal evaluation of the ifant formula response, which recommended that the agency review and update its compliance program to ensure it reflected the latest science on Cronobacter.

The agency says the updated program builds on lessons learned over the last several years to expand on its approaches for inspections, sampling, laboratory analysis, and imported formula products. For example, updates include instructions for annual environmental sampling of Cronobacter and Salmonella at powdered infant formula facilities. The compliance program provides instruction for FDA notification should a sample test positive for Cronobacter or Salmonella.

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 formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, is included in the updated compliance program. In addition, it further elaborates on new related requirements included in the Food and Drug Omnibus Reform Act of 2022.

All updates related to the oversight of infant formula can be found on FDA’s infant formula webpage.

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An ad hoc committee under the auspices of the National Academies of Sciences, Engineering, and Medicine (NASEM) will examine challenges in the supply, market competition, and regulation of infant formula in the U.S. The project is sponsored by FDA.

The study will explore the current state of the country’s infant formula market, including the diversity of manufacturers; the types of formulas they produce (e.g., non-specialty or specialty, powdered, or liquid); manufacturing facilities, production, and production capacity; the amounts of infant formula produced domestically and the amounts imported; and other characteristics.

The study will also examine how these characteristics compare with those of the market prior to the COVID-19 pandemic, and just prior to the Abbott recall in February 2022. The study will consider a range of conditions and systems that may be influencing competition in market. Additionally, the National Academies will examine the differences in the nutritional content, labeling, and other regulatory requirements between infant formula sold in the United States and formula sold in foreign markets, such as in the European Union.

As part of the Food and Drug Omnibus Reform Act of 2022, Congress directed FDA to develop an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, which was released in March 2023; to engage with NASEM on a deeper study of challenges in the U.S. supply, market competition, and regulation of infant formula; and then for FDA to use the information gained through the NASEM study to develop a long-term national strategy.

NASEM will submit its findings to both Congress and FDA.

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FDA has released an immediate national strategy to increase the resiliency of the U.S. infant formula market. The strategy follows a months-long infant formula shortage sparked by unsanitary conditions at one of the nation’s largest infant formula facilities, which led to a significant voluntary recall and multiple-month production shutdown.

As directed by Congress in the Food and Drug Omnibus Reform Act of 2022, the national strategy details the agency’s plans to improve the formula supply. It also traces the events that led up to and followed the voluntary recall of formula by Abbott Nutrition in February 2022, the temporary pause in production at the company’s facility in Sturgis, Michigan, as well as other factors that contributed to and exacerbated the shortages.

This strategy represents a first step toward issuing, with input from the National Academy of Science, Engineering and Medicine, a long-term national strategy in 2024 to improve preparedness against formula shortages by outlining methods to improve information-sharing, recommending measures for protecting the integrity of the formula supply chain, and preventing contamination. The long-term strategy will also explore new approaches to help facilitate entry of new infant formula manufacturers to increase supply and mitigate future shortages and recommend other necessary authorities to gain insight into the supply chain and risks for shortages.

Read the full strategy document.

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When foods make people sick, the U.S. Department of Justice (DOJ) often partners with FDA to investigate and prosecute violations of food safety laws that appear to involve willful failure to follow regulatory requirements. When DOJ elects to get involved, the alleged food safety violations are typically egregious and have caused significant harm to the public. In these circumstances, DOJ may pursue civil penalties, criminal charges, or both.

Abbott Laboratories recently confirmed that DOJ had opened a criminal investigation into operations at the company following the infant formula recall and ensuing crisis in 2022. It was reported that DOJ previously entered into a consent decree with Abbott to allow the company to resume operations as long as they complied with certain requirements imposed by the decree. Reports released about the operations at Abbott assert that senior management at the facility and company may have been aware of the alleged conditions that led to the recall and failed to correct the conditions. FDA additionally alleged that Abbott Laboratories infant formula may have caused the death of two infants.

Other companies have been targeted by DOJ in the past. DOJ has previously, for example, pursued criminal charges against Kerry Inc. for insanitary plant conditions that were linked to a Salmonella outbreak. Blue Bell Creameries and individuals responsible at the corporation were also the focus of DOJ investigations and ultimate charges for Listeria contamination of ice cream. DOJ also used its authority to charge and convict individuals responsible at the Peanut Corporation of America for their conspiracy to distribute Salmonella-contaminated peanut products into interstate commerce.

When the U.S. Congress passed the laws that give FDA authority to regulate food products, Congress expressly included penalties for violations by food companies. The Federal Food, Drug, and Cosmetic Act provides for criminal and civil penalties for violations of the act’s requirements. Specifically, the legislation sets the penalty for an initial violation of certain provisions of the act as imprisonment for no more than one year, a fine of no more than $1,000, or both—for each count. When a violation occurs after a previous conviction for a violation of the act, or if the violation is committed with the “intent to defraud or mislead,” the penalty can be imprisonment for no more than three years, a fine of no more than $10,000, or both imprisonment and a fine (21 U.S.C. § 331(a)). Again, this is for each alleged count.

When a violation is identified, DOJ is responsible for investigating the violation and determining whether civil or criminal penalties should be pursued. Because possible violations are identified every day by FDA, DOJ must evaluate each violation to determine if DOJ’s resources would be best used under those circumstances. Typically, cases are referred to DOJ by FDA after a review of the violation by the agency to determine if a criminal investigation is recommended. FDA has stated that, among other factors, it will consider the likelihood and severity of harm associated with the violation and whether the violation reflects a pattern of behavior or the disregard by the company of prior warnings. DOJ then conducts its own investigation after receiving a referral from FDA, and will consider similar criteria, in addition to evaluating the likelihood of successfully prosecuting the violation.

Voluntary Self Disclosure

Notably, DOJ recently announced a voluntary self-disclosure program that will be applicable to any corporate misconduct prosecutable by a U.S. attorney, including violations of the Federal Food, Drug, and Cosmetic Act. The program allows DOJ to enter into more favorable resolutions with companies that voluntarily self-disclose misconduct that may constitute a violation.

To qualify as a voluntary self-disclosure under the program, the disclosure must be voluntary and not be a disclosure required by a regulation, contract, or DOJ resolution; it must also be prompt and not in response to threat of disclosure or government investigation, and must include all relevant facts known to the company. Even when a disclosure does not meet each of these requirements, DOJ has stated that it will, nevertheless, still consider the disclosure favorably.

When evaluating the violation, DOJ will consider the disclosure, among other factors, when determining what resolution to seek. For example, DOJ will consider whether the company fully cooperated with DOJ. Additionally, timely and appropriate remediation by the company will be positively considered by DOJ. Finally, factors such as the pervasiveness of the conduct throughout the company, its impact on public health, and the knowledge of executive management will also be considered by DOJ.

When a company becomes aware of misconduct, DOJ seeks to encourage disclosure. The policy allows DOJ to recommend a reduced fine when a voluntary self-disclosure occurs. In addition, DOJ can utilize resolutions other than a guilty plea in such circumstances, which may allow the company to better remedy any violation and recover after the misconduct is resolved.

Deferred Prosecution

There are favorable resolutions available when a voluntary self-disclosure occurs. These include entering into a deferred prosecution agreement (DPA), which requires the company to institute certain procedures and protections to ensure future compliance with requirements. Under a DPA, DOJ agrees not to prosecute the underlying violation further if the company continues to comply with the additional requirements outlined in the agreement.

Indeed, in 2020, Chipotle entered into a DPA with DOJ. Under that agreement, DOJ agreed not to pursue a guilty plea based on the 2015 outbreaks associated with Chipotle and the underlying concerns with the company’s illness policy and training. In exchange, Chipotle was required to develop, implement, and maintain an improved food safety compliance program. In addition, the company was required to use independent experts to evaluate its approach to food safety. Ongoing certification of compliance by Chipotle was required for the duration of the agreement, and the company paid a criminal fine of $25,000,000. Had DOJ pursued charges, however, Chipotle might have faced much more significant penalties than were included in the DPA.

Individual Accountability

In addition to potential criminal and civil liability for a food company, responsible individuals within the company can also face liability. The Responsible Corporate Officer Doctrine, also referred to as the Park Doctrine, allows DOJ to expand criminal prosecution to companies and officers of the company, even without any intent to violate the law or awareness of the violation. In fact, DOJ attorneys have been directed to ensure that individuals are held accountable, as well as corporations, when misconduct occurs. To successfully prove a case against a corporate officer under the Park Doctrine, DOJ must demonstrate that the individual was in a position of responsibility relevant to the violation, that the individual was able to prevent or correct the violation, and that the individual failed to prevent or correct the violation.

A strong food safety culture throughout an organization can prevent corporate misconduct that could lead to investigations by DOJ. Recent DOJ resolutions with food companies, for example, have included criminal charges against individuals who knowingly and willingly covered up contamination of foods in commerce. When a violation of requirements becomes known to a company, rapid and effective action to prevent illness in consumers and to correct the underlying causes of the violation must be taken to reduce the risk of prosecution. In addition, any time a company learns that a consumer may have become ill as a result of consuming its products, company leadership should consult immediately with legal counsel to ensure it is taking appropriate actions in response. Doing so could make the difference between going to prison or staying out of jail.

Stevens is a food industry attorney and founder of Food Industry Counsel, LLC, and a member of the Food Quality & Safety Editorial Advisory Panel. Reach him at stevens@foodindustrycounsel.com. Presnell, a food industry consultant and lawyer who is also with Food Industry Counsel, has worked in the food industry for nearly a decade. Reach her at presnell@foodindustrycounsel.com.

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In early March, FDA sent a letter to members of the infant formula industry requesting that they better protect those using powdered formula. In the letter, which was sent to manufacturers, packers, distributors, exporters, importers, and retailers of formula, the agency requests that these companies be in full compliance with all relevant regulations.

FDA wants the infant formula industry to evaluate their systems of production and in-process controls at all stages of processing; be in full compliance with all relevant regulations, including infant formula requirements pertaining to current good manufacturing practices, quality control procedures, quality factors, records and reports, and notifications rule; implement a plan on when to take corrective actions; improve adherence to the notification requirement of an adulterated or misbranded infant formula any time this type of product has left a facility; and voluntarily notify FDA any time a product sample tests positive for Cronobacter or Salmonella.

This latest letter was sent in the wake of President Biden’s request for more than $7 billion for FDA as part of his latest budget proposal. The President requested the additional funding in part to boost food safety activities and invest more in infrastructure, with a renewed focus on farm-to-bottle assessment on infant formula.

While requesting that industry take a proactive approach to enforce safety standards, efficiently manage suppliers, and better prepare for recalls might seem like basic requests, critics argue that the regulatory apparatus moves too slowly.

Mitzi Baum, CEO of STOP Foodborne Illness, a nonprofit organization focused on the prevention of illness and death from foodborne pathogens, notes that five “areas of concern” identified in the letter are basic food safety concepts and are activities that all food manufacturing plants should be conducting daily to ensure that their systems are effective and their products are safe. “The request is to self-regulate when the FDA is not present,” she tells Food Quality & Safety. “This means the manufacturers must understand the regulations—which were cited in the letter along with hyperlinks—monitor to the regulatory standard, and document any findings and corrective actions.”

On March 21, the House Committee on Oversight and Accountability, called on FDA to provide documents and communications related to its response to the U.S. infant formula crisis, reiterating serious concerns over the Biden Administration’s failure to respond to the nationwide shortage. The committee has scheduled a hearing for March 27 and Frank Yiannas, former deputy commissioner for food policy and response at FDA, is expected to testify.

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A study conducted by researchers at the University of Buffalo in New York and recently published in the journal Current Problems in Pediatric and Adolescent Health Care looked at gaps in the U.S. regulation of toxic metals in baby foods such as rice cereal, formula, purees, and puffs.

The researchers determined that the U.S. doesn’t have the kind of strict regulations for commercially produced baby foods that parents might expect. “It is concerning that there are gaps in food contaminant federal guidelines, particularly for baby foods. Parents might expect and trust that their infant’s commercially produced baby food is automatically protected by tightly regulated guidelines, but that is just not the case,” says the study’s lead author, Sarah J. Ventre, MD, clinical assistant professor in the department of pediatrics in the Jacobs School of Medicine and Biomedical Sciences at the university.

Gauri Desai, PhD, MPH, a clinical assistant professor in the department of epidemiology and environmental health at the university and who was part of the study’s research team, notes that there are few clear, evidence-based guidelines on the maximum tolerable limits of toxic metals in foods and little understanding of toxicant exposure or adverse health effects attributable to dietary exposure in the current regulatory guidelines. “Several foods consistently appear in the literature as potential sources of toxic element exposure,” she says. “Both homemade as well as store-bought foods are found to contain toxicants. Contaminated drinking and cooking water, including water used to prepare infant formula, could also be a major exposure source.”

The researchers found that, while there is an increase in the number of studies focused on the presence of contaminants in foods consumed by children, there is still a dearth of information on the topic. The researchers were also struck by the scarcity of clear guidance that takes into account the complexity of issues—that multiple toxic element exposures may be occurring, and that these stem from the same diets that provide health-promoting nutrients. “First, we do not have a comprehensive picture on the extent of exposure to toxic elements in young children,” Katarzyna Kordas, PhD, associate professor of epidemiology and environmental health at the university’s School of Public Health and Health Professions and senior author of the study, tells Food Quality & Safety. “Second, we do not know how exposure to toxic elements through the diet is affecting child health. We know that toxic elements are bad for children’s development and health, but healthy foods in themselves are good because they provide beneficial vitamins, minerals, bioactive components, etc. Will that counterbalance the effects of toxic elements? While that is the hope, there are no studies to allow us to say this for sure.”

She adds that clearer recommendations are needed for parents, but this is not an issue they can be expected to address alone. There is a need for broader, systemic protections supported by well-developed research studies to address the knowledge gaps. “More frequent inspection of manufactured foods [and] better labeling, combined with public messaging on what the labels mean, should be part of the strategy to limit exposures in young children.”

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In the summer of 2022, Rep. Rosa DeLauro and Sen. Dick Durbin introduced the Food Safety Administration Act, which essentially calls for FDA to be divided into two agencies: one responsible for food and one responsible for drugs/medical devices.

“Food safety is currently a second-class citizen at the FDA,” DeLauro said when she introduced the bill. “Right now, there are no food policy experts in charge of food safety at the FDA. That is unacceptable and contributes to a string of product contaminations and subsequent recalls that disrupt the supply chain, contribute to rising prices, and in many cases, result in consumer illness and death.”

One needs only to look at 2022’s infant formula crisis, in which Abbott Laboratories’ Sturgis, Mich., facility was allegedly responsible for producing formula contaminated with Cronobacter sakazakii, to understand the Senator’s concern.

This type of issue is one reason the bill is looking to create a single food safety agency, led by a food policy expert, to ensure the safety of products that go to market.

Tyler Williams, CEO of ASI Food Safety, which oversees the certification process in more than 3,000 audits annually and has trained and consulted with numerous major food and beverage companies around the world to help improve their food safety practices, notes that longtime critics of FDA have been pushing for a split in the agency for several years. “Food safety experts argue that food safety and security is a secondhand thought after drugs and medical devices, whereas the pharmaceutical industry feels drug approvals are slowed down by the FDA being distracted by food industry recalls,” Williams says. “It feels like the food sector has been the red-headed stepchild of the FDA, or maybe the agency just simply has too much on its plate, but either way, the legislation being introduced by food policy experts calls for a division of power that will hopefully prioritize food safety and protect consumers.”

Cassandra LaRae-Perez, a food and beverage attorney at Gravel and Shea in Burlington, Vt., notes that proponents of the bill argue that a separate agency would bring leadership more focused on food safety, more accountability, and a unified and efficient structure, but it is unclear how a separate agency would perform better, and whether additional resources would be devoted to ensuring its success. “In short, the bill seeks to tighten regulation on food producers and to increase credibility and autonomy of the regulators responsible for food safety, but without a significant, perhaps outsized dedication of monetary and human resources and willing participation in the Senate to swiftly appoint a leader for the agency, it’s not clear how its aims can be achieved,” she says.

Reagan-Udall Foundation Report

Brian Ronholm, director of food policy for Consumer Reports, says that FDA has inadequately responded to outbreaks and missed deadlines for implementing critical food safety initiatives, which has undermined consumer confidence in the agency’s food program. “One of the big proposals that gets support is creating an empowered deputy commissioner position that would have oversight authority over the foods program at the agency,” he says. “That would put someone in charge of food, because that’s what is lacking.”

In July 2022, a few months after the infant formula crisis that was responsible for the death of at least two infants, FDA commissioner Robert Califf, MD, commissioned a review of the Human Foods Program by the Reagan-Udall Foundation, an independent group of experts. Their findings, released in December 2022, recommended a major overhaul and reform of FDA, essentially backing up the bill.

David Acheson, founder and CEO of The Acheson Group and former FDA associate commissioner for foods, notes that a split isn’t a new idea, but legislation has never gained much traction before. He says Dr. Califf’s call for the Reagan-Udall Foundation report is a good sign—much needed—that change is possible.

The report outlined several key problems within the agency’s culture, structure, resources, and authority. “The report uncovered several issues ranging from reporting structures and clear lines of authority to a lack of a clear and compelling vision, mission, and value statement specific to the Human Foods Program,” Williams says. “While some of these issues could be fixed with an agency split, most of these issues require a cultural change from a reactive approach to food safety to a proactive approach.”

Some recommendations from the report to improve the agency included requesting records from food manufacturers in advance of or in lieu of an inspection; being notified when designated food categories, such as infant formula, are likely to experience shortages or when supply chain disruptions are anticipated; expanding the criteria for suspension of registration for food facilities; invoking civil monetary penalties for various violations; and granting administrative authorities that allow FDA to use a progressive enforcement strategy that does not require a determination of serious adverse health consequences or death to humans or animals.

Additionally, the report recommended that FDA be bolder in strengthening its implementation and use of existing FSMA authority to collect user fees; use its mandatory recall authority more frequently—especially for life-sustaining products that are the only source of nutrition for certain populations; and more effectively identify opportunities to monitor both industry and consumer behavior to better understand industry implementation and consumer response to FDA’s nutrition initiatives.

Some recommendations called for radical changes within the agency, Acheson says, and now the industry is waiting for Dr. Califf to respond. “The priorities on the hill are not this, however, so, it may be more about what can be done without congressional approval, and that would mean an internal restructuring,” he adds. One example of this restructuring could involve creating a new component within FDA that would effectively contain everything that a new agency would contain, but with lower costs being and without the disruption and need for statute change, which Acheson believes is highly unlikely at the moment, despite the bill.

The Advantages of an Agency Split

While it’s hard to say whether there would be any immediate benefits for either industry or consumers without seeing a detailed action plan, Acheson believes one of the biggest potential benefits of separating FDA into two agencies is having a split leadership team. “Currently, most of FDA’s leadership comes from the drug and medical device industry,” he says. “By splitting the agency, we could see leaders with extensive knowledge in the industry they are regulating ensuring that doctors are not responsible for developing food safety policies and food safety experts aren’t weighing in on drug approvals.”

Additionally, a potential split of FDA between food and drugs could lead to a potential merger between USDA’s food safety responsibilities and those of FDA. “We’ve experienced so many issues within the food supply chain that come from the farming sector, later trickling down to manufacturing, then to retail, that it has left many food industry professionals questioning the separation of powers between the two agencies,” Williams says. “Due to the already existing overlap between the FDA and USDA, this could make regulating these products much easier in the future.”

Is a Split Really Possible?

While there are plenty of advocates for a split, making it happen would come with challenges. FDA would need to allocate team members to oversee each sector, hiring more experts to work on one side of the agency or even both, to keep things moving. Challenges within the food supply chain or the drug supply chain may also be burdensome.

Still, Williams says, “Never say never.”

“I think if the FDA is supportive of it, Congress will likely align with whatever the FDA thinks is best, as long as it’s not costing them more money,” he adds. “However, the split could mean a more immediate need for an increase to the FDA’s budget, which some members of Congress would likely not support. I also think the push from big pharma and their powerhouse of lobbyists could help push this along. The pharmaceutical industry feels that they would be able to get drugs approved faster if the agency was split, which has a direct impact on a pharmaceutical company’s bottom line.”

Ronholm agrees and expects more dialogue on the idea to happen in 2022. And even if it doesn’t, the Reagan-Udall Foundation report revealed a lot of organizational failures that validated what many food safety experts have been saying for years, and he believes FDA will take many of the ideas for betterment into consideration, which would have a huge impact on food safety going forward.

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Abbott Laboratories is under investigation by the U.S. Department of Justice (DOJ). The investigation follows the DOJ’s probe into the deaths of two infants last year who allegedly consumed infant formula produced at Abbott’s Sturgis plant in Michigan. The facility was shut down through June 2022 to address deficiencies, which resulted in a nationwide formula shortage.

Laurie J. Beyranevand, JD, a professor of law and director of the Center for Agriculture and Food Systems at Vermont Law and Graduate School in South Royalton, says it’s important to note that the DOJ has both a civil and criminal unit. “Last May, the civil unit of the DOJ filed a complaint and entered into a consent decree with Abbott Laboratories that enabled them to resume manufacturing of infant formula after having been previously enjoined from production,” she tells Food Quality & Safety. “The complaint alleged that Abbott manufactured adulterated powdered infant formula under insanitary conditions that failed to protect it from contamination from certain bacteria including Cronobakter sakazakii and Salmonella.”

Under the consent decree, the company was required to retain outside experts to bring the Sturgis, Mich., facility into compliance with the requirements under the Food, Drug, and Cosmetic Act and current good manufacturing practices.

This new investigation is a criminal investigation of the company, though the scope remains unclear. “Given the severity of the violations—including the fact that a whistleblower said the company knew about the contamination and falsified records to prevent FDA officials from identifying problems related to the company’s processes for monitoring the presence of bacteria in formula—in conjunction with the ongoing formula shortages, the DOJ may have determined civil penalties were not sufficient to address the issue,” Beyranevand says.

Abbott Laboratories says that it is cooperating fully with the investigation.

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USDA’s Food and Nutrition Service (FNS) is proposing changes to the foods prescribed to participants in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). These science-based revisions incorporate recommendations from the National Academies of Science, Engineering, and Medicine and the Dietary Guidelines for Americans, 2020-2025. FNS is proposing changes to align the program’s food packages with the latest nutrition science and support equitable access to nutritious foods during critical life stages.

Taken collectively, the changes will increase the current level of assistance while providing WIC state agencies with more flexibility to tailor the packages to accommodate personal and cultural food preferences and special dietary needs and increase variety and choice for WIC participants, making the program more appealing for current and potential participants.

The proposed revisions support fruit and vegetable consumption by increasing the amount provided and the varieties available for purchase. During the pandemic, Congress implemented a significant but temporary boost to the benefit provided to WIC participants for purchasing fruits and vegetables. FNS proposes making that increase permanent, providing participants with up to four times the amount they would otherwise receive. The agency also proposes revisions that give participants a greater variety of fruits and veggies to choose from and adjust the quantity of juice to reflect nutrition guidance, which emphasizes whole fruits and vegetables.

Other proposed changes include:

• Expanding whole grain options to include foods like quinoa, blue cornmeal, and teff to reflect dietary guidance and accommodate individual or cultural preferences;
• Providing more non-dairy substitution options such as soy-based yogurts and cheeses, and requiring lactose-free milk to be offered;
• Including canned fish in more food packages, creating more equitable access to this under-consumed food;
• Requiring canned beans to be offered in addition to dried; and
• Adding more flexibility in the amount of formula provided to partially breastfed infants to support individual breastfeeding goals.

The comment period on the proposed changes will be open through February 21, 2023.

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FDA is no longer accepting requests for enforcement discretion for certain requirements that apply to infant formula, the agency announced in November, based on its temporary guidance released in May 2022 and in effect through earlier this week. Now, FDA has said it will provide a pathway for formula manufacturers to continue marketing these products while they work toward fully meeting FDA requirements. “Under the new guidance, the period of enforcement discretion for these products is being extended until January 6, 2023, with further extensions possible for firms that express interest in and take steps toward remaining on the U.S. market,” FDA said in a statement.

For background, in May 2022, FDA issued new guidance to manufacturers of infant formula as a way to temporarily exercise enforcement discretion on certain requirements that applied to infant formula, an action the agency hoped would help increase the supply of infant formula in the United States. The need for increased supply of formula became even more pressing after two major occurrences—a February 2022 voluntary recall by Abbott Nutrition due to formula contaminated with Cronobacter sakazakii at the company’s Sturgis, Michigan, facility, and increased strains on supply chains experienced during the COVID-19 pandemic.

Additionally, on November 15, FDA announced plans to create a dedicated team of investigators for infant formula production as part of its ongoing strategy to prevent contamination of any product. Part of the agency’s plan would be to realign staff across the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs in hopes of better supporting the regulatory oversight of infant formula.

FDA has also released a proposed rule that Cronobacter infections be added to CDC’s list of national notifiable diseases, an action that would require physicians to report cases of infection to public health officials.

Other actions FDA is considering include reevaluating testing requirements to enhance safety of finished infant formula products; developing and improving consumer education on how to safely prepare and store infant formula; and providing added training for staff who inspect infant formula production facilities.

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