The meal kit industry continues to grow rapidly, with a market size projected to reach $17.8 billion in 2023, compared with $13.50 billion in 2022, according to a report from The Business Research Company. But this relatively new sector of the food industry faces some additional growing pains.

For example, FSIS reported last year that ground beef products in HelloFresh meal kits may have been associated with reported illnesses related to E. coli infection. Additionally, the plant-based meal delivery service Daily Harvest voluntarily recalled its French Lentil and Leek Crumbles product after dozens of people who ate the product became sick. The Wall Street Journal reported that several had to undergo gallbladder surgery after eating the product.

The flurry of alarming news raised concerns about the regulatory environment surrounding meal kit delivery services. The biggest issue? The lack of targeted regulatory oversight. For now, the places where meal kit delivery and food safety intersect represent a sort of wild west of food production and distribution.

A positive development happened in December 2022, however, when a trio of federal agencies—USDA, FDA, and the Centers for Disease Control and Prevention (CDC)—issued a 49-page guide for how to ensure food safety in the third-party delivery (TPD) industry. The guidelines are not regulations, and companies do not have to abide by the suggestions, but they represent a good first step.

Either way, the industry’s lack of specific oversight does not mean that the products completely escape safety inspections. When food products of any kind are manufactured and packaged, they follow normal federal regulations and oversight. So, that vacuum-sealed bag of chicken thighs or the pouch of rice for a kung pao chicken meal does withstand USDA and FDA scrutiny, but once it’s packaged up into a box for shipping, it’s a different story.

Navigating the “Last Mile”

The main problem with meal kit food safety revolves around everything that happens once a kit leaves a company’s facility and heads to a person’s home—what FDA dubs the “last mile.”

With traditional food channels, such as grocery stores, the link between the manufacturing facility and the refrigerated shelves of the supermarket remains intact. The trucks are refrigerated if items require refrigeration. Inspectors scrutinize the trucks for signs of rodents or insects, and for holes in the truck that allow unwanted creatures and substances to enter. When the trucks reach their destinations, workers unload the boxes and direct them to their proper places, including freezers and refrigerators. All of this undergoes recordkeeping and regulatory oversight.

But with most meal kit deliveries, oversight vanishes once the products get packed into boxes. From there, companies use services such as UPS, the U.S. Postal Service, DHL, Amazon Prime, and other delivery outfits to ship boxes to customers. What else are the trucks carrying, other than the meal kits? Potentially hazardous substances, such as containers of Drano and dishwashing detergents, aerosol cans, nail polish remover, pesticides? It might all be packed helter skelter in a delivery truck. Once the products reach their destinations, often front porches and apartment lobbies, they sit until their owners whisk them away to their kitchens and ovens. This entire leg of the journey lacks FDA or USDA oversight.

The meal kit facility itself can stand as a source of concern. A wilderness of potentially unregulated control points there could affect food safety. For example, workers at a meal kit company could use unsanitary tables to repackage food they have received from suppliers, such as meat processors.

Still, I think the larger issue hinges on delivery. The COVID-19 pandemic disrupted mail service, for example. Supply chain issues combined with labor shortages and increased reliance on home deliveries snarled delivery times. With many meal kits, packages are supposed to arrive within two to three days, and the cooling device they contain will be dry ice. But what happens if it takes five to seven days to get the package out? In a regulated environment, this would be rare, but in the world of meal kit delivery, it can be anyone’s guess.

The topic has been batted around in food safety circles for several years, especially regarding food delivery in general. Uber Eats and DoorDash have become prominent channels for food delivery, but the drivers have no training in food safety. Large companies that engage with food delivery, such as national pizza chains, often train their drivers in food safety and incorporate protocols and procedures surrounding packaging and temperature control that help protect food. But with TPD services, this training is absent. The same applies to meal kits. When it comes to the delivery part of the equation, training in food safety doesn’t happen.

Safeguarding Meal Kits Without Regulations

So far, the consequences of this lack of regulation have not been especially traumatic on a grand scale, but all it takes is one big food safety fail to change everything. I do believe FDA will eventually get more involved. Perhaps they will release more than just suggested guidelines, but right now, it’s such a petite sector of the food industry that it doesn’t dwell in the bullseye of the radar.

Until the meal kit industry submits to stiff oversight, I think these companies must continue to improve. One thing they can do is perform a risk assessment to determine what could be at risk. What if the package arrives one day late, or the ice doesn’t last as long as anticipated? What if the temperature outside is especially blazing? That’s where working with experts in food safety makes a difference—they understand the key variables and can help reduce risk as much as possible.

While consumers shouldn’t assume that meal kits delivered to their doorstep are safe upon arrival, the consumer does have the critical responsibility of cooking the food to its proper temperature. The risk for E. coli, for example, diminishes dramatically when food is cooked properly. Some people like to eat burgers and hear the cow moo. It’s never a safe idea, but overly rare burgers can be especially risky with meal kit delivery. Consumers don’t know how long a package has been in transit, what kind of truck was used, and how long the package sat outside the house. Given all of these factors, it’s vital for consumers to always follow directions closely for how to cook meal kit food.

The meal kit market is a new one, and I welcome it. These companies offer consumers access to new and thrilling dishes each week, compelling them to work on their cooking skills, improve their diets, and more. Although I will always champion this market, as with any new industry, regulations lag far behind, and safety is not as strong as it is in established sectors. I encourage the companies involved to ratchet up their attention to food safety, and closely review the new federal guidelines for meal kit safety.

As the industry matures, I also encourage FDA to pay increasing attention to this exciting new category within the food and beverage industry.

Williams is chief executive officer of ASI Food Safety, an auditing, training, and consulting company based in St. Louis, Mo. Reach him at twilliams@asifood.com.

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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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On August 23, James “Jim” Jones was named as FDA’s first-ever deputy commissioner of the Human Foods Program, effective September 24, 2023. In this role, Jones will report directly to Robert M. Califf, MD, FDA commissioner, and exercise decision-making authority over all the program’s entities.

As part of the newly created position, Jones is charged with setting and advancing priorities for a proposed unified Human Foods Program, which could include food safety, chemical safety, and innovative food products that will bolster the resilience of the U.S. food. He will also lead efforts on nutrition to help reduce diet-related diseases and improve health equity.

Jones has more than three decades of experience in the U.S. Environmental Protection Agency (EPA), stakeholder community, and private industry dealing with challenges related to chemical safety and environmental sustainability. His work has primarily focused on diminishing the impact that chemicals and pollution have on the U.S. food supply. While at EPA, Jones was instrumental in the 2016 overhaul of the Toxic Substances Control Act, the first update of that statute in more than four decades. He also was responsible for decision making related to regulation of pesticides and commercial chemicals.

Jones was also a member of the Reagan-Udall Foundation’s independent panel of experts that submitted an evaluation of FDA’s Human Foods Program in December 2022, so he’s chiefly aware of FDA’s challenges and opportunities as it aims to unify the program.

“I had the pleasure of serving on the expert panel that provided operational recommendations for the FDA’s foods-related activities, and I now look forward to helping the agency realize its vision for the proposed Human Foods Program, including carrying out important nutrition initiatives to improve the health of our country,” Jones said in a prepared statement. “As a former pesticide regulator, I have a deep understanding of the unique needs of government programs involved in upholding safety of the U.S. food supply, as well as the important role that the agriculture community and state partners play in this paradigm.”

Mike Taylor, former FDA deputy commissioner for foods and veterinary medicine and a board member emeritus of STOP Foodborne Illness, says Jones is the perfect choice for this critical role. “Commissioner Califf’s important organizational changes in FDA’s Human Food Program and full empowerment of the deputy commissioner make needed, unifying change possible, in the public health interest of America’s consumers and in the interest of the food system on which we all rely,” Taylor tells Food Quality & Safety. “Jim brings the vision and collaborative leadership style needed to make that change happen.”

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In late June, FDA announced an update to its January 31 proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). The update aims to enhance coordination, prevention, and response activities across the agency.

Since the original announcement, a group of agency officials with expertise in different functional and operational areas has been working to identify additional opportunities to bolster operations within the new Human Foods Program and the ORA. The plan was informed by both the external evaluation conducted by an expert panel facilitated by the Reagan-Udall Foundation and the internal review of the agency’s infant formula supply chain response completed last year.

“This shift would allow us to fully realize the preventive vision laid out in the FDA Food Safety Modernization Act, elevate the importance of nutrition, strengthen state partnerships, and embrace innovative food and agricultural technologies that will allow us to supply the nation—and the globe—with ample safe and nutritious food in the decades ahead,” an FDA spokesperson tells Food Quality & Safety.

Among the new recommendations are granting the new deputy commissioner for human foods oversight of all budget and resource allocations for the entire HFP, including ORA resources; merging compliance functions currently managed within ORA into the HFP to streamline operations and expedite decision making; realigning the eight human and animal food laboratories that are currently managed by ORA into the HFP; transitioning certain functions under the Office of Security and Emergency Management, currently in the Office of Operations, to ORA; and unifying state and local food safety partnership functions and certain aspects of international food safety partnerships into an Office of Integrated Food Safety System Partnerships in the HFP.

Matt Regusci, director of growth for ASI Food Safety, a St. Ann, Missouri-based food safety consulting and certification firm, notes that these updates are part of what food safety and consumer advocates have been asking for. “Many people will say that this move is great but doesn’t go all the way, as most want a full split and separate commissioner of human food—truly separating the food and drug administration,” he says. “Still, it is a huge step in the right direction. The consultation of departments under the addition of a new deputy commissioner of human foods would go a long way to increase the efficiency of dealing with outbreaks and saving human lives.”

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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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In January 2023, FDA announced that it would not regulate cannabidiol (CBD) edible products under the existing regulatory frameworks for dietary supplements, citing health concerns and a lack of safety data for the substance.

The agency said it had not found adequate evidence to determine how much CBD can be consumed and for how long before causing harm, so it would not pursue rulemaking for the substance in dietary supplements or conventional foods. “Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” Janet Woodcock, MD, Principal Deputy Commissioner at FDA, said in the statement.

Consumers eat food for reasons other than to take CBD, and they may end up taking more CBD than they meant to, according to an FDA spokesperson. They might also confuse eating CBD-infused food with non-CBD food, which the agency says is especially concerning for children when CBD takes the form of a candy or snack.

FDA did state that it is prepared to work with Congress to develop a new cross-agency regulatory framework to oversee these products. Until then, regulation in the U.S. is in the hands of each state. Seventeen states plus the District of Columbia have fully legalized CBD products, with the remainder offering varying degrees of conditional approval (see “The State of CBD Legalization in the U.S.,” below).

The FDA news was disappointing to many in the CBD industry, but not entirely unexpected. Industry experts say they were waiting for FDA to proceed with federal oversight following the 2018 Farm Bill, which legalized hemp-based CBD. “The FDA has been dragging its feet for four years now,” says Jonathan Miller, general counsel for the U.S. Hemp Roundtable in Washington, D.C. “This was just another way to kick the can down the road.”

He agrees that Congress needs to step in to implement a regulatory plan, but he doesn’t want to wait years for that to happen. He would like to see CBD regulated in the same way FDA regulates other dietary supplements, with strict good manufacturing practices and labeling requirements. Miller adds that FDA’s inaction continues to be damaging for everyone—from the farmers planning their crops to the companies that sell products.

What Should Regulations Cover?

CBD products should be screened for any impurities or contaminants, says David Vaillencourt, CEO of The GMP Collective, a Denver-based organization that works with cannabis and hemp businesses. He adds that these products should also be screened for microbials and toxins produced by microbials, and labels should give an accurate and full disclosure of what is in the product and in what quantity. He says that there should also be a standard for the laboratory certificate of analysis, and that, ultimately, the products should be reasonably expected to be safe. “Consumers should go to reputable stores like Whole Foods or major retailers rather than gas stations or convenience stores, which could be risky,” he says. “Otherwise, they take a risk every time they buy a product.”

Right now, the lack of federal oversight leaves the CBD-infused food and beverage market as a “wild west” of food safety. States have moved to their own regulatory patchwork, making it difficult for companies to develop a national brand, says Steve Mister, president and CEO of Washington, D.C.-based Council for Responsible Nutrition, which represents the dietary supplement industry. “The FDA decision has stifled a market that was supposed to take off after 2018,” Mister adds.

Drug Preclusion Provisions

Other than safety concerns related to the lack of research data on CBD, there are drug preclusion provisions in the federal Food, Drug and Cosmetic Act that say if a drug company gets an ingredient to the market first, it has a monopoly over that ingredient. The drug Epidiolex, which contains CBD, is an FDA-approved treatment for epilepsy care that is on the market.

Two bills re-introduced in mid-March by U.S. Representatives Morgan Griffith (R-Va.) and Angie Craig (D-Minn.) would exempt CBD from the preclusion provisions. The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 would subject hemp extract products to the regulatory framework for dietary supplements, and the CBD Product Safety and Standardization Act of 2023 would establish regulations for CBD as a food and beverage additive.

Be Careful What You Wish For

FDA’s actions have been predictable, says Chris Fortes, CEO of Trojan Horse Cannabis, which sells infused seltzers that include both CBD and THC. “The FDA doesn’t really want to get involved unless they’re forced explicitly through Congressional action,” he says.

The industry would have been helped if FDA came up with even minor safety guidelines for products, such as child-resistant containers, he adds, but that would mean that the agency also is condoning that the product is acceptable. “They’re not willing to do that, but I’m disappointed that they haven’t put some safety precautions in place for consumers,” he says.

However, he admits that he is “semi-terrified” of asking FDA to regulate CBD-infused products, however, because he doesn’t think the agency understands them well. “You may get what you ask for, but you may not get what you want,” he says. He thinks a new cross-agency framework is a better option, and he would like to have USDA, the U.S. Drug Enforcement Agency, and the Alcohol and Tobacco Tax and Trade Bureau involved alongside FDA. He says the agencies should hold CBD companies to good manufacturing practices and truth-in-labeling standards.

Gabe Parton Lee, general counsel for Wyld, a cannabis edibles company based in Bend, Ore., says he expects a cross-agency framework would include USDA, because all cannabis products come from plants, but he thinks that any ingestible product clearly falls under FDA’s jurisdiction.

With the CBD market regulated at a national scale, he said products could be standardized to make sure they are clearly marked so that consumers know they are not buying an intoxicating product. Wyld also is working with state legislatures to develop standardized programs. “States are the laboratories of democracy,” he says. “There’s a real opportunity to develop regulated programs that the federal government can model after.”

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As FDA continues its mission to develop food safety into a separate agency, some vested organizations have doubts about the success of the proposed restructure.

On January 31, Robert M. Califf, MD, FDA’s Commissioner of Food and Drugs, announced a plan that calls for the functions of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain functions of the Office of Regulatory Affairs (ORA) to be unified into a newly envisioned organization called the Human Foods Program. According to an FDA press release, the new program will be run by a single leader who reports directly to the commissioner. The agency says that this will unify and elevate the program while removing redundancies, enabling it to oversee human food more effectively and efficiently.

Critics of the plan say that it doesn’t follow the advice of a report conducted by the Reagan-Udall Foundation, an independent group of experts that Dr. Califf commissioned in 2022 to review the Human Foods Program following the powdered infant formula crisis; the report called for an overhaul and reform of the entire agency. “While we were first pleased by Dr. Califf’s announcement to advance an agency restructure, the details released on February 28, 2023, fall short of what is needed,” says Donna Garren, PhD, executive vice president of science and policy at the American Frozen Food Institute. “The plan fails to implement recommendations from the Reagan-Udall Foundation, including making bold structural changes to mitigate systemic cultural challenges within the organization.” She adds that FDA has indicated that it will continue to allow a divided and siloed organizational and leadership approach, which she says will ultimately impact the agency’s ability to set mission priorities and allow for quick and effective decision making regarding food safety.

Mitzi D. Baum, MSc, CEO of Stop Foodborne Illness, a nonprofit public health organization based in Chicago, also has concerns about the proposed restructuring. “The commissioner’s proposed incremental changes don’t get to the root of deeply embedded cultural issues,” she says. “The insularity of the ORA is of specific concern because it operates separately from science and policy areas. The plan will allow ORA to continue to have a culture of reaction rather than shifting to a proactive approach as mandated in FSMA.”

Specific Concerns of the Proposed Restructure

In particular, Baum says that the proposed changes don’t go far enough to provide consumers with the confidence that FDA leadership is doing everything possible to fix the fractured leadership and prevent another disaster like the powdered infant formula crisis. “Moreover, it’s essential to focus on the broader issue of food safety and prevention in today’s modern food system,” she adds. “It seems the commissioner chose the items and issues of least resistance to create this plan. He has ignored the experts he enlisted to provide recommendations and has continually dismissed the calls for change from external stakeholders. It’s a half measure that will not lead to safer food for consumers.”

Emily Moyer, PhD, vice president of regulatory compliance and global food safety standards at the International Fresh Produce Association in Washington, D.C., says that it’s unclear which functions of the ORA will become part of the Human Foods Program. ORA is the compliance arm that houses FDA’s inspectors and those who handle import safety, and it also oversees regulatory laboratories. “If they remain separate from the Human Foods Program, with different leadership, FDA would remain siloed, which would prevent FDA from fully embracing and achieving the preventive vision of FSMA,” she adds.

If the deputy commissioner’s role is to be truly empowered, this person needs to have a direct line of authority over the entirety of the Human Foods Program, Dr. Moyer says. Dr. Califf stated in a February 28 press release that the newly created deputy commissioner would set the strategic direction for food inspections and have budget authority, while also acknowledging that he is still “determining how to best empower the deputy commissioner, leaders of other programs, and the associate commissioner for regulatory affairs.”

Dr. Garren says that FDA, consumers, and the regulated community are best served by an empowered deputy commissioner of foods who has direct management authority over all components of FDA’s human and animal foods program, including CFSAN, the Center for Veterinary Medicine, and the food-related components of ORA. “Unfortunately, FDA’s current vision doesn’t pursue this bold approach to implement the needed structural changes to eliminate the existing inefficiencies and lack of transparency and collaboration,” she adds.

Tyler Williams, MS, chief technical officer at ASI Food Safety, a third-party food safety consulting agency based in St. Louis, Mo., is concerned about how the restructuring will impact FDA’s budget. Currently, FDA’s drug division already has a significantly higher budget when compared with food. “When politicians decide to increase FDA’s budget, more is always allocated to drugs and medical devices over food safety,” he says. “Currently, FDA doesn’t have the resources to inspect every food facility every two years as [FSMA] requires. I hope that when the restructuring comes to fruition, there’s not an increased difference between the food safety budget compared to drugs and medical devices.”

Some Positive Aspects

Despite its shortcomings, Dr. Moyer says that Dr. Califf’s restructuring plan is a significant step in the right direction because the foods program needs a single, empowered decision maker. “An external group of subject matter experts could provide great value in establishing a stronger collaboration between regulators, industry, and academia to address emerging food safety issues,” she says.

Williams says that having a split leadership team is one of the biggest potential benefits. Currently, most of FDA’s leadership comes from the drug and medical device industry. “Although clear roles are still undefined in FDA’s recent statement, food safety experts will be a part of the proposed Human Foods Advisory Committee to ensure that all of the agency’s decision-making activities are scientifically grounded, keeping emerging issues of our industry at the forefront,” he adds.

Ideal Outcomes of the Proposed Restructure

Dr. Garren hopes that any meaningful restructuring at FDA would result in a more unified foods program with a single chain of command and a prevention-focused approach to food safety as required under FSMA. “This would result in a more predictable regulatory process and an agency that could respond quickly and effectively on food safety matters,” she says.

As a result of creating an Office of Integrated Food Safety System Partnerships, Williams hopes that oversight will be more streamlined. This would unify FDA’s work with state and local regulators. “This is a step in the right direction, but I would like to see an actual plan on how it’s going to be implemented and what responsibilities will be held at local, state, and federal levels,” he adds.

While there might not be more oversight from a quantitative standpoint, Dr. Moyer says that, depending on the final structure, there’s an opportunity for FDA to become more targeted in its oversight, which would benefit public health.

FDA hopes to finalize its reorganization proposal this fall.

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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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GOOD Meat, the cultivated meat division of San Francisco-based food tech company Eat Just, Inc., received a “no questions” letter from FDA on March 20 that declared the company’s cultivated chicken product safe to eat.

FDA noted that the safety and quality validations submitted to them by GOOD Meat demonstrated that harvested cultivated chicken met poultry microbiological and purity standards, with microbiological levels significantly lower than in conventional chicken. Additionally, a product analysis revealed that the company’s cultivated chicken contains a high protein content and a well-balanced amino acid profile and is a rich source of minerals.

The letter follows a November 2022 FDA decision that allowed Berkeley, Calif.-based Upside Foods to proceed with its own lab-grown chicken, the first-ever go-ahead for cultivated meat in the U.S.

Two years ago, GOOD Meat received regulatory approval for its cultivated product in Singapore, but now is closer to having its product appear in U.S. restaurants and retail stores as well. The company is working closely with USDA on final approvals and is expected to be on the menu at a restaurant in Washington, D.C., later this year.

As of now, GOOD Meat is the lone cultivated meat producer in the world with the ability to sell to U.S. consumers. “Since Singapore approved GOOD Meat for sale, we knew this moment was next,” says Josh Tetrick, co-founder and CEO of GOOD Meat and Eat Just. “I am so proud to bring this new way of making meat to my country.”

Some analysts forecast that cultivated meat could become a $25 billion global industry by 2030 as more companies get involved in developing product. “Consumers and future generations deserve the foods they love made more sustainably and in ways that benefit the public good—ways that preserve our land and water, that protect our climate and global health, ways that allow for food security,” says Bruce Friedrich, president of Good Food Institute, a think tank focused on alternative protein innovation. He adds that, with global demand for meat expected to increase significantly in the coming years, it makes sense for governments to prioritize alternative proteins as a solution.

Robert Rankin, executive director of the Association for Meat, Poultry and Seafood Innovation (AMPS Innovation), an alliance of food companies dedicated to developing products directly from animal cells, called the “no questions” letter a momentous milestone and validation for the cell-cultured/cultivated meat, poultry, and seafood industry. “GOOD Meat is among the visionary start-ups advancing the food sector with new methods of producing high-quality, safe products that will help to meet the growing demand for meat, poultry, and seafood through delicious, healthy, and sustainable food options,” he says. “AMPS Innovation members continue to work closely with government agencies to create a safe, robust, and transparent pathway to market for cell-cultured/cultivated meat.”

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