This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
First pre-market consultation for a human food made from cultured animal cells. On November 16, FDA announced it had completed its first pre-market consultation for a human food made from cultured animal cells. Through its voluntary pre-market consultation process, the agency evaluated a submission from UPSIDE Foods for food made from cultured chicken cells and had no further questions regarding the firm’s safety evaluation. This process included FDA’s evaluation of the firm’s production process and the cultured cell material made by the production process, including the establishment of cell lines and cell banks, manufacturing controls, and all components and inputs. Because this is a poultry product, a transition to USDA’s Food Safety Inspection Service (FSIS) will take place during the cell harvest stage, per the 2019 formal agreement between the two agencies. Under that agreement, FSIS will oversee the post-harvest processing and labeling of human food products derived from the cells of livestock and poultry, while FDA will oversee these activities for the fish and seafood products it regulates. FDA’s announcement is significant as it paves the way for future cell-cultured products. In its press statements, FDA is encouraging additional firms to reach out to the agency “often and early” in the development phase, well in advance of any formal submission. The agency has also stated that it will be issuing draft guidance to assist firms in preparing for the voluntary consultations.
Bio-engineered salmon. On November 16, FDA announced the availability of a draft amended Environmental Assessment (EA) for an approved application concerning Atlantic salmon with an intentionally altered genome. The amended EA resulted from a lawsuit challenging FDA’s previous environmental impact determinations made in conjunction with FDA’s 2015 approval of an application concerning AquAdvantage Salmon. The agency will be holding a virtual public meeting to obtain input on the draft amended EA on December 15, 2022. Additional information can be found on FDA's website.
Long-awaited traceability rule. On November 15, FDA issued the long-awaited Final Rule: Requirements for Additional Traceability Records for Certain Foods which establishes additional traceability recordkeeping requirements for those that manufacture, process, pack or hold certain foods. More specifically, the final rule identifies Key Activities or Critical Tracking Events (CTEs) along the supply chain where records containing Key Data Elements (KDEs) will have to be created and maintained for foods on the Food Traceability List (FTL). While the final rule is limited in scope by statute, it sets the stage for the agency’s ultimate vision of end-to-end traceability across the food supply. For additional information, see our alert.
GAO report recommends that FDA obtain authority over “forever chemicals.” On November 8, the Government Accountability Office issued a formal report recommending that the FDA be granted the power to seek and receive information from food companies about the possible presence of so-called “forever chemicals” as contaminants in food products. The report explained precisely how food processing and packaging can lead to contamination of food and can present health risks. “FDA reviews information on the safety of such substances before their first use. As new information becomes available that suggests a substance may pose a health risk, FDA will occasionally reevaluate it based on the new information. But FDA doesn’t have specific authority to require companies to provide the information that the agency may need for such reviews – so re-evaluation may not be possible,” the GAO report said.
FDA explains its procedures for dealing with foodborne illnesses. On October 26, the FDA issued the transcript of a conversation among three of its top food experts explaining how the Agency protects the safety of the nation’s food, especially when it receives reports of foodborne illnesses and other serious problems. It noted that the agency’s Center for Food Safety and Applied Nutrition (CFSAN) receives most of the relevant complaints through its CFSAN Adverse Event Reporting System (CAERS). As an example of how this works, this past summer the agency learned about edible products containing THC that were being marketed like commonly consumed foods and popular brands of breakfast cereals, candy, and cookies. These products were being accidentally consumed by children, who are more vulnerable to serious effects from THC consumption. The FDA was able to explore the issue further and learned that poison centers had received more than 10,000 exposure reports involving edible THC products, more than 77 percent of which were in consumers under the age of 19, and 65 percent of whom reported accidental exposure. In one instance a pediatric patient died.
Health Canada to allow use of iodine as a supplemental ingredient in foods. Results of a recent premarket safety assessment by Health Canada’s Food Directorate supports the view that iodine can be safely used as a supplement in foods. In response to these results, Health Canada intends to alter the List of Permitted Supplemental Ingredients to allow the use of iodine. Questions or submissions about the new scientific information relevant to the safety of iodine use as a supplemental ingredient can be sent to this address until January 23, 2023.
FDA revises its standards for state food regulatory programs. On November 1, the FDA issued revised safety standards for state regulatory programs that oversee food facilities that manufacture, process, pack, or hold foods. These regulatory program standards were first issued by the agency in May 2007. The current changes include updates to defined terms and updates to the current standards. The standards are intended to achieve basic equivalency in food safety standards and laws and in inspection programs and practices among state and federal regulators by establishing a uniform basis for measuring and improving the activities of food regulatory programs in the United States.
Changes to grade verification of onions exported to the US from Canada. Agricultural products imported to the United States are subject to specific regulations. However, for some agricultural products imported from Canada, such as onions and potatoes, the USDA’s Agricultural Marketing Service (USDA-AMS) permits the Canadian Food Inspection Agency (CFIA) to certify the grade, size, quality and maturity of the products prior to export from Canada instead of the products being subject to USDA-AMS inspections on import. Following an audit of CFIA’s certification in spring 2022, the USDA-AMS has announced that any onions that are imported to the US from Canada will be subject to the defect tolerances and allowances of US grade standards. As of January 1, 2023, the CFIA is required to inspect all onions marked for export to the United States according to these grade standards and only those that meet these standards will be permitted to be imported to the United States. Canadian exporters will also have to update their Preventive Control Plan with the CFIA to confirm measures are in place to comply with these requirements.
Biden signs memorandum to strengthen food security and supply chain against threats. On November 10, President Joe Biden signed a national security memorandum aiming to strengthen the nation’s food security and agriculture protections. The memorandum noted the existence of several possible types of threats to the supply chain, among them cyberattacks, pandemics, avian influenza, and climate change. “It is the policy of the United States to ensure that our nation’s food and agriculture sector is secure and resilient in response to the possibility of high-consequence and catastrophic incidents,” the national security memorandum said. “To achieve this, the Federal Government will identify and assess threats, vulnerabilities, and impacts from these high-consequence and catastrophic incidents – including but not limited to those presented by CBRN [chemical, biological, radiological, and nuclear] threats, climate change, and cybersecurity – and will prioritize resources to prevent, protect against, mitigate, respond to, and recover from the threats and hazards that pose the greatest risk.”
Canada: Senate report recommends BC adopt flood control plan to avoid food security crisis. Last November, floods swept through BC’s Fraser Valley, causing an estimated $285 million in damage, damaging more than 1,000 farms, and killing 2.5 million pigs, cows, chicken and other livestock. Now, Canada’s Senate Committee on agriculture and forestry is calling for a flood control plan that includes a timeline for dike upgrades, the creation of a committee tasked with examining flood mitigation measures, emergency preparedness and response strategies. It asks that the plan be created by the federal and provincial governments with input from key stakeholders and in collaboration with the United States government.
GS1 Canada receives additional federal funding to assist small and micro food enterprises to enter the grocery and food services markets. Canada’s federal Minister of Agriculture and Agri-Food has announced CA$336,858 in federal funding through the AgriAssurance Program: National Industry Association (NIA) Component, a federal program that supports the food industry to make verifiable and credible claims about their products. The announced funding will be used by GS1 Canada, a nonprofit association that develops standards and programs for businesses, to develop learning modules and resources targeted at small and micro food businesses. It will include a certification program aimed at ensuring these businesses have the tools and knowledge to enter into the grocery, food distribution, and other food service sectors. Completion of the certification program will also allow these businesses to access GS1 Canada’s other programs for one year, including GS1’s program for licensed barcodes that are required by many Canadian retailers and distributors. Small enterprises form the bulk of all Canadian employer businesses; micro businesses, defined as businesses with one to four employees, accounted for more than half of all Canadian employer businesses in 2020.
Supplement industry leader testifies against proposed ban on sales to minors. On November 14, Kyle Turk, the vice president for government affairs of the Natural Products Association, testified in the New Jersey legislature in opposition to a bill that would restrict some sales of dietary supplements in brick-and-mortar stores in that state. The bill is very similar to a California bill recently vetoed by California Governor Gavin Newsom. The bill would prohibit the sale of any over-the-counter diet pill or muscle-building supplement to anyone under 18 years of age. Turk said there is no scientific basis to bar the sales of such products to minors. Supporters of such prohibitions have asserted that the use of these products by minors can lead to eating disorders or make the disorders worse. Turk, testifying on behalf of his group, said there is no credible scientific evidence that this is true.
Multi-state listeria outbreak in deli products. At least 16 infections, leading to one death and a miscarriage, have been traced to listeria in deli meats and cheese in six US states. The CDC said on November 10 that the particular strain of Listeria monocytogenes was linked to illnesses that occurred between April 2021 and September 2022 in New York, Maryland, Illinois, New Jersey, Massachusetts and California. Of the 16 infected patients, all had consumed meats or cheeses purchased from a deli counter; 13 were hospitalized; one died and another suffered a miscarriage. The CDC says that the actual number of people infected in this outbreak is likely higher and more widespread and that there are likely more recent cases as well. The symptoms of listeriosis mimic those of the flu and hit the elderly, immunocompromised and pregnant people the hardest – the average age of the 16 patients was 72. Investigators from the CDC, FDA, USDA and state agencies are working to identify the specific products linked to the outbreak, as well as to determine whether additional stores are involved.
Court dismisses case against maker of baby food pouches. Do food pouches for babies and young children containing pureed fruits and vegetables present long-term health risks? The District Court for the Northern District of California, ruling in a case brought against Sprout Foods Inc., which makes baby food pouches, dismissed allegations that such foods are likely to be harmful. The court found that it was unclear “why these products are per se harmful, rather than harmful after a series of contingencies outside the scope of this case.” The decision stated that the California Court of Appeal “has cautioned against permitting food labeling claims that rely on inferential leaps and which could ultimately ‘place almost any advertisement truthfully touting a product’s attributes at issue for litigation.’”
Former food company official pleads guilty to introducing adulterated food into commerce. On October 21, a former quality assurance director for Kerry Inc., a food manufacturer, pleaded guilty to charges related to the manufacture of a breakfast cereal linked to a 2018 outbreak of Salmonella poisoning. Ravi Kumar Chermala pleaded guilty in the US District Court for the Central District of Illinois to three misdemeanor counts of causing the introduction of adulterated food into interstate commerce. He was the company’s director of quality assurance, overseeing the sanitation programs at several Kerry manufacturing plants, including a facility in Gridley, Illinois, that manufactured Honey Smacks breakfast cereal for the Kellogg Co. Chermala admitted that for two years, he directed his subordinates not to report certain information to Kellogg’s about conditions at the plant. He also admitted that he directed his subordinates to alter the plant’s program for monitoring the presence of pathogens at the plant, limiting the company’s ability to detect unsanitary conditions. Chermala’s sentencing date is January 30, 2023.
Scientific article points to possibility of addiction to highly processed foods. An article published November 9 in Addiction, the journal of the Society for the Study of Addiction, looked at the history of the study of tobacco and the eventual conclusion that the product is highly addictive. It then concluded that “highly processed foods (HPFs) can meet the criteria to be labeled as addictive substances using the standards set for tobacco products. The addictive potential of HPFs may be a key factor contributing to the high public health costs associated with a food environment dominated by cheap, accessible and heavily marketed HPFs.” The article said that there is evidence that “an eating phenotype exists that reflects the hallmarks of addiction (eg, loss of control over intake, intense cravings, inability to cut down and continued use despite negative consequences)” and that as many as 14 percent of adults and 12 percent of children may suffer from this condition.