Food and Beverage News and Trends - March 8, 2024
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape.
Final guidance on foods derived from genome-edited plants. FDA has issued the final Guidance for Industry: Foods Derived from Plants Produced Using Genome Editing to clarify the applications of FDA’s Statement of Policy - Foods Derived from New Plant Varieties. The guidance describes the ways in which businesses may voluntarily engage with the FDA before marketing food from genome-edited plants. It reminds developers of genome-edited plants that they are subject to the allergen labeling requirements under section 403(w) of the FD&C Act. The guidance also describes two processes through which companies may voluntarily inform the FDA of the steps they have taken to ensure the safety of foods from their genome-edited plant varieties – voluntary premarket consultations and voluntary premarket meetings. These processes can help ease the pathway to market for foods from genome-edited plants, while keeping FDA safeguards in place, the agency said.
PFAS substances are no longer being sold for food contact use in the US market. FDA announced that grease-proofing substances containing per and polyfluoroalkyl substances (PFAS) are no longer being sold by manufacturers for food contact use in the US market. The completion of the voluntary market phase-out of these substances for use on food packaging paper and paperboard eliminates the primary source of dietary exposure to PFAS from authorized food contact uses. Their elimination marks the fulfillment of industry’s 2020 commitment from manufacturers to FDA to voluntarily stop selling such paper and paperboard packaging for food products, which had been used to prevent the leaking of grease and oil and for water-resistant purposes.
EPA classifies nine PFAS compounds as hazardous constituents. On February 8, the Environmental Protection Agency proposed changes to the regulations under the Resource Conservation and Recovery Act (RCRA) by adding nine additional per- and polyfluoroalkyl (PFAS) compounds, their salts, and their structural isomers to its list of hazardous constituents in Title 40 of the Code of Federal Regulations Part 261 Appendix VIII. For a chemical to be listed as a hazardous constituent under RCRA, scientific studies must show that it has toxic, carcinogenic, mutagenic, or teratogenic effects on humans or other life forms. The EPA evaluated toxicity and epidemiology data for these chemicals and determined that these nine PFAS compounds meet the criteria for such listing. Comments on this proposed change are due by April 8, 2024.
First FDA-approved medication to treat allergic reactions to foods. The FDA has approved Xolair, an injectable medication, for the treatment of allergic reactions to foods in adults and children over the age of 1. This is the first FDA-approved drug to reduce allergic reactions to more than one type of food after accidental exposure. Xolair should be taken every few weeks, in a healthcare setting, to reduce the risk of reactions over time; it is not approved for emergency treatment of allergic reactions, including anaphylaxis, and patients receiving it must still avoid the foods they are allergic to. “While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” noted Kelly Stone, MD, PhD, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. Nearly 6 percent of people in the US have a food allergy, and exposure can lead to potentially life-threatening allergic reactions, like anaphylaxis. There is currently no cure for food allergy.
Canadian federal government promotes innovation in pork sector. With the goal of improving Canada’s position in the global pork sector, the federal government has announced it will invest up to $10.6 million in Swine Innovation Porc (SIP) under the Sustainable Canadian Agricultural Partnership. The investment will fund research initiatives aiming to advance sustainability, resilience, and growth opportunities for Canada’s pork sector. Among the goals of the research: developing better strategies to reduce greenhouse gases and environmental impacts, increasing product quality, improving animal welfare, increasing the competitiveness of Canadian pork producers and processors.
FDA refines Ingredient Directory. On February 21, the FDA announced it has updated its Ingredient Directory, changing the title of the web page and refining the directory to take into account stakeholder feedback about the original version. The Ingredient Directory was created as a one-stop shop to allow the public to find out what the FDA has said about ingredients used in products marketed as dietary supplements and whether the agency has taken any action regarding the ingredient. Formerly, such information was available to the public, but on an array of FDA web pages. The web page is now called Information on Select Dietary Supplement Ingredients and Other Substances. Among the updates to the directory itself are more condensed introductory text and new categories for classifying the FDA action or communication for each listed ingredient, including setting out the date when an ingredient was added to the directory. The directory now includes 79 entries, a major increase from the 27 ingredients that were listed when it was first published in 2023.
FDA permits claims that yogurt can reduce risk of type 2 diabetes. On March 1, the FDA announced that it will now allow yogurt makers to claim that yogurt may reduce the risk of type 2 diabetes. Eating at least two cups or three servings of yogurt a week may reduce the risk of type 2 diabetes in this “qualified health claim,” the FDA said, noting “there is some credible evidence supporting a relationship between yogurt intake and reduced risk of type 2 diabetes, but this evidence is limited.” The FDA posted the letter in response to a petition filed about five years ago by Danone North America. A qualified health claim is one that is supported by scientific evidence but doesn’t meet the more rigorous “significant scientific agreement” standard required for an authorized health claim.
FDA updated list of chemicals in food supply. As part of its work to assist industry in meeting the responsibility to market safe food, on March 4 the FDA updated its List of Select Chemicals in the Food Supply Under FDA Review. The list, initially published in July 2023, provide insight on the status of the FDA’s post-market assessments of chemicals in the food supply, including the status of each chemical in the risk assessment and management process.
Final guidance on NDINs. The FDA has announced final guidance entitled Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry. The guidance aims to help manufacturers and distributors submit new dietary ingredient notifications (NDINs) via a question-and-answer format. Learn more about the guidance and how to submit comments here.
Funding opportunity on collection of data on antimicrobial use data in animals. The FDA is accepting proposals through May 13, 2024 for cooperative agreement funding grants to support the collection of antimicrobial use data from diverse animal sectors – prioritizing proposals that target data collection about cattle, swine, chickens, and turkeys. Each FY 2024 grant would provide up to $200,000 for one year of research support; additional funding for up to four more years is also possible. The agency hopes to build on its long-term efforts to better understand antimicrobial use in the US and improve antimicrobial stewardship in animals.
Updates on listeria recall. The FDA and CDC continue investigating an outbreak of listeria linked to dairy products manufactured by Rizo Lopez Foods of Modesto, California and sold by major retailers nationwide, often under house brands and at times without any branding. On February 22, the agency updated the list of recalled products, adding yet more regional and national retailers and products. As of that date, there have been 26 total illnesses, 23 hospitalizations, and 2 deaths associated with this outbreak across the US. The investigation is ongoing. In Canada, the Canadian Food Inspection Agency has also issued recalls of foods that include dairy products manufactured by Rizo Lopez Foods.
CFIA transforms inspection protocol for PEI potatoes exported to US. In a move set to roll out in March 2024, the Canadian Food Inspection Agency (CFIA) will change its inspection procedures for table stock potatoes originating from Prince Edward Island and bound for the United States. By transitioning from the traditional Certificate of Origin to the innovative Digital Service Delivery Platform, CFIA aims to enhance efficiency and compliance. These revamped inspection reports, meticulously documenting adherence to stringent phytosanitary standards, will ensure PEI potatoes meet US import requirements, including freedom from soil contamination and potato wart symptoms as stipulated in the USDA Federal Order (DA-2022-14). This move not only streamlines the inspection process but also facilitates seamless export documentation issuance, catering to exporters outside of PEI navigating the US market landscape.
US: Nationwide recall of raw cheddars. On February 17, the FDA and CDC announced that Raw Farm LLC of Fresno, California, is voluntarily recalling some of its cheeses because of possible contamination with E. coli. At least 10 people in four states have become ill in this outbreak, the CDC said, including four people who have been hospitalized and one who has developed hemolytic uremic syndrome, which can cause kidney failure. “The true number of sick people in this outbreak is likely much higher than the number reported, and the outbreak may not be limited to the states with known illnesses,” the CDC said. In a statement, Raw Farm president Aaron McAfee said that none of their products have tested positive for E. coli and that the voluntary recall was issued out of “an abundance of caution.”
CFIA changes a taxonomic name. The CFIA has updated the Automated Import Reference System (AIRS) and the application for permit to import aquatic animals and/or their offal (CFIA/ACIA 5670) for Pacific turbot. Previously, Pacific turbot was referred to as Psetta maxima. It is now referred to by its internationally accepted valid taxonomic name, Scophthalmus maximus. Those seeking to import Pacific turbot may find its import requirements in AIRS under that name.
Court strikes down a portion of a Massachusetts humane livestock law. On February 5, the US District Court for the District of Massachusetts, ruling in a case brought by Missouri-based Triumph Foods, found that a portion of the state’s Prevent Cruelty to Farm Animals Act is unconstitutional. The Massachusetts law – adopted through a ballot initiative approved by 77 percent of voters in 2016 – bars the sales of pork, veal, and eggs in the state from pigs, calves, and hens whose confinement failed to meet certain minimum space requirements. Last year, the Supreme Court rejected a challenge by the National Pork Producers Council and the American Farm Bureau Federation to California’s similar Proposition 12 law against animal confinement. In light of that decision, the Massachusetts court had already dismissed parts of Triumph's case; leaving only the company’s claim that an exemption in the law (allowed pork produced at federally inspected facilities in Massachusetts to be sold if buyers could take possession of the pork on-site at the plants ) discriminated against out-of-state pork processors, violating the Constitution’s Commerce Clause, which bars states from adopting laws that discriminate against or unduly burden interstate commerce. The court found that “the only way Triumph would be able to take advantage of the slaughterhouse exception would be to open its own federally inspected facility within the Commonwealth of Massachusetts, which the Supreme Court has held violates the Commerce Clause.” The court allowed this portion of the law to be severed; the rest of the measure survives the constitutional challenge.
Graham cracker labeling case moves ahead. On February 8, a US federal court found that supermarket chain Wakefern Food Corporation must face claims in a consumer class action that it falsely advertised its graham crackers as whole grain. The claim was that the crackers’ front label misleads consumers into believing the product has a greater absolute and relative amount of whole grain graham flour compared to nonwhole grain flour than it actually does and that it contains a non-de minimis amount of honey. Responding to Wakefern’s motion to dismiss the case, the US District Court for the Southern District of New York wrote that it is inappropriate at this stage “to resolve the highly factual inquiry of how a reasonable consumer understands representations about wholegrain graham flour.”
New York AG sues beef giant over net zero claims. On February 28, New York state Attorney General Letitia James filed a lawsuit against JBS USA Food Co., the US division of the world’s largest beef producer, for allegedly misleading the public about its products’ environmental impact. Through its Net Zero by 2040 marketing campaign, the attorney general’s office said, “JBS USA has claimed that it will achieve net zero greenhouse gas emissions by 2040, despite documented plans to increase production, and therefore increase its carbon footprint.” James is asking the court to require JBS USA to end its net zero marketing campaign, conduct a third-party audit of its compliance with New York consumer protection statutes, and disgorge any ill-gotten gains it earned by misleading the public about its business practices. “When companies falsely advertise their commitment to sustainability, they are misleading consumers and endangering our planet,” James said in the court complaint. “JBS USA’s greenwashing exploits the pocketbooks of everyday Americans and the promise of a healthy planet for future generations.”
Consumer and health groups urge TTB action on alcohol disclosures. On February 27, a coalition of consumer and health groups, including the Center for Science in the Public Interest, wrote a letter to Treasury Secretary Janet Yellen urging her to ensure that the Alcohol and Tobacco Tax and Trade Bureau will keep its commitment to require standardized alcohol labeling on all beer, wine, and distilled spirits products by initiating three promised rulemakings on nutrition, ingredients, and allergen labeling on an accelerated basis. The bureau, part of the Treasury Department, is responsible for regulating most alcoholic beverages in the United States. The letter said that despite its past promises, the bureau “is still following its 20-year playbook of delaying progress on alcohol labeling, this time by hosting a series of public listening sessions on labeling and advertising of alcoholic beverages instead of moving directly to rulemaking.”
Senator Sanders urges tough warnings on food and beverage labels. Senator Bernie Sanders (I-VT), on February 15 sent a letter to the FDA asking it to require food and beverage companies to place strong evidence-based warning labels on their products to protect the health of the American people. “I am encouraged that the FDA has begun the process of issuing a proposed front-of-package label rule that would better inform consumers about the health impacts of their products high in added sugars, sodium, and saturated fats,” wrote Sanders. “However, from what I have seen thus far, these efforts do not go nearly far enough.” Sanders continued, “In my view, we need strong front-of-package labels so that all consumers, especially children, can understand which products are harmful to their health. Tobacco labels in the United States do not say ‘high in tar, high in nicotine, high in carcinogens.’ They say, ‘cigarettes cause cancer.’”
Major investigative article faults industry and FDA on lead poisoning. On February 27, the New York Times published a major investigative article reporting on the failures by industry and government that permitted cinnamon-flavored applesauce pouches sold in grocery and dollar stores in 2023 to poison hundreds of American children with extremely high doses of lead. According to the article, interviews by Times reporters with government and company officials in multiple countries showed that “in the weeks and months before the recall, the tainted applesauce sailed through a series of checkpoints in a food-safety system meant to protect American consumers.” Children in 44 states have been affected. The Times wrote, “Time and again, the tainted cinnamon went untested and undiscovered, the result of an overstretched F.D.A. and a food-safety law that gives companies, at home and abroad, wide latitude on what toxins to look for and whether to test.”
