This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
Jones shares priorities for new Human Foods Program. Jim Jones, FDA’s new Deputy Commissioner for the Human Foods Program, shared his priorities for the program in a November 13 webinar with the Alliance for a Stronger FDA. Jones outlined the changes in the unified human foods program reorganization, such as combining the ORA inspectorate and CFSAN compliance offices. He also mentioned elevating priorities like preventing foodborne illness through a new Office of Food Safety and risk prioritization efforts, enhancing chemical safety (including food additives and contaminants) through a chemical safety workplan, and elevating the role of nutrition by creating a Nutrition Center of Excellence. Jones highlighted several regulatory priorities, among them finalizing rules on produce safety, agricultural water use, front-of-pack labeling, and revisions to the healthy label by early 2024. He also discussed moving forward on added sugars and front-of-pack proposals. Given that the reorganization package must be reviewed by OMB and the House and Senate, he targets June 2024 for finalizing.
US state legislators aim to curb cultivated meat. While a few cultivated meat products are slowly but surely moving through the US federal regulatory process, some state regulators are moving to restrain and even end such sales. In May, Texas passed a bill addressing the “labeling of analogue and cell-cultured products,” which requires cultivated meat products to be labeled “cell-cultured” or “lab-grown.” This month, Florida State Representative Tyler Sirois proposed legislation that would make it a criminal offense to sell cultivated meat in Florida; Sirois states that such products are an “affront to nature and creation” and are part of the “ESG agenda.” The proposed bill has the backing of Florida Agriculture Commissioner Wilton Simpson, who says, “Without this legislation, untested, potentially unsafe, and nearly unregulated laboratory produced meat could be made available in Florida.” On November 24, Nebraska State Senator Deb Fischer introduced the Real Marketing Edible Artificials Truthfully (Real MEAT) Act, which addresses plant-based products as well as cultivated meats and would require the word “imitation” to immediately proceed the name of such foods on their labels. Meanwhile, also this month, the Omeat company announced the completion of its new plant in Thousand Oaks, California, where it will manufacture its first product, a ground beef. Among Omeat’s backers are Bold Capital and Tyson Ventures.
Italy bans cultivated meat. Italy has banned the production of lab-grown meat (which regulators in the US are now calling cultivated meat) as well as other non-traditional foods, such as high-protein insect powder. The law also prevents producers from using meat-related words on labels to describe plant-based proteins. Supporters of the new law tout it as protecting both consumers and the traditional agricultural industry. Italy’s parliament approved the new law, but overall the legislation will have little effect because the European Food Safety Authority has not yet authorized the marketing of cultivated meat anywhere in the European Union. If such authorization were given, Italy’s ban could be challenged by the European Commission. To date, the only country allowing legal sales of cell-cultivated proteins is Singapore; in the US, two companies have successfully crossed some of the federal regulatory hurdles to eventually bring their cultivated chicken products to market. The Italian law also prevents producers from using meat-related words on labels to describe plant-based proteins. Farmers in Ireland are pushing for a similar law.
Latest food safety culture webinar coming next week. The ninth in the FDA’s ongoing series of webinars exploring food safety culture will take place Tuesday, December 6 from noon to 1 PM ET. “Food Safety Culture: Storytelling to Shape, Reinforce, and Inspire” will explore the importance of storytelling in building and reinforcing a strong food safety culture. The webinar series, Collaborating on Culture in the New Era of Smarter Food Safety, is in partnership with Stop Foodborne Illness, a nonprofit public health organization.
Probe of high lead levels in cinnamon applesauce pouches. On November 16, the FDA announced a recall of three brands of cinnamon applesauce pouches because they may have high levels of lead. High blood lead levels in seven toddlers across five US states have been linked to the recalled products. The agency and the Centers for Disease Control pointed out in the recall that lead is toxic to human beings and that protecting children from lead exposure is particularly important because children are more susceptible to it. The FDA suspects that the cinnamon used in the products may be the source of the current lead exposure. A cinnamon applesauce product sample tested by the FDA had 200 times more lead than the FDA allows in food. The source of the cinnamon is under investigation, and the FDA is screening shipments of cinnamon from outside of the United States for lead. The pouches were sold in sold and distributed online and in numerous retail outlets across the US.
Agencies issue report on the sources of foodborne illnesses in America. In November 2023, the FDA, along with the CDC and the USDA, issued a formal account of the scope of foodborne disease in the United States. The report links more than 75 percent of Salmonella illnesses to chicken, fruit, pork, seeded vegetables, other produce, beef, and turkey, and more than 80 percent of E. coli illnesses to vegetable row crops, such as leafy greens, and beef. Listeria illnesses were most often linked, at an 80 percent rate, to the same three categories, but the agencies said that the rarity of Listeria outbreaks made the data less reliable. The report estimates the most frequent origins of foodborne diseases in order to facilitate future agency action.
Reagan-Udall Foundation convenes major meeting on front-of-package nutrition labeling. On November 16, the Reagan-Udall Foundation convened a Front-of-Package Nutrition Labeling virtual public meeting that included opportunity for comments by stakeholders. The congressionally convened foundation works closely with the FDA to help it develop policy. After remarks by FDA leadership, including FDA Commissioner Robert Califf and FDA Deputy Commissioner James Jones, the agency shared an overview of its work to date on front-of-package nutrition labeling, including an update in its ongoing consumer research. The group then opened the microphone for brief public statements on three key topics: international experience with front-of-package labeling, design considerations, and potential intersection with other nutrition-related policies, such as other labeling efforts and nutrition assistance programs.
Updates to Leafy Greens STEC Action Plan. FDA has released an update to its Leafy Greens STEC Action Plan, which was first issued in 2020 in response to a number of reoccurring E. Coli outbreaks linked to leafy greens. The November 17 update includes additional information on sampling assignments, method developments, and a status update on the Agency’s long-term longitudinal studies in Arizona and California. FDA also released a fact sheet on Adjacent and Nearby Land Uses and their impact on the safety of produce grown nearby. Several recent produce outbreak investigations have identified conditions and practices on nearby lands as contributing factors, including the presence of wild and domesticated animals, recreational activities, worker practices, agricultural water, and trash storage. The Produce Safety Rule requires that these potential hazards be addressed to minimize risk.
FDA is told that consumer sugar preferences may be difficult to change. At a conference on November 6, food experts told the FDA that consumer preferences for intensely sweet products may not be as easy to change as consumer preferences for sodium. Thus, the experts concluded, a “stealth health” approach of slowly lowering added sugar throughout the food supply may not be an effective strategy for reducing sugar consumption. Rather, the experts said, a combination of approaches may be needed, including more aggressive consumer marketing for low-sugar products, an emphasis on sugar substitutes, and the use of new technology to find sugar substitutes that still “delight” consumers. The conference – a three-day virtual meeting and two listening sessions exploring strategies for reducing sugar consumption – was hosted by the FDA at the behest of the Biden Administration, whose National Strategy on Hunger, Nutrition and Health aims to foster physical activity and increase healthy eating.
Cantaloupe recall. On November 27, the FDA announced an outbreak investigation into fresh cantaloupes and products containing recalled cantaloupe due to Salmonella contamination. Being recalled are whole fresh cantaloupe bearing such labels as Malichita, Rudy, Crown Jewels Produce, Trufresh, and Pacific Trellis, as well as cut cantaloupe from such companies as Aldi, Vinyard, and Freshness Guaranteed. On November 24, Pacific Trellis announced it is recalling whole fresh cantaloupes distributed between October 18 and 26 in California, Illinois, Oklahoma, Texas, and Wisconsin and sold in various retail supermarkets. On November 22, Crown Jewels Produce recalled its whole fresh cantaloupes and Sofia Produce expanded its recall; that same day, CF Dallas initiated a recall of fresh cut fruit products made from whole cantaloupe affected by the Sofia Produce recall. CDC reports 99 cases of salmonella have been linked to this outbreak in 32 states as of November 24. The investigation into the outbreak is ongoing.
Stone fruit recall. On November 20, the FDA and CDC announced a recall of conventional peaches, plums, and nectarines sold in retail stores from May 1, 2022, through November 15, 2022, and from May 1, 2023, through November 15, 2023, because of an outbreak of listeriosis connected with these fruits. The affected fruit is past its expiration date and no longer in stores – he recall is being issued because the produce may still be in consumers’ freezers. Any fresh whole peaches, plums or nectarines that are currently sold in stores are not under the recall, the FDA said. The FDA and the CDC said there have been 10 hospitalizations and one death from the outbreak.
Food industry group says USDA should move slowly on “free range” claims. On November 16, FMI, the food industry association which represents retailers, wholesalers, and product suppliers, made comments to the USDA concerning the desirability of permitting companies to claim that their products are “free range” and “pasture raised.” The department’s Food Safety and Inspection Service is considering this change and has undertaken a formal notice and comment process. The association wrote, “Changes to labeling policies should be evaluated with a comprehensive evaluation of all factors beyond the words on the labels. Considerations include but are not limited to existing and emerging production practices; economics of production, products, and labels; exclusions or limitations of policy changes and impact on the industry and most importantly, evaluation and impact of any changes to consumers.” The group also said, “USDA should approach rulemaking to understand the scientific consensus around the appropriate definitions of these terms as agreed upon by experts such as veterinarians, animal behaviorists, and food safety professionals.”
Agribusiness and the Paris Agreement – FAO to issue comprehensive report. During COP28, which began on November 30 in Dubai, the UN Food & Agriculture Organization is expected to release its first comprehensive plan aiming to bring global agribusiness in line with the Paris climate agreement, and a key target of the plan will be the world’s consumption of meat. Food systems account for about a third of the world’s greenhouse gas emissions; about a third of those emissions have been linked to livestock farming. Pathways towards lower emissions – A global assessment of the greenhouse gas emissions and mitigation options from livestock agrifood systems strives to find a balance between feeding the growing global population and reducing the environmental impact and carbon footprint of livestock farming. It will advise countries that consume large amounts of meat to limit their intake, and will advise developing countries, where low meat consumption contributes to nutritional challenges, to bolster productivity by improving their livestock farming practices. The plan is being variously described in the media as “the global food systems’ road map to 1.5C” and “food’s first net zero plan.”