Food and Beverage News and Trends - December 15, 2023

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.

Bumpus named FDA principal deputy commissioner. Namandjé N. Bumpus, Ph.D., who had served as the FDA’s chief scientist since June 2022, has been named the agency’s Principal Deputy Commissioner. Commissioner Califf stated, “As Principal Deputy Commissioner, Namandjé will work closely with FDA leadership to develop, advance and implement key public health Initiatives, as well as to oversee the agency's day-to-day functions. Chief among those priorities is the proposed reorganization unifying the Human Foods Program, creating a new model for the Office of Regulatory Affairs, and strengthening the entire agency.” Dr. Bumpus steps into the position vacated by Janet Woodruff, who has retired.

December 22 is effective date for direct final rule revoking use of PHOs in food. The FDA has announced that the direct final rule regarding the revocation of uses of partially hydrogenated oils (PHOs) in food goes into effect on December 22, 2023. This completes all administrative actions arising from the agency’s June 2015 final determination that using PHOs in foods is no longer Generally Recognized as Safe (GRAS). These actions address artificial sources of trans fat; FDA also notes that trans fat will not be completely removed from the food supply because it occurs naturally in some foods.

Canada and Ontario commit to improving farming and food processing efficiency. The Canadian federal government and the Ontario provincial government have committed to investing up to $25 million to increase energy efficiency and expand production capacity in the food and agricultural sector. Eligible farm and food processing businesses deploying innovative technology and equipment projects can receive up to a 50 percent cost-share on the first $100,000 in costs. Eligible projects that exceed $100,000 in costs can receive up to a 35 percent cost-share, to a maximum of $100,000 in funding. The Sustainable Canadian Agricultural Partnership will administer funding, and businesses are encouraged to apply beginning February 15, 2024.

FDA issues updates to help companies understand its Food Traceability Rule. On November 30, the FDA announced a set of new tools and FAQs that will continue to help stakeholders understand the agency’s Food Traceability Rule and to help covered entities come into compliance with the rule. The rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. Foods subject to the final rule’s requirements appear on the Food Traceability List. The FDA’s update includes a new web page about traceability lot codes, including examples of how Key Data Elements could appear on invoices and bills of lading; a video highlighting some technological components of product tracing systems; some examples of a traceability plan; some new FAQs; new supply chain examples that relate to deli salads; and information on how a company should apply for a waiver or exemption, if eligible.

FDA and other agencies unveil strategy for reducing food waste. On December 4, the FDA, along with the USDA and EPA, released a national strategy designed to help the nation achieve its goal of reducing food loss and waste by 50 percent by 2030. The agencies said that food is the single most common material found in landfills. The new strategy identifies opportunities to reduce food loss and waste across the entire supply chain. “The FDA supports the mission to reduce food loss and waste. While we look forward to our continued partnership with USDA and EPA, we also want Americans to feel empowered and confident in their ability to play a part in that mission,” said FDA Commissioner Robert Califf. “Food loss and waste poses a real challenge to agriculture, food and the climate. In order to tackle this problem, and in turn build a resilient food system and mitigate climate impacts, we must explore and implement innovative solutions,” said Agriculture Secretary Tom Vilsack. Some jurisdictions in the US have launched food scrap recycling programs. Seattle has had such a program in place since 2005; in 2022, California began requiring cities to comply with SB 1383, a landmark bill that aims to reduce the quantity of solid waste, including food waste; and Chicago launched its food scrap recycling program in October this year.

Updates on lead poisoning from cinnamon applesauce pouches. On December 9, the Washington Post reported that there are at least 118 confirmed or suspected cases in 31 states of lead poisoning linked to tainted cinnamon applesauce pouches made by an Ecuador-based company, Austrofood, and sold under the brand names WanaBana, Schnucks, and Weis. The poisonings sparked an ongoing FDA international investigation that has not yet reached a definitive conclusion but has focused on the sources of the cinnamon used in the pouches. The FDA, which has noted only 64 reports of “adverse events,” has initiated an onsite inspection at the Austrofood facility in Ecuador. As the investigation has expanded, experts have grown alarmed at the potential level of lead in the pouches, some of which have tested at more than 500 times the acceptable thresholds.

Hanukkah chocolate coins face FDA recall. Just in time for Hanukkah, the FDA announced December 1 that a limited number of bags of Manischewitz dark chocolate coins recently sold in Connecticut are being recalled because they actually contain milk chocolate coins. These coins contain a milk allergen that is not declared on the label, posing the risk of serous allergic reactions in those with allergy or sensitivity to milk. The candy coins were distributed to stores nationwide, but were mostly sold in Connecticut, New Jersey, and New York. They are a seasonal item for the Jewish holiday, which started this year on December 7, and are often given to children as small gifts.

Salmonella outbreak in cantaloupe continues. On December 8, health officials in the US and Mexico reported that at least eight people, three in the United States and five in Mexico, have died, and that hundreds have become ill following a cantaloupe recall tied to a Salmonella outbreak. Since mid-November, 230 people in 38 US states have fallen ill after eating the affected melons. The recall began that month with TruFresh melons. Of those who have become ill, so far at least 96 have been hospitalized. The FDA reported that on November 30, Cut Fruit Express initiated a recall of fresh-cut fruit cup, clamshell, and tray products because they contain cantaloupe from TruFresh. According to data from the CDC, 78 of 105 cases stemmed from exposure to cantaloupe, and 42 people who fell ill report eating pre-cut cantaloupe. The CDC has urged that people should avoid pre-cut cantaloupe unless they know the brand is safe.

Canada: proposal to modernize regulations for foods for special dietary use and infant foods. Health Canada has opened a consultation on its proposal to modernize the regulations for foods for special dietary use and infant foods. A goal of these proposed regulations is to support the safety and nutritional adequacy of these foods, while also fostering increased innovation and alignment with international jurisdictions. The new regulations introduce a clear differentiation between products that meet the definition of “food for a special dietary purpose” (FSDP) and those that do not. This would subject FSDP to enhanced regulatory oversight, protecting public health. Public commentary will be used to inform the development of regulations for these foods and may be submitted online to Health Canada through February 6, 2024.‎

USDA updates List of Bioengineered Foods. On November 30 the USDA issued a final rule updating the List of Bioengineered Foods. Bioengineered foods are described as foods containing genetic material that has been modified through in vitro recombinant DNA (rDNA) techniques where the modification could not have been achieved by conventional breeding or found in nature. Regulated entities must disclose the presence of listed foods included in products unless they have maintained records establishing the ingredient is not bioengineered. The final rule adds to the List of Bioengineered Foods BT-insect-resistant sugarcane, and it amends its description of squash to mosaic virus-resistant summer squashes. The compliance date for disclosing these listed foods is June 23, 2025.

New supplemental draft guidance from FDA on menu labeling. The FDA has made available two additional "frequently asked questions" to the Draft Guidance for Industry: Menu Labeling Supplemental Guidance to address the voluntary declaration of added sugars and the voluntary declaration of nutrition information for menus on third-party platforms. The agency says that changes in the draft guidance align with the requirement that added sugars be declared on Nutrition Facts labels for packaged foods. In addition, the changes aim to improve menu labeling requirements for consumers who order meals online to help them make informed decisions.

Draft guidance on acidified foods and food allergens. In the fall, FDA released two new chapters to its Hazard Analysis and Risk-Based Preventive Controls for Human Food (PCHF) Draft Guidance - new draft Chapter 11, on food allergen programs, and new draft Chapter 16, on acidified foods. The new chapter on food allergens addresses allergen cross-contact controls, label controls, allergens controlled under a supply-chain program, and allergen advisory statements. Rather than serving as a prescriptive listing of required programs, the draft guidance aims to help companies develop food allergen programs that are appropriate to their operations. The recommendations may also help companies as they develop programs that address substances associated with food sensitivities. The new chapter on acidified foods aims to help manufacturers understand how the requirements in Part 117 that apply to all registered food facilities work with the requirements specific to manufacturers of acidified foods. To ensure consideration before the agency begins work on the final guidance documents, comments are requested by March 25, 2024.

Health Canada proposes to add chitosan to the List of Permitted Preservatives. Health Canada’s food directorate has concluded a pre-market safety and efficacy assessment on chitosan, which is derived from white button mushrooms (A. bisporus), as an antibacterial and antifungal agent in food to prevent spoilage. The results of the assessment support the use of chitosan as a preservative in select foods, detailed in part 2 and part 3 of the proposed additional information to be added to the List of Permitted Preservatives pursuant to the Food and Drug Regulations. It’s important to note that the proposed changes will not be in effect until the Government of Canada publishes the changes to the List of Permitted Food Preservatives, which will be announced by a Notice of Modification on the Government of Canada’s website.

Advisory body grapples with the correct classification of potatoes. On December 7, the Wall Street Journal published a feature article on a decision that will soon be facing the US Dietary Guidelines Advisory Committee – whether potatoes should continue to be classified as a “starchy vegetable” for the national dietary guidelines or should be reclassified as a carbohydrate along with rice and other grains. The committee is reviewing nutrition science and developing a scientific report that includes its independent advice for the Department of Health and Human Services and the USDA to consider in formulating the guidelines for 2025-2030. The National Potato Council, a trade group, says potatoes should still be classified in the same way, since they can be a “gateway vegetable” for children to enjoy as they learn to appreciate other vegetables.

Senate bill introduced to set limits for opiates in poppy seeds. On November 29, Senators Tom Cotton (R-AR), Richard Blumenthal (D-CT), and John Boozman (R-AR) reintroduced a bill that would direct the FDA to set limits for opiates that may contaminate poppy seeds sold to consumers. Poppy seeds come from the poppy plant, which can also yield opiates like morphine and codeine. The seeds themselves don’t contain substantial levels of these drugs, but they may be contaminated by plant parts that contain high levels of opiates. There are currently no US limits for opiate contamination in seeds, so improperly processed seeds may still reach consumers. When eaten, these contaminated seeds may trigger positive drug tests. When consumers brew poppy seeds into teas, concentrating the opiates, the levels can be high enough to cause overdoses and even death. “These contaminated seeds are essentially over-the-counter opiates and should not be available in the US. We should not have to worry about failing a drug test from eating a poppy seed muffin,” the nonprofit Center for Science in the Public Interest said in a statement.

Climate change comes for your olive oil too. The global olive oil market is grappling with the ripple effects arising from more than two years of drought in Spain, the world’s leading olive oil producer. The drought and consequent poor olive harvests, most notably in the province of Jaén, have cut this year’s production of Spanish olive oils more than 70 percent. While at present higher prices are most notable in Europe, scarcity is slowly pushing up the price of all olive oils worldwide. Observers are noting that consumers in some countries are beginning to purchase cheaper alternative oils, meaning they are turning away from this basic building block of the healthy Mediterranean diet. The Spanish drought is also reducing honey production and affecting supplies of fresh water, both for drinking and irrigation.

New website asks questions about lab-grown meat. On December 7, the Center for the Environment and Welfare, a group that supports food sustainability, announced the launch of LabMeat.com, a new website that is intended to “educate the public” about the technology behind lab-grown meat, also known as cell-cultured meat. CEW said that this marks the beginning of a sustained education campaign to discuss consumer concerns surrounding the product. The website explains that the new industry uses “immortalized cells,” growth factors, and other chemicals to produce the meat. The group is skeptical that lab-grown meat is good for human health and for the environment. “Immortalized cells have historically been used in scientific research – not consumed by people. And the data on its safety is lacking,” the group said. Our December 1 issue reports on other recent developments regarding cell-cultured meat.