Food and Beverage News and Trends - February 5, 2024

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

FDA updates its list of priority guidance documents for 2024. FDA added the following five guidance documents to its Foods Program Guidance Under Development:

• Action Levels for Lead in Food Intended for Babies and Young Children: This final guidance will update the 2023 draft guidance establishing an action level of 10ppb for fruits and vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/ puddings, and single-ingredients. Previously on the list were draft guidances to establish action levels for arsenic and cadmium in food intended for babies and young children as well.
• The Food Traceability Rule: Questions and Answers: This draft guidance will provide the industry with additional information on how to comply with the last of the major FSMA rules requiring industry to maintain and share key data elements that will enable faster traceback of potentially contaminated food. The compliance date for this rule is January 2026.
• Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): This draft guidance updates the voluntary targets issued in 2021 by establishing the next round of voluntary target reductions. While these are not required reductions, this guidance is consistent with FDA and the Biden Administration’s emphasis on reducing diet-related diseases.
• Draft Guidance for Industry: Preventive Controls for Chemical Hazards: In this draft guidance, FDA is releasing Chapter 12 in its guidance on the Hazard Analysis and Risk-Based Preventive Controls for Human Food regulation. Chemical hazards and ingredient safety are a stated priority for the New Human Foods Program.
• Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula: This draft guidance will provide industry with information on how to inform the Agency when a facility is not producing infant formula. It is the latest in FDA’s efforts to enhance its oversight of the infant formula supply.

New FDA website lists upcoming regulations. On January 25, FDA announced a new website listing regulations that it plans to publish by October 2024, as well as longer-term regulations that it is prioritizing for publication later. Highly anticipated rules that are targeted for publication this year include the final rule on “healthy” (final); standards for agricultural water (final); testing methods for talc-containing cosmetic products (proposed); and front-of-package labeling (proposed). Also on the list is a proposed rule to implement a Food Safey Modernization Act (FSMA) provision that would allow FDA to deny entry of potentially harmful imported food unless accompanies by a certification or other assurance of safely.

Illinois bill would ban five common food additives. Illinois SB 2637, introduced to the state legislature in November 2023, aimed to ban four food additives from retail sales in Illinois – brominated vegetable oil, potassium bromate, propylparaben, and red dye No. 3. On January 23, State Senator Willie Preston (D-16) amended the bill to add a ban on titanium dioxide. With that change, the bill goes further than California’s first-in-the-nation ban on food additives, which does not include titanium dioxide. Like the California law, the Illinois bill would not go into effect until 2027. State assemblies in New York and New Jersey are also considering bills that would ban these same five additives.

Canadian beef industry successfully reduces GHG emissions. A report released by the Canadian Roundtable for Sustainable Beef (CRSB) reveals a 15 percent reduction in greenhouse gas emissions (GHGs) per kilogram of beef produced in Canada since 2014. The CRSB attributes this significant reduction to efficiency improvements in raising cattle. This is an important milestone for the CRSB, which has targeted a 33 percent reduction in GHGs generated by beef producers by 2030.

US: Congressional panel asks for briefing from FDA on contaminated applesauce. On January 22, the leading members, in both parties, of the House Energy and Commerce Committee wrote to FDA Commissioner Robert Califf to request a formal briefing concerning the possible intentional lead contamination of applesauce pouches that has harmed dozens of American children. The committee members expressed urgency about meeting with Califf, noting that the FDA’s deputy commissioner for human foods recently suggested the lead contamination may have been an intentional, economically motivated act. The FDA’s probe into the contamination is continuing. The committee said it is “crucial to understand the FDA’s strategies for detecting and addressing intentional contamination in the food supply chain given the limited authority your agency has over contaminated cinnamon from abroad, which was identified as the potential source of this issue.” See our earlier coverage of this developing story.

Canada: Food industry urges BC government to reject chicken price increase. Some food industry groups have called on the government of British Columbia to stop a potential increase in the farm-level price of chicken in the province. The proposed hike would raise the cost of chicken ‎for consumers in BC – where chicken prices are already the highest in Canada – by 10 percent on average. Canada’s chicken industry is supply-managed, via a system that regulates production levels, wholesale prices, and trade. BC’s Chicken Marketing Board recently proposed a new pricing formula which seeks to take into account inflationary pressures – in particular, the rising cost of feed. That interim formula is under review by the BC Farm Industry Review Board. BC Minister of Agriculture and Food Pam Alexis stated that the pricing proposal is being evaluated by the review board “with an eye for supporting a sustainable poultry sector, our local food supply, and affordability for people.”

Canada to repeal food-related marketing authorizations. Canada’s Minister of Health has issued a notice of intent to repeal 16 food-related marketing authorizations. Fifteen of these comprise food additive related marketing authorizations that will subsequently be incorporated by reference into the Food and Drug Regulations (FDR). This is part of a regulatory proposal by Health Canada to consolidate and streamline provisions related to food-additives under the FDR. The 15 food-additive related market authorizations concern additives such as preservatives, bleaching agents, and anticaking agents. An additional market authorization, related to the addition of supplemental vitamin D in dairy products, will also be repealed. This market authorization was incorporated into the FDR by way of an amendment in June 2022 and is no longer needed. Public comments will be accepted by Health Canada’s Bureau of Policy, Intergovernmental and International Affairs until April 2024.

FDA updates its guidance to industry on food safety hazards. On January 30, the FDA released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry titled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry.” The changes address comments the agency received on the drafts that were made available in 2016, while providing additional context and information on hazards in food categories of current interest to ensure that the available draft documents adequately reflect the agency’s current thinking on the most relevant food safety hazards. The revised introduction includes additional information to better explain the purpose of the guidance along with general information applicable to all chapters. Among the new information: an expanded glossary of terms that are used and defined in later chapters, and three new sections on training, references, and resources.

Health Canada approves inclusion of green tea extract in supplemented foods. Health Canada’s food directorate has concluded an analysis on the safety of green tea extract (EGCG/catechins) and will now permit its use as a supplemental ingredient; however, adherence to the Government of Canada’s List of Permitted Supplemental Ingredients guidelines is required. Using green tea extract as a flavoring agent in foods is not regulated as a supplemental ingredient provided that certain conditions are met, including that the amount of EGCG and total catechins does not exceed 100 mg EGCG and 200 mg total catechins per day and the ingredient is not represented as a supplemental ingredient.

Canada approves funding for research on risks of microplastics. Canada’s federal Ministry of Health is providing $2.1 ‎million over the course of four years to McGill University, Memorial University of Newfoundland, and the ‎University of Toronto to increase research on microplastics and their potential impact on human health. This ‎research will examine potential exposure to microplastics from various sources, including food, ‎food packaging, drinking water, indoor/outdoor air, and dust. Research through this program aligns with the priorities of Canada’s Plastics Science Agenda and will fill knowledge gaps identified in the Government of Canada’s 2020 Science Assessment of Plastic Pollution. Minister of Health Mark Holland said, “There is a lot we don’t know about the effect of microplastics on human health. That is why programs like this one were created – to support Canadian scientists in improving the understanding of the human health impacts of microplastics.”

FDA webinar on food safety culture. On February 14, FDA is partnering with Stop Foodborne Illness, a non-profit public health organization, to hold a webinar food safety culture called “Are Food Safety Management Systems Enough?”. This webinar will feature key speakers from the private and public sectors to exchange ideas and experiences related to the importance of food safety culture in helping to ensure safe food production. You can register here.