This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including claims about yogurt lowering diabetes risk, new rules for voluntary “Product of USA” labeling claims, and more.
FDA Updates
FDA Issues Final Guidance for New Dietary Ingredient Notification Procedures
March 6: The FDA announced the availability of a final guidance for industry entitled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The guidance focuses on frequently asked questions about the new dietary ingredient notification submission and review process. The guidance is intended to help manufacturers and distributors of new dietary ingredients and dietary supplements prepare and submit new dietary ingredient notifications to FDA. More information can be found here.
FDA Collecting Information on Foodborne Illness Risk Factors in Restaurants and Retail Food Service Facilities
March 6: FDA is inviting comments on the collection of information concerning the “Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types”. The FDA conducted a study to measure trends in the occurrence of foodborne illness risk factors, preparation practices, and employee behaviors as contributing factors to foodborne illness outbreaks at retail establishments. The results of this study will be used to: develop retail food safety initiatives, policies, and targeted intervention strategies focused on controlling foodborne illness risk factors, as well as providing technical assistance to state and local regulatory professionals, identify FDA retail work plan priorities, and enhance retail food safety. Comments are due May 6, 2024. More information can be found here.
FDA Embraces the Potential of Artificial Intelligence to Revolutionize Advances in Medical Products and Food
March 15: FDA Commissioner Robert M. Califf discussed how Artificial Intelligence (AI) has the potential to enable advances in the development of more effective, less risky medical products and more nutritious food. The FDA is also exploring the use of AI to facilitate internal operations and regulatory processes. The FDA issued a paper on AI and medical products, which reaffirms their commitment to promoting responsible and ethical development of AI. More information can be found here.
FDA Allows Claim that Yogurt Lowers Diabetes Risk
March 1: The FDA announced that it does not intend to object to the use of certain qualified health claims regarding the consumption of yogurt and reduced risk of type 2 diabetes, provided that the qualified health claims are worded so as not to mislead consumers, and that other factors for the use of the claim are met. More information can be found here.
FDA Extends Comment Period for Draft Guidance Related to Food Allergen Program and Acidified Foods
March 22: The FDA extended the comment period for two new chapters of a draft guidance entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft guidance for Industry”. The guidance aims to assist food facilities in adhering to the preventive controls for human food rule, which is part of the FDA Food Safety Modernization Act (FSMA). The new chapters available for comment are Chapter 11, which covers the Food Allergen Program, and Chapter 16, which pertains to Acidified Foods. Comments on the draft guidance must be submitted by May 24, 2024. More information, as well as the draft guidance and information for submitting comments, can be found here and here.
FDA Issues Final Rule for Determining When Food Contact Notification is No Longer Effective
March 21: The FDA is revising its regulatory procedures to determine when a premarket notification for a food contact substance (FCN) is deemed no longer effective. The new rule introduces additional reasons that could form the basis for FDA to determine that an FCN is no longer effective. Furthermore, the final rule guarantees that manufacturers or suppliers are given an opportunity to provide input prior to an FDA decision that an FCN is no longer effective. These updates are being made to allow the FDA to better respond to new information on the safety and use of FCNs, adapt to changes in manufacturers’ business choices, and improve the efficiency of the premarket notification program. The rule goes into effect on May 21, 2024. More information can be found here.
FDA Hosts Virtual Public Meeting on Data-Driven Advances in Food Safety
March 25: The FDA is holding a virtual public meeting on April 24, 2024 focusing on Data and Technology in the New Era of Smarter Food Safety. The event aims to explore the use of data and technology to improve food safety and health outcomes. Stemming from the 2019 New Era of Smarter Food Safety initiative, which emphasizes modernization of the food safety system, the meeting will include FDA presentations on innovative data and tech opportunities to enhance food safety. It will also hold an afternoon session for public input. The meeting is free, but registration is required. The meeting will start a 60-day comment period beginning on April 24th. More information can be found here.
FDA Issues Import Alert to Safeguard Against Chemically Contaminated Foods, including PFAS
March 20: The FDA issued Import Alert 99-48, Detention without Physical Examination of Foods Due to Chemical Contamination, which allows the FDA to help prevent products entering the U.S. if they are found to be contaminated with chemical pollutants such as benzene, dioxins, PCBs, and PFAS. This measure is part of the FDA’s evolving strategy to minimize exposure to toxic chemicals and PFAS in foods. Firms with products detained under this alert must show corrective actions have been taken to re-establish compliance to have their items released. The FDA provides guidance for removal from the alert in its Regulatory Procedures Manual, Chapter 9-8. More information can be found here.
FDA Warning Letters
- Misbranded Food: FDA issued a warning letter to Glister-Mary Lee Corporation alleging that its Hy-Vee brand Hamburger Chili Macaroni Skillet Meal product label did not declare a major food allergen. FDA also issued a warning letter to Regal Health Food International, Inc. alleging that its Regal Gourmet Snacks Milk Chocolate Raisins label did not declare a major food allergen.
- Adulterated Seafood: Pursuant to a consumer complaint involving histamine poisoning from yellowfin tuna, FDA inspected a seafood processing facility and issued a warning letter for violations of the seafood Hazard Analysis and Critical Control Point regulation involving the packaging of tuna under insanitary conditions.
- Adulterated Juice: FDA issued a warning letter to Barsotti Juice Company, Inc. for violations of the Current Good Manufacturing Practice (CGMP) and alleging that the company’s organic carrot juice is adulterated in that it was prepared, packed, or held under insanitary conditions.
- Imported Food: FDA issued a warning letter to Dream Wholesale Inc. for failure to develop, maintain and follow a Foreign Supplier Verification Program for imported soda water, cooked chickpeas, grape leaves, dried apricot paste, and frozen spinach.
- Dietary Supplements: FDA issued a warning letter to Healthtex Distributors, Inc. alleging that its products are misbranded and violate CGMP regulations related to adulterated dietary supplements.
- Adulterated Animal Feed: FDA issued a warning letter to Woody’s Pet Food Deli after finding that its pet food was contaminated with Salmonella Reading and Listeria monocytogenes.
A database of warning letters can be found here.
USDA Updates
FSIS Releases New Rules for Voluntary “Product of USA” Labeling Claims
March 18: The U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) finalized a rule amending its regulations to better define conditions under which FSIS-regulated products may bear the voluntary “Product of USA” label. The final rule allows the voluntary “Product of USA” or “Made in the USA” label claim to be used on meat, poultry, and egg products only when they are derived from animals born, raised, slaughtered, and processed in the U.S. The rule goes into effect on May 17, 2024. Establishments voluntarily using a U.S.-origin claim subject to the final rule will need to comply with the new regulatory requirements by January 1, 2026. FSIS also updated its labeling guidance document to help establishments determine whether their labels must be submitted for approval. More information can be found here.
Other Articles of Interest
Trends in FDA Warning Letters under the Food Safety Modernization Act
March: Between January 2017 and December 2023, FDA issued 149 warning letters to human food facilities and 37 warning letters to animal food facilities citing violations of the applicable food current good manufacturing practice and preventive controls requirements. The most cited violations for human food facilities related to the agency’s sanitary operations, preventive controls, and hazard analysis requirements. The most cited violations for animal food facilities related to plant operations, hazard analysis, and sanitation. Warning letters reference hazard analysis and other requirements that were introduced as part of the Food Safety Modernization Act (FSMA). More information, along with best practice recommendations for food facilities to ensure the success of their next FDA inspection and reduce the risk of government scrutiny, can be found here.
Second Human Case of Bird Flu Confirmed: CDC Continues Monitoring and Emphasizes Low Public Risk
April 2: A second case of the avian influenza virus (H5N1) has been confirmed in a person in the U.S. following exposure to dairy cattle in Texas. The individual has mild symptoms, specifically eye redness, and is on antiviral treatment. The CDC assesses the risk to the general U.S. population as low but acknowledges higher risk for those with close contact with infected animals or contaminated environments. This is the second U.S. case after one reported in 2022. Despite this case, no changes in the human health risk assessment for bird flu are suggested. The CDC is overseeing preventative measures and working with the FDA and USDA to monitor for animal and human infection. The virus was confirmed by testing of unpasteurized milk and cattle throat swabs in Texas and Kansas, with cases also identified in Michigan. The CDC recommends avoiding exposure to sick or dead animals and their products, including raw milk from infected animals. The FDA confirms that the commercial milk supply remains safe due to pasteurization, which inactivates viruses. More information can be found here and in this Michael Best Client Alert.
Top 5 Regulatory Challenges in the Food Industry for 2024
March 31: In 2024, food industry professionals are navigating numerous regulatory compliance issues including 1) food traceability recordkeeping, 2) major food allergen enforcement, 3) PFAS regulations and state bans on synthetic chemicals, 4) Prop 65 short form labeling, and 5) FDA’s Unified Human Foods Program. These topics will be discussed at the American Conference Institute Food Law Summit in Chicago on April 30-May 1. More information can be found here.
Data Collection Tools and Strategies Available for Small and Midsize Food Manufacturers
March 25: Generating, collecting, and utilizing process data is a daunting task for most small and midsize food and beverage manufacturers. Addressing the challenges of data collection in the food industry has become easier with advancements in sensor technology. These improvements allow for non-invasive, accurate measurement of product characteristics. Low-cost tools are available that can make collection and utilization of data attainable for smaller businesses. More information can be found here.
AGs Urge Congress to Address Intoxicating Hemp Products in Farm Bill
March 21: A bipartisan coalition of 21 attorneys general is urging Congress to address the issue of hemp intoxicants in the upcoming reauthorization of the 2018 Farm Bill. The AGs argue that the 2018 Farm Bill created a loophole that allows for hemp-derived intoxicating products to be sold legally, which they believe poses a public health and safety crisis. The AGs want the definition of hemp to be amended to clarify that intoxicating products derived from hemp extracts are not legal under federal law. The AGs also want Congress to reaffirm that states are not limited in their ability to regulate or restrict cannabinoids or other derivatives of hemp. More information can be found here.
Lawsuits
Nestle Faces Lawsuit for Allegedly Impure Perrier Mineral Water
March 5: A proposed false advertising class action lawsuit was filed in the U.S. District Court for the Eastern District of New York alleging that Nestle USA Inc. misbranded Perrier products as “natural mineral water” from a spring in France when the company began blending water from multiple sources, as well as tap water. The French spring is contaminated and must be treated and filtered which is in violation of U.S. regulations governing mineral water. More information can be found here.
This Regulatory Update covers information from March 2024. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.