This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including the end of PFAS sales in food packaging, misbranded hot dog buns, an online system for identifying foodborne illness outbreaks, and more.
FDA Updates
FDA Announces the End the Sale of PFAS in Food Packaging
February 28: The FDA announced that grease-proofing materials containing per- and polyfluoroalkyl substances (PFAS) are no longer being sold for use in food packaging in the U.S. The announcement marks the fulfillment of a voluntary commitment by manufacturers to not sell food contact substances containing certain PFAS intended for use as grease-proofing agents in the U.S. More information can be found here.
FDA Updates Ingredient Directory for Dietary Supplements
February 21: FDA updated its Dietary Supplement Ingredient Directory, a webpage where the public can look up ingredients used in products marketed as dietary supplements to find what the FDA has said about that ingredient and whether the agency has taken any action regarding the ingredient. The updated Dietary Supplement Ingredient Directory can be found here.
FDA Warning Letters
- Imported Food: FDA issued a warning letter to Indian Groceries and Spices, Inc. of Chicago, IL for failure to develop, maintain and follow a Foreign Supplier Verification Program (FSVP) for imported spices.
- Dietary Supplements: FDA issued a warning letter to Pacific BioLogic Co. alleging that its products are misbranded and unapproved new drugs and they violate Current Good Manufacturing Practice (CGMP) regulations related to adulterated dietary supplements.
- Misbranded Hot Dog Buns: FDA issued a warning letter to Aunt Millie’s Bakeries alleging that its hot dog buns are misbranded because the label did not declare that it contains sesame which is a major food allergen.
- Adulterated Food: FDA issued a warning letter to Lucky L.T. Co., Inc. alleging that its noodle products were prepared, packed, or held under insanitary conditions.
- Adulterated Animal Feed: Pursuant to a complaint involving the death of cattle from consuming non-medicated animal feed, FDA inspected and issued a warning letter to Progressive Nutrition after finding that its product contained excessive levels of non-protein nitrogen.
A database of warning letters can be found here.
USDA Updates
FSIS Releases 2023 Foodborne Illness Outbreak Investigations Report
February 23: The U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) released a summary of outbreaks investigated during FY 2023. This report summarizes outbreaks investigated by FSIS during FY 2023 and includes information on pathogens, implicated sources, illnesses, and lessons learned from outbreak investigation after-action reviews. More information about outbreaks investigated by FSIS, previous annual summary reports and resources can be found on the FSIS website.
Other Articles of Interest
Wisconsin Launches Online System for Identifying Foodborne Illness Outbreaks
February 2: The Wisconsin Department of Health launched a system to help people report foodborne illnesses to identify outbreaks more quickly. Through an online survey, the system allows people who suspect their illness might be from eating or drinking something contaminated to report symptoms, recent food items eaten, and places visited before becoming sick. The online survey can help officials identify a source of contamination and learn more about water and food-related illnesses. More information can be found here.
USDA Strengthening Organic Enforcement Rule to go into Effect
February 20: The USDA Strengthening Organic Enforcement (SOE) Rule goes into effect on March 19, 2024. The rule is meant to fortify the integrity of USDA organic products. Businesses across the supply chain, including manufacturers and retailers, must adjust their procedures and practices to comply with the updated rule. The SOE Rule calls for more rigorous certification practices for various types of businesses, such as importers, exporters, brokers, traders, and storage facilities. Businesses that aggregate, cull, package, repackage, or store USDA organic products must now obtain certified organic status. The certification process involves completing an application, submitting documentation, an on-site inspection, and technical review. The SOE Rule also calls for a mandatory electronic National Organic Program (NOP) Import Certificate for any organic product entering the US. Businesses must create or update an Organic Systems Plan (OSP) to comply with the rule. More information can be found here.
Family Dollar to Pay Millions of Dollars for Rodent Infestation
February 27: Family Dollar Stores LLC was fined $41.675 million for holding food, drugs, medical devices, and cosmetics under unsanitary conditions related to a rodent infestation in the largest ever monetary criminal penalty in a food safety case. The plea agreement requires Family Dollar and Dollar Tree to meet corporate compliance and reporting requirements for three years. The rodent infestation was first reported in August 2020, and by January 2021, the company was aware that the unsanitary conditions violated the Federal Food, Drug, and Cosmetic Act. The company continued to ship products from the warehouse until January 2022, when an FDA inspection revealed the extent of the infestation. More information can be found here.
This Regulatory Update covers information from February 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.