This update includes FDA and USDA updates, FDA warning letters, lawsuits, and other articles of interest, including funding to combat avian flu in the dairy industry, a ruling on “all natural” labeling, and the FDA’s determination on the GRAS status of tara flour.
FDA Updates
FDA Issues Final Rule to Modify Agricultural Water Provisions of the Produce Safety Regulation
May 6: FDA issued a final rule updating pre-harvest agricultural water provisions for covered produce, excluding sprouts, under Subpart E of the FDA Food Safety Modernization Act Produce Safety Rule. The new rule replaces the previous pre-harvest water microbial quality criteria and testing requirements for covered produce (other than sprouts) with requirements for systems-based, pre-harvest agricultural water assessments for hazard identification and risk management decision-making purposes. The updated regulation will better address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem. The rule becomes effective July 5, 2024. More information can be found here.
FDA Says Tara Flour is an Unapproved Food Additive
May 15: FDA determined that tara flour in human food does not meet the Generally Recognized As Safe (or GRAS) standard and is an unapproved food additive. The FDA’s evaluation revealed that there is not enough data on the use of tara flour in food, or a history of its safe use, to consider it GRAS. In addition, there is no food additive regulation authorizing the use of tara flour in food. The FDA issued a memo detailing its assessment of the ingredient. More information can be found here.
FDA Extends Comment Period for Color Additive Certification Services Fees
May 28: The FDA is extending the comment period for the reopening notice entitled “Color Additive Certification; Increase in Fees for Certification Services.” The deadline for submitting comments is June 27, 2024. More information can be found here.
Renewed U.S. Interagency Collaboration Aims to Cut Food Waste
May 30: The FDA has renewed its commitment to the Federal Interagency Collaboration to Reduce Food Loss and Waste (FIFLAW) along with the USDA and EPA. The U.S. Agency for International Development (USAID) also joined the collaboration. The agencies want to reduce food loss and waste in half by 2030 and encourage consumers and retailers to utilize resources provided by the FDA to help reach this goal. Collaborative efforts include education, outreach, research, community investments, voluntary programs, technical assistance, policy discourse, and public-private partnerships. The participation of USAID is expected to improve international stakeholder engagement and optimize the use of government resources. More information can be found here.
FDA’s Reorganization Approved for Unified Human Foods Program
May 30: The FDA is undergoing a reorganization which includes the establishment of the Human Foods Program, a new model for field operations, and other modernizations, with implementation targeted for October 1, 2024. The restructuring seeks to make the FDA more efficient and responsive to changes in industry, technology, and global factors like climate change. According to FDA, the new Human Foods Program will strengthen the FDA’s preventative measures, enhance nutrition importance, improve partnerships, and better manage innovative food products and agricultural technology. The FDA states that it will be better positioned to uphold the safety of the nation’s food supply, and respond to food-related emergencies, such as the 2022 infant formula shortages. The reorganization includes realigning functions from existing food safety and regulatory offices under one program and renaming the Office of Regulatory Affairs to the Office of Inspections and Investigations to reflect its role in inspections, investigations, and product safety assurance. More information can be found here.
FDA Extends Comment Period for Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food
May 31: The FDA is extending the comment period for a revised draft Introduction, and a revised draft Appendix 1, within a guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food” by an additional 60 days. Comments must be submitted by August 2, 2024. More information can be found here.
FDA Achieves Lab Capacity for Mycotoxin Testing under LAAF Program
May 31: The FDA announced that sufficient laboratory capacity has been reached for mycotoxins testing in foods related to imports under the Laboratory Accreditation for Analyses of Foods (LAAF) program. The FDA’s LAAF program was created to enhance food testing standards and procedures. Importers must use accredited labs for mycotoxin food testing starting December 1, 2024. As the program expands capacity for other analytes, they will be listed on the LAAF Dashboard with the compliance date set at six months from the date a specific analyte is posted onto the Dashboard. More information can be found here.
FDA Warning Letters
Misbranded Food: FDA issued a warning letter to California Bread Company alleging that its Egg Bread product is adulterated because it contains a color additive which is unsafe. FDA also alleged significant violations of the labeling regulations for foods and significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
Misbranded Cookie Dough: FDA issued a warning letter to Cookies and Milk LLC alleging that its ready-to-eat Peanut Butter Cup Edible Cookie is misbranded in that the product labels did not declare a peanut allergen and it failed to declare all the common or usual names of each ingredient used.
Low Acid Canned Food: FDA issued a warning letter to two foreign companies alleging violations of the Emergency Permit Control regulation and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation. The violations also render the LACF products adulterated.
Adulterated Dietary Supplements: The FDA issued a warning letter to Carbon Fire, LLC involving its 213° Metabolism Boosting Complex, which is labeled as a dietary supplement. The FDA alleged the product is an adulterated dietary supplement because it contains a new dietary ingredient under the federal Food, Drug, and Cosmetic Act.
A database of warning letters can be found here.
USDA Updates
FSIS Classifies NRTE Breaded Stuffed Chicken Products with Salmonella Over 1 CFU/g as Adulterated
May 1: The Food Safety and Inspection Service (FSIS) announced a final determination that not ready-to-eat (NRTE) breaded stuffed chicken products, which have Salmonella levels of 1 Colony Forming Unit per gram (1 CFU/g) or above, are considered adulterated under the Poultry Products Inspection Act (PPIA). Additionally, FSIS plans to implement verification procedures that include sampling and testing the raw chicken ingredients used in these NRTE breaded stuffed chicken products before they are stuffed and breaded. The final determination will be effective May 1, 2025. More information can be found here.
FSIS Announces Adjusted Dollar Limitations for Retail Exemptions
May 17: The FSIS announced the dollar limitations on the amount of meat and poultry that a retail store can sell to hotels, restaurants, and similar institutions without disqualifying itself for exemption from federal inspection requirements. In accordance with FSIS regulations, for calendar year 2024, the value for the retail dollar limitation for meat and meat products (including Siluriformes) is $100,900, and the value for the retail dollar limitation for poultry and poultry products is $74,200. These dollar limitations will be effective on June 17, 2024. More information can be found here.
FSIS Updates Guidance on Donations of Meat, Poultry and Egg Products to Non-Profits
May 23: The FSIS has updated its Guideline to Assist with the Donation of Eligible Meat and Poultry Products to Non-Profit Organization. The guideline addresses food donation questions from meat and poultry establishments and non-profit organizations and explains inspection, labeling, shipping requirements, and exemptions. More information can be found here.
Other Articles of Interest
Joint USDA, FDA and HHS Funding Announced to Fight Avian Flu in Dairy Industry
May 13: The USDA, FDA and HHS are coordinating efforts to combat the spread of Avian Flu (H5N1) and provide financial support for lost milk production. The USDA is providing financial support and assistance to improve biosecurity and mitigate spread among humans and animals. They are offering up to $2,000 per month for personal protective equipment (PPE) and worker studies, $1,500 for biosecurity plans, $2,000 for waste milk heat treatment, reimbursement for veterinary costs up to $10,000, and covering shipping costs for testing. There is also funding available for producers with milk production loss and state partnership for movement restrictions. The HHS is investing $101 million through the CDC and FDA for testing, surveillance, and treatment. A $3 million wastewater pilot is also being launched. FDA announced an additional $8 million to help with pasteurization criteria validation, surveillance, lab capacity, biosecurity training, partner activities, and research collaborations. More information can be found here.
U.S. Justice Department Proposes Regulation to Reschedule Marijuana
May 16: The Justice Department announced a proposal to consider reclassifying marijuana as a Schedule III drug under the Controlled Substances Act, initiating a review process requested by President Biden. Marijuana has been listed as a Schedule I substance since 1970 but following scientific review by Health and Human Services and legal advice from the Office of Legal Counsel (OLC), the Attorney General is using his authority to potentially change its classification. The formal rulemaking process involves public notice, commentary, and a hearing. Until a final ruling, marijuana continues to be treated as a Schedule I drug. More information can be found here, along with a copy of the notice of proposed rulemaking and the OLC memorandum.
Update on USDA H5N1 Beef Safety Studies
May 24: The FSIS conducted tests on beef tissue from 96 cull dairy cows condemned at select FSIS-inspected facilities. Meat from condemned cows is prohibited from entering the food supply. On May 22, 2024, viral particles were detected in tissue samples, including muscle, from one cow. To date, samples from 95 cows have tested negative for viral particles. No meat from these dairy cattle entered the food supply and USDA is confident that the meat supply is safe. More information can be found here.
FDA Proposes to Ban Brominated Vegetable Oil
May 24: In November 2023, the FDA proposed a new rule to ban the use of brominated vegetable oil (BVO) in food. BVO is commonly used as an emulsifier and stabilizing agent in citrus sodas and other beverages. However, studies have shown adverse health effects in animals, leading the FDA to reconsider its safety. BVO is a vegetable oil modified with bromine, and its use has been linked to thyroid and heart problems. BVO will be banned in California in 2027. Japan, India, and parts of Europe have previously banned BVO in drinks and food products. More information can be found here.
USDA Allocates $824 Million to Protect Livestock Health Amid H5N1 Concerns
May 30: The USDA announced $824 million in new funding to protect livestock health to bolster efforts in response to the detection of the H5N1 virus in dairy cattle. Additionally, USDA is launching a Voluntary H5N1 Dairy Herd Status Pilot Program, which provides dairy producers with more options to monitor herd health and move cows efficiently while expanding understanding of the disease. The emergency funding will support rapid response activities, diagnostics, field response, and food safety studies, among other critical efforts. More information can be found here.
Federal Government on Course to Update Dietary Guidelines for Americans
May 31: The 2025 Dietary Guidelines Advisory Committee is on schedule with the federal government’s five-year mandated timetable for another version of the Dietary Guidelines for Americans. The Committee is a collaborative effort between the U.S. Departments of Health and Human Services (HHS) and USDA and is made up of 20 members, drawn mostly from academic backgrounds. Having completed the fifth of five scheduled work sessions, it is still unclear what recommendations the 2025 Dietary Guidelines for Americans will contain. Wine could be at risk of being eliminated as the World Health Organization pushes for prohibition. Potatoes appear safe, while lactose illnesses in certain minority populations have dairy under scrutiny. The USDA and HHS are jointly responsible for updating the guidelines. More information can be found here.
Lawsuits
U.S. Court of Appeals Rules in Favor of Kind Over ‘All Natural’ Labeling
May 1: The U.S. Court of Appeals Second Circuit affirmed a summary judgment for Kind LLC against a group of buyers who claimed the company misled consumers by labeling products as “all natural”. The Court said that the plaintiffs failed to establish through evidence how a reasonable buyer would understand the term. The Court’s opinion closes out litigation that was launched in 2015 after the FDA issued a warning letter that Kind’s “healthy and tasty” packages constituted an implied nutrient content subject to federal regulations and that the products did not meet FDA’s saturated fat content requirements to describe food as healthy. A copy of the Court’s opinion can be found here.
Sports Drink Company Accused of Mislabeling Caffeine
May 9: A proposed class action was filed against Prime Hydration LLC, a sports drink company founded by YouTubers Logan Paul and KSI, alleging that the company practices false and deceptive advertising by understating the caffeine in its energy drinks. According to the complaint filed in the US District Court for the Southern District of New York, beverages in the Prime Energy line are advertised to contain 200 mg of caffeine but contain substantially more than that. Prime’s audience includes a large share of adolescents. A copy of the complaint can be found here.
Publix ‘Naturally Flavored’ Cereal Bars Lawsuit Dismissed
May 23: A federal judge for the U.S. District Court for the Middle District of Florida dismissed a proposed class action against Publix Super Markets Inc. that alleged its apple and strawberry flavored cereal bars were deceptively advertised as “naturally flavored” when they contained DL-malic acid. The judge said that none of the packaging labels state that the bars lack artificial flavor or that the bars include only flavor from a ‘natural’ strawberry or apple. More information can be found here.
Bai WonderWater Maker Faces False Advertising Lawsuit over Artificial Sweetener
May 24: A new proposed class action was filed in the US District Court for the Southern District of New York alleging that Bai Brands LLC deceptively advertised its flavored waters as free from artificial sweeteners despite containing artificial sugar replacements such as stevia leaf extract, erythritol, or monk fruit extract. The consumers brought claims for deceptive trade practices and misrepresentation arguing that even though each of the alleged sweeteners comes from a plant, they undergo extensive industrial processing before being used as a sugar substitute and therefore are not natural.
Barilla Italian Pasta Label Suit Gets Class Certified
May 29: A federal judge for the U.S. District Court for the Northern District of California granted class certification to consumers alleging Barilla America Inc. deceived them into believing some of their pastas were made and sourced in Italy, because of packaging labels that said, “Italy’s #1 Brand of Pasta.” The Consumers sued Barilla in 2022 over the Italy statement as being deceptive because the pastas are made in Iowa and New York. The judge previously denied Barilla’s motion to dismiss the class action lawsuit, ruling that the plaintiffs had standing to sue the company. More information can be found here.
This Regulatory Update covers information from May 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.