This update includes FDA updates, USDA updates, FDA warning letters, and other developments, including a proposed rule to reduce sodium intake, new education materials on GMOs for consumers, and more.
FDA Updates
FDA Amends Yogurt Rule, Denies Request for Public Hearing April 13: FDA modified provisions of a 2021 final rule that revoked standards of identity for lowfat and nonfat yogurt and amended the standard of identity for yogurt. Under the 2021 final rule, FDA required that yogurt have a titratable acidity of not less than 0.7 percent, expressed as lactic acid, or a pH of 4.6 or less before the addition of bulky flavorizing ingredients. After the rule was finalized, the International Dairy Foods Association (IDFA) filed a request for public hearing, objecting to these provisions of the rule. Under the modified rule, FDA will simply require products to have a pH of 4.6 or lower. Concurrent with the modification of the final rule, FDA denied IDFA’s request for a public hearing. The Federal Register notice can be found here.
FDA Issues Proposed Rule to Reduce Sodium Intake April 10: FDA issued a proposed rule to amend standard of identity regulations that specify salt (sodium chloride) as a required or optional ingredient in standardized foods to instead allow for the use of salt substitutes, in order to reduce sodium content. FDA states that this rule, if finalized, would help support a healthier food supply by providing flexibility to facilitate industry innovation in the production of standardized foods lower in sodium while maintaining the basic nature and essential characteristics of the foods. More information can be found here. To assure consideration, comments must be submitted by August 8, 2023.
FDA Requests Information about Online Grocery Shopping Food Labeling April 24: The FDA is requesting information on whether and how online grocery retailers, food manufacturers, and third-party online grocery providers are displaying nutrition, ingredient, and allergen information through online grocery shopping platforms. The purpose of this request is to obtain information on the content, format, and accuracy of food label information provided to consumers through online grocery shopping. Comments are due July 24, 2023. More information can be found here.
Comment Period for Guidance on Labeling of Plant-Based Milk Alternatives Reopened April 30: FDA reopened the comment period for the draft guidance entitled “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Guidance for Industry,” which was published on February 23, 2023. The guidance will provide industry with recommendations that will result in clear labeling to help consumers make informed decisions and understand certain nutritional differences between plant-based milk alternatives (PBMA) products and milk. The FDA also recommends that PBMA products that are labeled with the term “milk” in their names, such as “soy milk” or “almond milk,” and that have a nutrient composition that is different than milk, include a voluntary nutrient statement that conveys how the product compares with milk. A copy of the draft guidance and a link for submitting comments can be found here Comments on the draft guidance are now due July 31, 2023.
“Feed Your Mind” Education Materials on GMOs for Consumers April 19: FDA released new materials for consumers to provide science-based information on genetically modified organisms (GMOs). “Feed Your Mind” is an educational initiative launched in 2020 to help consumers better understand GMOs. The new materials include information about genome editing, GMO benefits to the environment, farmers, and consumers, GMO regulations in the U.S., and videos from GMO growth experts. The “Feed Your Mind” materials can be found here.
FDA Warning Letters
Imported Food: Inspectors found an Illinois food importer was not in compliance with the Foreign Supplier Verification Program (FSVP) for imported food.
Quick Frozen Shrimp: A Mississippi seafood freezing and processing facility received a warning letter for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
USDA Announces Funding Available to Expand Meat and Poultry Processing Options for Underserved Producers and Tribal Communities April 19: USDA announced the availability of up to $125 million through two new grant programs that will create more options for producers by investing in independent, local meat and poultry processing projects that increase competition and enhance the resiliency of the food supply chain, including new capacity for indigenous meat processing to support tribal food systems.
The new grant programs, the Indigenous Animals Harvesting and Meat Processing Grant Program and the Local Meat Capacity Grant Program, are part of the $1 billion American Rescue Plan investment by the Biden Administration to expand processing capacity for small and midsized meat and poultry processors. More information is available on the Agricultural Marketing Service’s Local MCap webpage and here. Grant applications will be accepted through July 19, 2023.
Other Developments
Groups Oppose California Bill to Ban Unsafe Food Additives Earlier this year, legislators in California introduced Assembly Bill 418, a bill that would prohibit the manufacture, sale or distribution of any food product in California containing red dye No. 3, titanium dioxide, potassium bromate, brominated vegetable oil, or propyl paraben beginning January 1, 2027. The Consumer Brands Association, the American Beverage Association, the American Bakers Association and The North American Millers’ Association are among a number of groups opposing the bill. The groups opposing the bill said California already has a process by which unsafe chemicals are removed from the market or mandated to include warning labels. The bill, which passed the Assembly and is currently in committee in the State Senate, would be the first in the nation to ban chemicals intentionally added to foods as preservatives or to enhance colors and flavors.
This Regulatory Update covers information for June 2023. 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.
This update includes FDA updates, USDA updates, and FDA warning letters, including the issuance of a notice announcing the status of COVID-19 guidance documents, proposed updated rules governing voluntary “Product of USA” claims, and more.
FDA Updates
FDA Issues Draft Guidance About Dietary Guidance Statements in Food Labeling March 27:FDA issued a draft guidance for industry titled “Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry.” The draft guidance will provide information and FDA’s current thinking on the use of Dietary Guidance Statements on packaged food labels and more broadly in the labeling of foods, including any written, printed, or graphic material accompanying a food, such as labeling on websites. In general, Dietary Guidance Statements are statements relating a food or food group to a nutritious dietary pattern, with such statements based on key or principal recommendations from consensus reports. The draft guidance can be found here. The deadline to submit public comments has been extended to September 25, 2023.
FDA Issues Notice Announcing the Status of COVID-19 Guidance Documents March 13: The FDA issued a notice in the Federal Register to explain how the end of the federal Public Health Emergency (PHE) associated with COVID-19 impacts the agency’s pandemic-era guidance documents. As of the expiration of the PHE on May 11, 2023, many of the guidance documents are no longer in effect or will expire shortly after the PHE ends, while FDA has indicated that other guidance will continue to be effective. A list of affected guidance documents and their current status can be found here.
FDA Warning Letters
RTE Product: Upon inspection, a Florida food manufacturer of ready-to-eat (RTE) sandwiches received a warning letter after FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. During this inspection, FDA collected environmental samples from various areas and found the presence of Listeria monocytogenes.
Soft Cheese: A Michigan soft and semi-soft cheese producer was inspected after a multistate outbreak of Listeria was linked to RTE soft cheese products supplied by the facility. FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulations leading to a warning letter.
Pretzels: During an inspection of a Michigan RTE seasoned hard pretzels producer, inspectors found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
FSIS Proposes Updated Rules Governing Voluntary “Product of USA” Claims March 6: UDA’s Food Safety and Inspection Service (FSIS) proposed to amend its regulations to define the conditions under which the labeling of meat, poultry, and egg products, as well as voluntarily inspected products, may bear voluntary label claims indicating that the product is of United States origin. View the Federal Register notice here.
Other Developments
Fourth Circuit Affirms Gruyere Certification Mark Rejection The federal Court of Appeals for the Fourth Circuit affirmed a lower court’s grant of summary judgment in favor of the opposers of a certification mark (a type of trademark used to show consumers that certain standards have been met by a product) for “GRUYERE” to designate cheese that originates in the Gruyère region of Switzerland and France. The three-judge panel concluded that “cheese consumers in the US understand ‘GRUYERE’ to refer to a type of cheese, which renders the term generic,” and thus deemed the term unregistrable as a certification mark. This ruling is a win for cheese producers that make cheeses with names associated with physical places such as Gruyere, Havarti, Cheddar, and Swiss.
This Regulatory Update covers information for March 2023. 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.
This update includes FDA updates, USDA updates, and FDA priority guidance topics for 2023, including the withdrawal of a proposed rule on general principles and food standards modernization, enforcement discretion for claims related to high flavanol cocoa powder, and more.
FDA Updates
FDA Withdraws Proposed Rule on General Principles and Food Standards Modernization February 28: FDA and USDA’s Food Safety and Inspection Service (FSIS) have announced the withdrawal of the proposed rule titled “General Principles and Food Standards Modernization,” originally published in the May 20, 2005 Federal Register. In what was viewed as a part of renewed efforts by FDA to work towards modernizing standards of identity, FDA held public meetings on the topic in July 2018 and September 2019. FDA subsequently reopened the comment period in 2020 for FDA-specific aspects of the 2005 proposed rule. As a result of comments received in 2005 and 2020, FDA and FSIS are now withdrawing the proposed rule with plans to create a new proposed rule on principles for food standards modernization in the future. The withdrawal is effective March 1, 2023. More information can be found here and in this Constituent Update.
FDA Releases Draft Guidance on the Labeling of Plant-Based Milk Alternatives February 22: FDA released draft guidance that will provide industry with FDA’s view on the labeling of plant-based food products that are marketed and sold as alternatives to milk (plant-based milk alternatives) and recommendations for the use of voluntary nutrient statements on such products. More information on the changes can be found here. The comment period has been extended through July 31, 2023.
FDA Announces Enforcement Discretion for Claims Related to High Flavanol Cocoa Powder February 3: The FDA issued a letter of enforcement discretion stating that it “does not intend to object to the use of certain qualified health claims regarding the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease for conventional foods, provided that the qualified claim is appropriately worded so as not to mislead consumers and that other factors for the use of the claim are met.”
FDA’s decision to exercise enforcement discretion comes in response to a qualified health claim petition submitted by Barry Callebaut AG, Switzerland. It applies specifically to cocoa flavanols in high flavanol cocoa powder and foods that contain high flavanol cocoa powder. The claim may not be used in connection with regular cocoa powder, foods containing regular cocoa powder, or other food products made from cacao beans, such as chocolate. More information can be found here.
FDA Launches Directory of Dietary Supplement Ingredients March 6: The FDA introduced a new Dietary Supplement Ingredient Directory, a webpage where the public can look up ingredients used in products marketed as dietary supplements and quickly find what the FDA has said about that ingredient and whether the Agency has taken any action with regard to the ingredient. The directory can be found here.
FDA Priority Guidance Topics for 2023
FDA has released a list of draft and final guidance topics related to food and nutrition (including allergen labeling, food safety, food additives, Food Safety Modernization Act (FSMA) implementation, and nutrition) that are a priority for the agency to publish by December 2023. The targeted guidance documents currently include:
Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Guidance for Industry
Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact; Draft Guidance for FDA Staff
Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Stakeholders
New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes; Guidance for Industry
Dietary Supplement Master Files: Draft Guidance for Industry
Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations): Draft Guidance for Industry
Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry
Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
Inorganic Arsenic in Apple Juice: Action Level; Draft Guidance for Industry
Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer’s Goods from DWPE; Draft Guidance for Industry
Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff
Evaluation and Establishment of Safety of Low-Moisture Ready-to-Eat Foods Following Equipment Microbiological Contamination Event: Guidance for Industry
Action Levels for Arsenic in Food Intended for Babies and Young Children: Draft Guidance for Industry
Action Levels for Cadmium in Food Intended for Babies and Young Children: Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 9: Validation of Process Controls; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Acidified Foods; Draft Guidance for Industry
Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations: Guidance for Industry
Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
Questions and Answers About Dietary Guidance Statements in Food Labeling; Draft Guidance for Industry
Use of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products: Draft Guidance for Industry
Amendment to Guidance for Industry: Menu Labeling Supplemental Guidance
Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein: Guidance for Industry
Stakeholders should monitor the Federal Register for the opportunity to comment on guidance that affects their business operations. More information can be found here.
USDA Updates
USDA Reports on Salmonella Trends February 10: The National Antimicrobial Resistance Monitoring System (NARMS) released a report highlighting Salmonella antimicrobial resistance (AMR) trends from 2014-2019. The report outlines the trends in antibiotic resistance in slaughter facilities and is linked here.
USDA Aligning Regulations for Cured and Cooked Meats February 21: USDA has issued notice to revise the regulations for cured or cooked meat from regions where foot-and-mouth disease exists to reflect changes to the USDA FSIS regulations regarding thermally processed, commercially sterile meat. The Federal Register notice can be found here.
Other Developments
Child Labor Caught in Tug of War During Labor Shortage In Michigan, a New York Times article exposing the employment of migrant children led to the Department of Labor and Department of Health & Human Services announcing action to “increase their efforts to thoroughly vet sponsors of migrant children, investigate child labor violations and hold the companies accountable.” More information on the New York Times article can be found here.
This Regulatory Update covers information for February 2023. 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.
This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including the deadline for front of package labeling comments, a Legionnaire’s Disease outbreak, FSIS guidelines for label approval, and more.
FDA Updates
FDA Commissioner Califf Proposes Redesign of Human Food Program FDA Commissioner Robert Califf announced a new vision for the FDA Human Foods Program that would unify the functions of the Center for Food Safety and Applied Nutrition (“CFSAN”), the Office of Food Policy and Response (“OFPR”), and certain functions of the Office of Regulatory Affairs. The Agency seeks to kick off the restructuring by appointing a new Deputy Commissioner of the Human Foods Program and establishing an Advisory Committee. The announcement can be found here.
Front of Package Labeling Comments Open Until March 27 The FDA is seeking comments regarding front of package (“FOP”) labeling and information in contemplation of a system to help consumers interpret the nutrient information on food products. The increased attention in recent years to FOP labeling, and the experiences of countries that have adopted FOP labeling, suggests that FOP labeling may aid consumer’s nutrition comprehension and lead to healthier choices. The request can be found here, and comments are due March 27, 2023.
FDA Allows Vitamin D in Breakfast Cereals and Grain-Based Bars The FDA is amending its food additive regulations to provide for the safe supplementation of vitamin D3 in breakfast cereals and grain-based bars, and to update the Vitamin D3 specifications. The Agency is taking this action in response to a petition filed by Kellogg Company, and the Register Notice can be found here.
Final Guidance on Foreign Supplier Verification Programs Arrives The FDA has issued a final guidance entitled “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry.” This guidance document covers how importers of food for humans and animals can comply with the regulation on foreign supplier verification programs (FSVPs). These regulations were enacted on November 27, 2015, and a draft guidance of the same title was issued January 24, 2018. The final guidance can be found here.
FDA Punts on CBD Rules The FDA denied three citizen petitions that asked it to conduct rulemaking to allow the marketing of CBD products as dietary supplements. The FDA opted to work with Congress on a new way forward, as the existing regulations are not appropriate for CBD Products. The announcement can be found here.
FDA Seeks Comments on Food Additives and Color Additive Petitions The FDA is seeking comments until April 4, 2023 on several topics related to food additive petitions and color additive petitions (“FAPs and CAPs”) used in food production. The Agency is requesting feedback on the information collection provisions and the labeling requirements. More information can be found here.
Final Guidance on Practices to Prevent Contamination of Medicated Feeds Now Available A final guidance has been released by the FDA describing practices that medicated feed manufacturers should use to prevent unsafe contamination from drug carryover into a non-medicated animal feed and to prevent an animal feed containing a different approved new animal drug. Errors surrounding medicated feed are a huge liability to feed producers. This guidance provides details on preventative measures such as cleanout, flushing, and sequencing that the Agency will expect to see implemented in forthcoming inspections. Feed producers should view the guidance found here.
FDA Warning Letters
Hummus and Cheese: A ready-to-eat hummus and cheese manufacturing facility was issued a warning letter after investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (“CGMP & PC rule”).
Salmonella Outbreak Leads to Warning Letter for J.M. Smucker: An inspection was initiated as part of a multistate foodborne outbreak investigation of Salmonella illnesses linked to the manufacturer’s Jif peanut butter. Investigators found serious violations of the CGMP & PC rule. The Agency had concerns associated with water allowed to puddle in the facility. Environmental monitoring showed multiple positive environmental swabs. However, the outbreak was not contained.
Legionnaire’s Disease Outbreak: After three passengers were diagnosed with Legionnaire’s disease aboard American Cruise Line Cruises, the company was inspected and subsequently issued a warning letter. During the inspection, FDA investigators collected biofilm swabs and potable water samples from the vessels which identified Legionella in the potable water system.
Low-Acid Canned Food Recall Leads to Warning Letter: A commercial processor of low-acid foods packaged in hermetically sealed containers was issued a warning letter after the processor released product with microbiological contamination (Cronobacter sakazakii and Clostridium botulinum) and continued processing. Intensive action has since been taken as the processor has recalled products and taken steps to correct the contamination issue.
A database of warning letters issued by the FDA can be found here.
USDA Updates
USDA Strengthens Certified-Organic Regulations USDA has strengthened the National Organic Program (“NOP”) with the intent to reduce the incidences of suppliers selling conventional products as certified organic. One change is that the new rules will require the use of NOP import certificates for all organic products entering the United States. Changes go into effect March 19, 2024. More information can be found here.
USDA FSIS Issues Strategic Plan for 2023-2026 USDA’s FSIS has released its strategic plan for 2023-2026 with three strategic goals: “Prevent Foodborne Illness and Protect Public Health,” “Transform Inspection Strategies, Policies, and Scientific Approaches to Improve Public Health,” and “Achieve Operational Excellence.” More information can be found here.
USDA FSIS Issues Guidelines for Label Approval USDA’s Food Safety and Inspection Service (“FSIS”) has released guidance to help establishments determine whether their labels must be submitted to FSIS Labeling and Program Delivery Staff (LPDS) for approval. The guidance expands the generic labeling approval of meat, poultry, and eggs products. More information can be found here.
Consumer Reports Promotes Petition to Ban Red Dye No. 3 Consumer Reports has been on the offensive against Red Dye No. 3, which is already banned in cosmetics but allowed in foods. According to the organization, the dye has been linked to hyperactivity and other neurobehavioral effects in children. More information can be found here on Consumer Reports’ website.
Other Items of Interest
Plaintiff’s Suit Secures $4 Million for Victim of an Ice Cream Listeria Outbreak A judge awarded $4 million in damages to the family of a 79-year-old woman that died as a result of a listeria outbreak in Big Olaf Creamery’s Ice Cream.
This Regulatory Update covers information from January 1 – January 31, 2023. Please contact Paul Benson, Taylor Fritsch, Liz Simonis, 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.
This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including the adding of sesame to the major allergen list, listeria in ice cream, the legalization of raw milk, and more.
FDA Updates
Reminder: Sesame Added to Major Allergen List The Food Allergy Safety, Treatment, Education, and Research Act of 2021 established sesame as the 9th major food allergen. As of January 1, 2023, any food containing sesame is subject to specific food regulatory requirements regarding major allergens. At the end of November, the FDA issued a question-and-answer guidance document to help provide information regarding the new labeling requirements for products containing sesame. The guidance can be found here.
FDA Releases 2022 Food Code The annual update (and 30th edition) of the Food Code was released by the FDA in December. The 2022 Food Code specifically addresses food donations, creates new requirements for the allowance of pet dogs in outdoor dining spaces and revises the definition of intact meat. It also updates provisions related to sesame which is now a major food allergen. A summary of the changes, more information, and a copy of the 2022 Food Code can be found here.
FDA Denies Requests From Industry on Yogurt Standards The FDA received objections and requests for a hearing from the International Dairy Foods Association (IDFA) and Chobani, Inc. on a final rule published on June 11, 2021, which revoked the standards of identity for lowfat yogurt and nonfat yogurt and amended the standard of identity for yogurt in numerous respects. The FDA denied the request on Dec. 15th, 2021 which lifted the stay of the effectiveness on the final regulation. Though the objections and requests were not moved forward by the FDA, the changes were a major advocacy win for the industry as seeks to modernize. The final regulation comes into force on January 17, 2023 with a deadline for compliance on Jan. 1, 2024. The notice in the Federal Register can be found here.
FDA is Seeking Public Comments on Proposed Collection of Information Related to Animal Feed The FDA is seeking public comment on the proposed collection of certain information by the Agency related to animal feed including dog, cat, cattle, horse, and livestock feed. The Center for Veterinary Medicine and the Partnership for Food Protection developed a web-based tracking network to allow Federal, State, and Territorial regulatory and public health agencies to share safety information about animal food. The notice in the Federal Register can be found here.
FDA Releases Guidance for Best Practices for Convening GRAS Panel The FDA released a final guidance for industry entitled “Best Practices for Convening a GRAS Panel.” The guidance helps individuals involved in the process of determining if a substance may be used in food on the basis that it is Generally Recognized as Safe (“GRAS”). The guidance can be found here.
FDA Warning Letters
Listeria in Ice Cream: December’s lone warning letter was issued to a Ice Cream producer after a Listeria outbreak linked to one death and one fetal fatality was traced back to the facility. The ice cream products were found to be adulterated because they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. The inspection also cited serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation. No response was issued to the Form 483 and the December 9 warning letter was subsequently issued.
A database of warning letters issued by the FDA can be found here.
USDA Updates
FSIS Sets January 1, 2026, for Implementing Meat and Poultry Labeling Regulations FSIS established January 1, 2026, as the uniform compliance date for new meat and poultry product labeling regulations that will be issued between January 1, 2023 and December 31, 2024. This gives packers time to implement changes as a result of new meat and poultry product labeling regulations to minimize the economic impact of label changes. As new labeling requirements are issued, meat and poultry packers should keep this timetable in mind.
USDA Publishes Pesticide Residue Results The 2021 Pesticide Data Program was released and reflected producers’ commitment to halt pesticide residues in food. Each year, the USDA and EPA work together to sample thousands of food products for pesticide residues. Overall, over 99% of the 10,127 samples tested had residues below the tolerances established by the EPA, with 24.0% having no detectable residue. Residues exceeding the tolerance were detected in only 54 samples and of those detections, 29 were domestic (53.7%), 24 were imported (44.4%), and 1 was of unknown origin (1.9%). The full Pesticide Data Program Summary can be found here.
Other Items of Interest
FDA Faces Heavy Scrutiny for Lack of Leadership Despite Increasing Budget Earlier this year, Commissioner Robert Califf authorized an independent evaluation of the FDA by the Reagan-Udall Foundation to evaluate the agency’s human food program and provide recommendations for the agency. Major questions surrounding the FDA include whether the food divisions should be severed from the agency to form a new agency reporting directly to HHS. The report weights the options and cites the current culture including a lack of clear vision, disparate structure, and lack of leadership as major factors in the agency’s struggle. There is a silver lining for the agency: a recently signed omnibus spending bill covering FY 2023 appropriations funding gives the FDA an additional $226 million in budget authority funding, a more than 6.5% increase. Changes are expected as food security gets a larger focus from the FDA. The full Reagan-Udall Report can be found here.
Group Urges for the Inclusion of Cranberries in the Definition of “Healthy” A bipartisan group of twenty-eight (28) House Members and Senators joined together to urge the FDA to amend its proposed definition of “healthy” to include more cranberry products. The current proposed rule would exclude most cranberry and tart cherry products.
Missouri Seeks to Legalize the Sale of Raw Milk This January, the Missouri Legislature will look at legislation that would legalize the sale of Grade A raw milk or cream in Missouri as long as it has a clearly marked warning label. This follows the apparent trend of relaxing food laws gaining popularity within state legislatures over the last ten years.
Hershey’s is Among Chocolatiers Facing Scrutiny for Lead and Heavy Metals In December 2022, a suit was filed in a New York federal court related to lead and cadmium levels in chocolate bars. This isn’t the only bitter news for chocolatiers. The National Confectioners Association has had to defend the safety of dark chocolate after Consumer Reports brought attention to the amount of cadmium and lead in the products in a report issued December 15, 2023. This likely signals an increased focus on heavy metals in chocolate products moving forward.
This Regulatory Update covers information from December 1 – December 30, 2022. Please contact Paul Benson, Taylor Fritsch, Liz Simonis, 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.
This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including the final rule issued for records of products on the Food Traceability List, warning letter for unapproved CBD products, the Biden administration’s investment in meat and poultry processing, and more.
FDA Updates
Draft Guidance on Question and Answers for Allergen Labeling Released The FDA released draft guidance that, when finalized, will explain FDA’s current thinking on several issues related to the labeling of food allergens, including requirements in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act). Comments can be submitted until January 30, 2023. The Register Notice can be found here.
Final Rule Issued for Records of Products on the Food Traceability List The FDA is issuing a final rule establishing additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods that the agency designated for inclusion on the Food Traceability List (FTL). The final rule adopts provisions requiring these entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods. FDA is issuing this regulation in accordance with the Food Safety Modernization Act (FSMA). More information from FDA can be found here.
Comment Period for “Healthy” Definition Extended through February The comment period for the proposed rule entitled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy’ ” was extended by FDA through February 16, 2023.
FDA Allows Spirulina as a Color Additive After Petition In a response to a petition filed by GNT USA, Inc., the Food and Drug Administration is amending the color additive regulations to allow the safe use of spirulina (Arthrospira platensis) extract as a coloring agent in certain products. The notice can be found here.
FDA Issues Updated Manufactured Food Regulatory Program Standards The U.S. Food and Drug Administration (FDA) has issued revised food safety standards for state regulatory programs, known as the Manufactured Food Regulatory Program Standards (MFRPS), that oversee food facilities that manufacture, process, pack, or hold foods. The update includes changes to defined terms, new job aides, as well as updates to the current standards. More information can be found here.
FDA Warning Letters
Grain Elevator: CHS River Plains was issued a warning letter after an inspection revealed evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.
Feed Mill Warned for VFD Violation: Land View, Inc. was issued a warning letter for various violations at its Rupert Feed Mill. Notably, the letter cited VFD requirement violations after feed was produced with an incorrect level of oxytetracycline.
CBD Companies Warned: Five companies that produce CBD gummies, fruit snacks, lollipops, pet treats, and more were issued warning letters for selling unapproved CBD products. The warning letters emphasized the products’ appeal to children. This could explain the focus on the CBD product despite the largely temperate response the agency has to CBD which is not allowed in foods sold interstate commerce.
Response to Hepatitis A in Strawberries: Bainbridge Beverage West was issued a warning letter for serious violations of the FDA’s juice Hazard Analysis and Critical Control Point (HACCP) regulation related to their response to a potential contamination of Hepatitis A in strawberries used in their products.
Cardiovascular Claim Crackdown: In November, FDA warned seven companies for selling dietary supplements with claims to treat cardiovascular disease. The warning letters were issued to: Essential Elements (Scale Media Inc.); Calroy Health Sciences LLC; BergaMet North America LLC; Healthy Trends Worldwide LLC (Golden After 50); Chambers’ Apothecary; and Anabolic Laboratories, LLC.
Winfrey’s Olde English Fudge: A Massachusetts fudge company was issued a warning for misbranding and adulteration after inspectors found labeling and preventive control violations.
Claims for Herbal Teas: Wise Woman Herbals was issued a warning letter for making multiple drug claims on their website.
Dollar Tree: Dollar Tree was issued a warning letter for serious pest issues. Highlights include numerous dead animals found through the warehouse, and samples of human food products were tested and found to be contaminated with rodent urine, excreta, and hair.
A database of warning letters issued by the FDA can be found here.
USDA Updates
USDA Organic Standards Board Updates National List The Organic Standards Board submitted recommendations for updates to the National List of Allowed and Prohibited Substances. The National List identifies the synthetic substances that may be used and the non-synthetic (natural) substances that may not be used in organic crop and livestock production. This rule allows low-acyl gellan gum and paper-based crop planting aids, adds a definition for “paper-based crop planting aids” to 7 CFR 205.2, and replaces the term “wood resin” at 7 CFR 205.605(a) with the term “wood rosin” to reflect the popular spelling. The Federal Register notice can be found here.
Biden-Harris Administration Invests in Meat and Poultry Processing USDA Secretary Tom Vilsack announced the investment of $73 million in projects through the first round of the Meat and Poultry Processing Expansion Program (MPPEP). The goal is to increase meat processing capacity and competition to deliver lower meat costs to working families. The press release can be found here.
USDA Updates Listeria and E. Coli Procedures in Two Directives The FSIS’s new directive provides Enforcement, Investigations and Analysis Officers (EIAOs) with instructions for collecting samples under the routine risk-based Listeria monocytogenes (RLm) sampling program. Information on the new sampling procedures can be found here. Similarly, FSIS expanded its routine testing of beef for six Shiga toxin-producing E. Coli strains. Information for those testing procedures can be found here.
Other Items of Interest
GAO Weighs In on FDA’s Role in Food Packaging A report issued by the Government Accountability Office suggested the FDA could do more to ensure that food packaging products, like bags around salads or bread, are safe. There has been recent interest on whether compounds such as PFAs could leech into the food. The GAO has made two recommendations to FDA in support of their oversight of food packaging. The first recommends that the agency request specific legal authority from Congress to compel companies to provide the information needed to reassess the safety of substances. The second recommendation is for the FDA to track the dates of the last reviews for all food contact substances to allow FDA to easily identify substances that may need review. The recommendation can be found here.
Food Illness Outbreak Report for 2020 Released On November 4, 2022, the Interagency Food Safety Analytics Collaboration’s (IFSAC) newest annual report, “Foodborne illness source attribution estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States,” was released. The update helps to shape agency priorities and determine if prevention measures are working. While the report attributes Salmonella to a variety of foods, it links E. coli O157 to vegetable row crops and Listeria monocytogenes to dairy products, fruits, and vegetable row crops. The full report can be found here.
Consumer Brands Association Urges FDA to Modernize Sarah Gallo, vice president of product policy for the Consumer Brands Association (formerly known as the Grocery Manufacturers Association), urged the FDA to “create a modernized regulatory system, paired with key structural and governance changes, to better provide for consumer safety and keep pace with rapidly evolving consumer preferences and growing opportunities to introduce innovative products to the marketplace.” The article includes nine policy points by the CBA and can be found here.
This Regulatory Update covers information from November 1 – November 30, 2023. Please contact Paul Benson, Taylor Fritsch, Liz Simonis, 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.
This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including the role of seafood consumption in children’s development, the recall of a frozen falafel product sold at ALDI, and more.
FDA Updates
FDA Solicits Comments on Information Collection Provisions of HACCP Principles Regarding the Processing and Importing of Fruit and Vegetable Juices The FDA is seeking comments regarding the regulations mandating the application of hazard analysis and critical control point (HACCP) principles to the processing and importing of fruit and vegetable juices. The notice can be found here.
FDA Launches an Independent Study on the Role of Seafood Consumption on Children’s Development The FDA announced the launch of an independent study by the National Academies of Sciences, Engineering, and Medicine (NASEM) on the Role of Seafood Consumption in Child Growth and Development. This joint project seeks to support the goals of the FDA’s Closer to Zero Action Plan for reducing the exposure of babies and young children to mercury, arsenic, lead, and cadmium from foods.
FDA Announces Effective Date of October 31, 2022 for the Updates of Two Final Rules The FDA announced an effective date of October 31, 2022 for requirements related to establishing and implementing supply-chain programs, records documenting supply-chain programs, and onsite audits in two final rules promulgated under the Food Safety Modernization Act (FSMA): (1) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and (2) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, both of which appeared in the Federal Register of September 17, 2015. The notice can be found here.
FDA Releases Guidance for Foreign Food Establishments Relating to Refusal to Permit Entry In October, FDA released final guidance titled, “Refusal of Inspection by a Foreign Food Establishment or Foreign Government: Guidance for Industry.” The guidance will provide information for foreign food establishments subject to FDA inspection, as well as foreign governments, on when the agency may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by FDA as provided in the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Guidance can be found here.
Recall Alert
E. Coli Outbreak in Falafel Sold at ALDIs Cuisine Innovations issued a voluntary recall of its frozen falafel product sold at ALDIs after a multistate outbreak of E. coli was linked to Earth Grown Frozen Falafel. Michigan and Wisconsin had the greatest incidents of infection related to this strain.
FDA Warning Letters
Happy Sprouts: October’s lone Warning Letter related to food was for mung bean and soybean sprout products that were deemed adulterated because they were prepared, packed, or held under insanitary conditions.
A database of warning letters issued by the FDA can be found here.
USDA Updates
AMS Seeks More Comments on USDA Regulations of Inert Ingredients In Pesticides Used in Organic Production The Agricultural Marketing Service (AMS) is providing additional time for the public to submit comments and information about how to update USDA organic regulations on inert ingredients in pesticides used in organic production. AMS seeks comments on alternatives to its existing regulations that would align with the Organic Foods Production Act of 1990 (OFPA) and the EPA’s regulatory framework for inert ingredients. Comments must be submitted on or before December 31, 2022. The original notice can be found here.
USDA Proposes Changes to Poultry Industry to Reduce Food Poisoning There has been significant regulatory movement geared toward addressing salmonella in the poultry industry over the last few months. To curtail salmonella outbreaks in poultry, the AMS is proposing a regulatory framework that would include testing incoming flocks of chickens and turkeys for the bacterial disease that commonly affects the intestinal tract and affects 1.3 million people annually with symptoms that may include diarrhea, nausea and vomiting which could last for several days. An overview of the changes and opportunities for comments can be found here.
Other Items of Interest
Farm Bureau Releases Priorities for 2023 Farm Bill The American Farm Bureau Federation released its priorities for next year’s bill, including maintaining the funding level from the 2018 Farm Bill, which the Congressional Budget Office estimated at about $428 billion. The legislation, which Congress writes every five years, includes funding for key programs like farm conservation and federal nutrition aid.
FDA Releases Video on How the FDA Responds to Foodborne Outbreaks The FDA released a video entitled “How Does the FDA Respond to Foodborne Outbreaks?” It explains a “complex web of steps” and is useful to producers looking to understand the Agency’s approach. The video can be found here.
FDA FOIA Request Reveals Trouble Looming for Peanut Producer The Salmonella outbreak linked to JIF peanut butter earlier this year was caused by defective flanges that allowed rainwater and air to enter the peanut roasters, according to a report from Food Safety News. According to information gleaned from an FDA FOIA request, management at the company’s Lexington, Kentucky plant was supposedly aware some products were tainted. The Agency’s action against management could be the first test of the FDA/DOJ’s strengthened use of the Responsible Corporate Officer Doctrine since the Blue Bell Creameries case earlier this year.
EPA Faces Food Safety Org Lawsuit Over Pesticides A group of food safety organizations are alleging that more than half of inert ingredients in pesticides are considered “hazardous air and water pollutants of at least moderate risk” and hundreds of them have also been used as active ingredients in other formulations. Additionally, the groups said, inert ingredients can increase the toxicity of active ingredients when they are combined in a pesticide formulation — adding greater concern to the EPA’s alleged practice of ignoring them.
Developments in Notable Labeling and Marketing Claims Actions Several active lawsuits took steps, both forward and backwards, to resolutions. These cases largely relate to labeling and marketing claims. Below is a summary of cases and the recent action:
Dark Chocolate: Mondelez toppled a proposed class suit over dark chocolate label. A judge in the federal district court for the Southern District of New York dismissing a proposed class action suit over a “dark chocolate” label, finding that the label was not misleading because the products actually contained cacao derivatives.
Carbon Neutral Statements on Water: A California woman has filed a proposed class action suit against Danone Waters of America Inc., arguing that Danone deceptively markets Evian water as “carbon neutral.” The plaintiff states the company engages in “greenwashing” to attract environmentally conscious consumers.
Iced Tea Preservative: Arizona iced tea buyers recently saw their “no preservative” claims advance. The claimants were allowed by a New York federal court to pursue most of their claims in a proposed class suit alleging Arizona Beverages USA LLC and affiliated companies misleadingly market the drinks as having “no preservatives” despite the inclusion of citric acid.
Protein Labeling in Pancakes: Birch Benders will face a class action lawsuit claiming that its pancake and waffle mix packaging omitted necessary information about the amount of protein.
Smoked Gouda: Kroger Co. lost its bid to end consumer litigation over an artificially flavored Gouda cheese brand it labels “smoked,” but a federal judge in Milwaukee narrowed the proposed class action, throwing out claims for fraud, breach of warranty, and unjust enrichment.
Black Raspberry Flavoring: A Costco consumer’s contention that red coloring, a picture of two black raspberries, and the words “Black Raspberry Flavor” meant that there was actual black raspberry juice in the sparkling water was dismissed by a federal judge.
Palm Oil in Pudding: A consumer plaintiff alleged Conagra misled consumers by including the words “Pudding,” “NEW SMOOTHER RECIPE!,” and “Made with Real Milk” on the front of Snack Pack packages. Instead of being made mostly with whole milk, the pudding contains palm oil, which is considered a cheaper alternative. The suit has been voluntarily dropped after a federal judge rejected one of her theories as “fanciful.”
White Chocolate Label: A price tag abbreviating Target Corp.’s White Baking Morsels as “WHT CHOCO” could lead a reasonable consumer to believe that they’re made of white chocolate, a California appeals court said, reinstating a proposed class suit alleging the retailer deceptively markets its store brand product.
“100% Real Fruit”: A Mott’s applesauce consumer’s belief that “Made From 100% Real Fruit” means nothing other than fruit is “extremely reasonable,” according to a federal court in Illinois, advancing a proposed class suit alleging the inclusion of corn syrup and ascorbic acid made the label deceptive.
This Regulatory Update covers information from October 1 – October 31, 2022. Please contact Paul Benson, Taylor Fritsch, Liz Simonis 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.
This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including available funding to create USDA Regional Food Business Centers, human and animal food facility registration renewal, Salmonella being added as an adulterant to breaded and stuffed chicken products, and more.
FDA Updates
MUST READ: Registration Renewal for Human and Animal Food Facilities Runs from October 1 to December 31 FDA is reminding facilities to renew human and animal food facility registrations. FDA will consider the registration of a food facility to be expired if a facility’s registration is not renewed by December 31, 2022. There is no fee associated with registration or renewal. Owners, operators, or agents in charge of food facilities must submit their renewal information electronically through their FDA Industry Systems account, unless they have received a waiver that allows for paper submission. More information can be found here.
White House and FDA Look to Define the Term “Healthy” with Proposed Rule FDA has proposed an update to the definition for the use of the claim “healthy” and will seek comments from the public until December 28, 2022. “Healthy” has been used for centuries to describe food, but regulation around the term has been a challenge. On the heels of the White House Conference on Hunger, Nutrition, and Health, FDA has released a proposed rule that, if finalized, will prescribe regulatory requirements for using the term “healthy” in food labeling. A regulatory definition would be helpful to food manufacturers looking to ensure labels are truthful and non-misleading and limit risk of consumer actions associated with “healthy” claims. The proposed rule can be found here, in the Federal Register. To ensure consideration, comments on the proposed rule must be submitted by December 28.
FDA Releases Prevention Strategies to Enhance Food Safety in Mushrooms and Onions In September, the FDA released food safety strategies to help prevent food safety issues in mushrooms and onions. The prevention strategies build on the foundational work established by the Food Safety Modernization Act (FSMA) and FDA’s Strategy for the Safety of Imported Food. The first two strategies include actions for addressing Salmonellosis and Listeriosis associated with imported enoki and wood ear mushrooms, as well as Salmonellosis associated with bulb onions. More information can be found here.
Comment Period Reopening for Information on the Use of Ortho-Phthalates for Food The FDA is seeking comments through December 27, 2022, regarding the use of Ortho-phthalates in food contact products. Ortho-phthalates may be used as plasticizers for polymers, most commonly poly (vinyl chloride), to make the polymers less brittle or to soften them. These polymers are then used in a wide range of products, such as toys, vinyl flooring and wall covering, detergents, lubricants, food packaging, pharmaceuticals, and personal care products.
FDA Releases Overview of Activities Underway to Enhance the Safety of Imported Produce In September, the FDA has released an overview of its comprehensive approach to enhancing the safety of food imported into the United States. The Agency seeks to provide an overview of the work underway to advance the safety of produce imported into the United States. The Overview can be found here.
Petition to Amend Color Additive Regulations to Include Calcium Carbonate A petition was submitted proposing to amend the color additive regulations in 21 CFR § 73.70 “Calcium Carbonate,” by expanding the permitted uses of calcium carbonate to include use in dietary supplement tablets and capsules, including coatings and printing inks, in amounts consistent with good manufacturing practice. The petition can be found here.
FDA Releases Q & A on Shell Egg Rule The Agency’s new guidance explains the FDA’s current interpretation of the requirements in the egg rule with regard to production systems that provide laying hens with access to areas outside of a poultry house. The questions and answers cover definitions, Salmonella enteritidis (SE) prevention measures, and environmental sampling for SE. The guidance can be found here.
FDA Announces the Renewal of the Allergenic Products Advisory Committee The FDA Commissioner has determined that it is in the public interest to renew the Allergenic Products Advisory Committee for an additional 2 years beyond the charter expiration date. The nine-member committee reviews and evaluates the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease, and makes appropriate recommendations to the Commissioner of Food and Drugs of its findings. The new charter will be in effect until the July 9, 2024 expiration date.
FDA Hires External Experts to Evaluate Parts of Agency FDA Commissioner Robert Califf announced he has recruited new external agency experts to conduct a comprehensive evaluation for the Agency’s human foods program, including the Office of Food Response and Policy (OFPR), Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA). This comes after criticism of the Agency and calls for changes from both side of the political aisle.
FDA Releases Final Guidance Regarding “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House): Questions and Answers Regarding the Final Rule.” This guidance provides recommendations on how egg producers who allow hens access to areas outside the poultry house can meet requirements to prevent Salmonella Enteritidis (SE) from contaminating shell eggs on the farm. The guidance designates porches as areas outside of the poultry house and would allow egg producers the ability to provide laying hens with access to areas outside the poultry house, which includes porches, outdoor runs and pastures, and still comply with the egg rule. To be compliant, egg producers must take steps to ensure there is no introduction or transfer of SE into or among poultry houses. The Guidance can be found here.
FDA adds Fumonisin Esterase to Permitted Feed and Drinking Water Additives for Swine After receiving a petition for Biomin GmbH, FDA is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of fumonisin esterase to degrade fumonisin mycotoxins present in swine feed. A link to the final rule can be found here.
FDA Releases FY 2020 Pesticide Residue Monitoring Program Report The FDA released the annual Pesticide Residue Monitoring Program Report for Fiscal Year 2020, summarizing findings from the program’s monitoring of human and animal foods in FY 2020. The report can be found here.
FDA Releases Final Guidance on Enforcement Discretion of Certain NAC Products FDA announced the availability of a final guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). The guidance indicates the Agency’s intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that are labeled as dietary supplements to permit the use of NAC in or as a dietary supplement. This enforcement discretion policy applies to products that would be lawfully marketed as dietary supplements if NAC were not excluded from the definition of “dietary supplement,” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance can be found here.
FDA Moves into the Future with the Third Phase of Artificial Intelligence Imported Seafood Pilot Program The FDA is using AI to strengthen import screening in its Imported Seafood Pilot program which is entering its third phase. The third phase will help to determine the feasibility of deploying in-house AI and Machine Learning models using the intelligence that FDA extracts from the data we collect reviewing millions of import entries per year. The Success in the Seafood Pilot Program is a good indicator of future screening methods for other products being imported. An update can be found here.
FDA Issues 2022 Voluntary National Retail Food Regulatory Program Standards In August, the FDA release an update of The Retail Program Standards. The Retail Program Standards provide recommendations for designing and managing retail food regulatory programs and help regulatory jurisdictions (or other responsible organizations) facilitate more effective inspections, implement foodborne illness prevention strategies, and identify program areas in need of improvement. The Standards can be found here.
FDA Warning Letters
Deggeh Foods, Inc.: The company sold several misbranded dietary supplements that contained unapproved new drugs with various unsupported claims. When inspected, the facility had serious CGMP violations leading to product adulteration violations.
Oregon’s Wild Harvest, Inc.: The company’s CGMP program was found to have a variety of issues resulting in a warning letter citing adulteration.
Nutritional Laboratories International, Inc. dba Elite One Source Nutritional Services, Inc.: The company was issued a warning letter for adulteration after several mistakes were found on the product labels.
The Elderberry Fairy & Co., LLC: The FDA issued a warning letter based on numerous health claims made on the company’s website and social media that listed the products as intended for use in the cure, mitigation, treatment, or prevention of diseases.
Sun Sen Co. Inc.: The FDA issued a warning letter citing adulteration after an inspection found the bean and sprout facility were preparing, packing, or holding the product in insanitary conditions.
International Seafood HACCP Focus: Myllan-ORA ehf, an Icelandic company, Mahi Frozen Foods, a Pakistani Company, Vlazar Costa Caribe S.A., a Nicaraguan company, and CR Grupo Comercial Alvacora S.A., also a Nicaraguan company, were issued warning letters for violations of the seafood HACCP regulation.
The Royal Ice Cream Company Inc.: The ice cream manufacturer was issued a warning letter for adulteration in that the products were prepared, packed, or held in insanitary conditions. The inspection revealed two positive swabs for Listeria monocytogenes, a bacterium for which the facility had previously had positive swabs.
A database of warning letters issued by the FDA can be found here.
USDA Updates
USDA Announces $400 million in Funding Available to Create USDA Regional Food Business Centers The USDA announced plans to use $400 million to fund USDA Regional Food Business Centers. The newly formed Regional Food Business Centers will provide coordination, technical assistance, and capacity building to help farmers, ranchers, and other food businesses access new markets and navigate federal, state and local resources, thereby closing the gaps and barriers to success. More information can be found here.
USDA Adds Salmonella as an Adulterant to Breaded and Stuffed Chicken Products On August 1, 2022, USDA’s Food Safety and Inspection Service (“FSIS”) announced it will be declaring Salmonella an adulterant in breaded and stuffed raw chicken products. The notice is expected to publish in the Federal Register in the fall. FSIS will be proposing to set the limit at 1 cfu of Salmonella per gram for these products, a level that the Agency believes will significantly reduce the risk of illness from consuming breaded and stuffed raw chicken products. FSIS will be seeking public comments that address what the standard should be as well as to inform a final implementation plan, including a verification testing program. When the proposal is finalized, FSIS will announce its final implementation plans and the date it will begin routine testing for Salmonella in these products. More information can be found here.
Judge Backs Most of GMO Labeling Rule but Stops Short for QR Codes A California federal judge on Wednesday shot down the majority of claims challenging a Trump-era organic food labeling rule but sided with food advocacy groups in ruling that electronic quick response codes aren’t adequate methods of informing shoppers that food was bioengineered.
Other Items of Interest
New Traceability Rule Becomes Official on Nov. 7 A variety of foods will have added traceability requirements as the FDA seeks to tighten safety of high-risk foods. The onerous requirements will likely shift the last holdouts of pen and paper recordkeeping to a barcode system, a cost that the Agency feels the benefits outweigh. For information on the requirements and a list of impacted foods, an overview of the proposed rule can be found here.
Growing Support for Including Environmental Issues in the Farm Bill A letter signed by more than 150 organizations, and addressed to President Joe Biden, calls for the next farm bill to address economic inequality, racial divides, hunger, climate change, nutrition and food safety while supporting farmers, workers, and communities. This could signal a shift in farm policy toward ESG initiatives in the 2023 farm bill. A copy of the letter can be found here.
Former Blue Bell President Avoids Conviction for Listeria Deaths A hung jury led to the acquittal of the former CEO of Blue Bell, who faced charges for alleged fraud and conspiracy committed during a Listeria outbreak in Blue Bell Ice Cream Products that killed three people. Nineteen expert researchers concluded that the lack of regulatory oversight was responsible for the low-level contamination without detection for years. Ice cream was not seen as a source of listeriosis before this outbreak, which has triggered increased scrutiny of ice cream manufacturers.
FDA Announces Targeted Sampling, Additional Efforts to Enhance the Safety of Leafy Greens Under the Leafy Greens STEC Action Plan (LGAP), the FDA is announcing targeted sampling of leafy greens grown during the fall 2022 harvest season in the Salinas Valley region of California, releasing results from a 2021 sampling assignment, and providing an update on other work under the action plan. More details on the FDA’s action plan can be found here.
Canada Modernizes Food Labelling Framework and Moves Saturated Fats, Sugars, and Sodium Front and Center The Canadian Government has updated the requirements for labelling prepackaged food products (Modernized Food Labelling Framework). Health Canada has also introduced a new requirement for front-of-package nutrition symbol labelling for select prepackaged products containing nutrients of public health concern (saturated fat, sugars, and sodium), and updated the requirements for certain nutrient content claims. Advocacy group the Center for Science in the Public Interest and other health groups have asked the FDA to require front-of-package nutrition labels to inform consumers about nutritional content of packaged foods.
California Plastics Law Impacts Packaging, Single-Use Service Ware Manufacturers Across the Country California’s Plastic Pollution Prevention and Packaging Producer Responsibility Act (SB 54) will impose new sustainability regulatory requirements on all businesses manufacturing single-use packaging or plastic single-use service ware. Companies that produce these products must join a Producer Responsibility Organization by Jan 1, 2024, or they will be prohibited from selling, offering for sale, importing, or distributing such covered materials in California. These organizations are asked to reduce the amount of plastic packaging by 25% by 2032. A copy of the Act can be found here.
This Regulatory Update covers information from August 1 – September 30, 2022. 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.
This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including proposed rulemaking relating to agricultural water, the proposed rule to protect poultry growers from abuse, a Minnesota bill allowing CBD in food despite FDA prohibition, and more.
FDA Updates
MUST READ: Proposed Rulemaking for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water On July 19th, the FDA issued a supplemental notice of proposed rulemaking to the requirements the agency recommended in a recent 2021 agricultural water proposed rule. If finalized, the pre-harvest agricultural requirements mandate covered farms to conduct system-based agricultural water assessments on an annual basis, to minimize potential risks associated with pre-harvest agricultural water. In its most recent update to the proposed rule, the FDA specifies the dates on which it intends to impose enforcement discretion for the harvest and post-harvest agricultural water requirements for covered produce other than sprouts. These dates range from 9 months to almost 3 years. Enforcement discretion would then allow for flexible application until January 26, 2025 for very small businesses, January 26, 2024 for small businesses, and January 26, 2023 for all other businesses.
FDA Announces Voluntary Phase Out of Certain PFAS in Food Packaging In late February, FDA released new information regarding the Agency’s progress to voluntarily phase out certain short-chain PFAS used in food packaging. The phase out effects certain type of short-chain per- and poly-fluoroalkyl substances (PFAS), that contain 6:2 fluorotelomer alcohol (6:2 FTOH), which may be found in certain food contact substances used as grease-proofing agents on paper and paperboard food packaging Additional information regarding the FDA phase-out of PFAS in Food packaging can be found here.
FDA Launches Agricultural Water Assessment Builder to Help Farms Understand Agricultural Water Proposed Rule Requirements In late March, FDA launched a new online Agricultural Water Assessment Builder aimed at helping farms understand the proposed requirements for agricultural water assessments in the Agricultural Water Proposed Rule. The Agricultural Water Proposed Rule was released in early January and, if finalized, it would require farms to conduct systems-based agricultural water assessments. The Agricultural Water Assessment Builder can be found here.
FDA Takes Steps to Limit Lead in Fruit Juice The draft guidance lowers action levels for lead in juice and is intended to lower consumer exposure to toxic elements in food, especially for children. The full draft guidance for lead in juice can be found here.
Indirect Food Additives Amended Regulations: FDA limits the use of certain phthalates in food packaging and issues request for information about current food contact use and safety data The amended regulation revokes authorizations for the food contact use of 23 phthalates that the agency has deemed abandoned. The substances are used as plasticizers, adhesives, defoaming agents, surface lubricants, resins, and slimicides. This action now limits the use of phthalates in food contact applications to nine phthalates. Subsequently, the agency requested new use level, dietary exposure, and safety information regarding the phthalates currently authorized to reassess their safety and usage. The amended rule can be found here.
Final Guidance Issued for Reducing Microbial Food Safety Hazards in the Production of Seed Sprouts On May 13, 2022, the FDA issued a final guidance addressing the agencies serious concerns with the continued outbreaks of foodborne illness associated with sprouts and providing recommendations for companies throughout the supply chain. The full guidance for seeds used for sprouting can be found here.
Groups Urge FDA for New Amendments for BPH A coalition consisting of environmental groups, consumer groups, and a university recently submitted a petition to the FDA arguing that food additive regulations be amended to restrict or remove authorization for the use of bisphenol A (BPA) in food adhesives, resinous and polymeric coatings, and resins used in contact with food. More information regarding this proposed rule can be found here.
FDA Updates Public on 5-Year Veterinary Stewardship Plan At the end of June, the FDA’s Center for Veterinary Medicine released a status update on Phase I of its five-year action plan for Supporting Antimicrobial Stewardship in Veterinary Settings. The report touts an 88% success rate for implementing the plan from 2019-2021, with twenty-one action items completed. Phase II will begin soon and will continue efforts by the agency to protect public health while mitigating the development of antimicrobial resistance. Phase II actions include bringing more OTC drug under veterinary supervision, solidifying an approach for defining durations of use, building an approach for collecting data on antimicrobial use in food-producing animals, and continuing to advance AMR surveillance and monitoring programs through the activities outlines in the National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan.
The original rule proposed in December 2021 can be found here.
Draft Guidance Issued on Conducting Remote Regulatory Assessments In late July, the FDA issued draft guidance to describe the Agency’s current views on the use of remote regulatory assessments (RRAs) to increase public understanding of the FDA’s use and processes for conducting RRAs. The draft guidance can be found here.
FDA Warning Letters
Medina Baking and Power Products, Inc.: The Company was issued a warning letter when it misspelled ingredients, did not include required statements in Spanish on labeling, and omitted common names from product labeling.
Langlinais’ Baking Company: The Company was issued a warning letter citing failures to include allergen information on packaging, potential contamination of allergens on production lines, and improper sanitation.
Joy Gourmet Foods, LLC: The Company was issued a warning letter after it failed to conduct hazard analysis for food which enters their facilities, assess potential allergens, and identify and evaluate chemical hazards resulting from mis-formulation and incorrect labeling of substances. Contamination from drip and condensate from pipes and ducts were also noted.
Companies Illegally Selling Unapproved CBD Products for Animals: Several Companies were issued warning letters for selling CBD products for animals. FDA’s position is that under current federal law, these CBD products are considered to be drugs because their intention is to affect the structure or function of animals’ bodies. Because CBD products have not been approved by the agency, they are considered by the agency to be illegal drugs.
Unapproved Kratom Products: The FDA, in conjunction with the Federal Trade Commission, issued warning letters to four companies for selling unapproved kratom products for the treatment or cure of opioid use disorder and withdrawal symptoms. FDA has not approved any kratom products for this purpose and is currently evaluating concerning reports about the safety of kratom.
A database of warning letters issued by the FDA can be found here.
USDA Updates
USDA Publishes Origin of Livestock Final Rule for Organic Dairy The USDA recently published the Origin of Livestock (OOL) final rule for organic dairy. This rule intends to promote a fairer and more competitive market for organic dairy producers, making sure that all certified USDA organic dairy products are produced to the same standard. USDA’s National Organic Program will oversee the new rule. Additional information on the Origin of Livestock rule can be found here. The USDA’s full report can be found here.
USDA Announces New Proposed Rule to Protect Poultry Growers From Abuse USDA announced a new proposed rule which it asserts will provide more transparency and accountability in the poultry growing system. The new guidance takes steps to provide clarity for growers in ways such as requiring processors to disclose details into the ranking systems such as compensation and ranking attributes. The proposed rule can be read here.
USDA Eyes New Salmonella Standards for Raw Pork Products As outbreaks emerge throughout the country, the USDA Food Safety Inspection Services (FSIS) is considering imposing new salmonella performance standards focused on raw pork products. A journal article outlining the changes in pork-related salmonella can be read here.
Other Items of Interest
Minnesota Bill would Allow CBD in Food Despite FDA Prohibition Three Democrats in the Minnesota House of Representatives introduced HF2996 in early February. Under the proposed law, industrial hemp extract would be considered an approved food additive legal for intrastate commerce. Additional information on House Bill 2996 can be found here.
Packaging Material Prices Continue to Rise Global supply chain woes leading to continued price increases for food packaging are expected over the next twelve months, resulting from the conflict between Russia and Ukraine, in addition to rising energy, transportation, and labor costs. A report by Rabobank expects energy and paper packaging costs to rise 3.4% and anywhere from 2.3% to 3.6%, respectively. The report published by Rabobank can be found here.
Cultured meat could come further out of the lab in 2022 Forecasters predict that the global market for cultured meat will reach almost $500 million by 2030. JBS, the world’s biggest meat company recently unveiled plans to invest $100 million in cultured meat products. Capital investment grew 336% last year to $1.38 billion, led by Future Meat Technologies. The company recently reported plans to identify future production sites in the US while also reporting it had cut the cost of producing cultured chicken breasts from $18 per pound to $7.70 in six months.
While businesses are taking note of the developments in the meat industry, so too are regulatory bodies. In the US, the FDA and USDA began in 2019 to establish regulatory framework for cell cultured products. In 2021, the USDA’s Food Safety Inspection Service solicited public comments and the Department announced a $10 million investment over the next five years to develop a National Institute for Cellular Agriculture at Tufts University. More information about the National Institute for Cellular Agriculture can be found here.
Culver’s Restaurants Looking to Phase Out ‘Forever Chemicals’ Fast-food chain Culver’s is looking to phase out the usage of wrappers containing PFAS, sometimes referred to as “forever chemicals.” Consumer Reports tested 118 types of food packaging from 24 popular restaurants and 68% contained evidence of PFAS. However, currently, there is not enough reliable data available to estimate the risk from food packaging exposure. Generally, the chemicals enter the human body largely though drinking water. Data concerning ‘forever chemicals’ from Consumer Reports can be found here.
A Bill in Congress Aims to Open New Agency for Food Safety In July, Congresswoman Rosa DeLauro (D-CT) and Senator Dick Durbin (D-IL) introduced the Food Safety Administration Act into their respective chambers aiming to establish the Food Safety Administration as the single food safety agency withing the U.S. Department of Health and Human Services. Onlookers have been critical of the functionality and effectiveness of the Food and Drug Administration, suggesting the agency has failed to recognize the dangers of prescription drugs and protect children from e-cigarette products. The proposed legislation would transfer all current authority on food to the new agency and be led by a food safety expert confirmed by the Senate. Currently, the FDA regulates approximately 80% of the U.S. food supply. The original text of the legislation can be found here.
Consumer Reports finds Potentially Harmful Bacteria in Ground Meat Consumer Reports recently evaluated 351 packages of ground chicken, beef, turkey, and pork from supermarkets across America, finding the presence of salmonella in almost one-third of the seventy-five pounds of ground chicken packages tested. Earlier this year, Consumer Reports found a strain of e-coli in ground beef, which triggered a recall of more than 28,000 pounds of meat in seven Western states. In a statement to CBS News, the Food Safety and Inspection Service stated this finding underscores why FSIS is redeveloping its strategies to reduce salmonella in poultry products.
Infant Formula Recall Causes Supply Chain Disruptions Though a shortage still exists, infant formula has begun to return to store shelves after a severe shortage of infant formula as a result of the 2021–2022 global supply chain crisis, compounded by a large-scale product recall after two babies allegedly died after consuming tainted infant formula. Efforts by numerous agencies were untaken to alleviate the shortage and make product available to key demographics, including special formulas for babies with allergies and diet restrictions as well as parents that rely on WIC funding for formula.
More information on the federal government’s response to the ongoing infant formula shortage can be found here.
This Regulatory Update covers information from February 15 – July 30, 2022. 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.
This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including the release of an online tool for suspected anticompetitive practices, guidance for the enforcement approach to human food with chlorpyrifos residues, the publishing of the origin of livestock final rule for organic dairy, and more.
FDA Updates
FDA Releases Guidance for Industry on Enforcement Approach to Human Food with Chlorpyrifos Residues Following EPA Tolerance Revocation In early February, FDA released a new question-and-answer guidance to help producers handle foods potentially containing residues of the pesticide chlorpyrifos. Per the guidance, foods are not deemed unsafe solely based on the presence of chlorpyrifos if the chemical compound was applied prior to the expiration of EPA tolerance policy and if the residue does not contain a level exceeding the amount permitted by the agency at the time of application. This FDA guidance comes as the EPA recently revoked all tolerances for chlorpyrifos effective February 28, 2022. The FDA is responsible for enforcing all EPA pesticide tolerances in all food products except for certain meats, poultry, and fish regulated by USDA.
Motif FoodWorks, Inc. Files Color Additive Petition Motif FoodWorks, Inc. has submitted a petition to amend current color additive regulations by exempting myoglobin as a safe color additive in meat and poultry analogue products (e.g., plant-based meat and poultry substitutes). If the federal agency determines an exemption applies, neither an environmental assessment nor environmental impact statement will be required. The company argues myoglobin occurs naturally and does not significantly alter the concentration or distribution of the substance, its metabolites, or degradation in the environment. If the FDA determines the exemption does not apply, it will request an environmental assessment and make it available to the public.
Bakery Project Inc. dba Delano Bakery FDA recently notified Bakery Project, Inc. regarding the results of an inspection of their Kansas facilities from August 3, 2021 – August 27, 2021. The agency alleges numerous violations including nearly fifteen cockroach sightings in proofer and packaging areas. Rodent droppings and dead insects were also reported. In addition, baking appliances and personal hygiene practices did not meet acceptable cleanliness standards.
A comprehensive database of all FDA Warning Letters can be found here.
USDA Updates
USDA Publishes Origin of Livestock Final Rule for Organic Dairy The USDA recently published the Origin of Livestock (OOL) final rule for organic dairy. This rule intends to promote a fairer and more competitive market for organic dairy producers, making sure that all certified USDA organic dairy products are produced to the same standard. USDA’s National Organic Program will oversee the new rule. Additional information on the Origin of Livestock rule can be found here. The USDA’s full report can be found here.
USDA, DOJ Launch Online Tool Allowing Farmers, Ranchers to Report Suspected Anticompetitive Practices The U.S. Departments of Agriculture and Justice announced earlier this month a combined effort to reduce unfair and anti-competitive practices in the meat and poultry sectors. Farmers and ranchers can now anonymously report potentially illegal and unfair practices to a database collected by the two agencies. USDA Packers and Stockyards Division staff and DOJ staff will review the tips and, if necessary, elevate concerns to appropriate agencies. This new tool is aimed to advance the Biden Administration’s Action Plan for a Fairer, More Competitive, and More Resilient Meat and Poultry Supply Chain, by creating more competitive agricultural markets.
USDA Sets Meal Standards to Help Ease School Supply Issues In February, USDA announced new transitional standards for school meal programs set for the 2022-23 and 2023-24 school years. The changes allow child-care providers serving children ages 6 and older to offer flavored low-fat (1%) milk in addition to the current milk offerings. In addition, the weekly sodium limit will decrease 10% in 2023-24 to align with USDA’s guidance on voluntary sodium reduction targets for processed and packaged foods. The COVID-19 pandemic and subsequent supply chain issues have made healthy school lunches a major challenge. In a November 2021 School Nutrition Association supply chain survey, 96% of respondents highlighted challenges with suppliers not carrying sufficient menu items to meet whole grain, sodium and fat nutrition standards.
This Regulatory Update covers information from February 1 – February 14, 2022. 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.
