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 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FDA Releases Draft Guidance on the Labeling of Plant-Based Milk Alternatives
February 22: FDA released draft guidance that will provide industry with FDA’s view on the labeling of plant-based food products that are marketed and sold as alternatives to milk (plant-based milk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 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.
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.