In efforts to increase transparency and support stakeholders with understanding the FDA’s regulatory agenda, the Agency unveiled its new website identifying regulations that the Agency plans to publish by October 2024, and longer-term regulations the FDA is prioritizing for publication at a later date. Aimed at informing industry on “what’s ahead”, the FDA Foods Program Regulations portal marks a noteworthy effort at centralizing happenings at the Agency and the regulatory status of various regulations and guidance documents.
Each spring and fall, the Office of Information and Regulatory Affairs in the Office of Management and Budget publishes the Unified Agenda of Regulatory and Deregulatory Actions. The Unified Agenda is aimed at promoting transparency and providing information that FDA, and other administrative agencies, plan to publish in both the short- and long-term.
FDA’s Food Program regulations includes regulations for cosmetic and personal care products, as anticipated under MoCRA (the Modernization of Cosmetics Regulation Act), such as testing methods for detecting and identifying asbestos in talc-containing cosmetic products. We anticipate FDA’s proposed regulation regarding detecting and identifying asbestos in talc-containing products will issue Q1 of 2024. We recommend businesses determine if talc is used in any products, and work to obtain asbestos free certificates now.
The below list is a list of FDA Foods Program regulations that are included on the current Unified Agenda. The list includes a rather delectable starter that will revoke the standard of identity and standard of quality with frozen cherry pie, the only fruit pie on the market which has an established standard of identity and quality. FDA’s revocation of the standard would provide greater flexibility in the production of frozen cherry pie products:
Regulation Title | Goal Publication Date |
Frozen Cherry Pie: Proposed Revocation of a Standard of Identity and a Standard of Quality | 2023/11 |
Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products | 2023/12 |
Certifications Concerning Imported Foods | 2024/01 |
Amendments to Registration of Food Facilities | 2024/02 |
Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption Relating to Agricultural Water | 2024/02 |
Color Additive Certification: Increase in Fees for Certification Services | 2024/04 |
Food Additives: Food Contact Substance Notification that is No Longer Effective | 2024/04 |
Nutrient Content Claims, Definition of Term: Healthy | 2024/04 |
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food | 2024/05 |
Cheese and Related Cheese Products: Proposal to Permit the Use of Ultrafiltered Milk | 2024/06 |
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals | 2024/06 |
Front-of-Package Nutrition Labeling | 2024/06 |
Use of Formaldehyde and Formaldehyde-Releasing Chemicals as an Ingredient in Hair Smoothing Products or Hair Straightening Products | 2024/07 |
Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods | 2024/08 |
The FDA Food Safety Modernization Act: Amendments to Exemption Provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Regulation | 2024/08 |
Food Labeling: Health Claim: Soy Protein and Coronary Heart Disease | 2024/10 |
Food Standards: General Principles and Food Standards Modernization | 2024/10 |
Streamlining Provisions Requiring Disclosure to and Receipt of Written Assurances from Commercial Customers in the Foreign Supplier Verification Programs Rule | 2024/10 |
Fish and Shellfish: Canned Tuna Standard of Identity and Standard Fill of Container | |
Permanent Listing of Color Additive Lakes | 2025/02; Long-Term Action |
Amendment of Procedural Requirements for Food Additive Petitions | 2025/06; Long-Term Action |
Amendment of Procedural Requirements for Color Additive Petitions | 2025/06; Long-Term Action |
The FDA also updated the list of guidance topics that it is considering and expects to publish by the end of 2024. This list was last updated in July 2023. The list of guidance documents that the FDA expects to finalize by year-end include:
- Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry
- Action Levels for Lead in Food Intended for Babies and Young Children: Guidance for Industry
- The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards: Draft Guidance for Industry
- Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged and Prepared Foods (Edition 2): Draft Guidance for industry
We will continue to monitor and provide regular updates on the FDA’s commitments. For any questions on food or cosmetics regulatory compliance matters, including support with legally launching product to the U.S. and/or responding to FDA enforcement issues, please contact us at info@garg-law.com.
