FDA Restructures its Food Resources
Although there were a number of significant new regulations, the most significant food industry change in 2024 was the overhaul of how FDA structures itself to regulate foods generally.
In October, FDA eliminated the Center for Food Safety and Applied Nutrition and created the Human Foods Program. Under the new structure, food policy and response functions and field operations are combined to provide a more holistic regulatory platform on which to regulate foods. There is also a new Office of Inspections and Investigations that will work more closely with state food agencies. The Office of Nutrition and Labeling remains to address labeling issues including the ongoing discussions around front of pack labeling, but is now housed in the Nutrition Center of Excellence.
The new Deputy Commissioner for Human Foods, Jim Jones, reports directly to the FDA Commissioner and has authority over all components of the Human Foods Program. Management functions are organized into three offices:
- The Nutrition Center of Excellence—to better focus on the critical nature of human nutrition and its relationship to disease.
- The Office of Microbiological Food Safety—to more effectively monitor and address microbiological risk in the United States and in the global food supply.
- The Office of Food Chemical Safety, Dietary Supplements, and Innovation—to more effectively and holistically regulate ingredient safety and innovation.
New Guidances in 2024
As with prior years, and notwithstanding (or perhaps in light of) the US Supreme Court’s decision in Loper Bright, FDA continued to issue many more substantial guidances than regulations in 2024.
Hazard Analysis and Risk-Based Preventive Controls for Human Food
The draft guidance from January is a massive multipart policy that outlines the FDA’s thinking on how to conduct hazard analysis and implement risk-based preventative controls, including how to prepare a food plan, conduct hazard analysis and identify risks, prepare and conduct corrective and preventive actions (CAPAs) and maintain appropriate records, in order to comply with the requirements of the Food Safety Modernization Act. The guidance addresses comments received from industry since 2016.
Foods Derived from Plants Produced Using Genome Editing
This final guidance from February is an update to FDA’s 1992 rule involving the use of biotechnology in plants used for food. The guidance focuses on identifying unintended effects and risks from genome editing, including introduction or transference of allergens, changes that affect the nutritional profile of the food or potentially increase toxicant levels, consideration of effects of genome-edited foods used for animal feed, and circumstances when FDA would recommend manufacturers have a “consultation” with FDA before going to market. The guidance also discusses genome editing changes for which FDA recommends a pre-market meeting.
New Dietary Ingredient Notification Procedures and Timeframes
This final guidance from March updates FDA’s general guidance on submission of new dietary ingredient notices to FDA with timelines and expectations for meeting with the agency.
New Dietary Ingredient Notifications and Related Issues
This guidance from April provides additional information about the use of master files for new dietary ingredients. As with drug products, master files are intended to provide methods for manufacturers to provide confidential proprietary information to FDA without making it publicly available.
FDA Small Entity Guidance on Uses of Partially Hydrogenated Oils in Foods
This guidance from April further explains FDA’s direct final rule in 2023 on Revocation of Uses of Partially Hydrogenated Oils in Foods, including canned fish/tuna and peanut butter, in which FDA concluded that PHOs are no longer generally recognized as safe.
Further Voluntary Reduction of Sodium Levels in Food
This draft guidance from August provides a mean and upper bound level for sodium in food, consistent with FDA’s decades-long effort to have the food industry reduce the amount of sodium in the food supply. Although not required, the guidance is a strong signal to industry as to what FDA considers a nutritious and healthy food, and could be important as FDA progresses its agenda on front of pack nutritional labeling and enforces the new healthy rule.
FDA Enforcement Policy for AAFCO-Defined Ingredients in Animal Foods
Notwithstanding its break-up with the Association of American Feed Control Officials to assist in designating and approving ingredients for animal foods and associated claims for them, FDA issued a policy in October that it would continue to allow those ingredients contained in the AAFCO handbook unless there is a safety reason to reconsider them.
Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula
This draft guidance from December provides details of when and how a manufacturer of infant formula, now designated as a critical food, must notify FDA of either permanent discontinuance or substantial interruption.
FDA's Voluntary Qualified Importer Program
This final guidance from November makes certain changes to the Voluntary Qualified Importer Program (VQIP), a fee-based program that pre-certifies certain importers with robust compliance histories to allow FDA to rely on other resources to confirm compliance history of an importer and its facilities and to attempt to lower the fees associated with the program and encourage more importers to participate.
Use of the Term Healthy on a Food Product
Note—this regulation has been frozen for review by the Trump administration.
For the last 20 years, FDA has promised to update its rule on the use of the claim “healthy” on food products, to be more consistent with current day nutrition guidance and the US Dietary Guidelines. FDA finally issued its final rule in December with 100 pages of comments from both industry and consumer advocates.
In order to use the claim on a food, it must be a food that is considered part of a healthy diet (e.g., vegetable, fruit, grain, dairy product, seafood, meat, eggs, legumes, seeds and nuts, or oil), contain a meaningful amount of that food group (called a food group equivalent), and not contain more than identified low levels of added sugars, saturated fats, or sodium (called nutrients to limit or NTLs) based on a percentage of Daily Value. The rule analyzes each of the major food groups and explains how certain food groups can qualify to use the claim, and discusses nutrient calculations for individual foods, mixed foods (i.e., foods with one or more food groups) and meals.
Many commenters opposed the rule as being too stringent with regard to disqualifying levels of NTLs and noted that many nutrient-dense foods that provide good sources of certain nutrients (e.g., many ready-to-eat cereals and full-fat dairy products and cheese) will no longer be eligible to use the claim, and many food manufacturers will need to reformulate their products to qualify. Several new categories of foods like bottled water, tea, and coffee can now use the claim. FDA confirmed that use of the term on a food label would generally be considered an implied claim of beneficial nutrition but kept open the possibility that not every use of the term “healthy” on a food label would necessarily trigger the rule, including if there is an existing trademarked use of “healthy” on a food label.
The rule becomes effective three years after the published date, but the claim can be used before the effective date if the food qualifies per the new rule. Manufacturers are required to keep records for two years after distribution to substantiate their calculations unless the claim can be verified based on the information in the Nutrition Facts Label. Manufacturers will have to carefully review the nutrient content of their products and the nuances of the rule (e.g., there are special rules for calculating good vs. NTL fats in seafood and fish) to determine if they qualify.
There were many comments that challenged FDA’s authority to dictate the criteria for use of the claim under the First Amendment and pursuant to the Supreme Court decision in Loper-Bright, 144 S. Ct. 2244 (2024). Whether there will be actual legal challenges to the rule is still unclear.
Looking Forward to 2025: What to Expect?
FDA’s Human Foods Program has identified as some of its priorities:
- Additional focus on microbiological hazards including water and produce safety and imported seafood guidelines, and continued investment in food traceability tools to assist in implementation of the rule in 2026
- Collecting, analyzing, and publishing data on food-borne outbreaks like salmonella
- Front of package nutrition labeling
- Greater focus on food ingredients, and processes for introducing new ingredients into foods and dietary supplements
- Additional focus on contaminant-level standards for foods for infants and children, including formula
- Focus on bird flu and its potential impact on the food supply
With FDA’s leadership under the new presidential administration (and the priorities that it will bring to the agency) still up in the air at the time of publication, whether these previously stated priorities will shift as we move further into 2025 remains to be seen. For now, the implementation of many of the new final regulations has been frozen to allow review by the Trump administration.