The US Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2024 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP). The user fee rates are authorized by the FDA Food Safety Modernization Act (FSMA) and allow the agency to assess and collect fees to cover the FDA’s cost of administering these programs.

VQIP is a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.

The FY2024 VQIP user fee rate will be effective on August 1, 2023, and supports program benefits from October 1, 2023, through September 30, 2024. Currently, the agency is not offering an adjusted fee for small businesses. Approved VQIP applicants must pay the user fee before October 1, 2023, to begin receiving benefits for the 2024 fiscal year.

TPP is a voluntary program in which FDA recognizes “accreditation bodies” that may accredit third-party “certification bodies.” The certification bodies can conduct food safety audits and issue certifications of foreign food facilities.

The FY2024 TPP user fee rate will be effective on October 1, 2023, and will remain in effect through September 30, 2024.

Please direct any questions regarding VQIP to the VQIP Importers Help Desk at 1-301-796-8745 or FSMAVQIP@fda.hhs.gov. Questions regarding TPP can be sent to FDAthirdpartyprogram@fda.hhs.gov. You can also subscribe to receive updates about the U.S. Import programs, policies and regulations.

Additional Information

Federal Register Notice announcing the FY2024 VQIP User Fee Rates

Voluntary Qualified Importer Program (VQIP)

Federal Register Notice announcing the FY2024 Third-Party Certification Program User Fee Rates

Accredited Third-Party Certification Program

Fees under the FSMA

FDA User Fee Programs

The US Food and Drug Administration (FDA) has released a public inventory of certain food ingredients that the agency has determined to have unsafe uses in food because they are unapproved food additives and lists of select chemicals currently under the agency’s review. The FDA also released a Conversations with experts about the agency’s work to enhance the assessment of ingredients in foods on the market. These resources are intended to provide more insight on the FDA’s post-market assessments.

In addition to the FDA’s pre-market programs, the agency’s active post-market monitoring of new safety information related to food ingredients is also essential to the safety of the US food supply. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, any ingredient used or intended for use in food must be authorized by the FDA for use as a food additive unless that use is Generally Recognized As Safe or GRAS by qualified experts or meets a listed exception to the food additive definition in the FD&C Act. An unapproved food additive is deemed to be unsafe under the FD&C Act.

The inventory includes some of the FDA’s post-market assessments of food ingredients and may include links to some activities related to such an ingredient since 2004. When the FDA becomes aware of an ingredient for which there is no authorization as a food additive, the FDA reviews the regulatory status of this ingredient, including whether the publicly available data and information show the use is safe and meets the GRAS standard. This determination informs the agency’s actions to protect public health, including enforcement actions and other post-market activities that warn manufacturers and the public of unsafe food additives and can result in the removal of unsafe products from the market.

This inventory is not intended to be a complete list of food ingredients that may be unlawful if used in food and may not include all post-market activities the agency has taken with respect to unsafe food additives. Specifically, the inventory includes the name of the unsafe food additive, information about some post-market activities and public communications, and the FDA’s memo that describes reviews in which the agency concluded the use of the ingredient did not meet the GRAS standard. The post-market activities include warning letters, import alerts, seizures and injunctions.

The lists that were also made available, include select ingredients considered GRAS, food and color additives, food contact substances, and contaminants currently under FDA review. These represent some of the chemicals of interest to the agency and those that are of high interest among stakeholders who have asked the FDA to review their safety. The FDA anticipates updating the inventory and these lists periodically.

Lastly, the Conversations with Experts features Dr. Kristi Muldoon-Jacobs, acting Director of the Office of Food Additive Safety, sharing her insight about the FDA’s current post-market assessment of ingredients and food contact substances and how we envision enhancing our approach to support this work.

The FDA’s assessment of chemicals in the food supply is part of our commitment to food safety.

For More Information

Post-market Determinations that the Use of a Substance is Not GRAS

FDA Works to Enhance the Assessment of Ingredients in Foods and Food Contact Substances on the Market

Lists of Select Chemicals in the Food Supply Under FDA Review

Food Chemical Safety

The FDA posted new frequently asked questions and additional tools to provide industry with more information about the FDA Food Safety Modernization Act (FSMA) Food Traceability Rule.

The Food Traceability Rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. Foods subject to the final rule requirements appear on the Food Traceability List (FTL).

The new FAQs address questions to help clarify how the rule applies to specific situations and are largely based on questions received during the FDA’s regular interactions with industry and on questions sent via the Technical Assistance Network, a central source of information for questions related to the FSMA rules, programs, and implementation strategies.

Along with the FAQs, additional tools developed to help further educate and inform industry subject to the Food Traceability Rule are accessible from the FDA’s traceability website, including:

• addition of the results for all foods and associated commodity-hazard pairs included in the Risk-Ranking Model for Food Tracing – beyond what appear on the food traceability list,
• additional description on the Food Traceability List webpage to clarify that “nut butters” include all forms of nut butters – shelf-stable, refrigerated, and frozen products,
• eight new supply chain examples that illustrate how the rule is applied in different scenarios for different commodities,
• What you need to know about the Food Traceability Rule fact sheets:
  • Recordkeeping Information for Produce Farms
  • Coverage and Exemption for Produce Farms
• guide to Getting Started with the Food Traceability Rule
• additional foreign language translations of the Critical Tracking Event and Key Data Elements interactive tool and supply chain examples.

The compliance date for all persons subject to the Food Traceability Rule is January 20, 2026.

The rule is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA).

Resources:

Traceability Rule: Federal Register Notice

Full and Partial Exemptions to the Food Traceability Rule

The US Food and Drug Administration has issued a 30-day procedural notice on its plans to conduct a study entitled “Quantitative Research on Front of Package Labeling on Packaged Foods.” The study is a follow up to focus groups conducted in 2022 to further explore consumer responses to various front-of-package labeling schemes. As part of the Paperwork Reduction Act, federal agencies are required to publish a notice in the Federal Register on each proposed information collection to give the public the opportunity to comment.

The FDA is conducting this consumer research to help explore the development of a front-of-package labeling scheme, which is part of the National Strategy on Hunger, Nutrition, and Health, issued as part of the White House Conference held in September 2022 focused on ending hunger and reducing diet-related disease. Front-of-package labeling is intended to complement the Nutrition Facts label on packaged foods by giving consumers additional context to help them identify healthier food selections. A standardized, science-based scheme could help consumers, particularly those with less nutrition knowledge, quickly and easily identify foods that can help them build a healthy eating pattern. The experiences of countries worldwide that have adopted front-of-package labeling suggest that such labeling may help nutrition comprehension and the ability to make healthier choices.

The U.S. continues to face an epidemic of diet-related chronic diseases, many of which are experienced disproportionately by racial and ethnic minority groups, those with lower socioeconomic status, and those living in rural areas. To help address this, the FDA is continuing to prioritize its nutrition activities to help empower consumers with nutrition information to identify healthier choices more easily. The consumer research the FDA is announcing today is intended to further inform our work in this important area.

The comment period opens June 15, 2023. Comments on the notice are due to OMB by July 17, 2023. To find this information collection, visit Docket No. FDA-2023-N-0155 on Regulations.gov and select “Currently Under Review – Open for Public Comments” or use the search function. See the Federal Register notice for additional information on commenting.

For Additional Information

Federal Register Notice

Food Labeling & Nutrition

Front-of-Package Nutrition Labeling

The US Food and Drug Administration (FDA) is extending the comment period for the Draft Guidance for Industry entitled “Questions and Answers About Dietary Guidance Statements in Food Labeling” that appeared in the Federal Register on March 27, 2023. The new deadline for comments is September 25, 2023. The FDA is extending the comment period by 90 days in response to multiple requests from stakeholders to allow additional time for interested persons to develop and submit comments. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2023-D-1027.