In This Week’s Edition:
- PFAs Import Alert
- FDA Issues Final Rule on Revoking the Authorizations for Food Contact Substances
- USDA Food Safety and Inspection Service Foreign Audit Report: Netherlands and Thailand
- Filing of Color Additive Petition: Beetroot Red
- FSIS Publishes Notice on Voluntary Labeling of U.S. Country of Origin
- FDA and Federal Partners Launch Study on the Role of Seafood Consumption in Child Growth and Development
- USDA Organic Product Import Rules Go In to Effect
- FTC Releases Report on Grocery Supply Chain Disruptions; Market Power
- Frozen Cherry Pie; Revocation of a Standard of Identity and a Standard of Quality
- USDA Dairy Import License Informational Webinar
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
PFAs Import Alert
FDA issued a new import alert for human food products with detectable levels of chemical contaminants that may present a safety concern to human health. The Import Alert 99-48, Detention without Physical Examination of Foods Due to Chemical Contamination, gives the FDA the ability to help prevent entry of human food products into the U.S. if they are found to be contaminated with a broad range of human-made chemicals including benzene, dioxins and polychlorinated biphenyls, and per- and polyfluoroalkyl substances, among others.
FDA Issues Final Rule on Revoking the Authorizations for Food Contact Substances
FDA issued a final rule to amend the regulations (21 CFR 170.105 and 21 CFR 170.102) on how and when the FDA may determine that a food contact notification (FCN) is no longer effective. An effective FCN authorizes the use of a food contact substance from the manufacturer or supplier identified in the FCN. These changes will increase the efficiency of the FDA’s FCN program by allowing the FDA to determine an FCN is no longer effective for reasons other than safety. These changes also enable the FDA to more effectively respond to new information on the safety and use of food contact substances. A list of effective FCNs can be found on the FDA’s website.
USDA Food Safety and Inspection Service Foreign Audit Report: Netherlands and Thailand
FSIS maintains a list of comprehensive audits of foreign country inspection systems to ensure compliance with certain regulatory requirements. Netherlands and Thailand have been added to this list.
Filing of Color Additive Petition From Phytolon Ltd.
FDA is announcing that they have filed a petition, submitted by Phytolon Ltd., proposing that the color additive regulations be amended to provide for the safe use of beetroot red for the coloring of foods generally in amounts consistent with current good manufacturing practice.
USDA Finalizes Voluntary “Product of USA” Label Claim to Enhance Consumer Protection
USDA Secretary Tom Vilsack announced the finalization of a rule to align the voluntary “Product of USA” label claim with consumer understanding of what the claim means. “Product of USA” and “Made in the USA” will be generically approved (1) for use on single ingredient FSIS-regulated products ( i.e., products produced under FSIS mandatory or voluntary inspection services) derived from animals born, raised, slaughtered, and processed in the United States. The two voluntary label claims “Product of USA” and “Made in the USA” will also be generically approved for use on multi-ingredient FSIS-regulated products and (3) the preparation and processing steps for the multi-ingredient product have occurred in the United States.
Also consistent with the proposed rule, label claims other than “Product of USA” or “Made in the USA” that indicate that a preparation or processing step of a FSIS-regulated product is of U.S. origin (referred to in the proposed rule as “qualified claims” (88 FR 15290, 15291) will be generically approved for use, (2) but such claims will need to include the preparation and processing steps (including slaughter) that occurred in the United States upon which the claim is made.
FSIS Publishes Notice on Voluntary Labeling of U.S. Country of Origin
This notice informs inspection program personnel (IPP) that FSIS is amending its regulations to define the conditions under which the labeling of meat, poultry, and egg products under mandatory inspection, as well as voluntarily inspected products, may bear voluntary label claims indicating that the product is of United States origin. As of January 1, 2026, if establishments choose to include these voluntary claims on their labels, they will need to meet the new labeling requirements. IPP should also be aware that FSIS has updated its guidance on the use of voluntary U.S.-origin labels eligible for generic approval.
FDA and Federal Partners Launch Study on the Role of Seafood Consumption in Child Growth and Development
The National Academies of Sciences, Engineering, and Medicine released a pre-publication version of the FDA-sponsored report, The Role of Seafood in Child Growth and Development. The final release of the report will occur May 2024.
USDA Organic Product Import Rules Go In To Effect
The USDA AMS NOP – Strengthening Organic Enforcement regulations become mandatory effective March 19, 2024. USDA published the Strengthening Organic Enforcement (SOE) final rule on January 19, 2023. The rule requires the use of electronic NOP Import Certificates for organic agricultural products imported into the U.S. This will improve the oversight and traceability of imported organic products.
FTC Releases Report on Grocery Supply Chain Disruptions; Market Power
The Federal Trade Commission issued a report on the causes behind grocery supply chain disruptions resulting from the COVID-19 pandemic. The report states that large market participants accelerated and distorted the negative effects associated with supply chain disruptions. See the report here.
Frozen Cherry Pie; Revocation of a Standard of Identity and a Standard of Quality
FDA is revoking the standard of identity and the standard of quality for frozen cherry pie. This action, in part, responds to a citizen petition submitted by the American Bakers Association. We conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. Revocation of the standards of identity and quality for frozen cherry pie will provide greater flexibility in the product’s manufacture, consistent with comparable, nonstandardized foods available in the marketplace.
USDA Dairy Import License Informational Webinar
USDA’s Dairy Import Licensing Program, in partnership with CBP Quota Branch, will hold an informational webinar at 2:00 p.m. ET on Wednesday, March 27, 2024, on Microsoft Teams. This webinar will provide introductory information for companies and individuals interested in learning more about the requirements and processes for importing dairy products under the program. Topics such as program eligibility, the license lottery process, and important programming dates, among other licensing details, will be discussed.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- There are no updates to this week’s table.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Warning Letters
Wagco Distribution, Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Jiangsu Shenli Medical Production Co., Ltd. |
CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
Medline Industries, LP |
CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
Sol-Millennium Medical, Inc. |
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
Furst-McNess Company |
CGMP/Medicated Feeds/Adulterated |
Skull Smash LLC |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded |