In This Week’s Edition:
- FDA: An Update on Sesame Allergen Labeling on Food Packages
- FSMA Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for FY 2024
- FSMA Third-Party Certification Program User Fee Rate for FY 2024
- FSMA Voluntary Qualified Importer Program User Fee Rate for FY 2024
- National Advisory Committee on Microbiological Criteria for Foods
- Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
- USDA Semiannual Regulatory Agenda, Spring 2023
- FDA Issues Second Procedural Notice on Consumer Research on Front-of-Package Labeling
- Milk in the Northeast and Other Marketing Areas; Notice of Hearing on Proposed Amendments to Marketing Agreements and Orders
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
FDA: An Update on Sesame Allergen Labeling on Food Packages
Earlier this year sesame was added as the ninth major food allergen when the Food Allergy Safety, Treatment, Education, and Research Act became effective on Jan. 1, 2023. This means that sesame is now required to be listed on food labels as a major allergen. Robert M. Califf, Commisioner of FDA shares information on allergen labeling and why it is one of the most useful tools available to consumers with food allergies.
FSMA Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for FY 2024
FDA is announcing the fiscal year (FY) 2024 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Food Safety Modernization Act (FSMA). The rate is $291/hour if domestic travel is required and $312/hour if foreign travel is required.
FSMA Third-Party Certification Program User Fee Rate for FY 2024
FDA is announcing the FY 2024 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the FSMA. They are also announcing the fee rate for certification bodies that are applying to be directly accredited by FDA. The initial fee for an accreditation or certification body is $45,440.00 and the renewal fee is $27,888.00 among other fees.
FSMA Voluntary Qualified Importer Program User Fee Rate for FY 2024
FDA is announcing the FY 2024 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program that is authorized by the FD&C Act, as amended by FSMA. The fee is $14,975.00
National Advisory Committee on Microbiological Criteria for Foods
This notice is announcing that the National Advisory Committee on Microbiological Criteria for Foods will hold a virtual public meeting of the full Committee on August 30, 2023. The Committee will discuss and vote to adopt the following report: Cyclospora cayetanensis in Produce. The Committee will also provide an update on the Cronobacter spp. in Powdered Infant Formula charge.
Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
FDA is announcing that they have filed a petition, submitted by Kemin Industries, Inc., proposing that the food additive regulations be amended to provide for the safe use of chromium propionate to be used as a source of chromium in turkey feed.
USDA Semiannual Regulatory Agenda, Spring 2023
This agenda provides summary descriptions of regulations being developed in agencies of the USDA in conformance with Executive Orders 12866, “Regulatory Planning and Review,” 13563, “Improving Regulation and Regulatory Review,” and 14094, “Modernizing Regulatory Review.” The agenda indicates rules that are currently in the final and proposed stages as well as long-term agency actions.
FDA Issues Second Procedural Notice on Consumer Research on Front-of-Package Labeling
FDA will reopen the comment period for the 30-day procedural notice to conduct a study entitled “Quantitative Research on Front of Package Labeling on Packaged Foods” that appeared in the Federal Register on June 15, 2023. Given technical challenges experienced with the comment submission portal, FDA is reopening the portal on the morning of Monday, July 24, and the new deadline for comments will be 11:59 PM on Wednesday, July 26, 2023
Milk in the Northeast and Other Marketing Areas; Notice of Hearing on Proposed Amendments to Marketing Agreements and Orders
A national public hearing is being held to consider and take evidence on proposals to amend the pricing formulas in the 11 Federal Milk Marketing Orders.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- A new outbreak of Cyclospora cayetanensis (ref #1171) in a not yet identified product has been added to the table. There are currently 39 cases. FDA and state partners have initiated sample collection and testing and FDA has initiated traceback.
- A new outbreak of E. coli O26 (ref #1165) with 13 cases linked to a not yet identified product has been added to the table. FDA has initiated traceback.
- For the outbreak of Cyclospora cayetanensis (ref #1163), the case count has increased from 118 to 121 cases and FDA has initiated traceback.
- For the outbreak of Salmonella Paratyphi B var. L(+) tartrate+ (ref #1157), the case count has increased from 34 to 35 cases.
- For the outbreak of Cyclospora cayetanensis (ref #1159), the case count has increased from 43 to 68 cases.
- For the outbreak of hepatitis A virus (ref #1143) linked to frozen strawberries, the advisory was updated on July 20, 2023 to include one additional case. FDA reminds consumers to check their freezers and not eat recalled frozen strawberries.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include food products due to the presence of Salmonella, human and animal foods for pesticides, and more.
FDA Warning Letters
Smooth Vapes Hawaii |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Stella Blues Vapors Inc |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
EC Supply, Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
ABS Distribution Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Easy Wholesale, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Cheshni Foods LLC |
Foreign Supplier Verification Program (FSVP) |
Gadget Island, Inc. |
Unapproved New Drugs/Misbranded |
Five Leaf Pet Botanicals, Inc. |
Unapproved New Animal Drug Products |
Koi CBD, LLC |
Adulterated Human Foods/Misbranded |
Baits and Sea Foods, S.A. |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
Wise Women’s Choice |
Unapproved New Drugs/Misbranded |
Stratus Biosystems, LLC dba CellGenuity Regenerative Science |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
Northland Vapor Company, LLC |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |