In This Week’s Edition:
- USDA Codex Meeting: Committee on Food Hygiene
- FDA Releases Guidance on Prior Notice of Imported Food Questions and Answers
- Eligibility of Lithuania to Export Egg Products to the United States
- FDA Update on Daily Harvest Investigation: Lentil and Leek Crumbles
- USDA FY2023 Sugar Quota
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
USDA Codex Meeting: Committee on Food Hygiene
The U.S Codex Office is sponsoring a virtual public meeting on October 27, 2022. The objective of the public meeting is to provide information and receive public comments on agenda items and draft U.S. positions to be discussed at the 53rd Session of the Codex Committee on Food Hygiene of the Codex Alimentarius Commission, which will take place November 29-December 2, 2022, with the report adoption on December 8, 2022.
FDA Releases Guidance on Prior Notice of Imported Food Questions and Answers
FDA is announcing the availability of a draft guidance for industry entitled “Prior Notice
of Imported Food Questions and Answers; Draft Guidance for Industry.” The draft guidance adds three additional questions. One question relates to any effect systems recognition or equivalency determinations have on prior notice requirements. The other two questions relate to FDA’s notice to a submitter of prior notice of an FDA refusal for inadequate prior notice or hold if the food article is from a foreign facility that is not registered, and address the timeframe for making requests for FDA review of such a refusal or hold.
Eligibility of Lithuania to Export Egg Products to the United States
This notice provides instructions to inspection program personnel at official import inspection establishments on actions to take when verifying the accuracy of inspection certificates for egg products imported from Lithuania. These certificates, provided by the State Food and Veterinary Service, Lithuania’s central competent authority in charge of food inspection, assure that these products meet FSIS requirements.
FDA Update on Daily Harvest Investigation: Lentil & Leek Crumbles
On June 17, 2022, in response to consumer complaints submitted to the company, Daily Harvest voluntarily initiated a recall of their French Lentil & Leek Crumbles. In response to Consumer Adverse Event Reports (CAERS) and Consumer Complaints submitted to the FDA, the FDA has initiated an investigation, including an inspection and sample collection in an effort to determine the cause of illnesses. As of September 15, 2022, the FDA has received 386 CAERS reports and Consumer Complaints related to this product.
FDA’s investigation is ongoing, and more information will be provided as it becomes available.
USDA FY 2023 Sugar Quota
The Office of the Secretary of the Department of Agriculture announced the establishment of the Fiscal Year 2023 in-quota aggregate quantity of certain sugars, syrups, and molasses (also referred to as refined sugar) at 222,000 metric tons raw value.
Interview with New CTP Director Brian King
Read the full interview with the new Center for Tobacco Products Director Dr. Brian King, where he coves the following questions and topics:
- What are your top priorities as the new Director of the Center for Tobacco Products?
- How do you think your experience as a scientist has uniquely prepared you for this role in tobacco regulation?
- What are your plans for combatting youth vaping?
- The Center for Tobacco Products is still a relatively new organization within FDA. What contributions do you see yourself making to continue building a strong foundation for the protection of public health through tobacco regulation?
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- A new outbreak of Listeria monocytogenes (ref# 1106) in a not yet identified product has been added to the table. FDA has initiated an on-site inspection and sample collection and analysis.
- For the Salmonella Mississippi outbreak (ref# 1097) in a not yet identified product the case count has increased from 100 to 102 cases.
- To highlight ongoing investigations, all incidents with a closed investigation and an outbreak that has ended will now be archived, by year, in the tables located below the Active Investigations table.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include foods containing undeclared major food allergens or foods that fail to properly label major food allergens, suppliers who are not in compliance with the requirements of FSVP, and more.
FDA Warning Letters
The Vapor Studio LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Massive Vapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Team MC Inc. d/b/a Community Vapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
U.S. Vapes |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Freaz LLC d/b/a Vapor Wize |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
The Royal Ice Cream Company Inc. |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
Countryside Feed LLC |
CGMP/Animal Food/Adulterated |
Virgin Scent Inc. dba Artnaturals |
CGMP/Finished Pharmaceuticals/Adulterated |
Sanitizer Supply LLC |
CGMP/Finished Pharmaceuticals/Adulterated |
10 Days Inc d/b/a Pod Juice |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
J Vapes LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Chaur Fong Inc. dba 888 Food Company |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
Doc Ike Retail, LLC d/b/a Bama Vapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Osment Enterprises, LLC d/b/a The Vapor Apothecary |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Texas Longhorn RX, LLC |
Compounding Pharmacy/Adulterated Drug Products |
Kuzmir Imports Inc. |
Foreign Supplier Verification Program (FSVP) |
Banks Square Market Corp. dba The Produce Connection |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
CR Grupo Comercial Alvacora S.A. |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
Vlazar Costa Caribe S.A. |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
Mahi Frozen Foods |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
Myllan-ORA ehf |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
Mad Buck Vapes Inc d/b/a Detroit Rock Candy |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Vape Hut, Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |