In This Week’s Edition:
- FDA Ends Enforcement Discretion on FSVP Entry Data
- FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars
- FDA Issues the Accredited Third-Party Certification Program
- FDA Takes Steps to Limit Lead in Juice to Further Reduce Exposure to Toxic Elements in Foods
- USDA Opens Grants Application to Improve SNAP Customer Service
- Survey on the FDA/CORE Outbreak Investigation Table
- 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 Ends Enforcement Discretion on FSVP Entry Data
Currently, FDA guidance provides that FSVP Importers may temporarily submit “UNK” (unknown) in place of the DUNS number for the FSVP Importer in entry filings. Beginning July 24, 2022, FDA will end its temporary policy of permitting use of the entity identification code “UNK.” Accordingly, consistent with 21 CFR 1.509(a), the FSVP importer must ensure that their valid, 9-digit DUNS number is provided in the Entity Number field. No earlier than July 24, 2022, CBP will reject an entry line of a food subject to the FSVP regulation when the importer’s DUNS number is not provided in the Entity Number field. For more information, please see the updated Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation: Guidance for Industry and CSMS #51738135.
FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars
FDA announced proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars.
FDA Issues the FSMA Accredited Third-Party Certification Program
FDA announced the availability of a draft guidance for industry entitled The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry. The draft guidance, when finalized, will provide answers to frequently asked questions relating to the requirements of the Accredited Third-Party Certification Program under FSMA, and is intended to assist accreditation bodies’, third-party certification bodies’, and eligible entities’ understanding of the regulation and program requirements.
FDA Takes Steps to Limit Lead in Juice to Further Reduce Exposure to Toxic Elements in Foods
FDA issued draft action levels for lead in single-strength (ready to drink) apple juice and other single-strength juices and juice blends. This action is intended to reduce the potential for negative health effects from dietary exposure to lead and supports the agency’s Closer to Zero action plan that sets forth the FDA’s science-based approach to reducing exposure to toxic elements in foods.
USDA Opens Grants Application to Improve SNAP Customer Service
The USDA’s Food and Nutrition Service announced that $5 million in competitive grants are being made available to enhance efficiency and access in the Supplemental Nutrition Assistance Program through process and technology improvements.
Survey on the FDA/CORE Outbreak Investigation Table
FDA’s Coordinated Outbreak Response and Evaluation (CORE) would like your feedback on its newly released CORE Outbreak Investigation Table (CIT). The CIT, located about halfway down the webpage, is a list of outbreak investigations being managed by FDA’s CORE Response Teams. The CIT was developed to publicly share current outbreaks earlier on in the investigation process, even if there isn’t actionable advice for the public yet. Take the survey here.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the investigation with a reference number 1064, the total adverse event reports have increased to 446.
- For the Listeria monocytogenes outbreak in a not yet identified food (reference #1040), the case count has increased to 19 cases.
- The investigation has closed for the Salmonella Saintpaul outbreak in an unidentified food.
- For the Listeria monocytogenes outbreak in a not yet identified food (reference #1057), the case count has increased to 17 cases.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include unsafe food additives, dried fruit with lead, and pesticides
FDA Warning Letters
Smoke-Free Planet, LLC d/b/a Smoke Free Nation |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Vape Junkie EJuice |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
7333 LLC |
Foreign Supplier Verification Program (FSVP) |
Vitae Enim Vitae Scientific Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |
White Horse Vapor Store, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Clinical Resolution Laboratory Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |
Guangzhou Zhongkebaishi Health Industry Co., Ltd. |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
Fresh Farms LLC |
CGMP/Finished Pharmaceuticals/Adulterated |
Alymar LLC |
Foreign Supplier Verification Program (FSVP) |
Cetylite Industries, Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |