In This Week’s Edition:
- FDA Completes Final Administrative Actions to Prohibit Partially Hydrogenated Oils in Foods
- APHIS Increases User Fees for Agricultural Quarantine and Inspection Services
- International Standard-Setting Activities
- NACMCF To Hold Public Meeting on Cyclospora Report and Cronobacter work
- Solicitation of Nominations for Members of the Grain Inspection Advisory Committee
- FDA Issues Draft Guidance on MOCRA Registration and Listing of Cosmetic Product Facilities and Products
- 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 Completes Final Administrative Actions to Prohibit Partially Hydrogenated Oils in Foods
FDA is issuing a direct final rule to complete administrative actions that reflect the agency’s June 2015 final determination that the use of partially hydrogenated oils (PHOs) in foods is no longer Generally Recognized as Safe (GRAS). In the 2015 final determination, the FDA indicated that there were outdated references to PHOs in regulations that the FDA would address separately. With respect to removing PHOs from the food supply, the FDA established January 1, 2021, as the final compliance date to allow manufacturers time to reformulate foods and ensure an orderly transition in the marketplace.
APHIS Increases User Fees for Agricultural Quarantine and Inspection Services
APHIS is proposing to update and amend the user fee regulations associated with the agricultural quarantine and inspection (AQI) program. Specifically, APHIS proposes to increase the fees for certain AQI services that are provided in connection with certain commercial vessels, commercial trucks, commercial railroad cars, commercial aircraft, and international passengers arriving at ports in the customs territory of the United States; adjust the caps on prepaid fees associated with commercial trucks and commercial railroad cars; remove certain fee exemptions that are no longer justifiable based upon pathway analyses of risk; and restructure the treatment monitoring fee.
International Standard-Setting Activities
This notice informs the public of the sanitary and phytosanitary standard-setting activities of the Codex Alimentarius (Codex), in accordance with section 491 of the Trade Agreements Act of 1979, as amended, and the Uruguay Round Agreements Act. This notice also provides a list of other standard-setting activities of Codex, including commodity standards, guidelines, codes of practice, and revised texts.
NACMCF To Hold Public Meeting on Cyclospora Report and Cronobacter work
The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will hold a virtual public meeting on August 30, 2023, to discuss and vote to adopt a report on Cyclospora cayetanensis in produce. During the meeting the Committee will also provide an update on the Cronobacter spp. in Powdered Infant Formula subcommittee work.
Solicitation of Nominations for Members of the Grain Inspection Advisory Committee
USDA’s AMS is seeking nominations for individuals to serve on the Grain Inspection Advisory Committee. The Advisory Committee meets no less than once annually to advise AMS on the programs and services it delivers pursuant to the U.S. Grain Standards Act and in accordance with the Federal Advisory Committee Act, as amended. Recommendations by the Advisory Committee help AMS better meet the needs of its customers who operate in a dynamic and changing marketplace.
FDA Issues Draft Guidance on MOCRA Registration and Listing of Cosmetic Product Facilities and Products
FDA issued draft guidance on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MOCRA).
When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, and when to submit, as well as certain exemptions to the registration and listing requirements.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- A new outbreak of Listeria monocytogenes (ref #1172) in a not yet identified product has been added to the table. There are two cases in this outbreak. FDA has initiated traceback.
- For the outbreak of Cyclospora cayetanensis (ref #1171), the case count has increased from 47 to 55 cases.
- For the outbreak of E. coli O157:H7 (ref #1166), the outbreak has ended and FDA’s investigation has closed.
- For the outbreak of Salmonella Paratyphi B var. L(+) tartrate+ (ref #1157), the case count has increased from 36 to 37 cases.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include foods that are or contain an unsafe additive, foreign suppliers who are not in compliance with FSVP, and more.
FDA Warning Letters
Amarillo Snuff Co. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Illumivaption Inc. dba Nashville Vapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Game Trader |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
US Specialty Formulations, LLC |
Compounding Pharmacy/Adulterated Drug Products |
Fancystage Unipessoal, LDA |
CGMP/Finished Pharmaceuticals/Adulterated |
Avaria Health & Beauty Corp. |
CGMP/Finished Pharmaceuticals/Adulterated |
LCC Ltd. |
CGMP/Finished Pharmaceuticals/Adulterated |
Suhan Aerosol |
CGMP/Finished Pharmaceuticals/Adulterated |
STC India Private Limited |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
KM Pharmaceutical Co. Ltd. |
Refusal to Provide Access to and Copying of Records |
Orchid Lifesciences |
CGMP/Finished Pharmaceuticals/Adulterated |
Tan Alize Kozmetik Ve Temizlik Urunleri |
CGMP/Finished Pharmaceuticals/Adulterated |
Cergomex Imports, LLC |
Refusal to Provide Access to and Copying of Records |
Skyline Herbals Private Limited |
Refusal to Provide Access to and Copying of Records |
Daxal Cosmetics Private Limited |
Refusal to Provide Access to and Copying of Records |
GTP International Corp |
Refusal to Provide Access to and Copying of Records |