In This Week’s Edition:
- FDA to Ban Brominated Vegetable Oil
- USDA Announces Early Release of Select Commodity Tables for Agricultural Projections to 2033
- Addition of Belarus to the List of Regions Affected With Highly Pathogenic Avian Influenza
- FDA Approves Jagua Blue Color
- ITC Continues Countervailing Duties on Spanish Olives
- Interstate Certified Shellfish Shippers List
- FDA Proposes to Require Tracking Information for Prior Notice of Imported Food Shipments Arriving by Mail
- FDA Issues Update on Cosmetic Product Facility Registration and Cosmetic Product Listing
- ITC Opens Anti-Dumping Investigation into Frozen Warmwater Shrimp From Ecuador, India, Indonesia, and Vietnam
- 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 to Ban Brominated Vegetable Oil
FDA proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. The agency concluded that the intended use of BVO in food is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health found the potential for adverse health effects in humans. FDA is assessing other currently approved ingredients for safety including Red No. 3.
USDA Announces Early Release of Select Commodity Tables for Agricultural Projections to 2033
On November 7, 2023, at 3 p.m. EST, the USDA will release selected tables from the upcoming USDA Agricultural Projections to 2033 report prepared in support of the President’s annual budget process as defined in the Budget Control Act. These tables will include 10-year projections for major U.S. crops and livestock products and will be followed in February 2024 by USDA’s Agricultural Projections to 2033 report that will include a full discussion of the commodity supply and use projections, and projections for farm income and global commodity trade.
Addition of Belarus to the List of Regions Affected With Highly Pathogenic Avian Influenza
USDA is advising the public that they have added Belarus to the list of regions that the Animal and Plant Health Inspection Service considers to be affected by highly pathogenic avian influenza (HPAI). This action follows USDA’s imposition of HPAI-related restrictions on avian commodities originating from or transiting Belarus, as a result of reports of HPAI in that country.
FDA Approves Jagua Blue Color
FDA is amending the color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice. FDA is taking this action in response to a color additive petition submitted by Exponent, Inc. on behalf of Ecoflora SAS.
ITC Continues Countervailing Duties on Spanish Olives
U.S. Department of Commerce finds that revocation of the countervailing duty order on ripe olives from Spain would be likely to lead to continuation or recurrence of countervailable subsidies at the levels indicated in the “Final Results of Sunset Review” section of this notice.
Interstate Certified Shellfish Shippers List
The ICSSL is published monthly, see the November list here.
FDA Proposes to Require Tracking Information for Prior Notice of Imported Food Shipments Arriving by Mail
The FDA issued a proposed rule which, if finalized, would amend its prior notice regulations to:
- Require that prior notice for articles of human and animal food arriving by international mail include the name of the mail service and a mail tracking number.
- Require that prior notice and food facility registration information be submitted within a certain timeframe after certain notices of refusal or hold have been issued (“post-refusal” and “post-hold” submission).
FDA Issues Update on Cosmetic Product Facility Registration and Cosmetic Product Listing
FDA is providing an update on ongoing activities related to the new cosmetic product facility registration and cosmetic product listing mandated by the Modernization of Cosmetics Regulation Act of 2022.
In August 2023, FDA issued draft guidance on cosmetic product facility registrations and product listings. FDA received more than 40 comments on the draft guidance and is in the process of evaluating the comments. The draft guidance, when finalized, will provide recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA. FDA intends to finalize the guidance as quickly as possible.
ITC Opens Anti-Dumping Investigation into Frozen Warmwater Shrimp From Ecuador, India, Indonesia, and Vietnam
ITC gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-699-702 and 731-TA-1659-1660 pursuant to the Tariff Act of 1930 to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of frozen warmwater shrimp from Ecuador and Indonesia provided for in statistical reporting numbers of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Governments of Ecuador, India, Indonesia, and Vietnam.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- A new outbreak of E. coli O121:H19 (ref # 1195) in a not yet identified product has been added to the table. FDA has initiated traceback.
- For the outbreak of Listeria monocytogenes (ref # 1172) linked to Ice cream, the advisory was updated on October 26, 2023. The outbreak has ended, and FDA’s investigation is closed.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include imported food products that appear to be misbranded, foods containing undeclared/illegal colors.
FDA Warning Letters
HomeTown Vapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Wolfe Trading Company LLC d/b/a East Coast Vapors |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
8OHM1 d/b/a Digital Smoke |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Velvet Vapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Jams Vaporium |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
ALI Pharmaceutical Manufacturing, LLC |
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
Samm Solutions, Inc., d.b.a. BTS Research |
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies |
WAVi Co. |
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
Maria W. Greenwald, M.D. |
Clinical Investigator |