In This Week’s Edition:
- TTB Proposes Changes Standards of Fill for Wine and Distilled Spirits
- FDA Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
- Update on FDA Investigation of Salmonella Outbreak in Peanut Butter
- FDA to Hold Webinar on the Draft Guidance for Industry on Action Levels for Lead in Juice
- FDA Warns Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals
- FDA Follow-up on New Era of Smarter Food Safety Webinar: Q&A
- USDA Authorizes the Importation of Fresh Avocado Fruit From Continental Ecuador
- USDA to Host Meeting on Antimicrobial Resistance
- CBP Trade and Security Symposium to be Held July 18-20 in Anaheim, CA
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
TTB Proposes Changes to Standards of Fill for Wine and Distilled Spirits
The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to amend the regulations governing wine and distilled spirits containers. TTB is proposing to add 10 additional authorized standards of fill for wine, along with related technical and other harmonizing changes. TTB also is considering, as an alternative, eliminating all but a minimum standard of fill for wine containers and all but a minimum and maximum for distilled spirits containers, thus potentially eliminating unnecessary regulatory requirements, reducing barriers to competition, and providing consumers broader purchasing options.
Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
The FDA has announced that it will exercise enforcement discretion with respect to the specific infant formula products listed in the link, to increase infant formula supplies in the United States. The FDA will update this list on a regular basis. Additional information is here.
Outbreak Investigation of Salmonella: Peanut Butter
The FDA, along with CDC and state and local partners, are investigating a multistate outbreak of Salmonella Senftenberg infections linked to certain Jif brand peanut butter products produced at the J.M. Smucker Company facility in Lexington, Kentucky. Consumers, restaurants, and retailers should not eat, sell, or serve any recalled Jif brand peanut butter, including recalled products that contain the recalled Jif peanut butter. Consumers should also avoid feeding recalled peanut butter to pets or other animals, including wild birds.
FDA to Hold Webinar on the Draft Guidance for Industry on Action Levels for Lead in Juice
The FDA is holding a webinar on Tuesday, June 14, 2022, at 1:00 pm (ET) to discuss the recent draft guidance on lead action levels for juice. The draft guidance, titled “Action Levels for Lead in Juice; Draft Guidance for Industry,” issued in April provides action levels for lead in single-strength (ready to drink) apple juice and in other single-strength juices and juice blends. These draft action levels support the agency’s broader effort to reduce exposure to arsenic, lead, cadmium, and mercury from foods, and advance goals in the Closer to Zero action plan.
FDA Warns Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals
FDA has issued warning letters to four companies illegally selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food-producing animals. The companies include Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest. While the FDA does not know the current extent of CBD use in food-producing animals, the agency is taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply.
FDA Follow-up on New Era of Smarter Food Safety Webinar: Q&A
The Q&A follow up for the April 13 meeting may be found here.
USDA Authorizes the Importation of Fresh Avocado Fruit From Continental Ecuador
USDA has decided to authorize the importation of fresh avocado fruit from continental Ecuador into the continental United States. Based on the findings of a pest risk analysis, which USDA made available to the public for review and comment, they have determined that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh avocado fruit from continental Ecuador.
USDA to Host Meeting on Antimicrobial Resistance
The meeting will be held August 30, details here.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- The outbreak of Salmonella Senftenberg linked to Jif brand peanut butter was added to the table. A recall was initiated, an outbreak advisory was issued, and FDA initiated an on-site inspection and sample collection.
- For the outbreak of Listeria monocytogenes (reference #1057) in a not yet identified product, the total case count has increased to 20.
- The adverse events associated with meal replacement drinks have ended and the FDA investigation has closed.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- Brazil
- Chile
- Germany
- Honduras
- Uruguay
FDA Import Alerts
The latest FDA import alerts include salmonella, illegal/undeclared colors, fruit juices due to heavy metal contamination, and more.
FDA Warning Letters
Freeman and Biddy, LLC d/b/a Freedom Vapes |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Hope Botanicals, LLC |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
Plantacea, LLC dba Kahm |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
Haniel Concepts, Inc. DBA Free State Oils, LLC |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
JVS Vapor Inc d/b/a Jacks Vapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Coastal Fresh Farms, Inc. |
Foreign Supplier Verification Program (FSVP) |
Santhigram Kerala Ayurvedic Co. of U.S., Inc. |
Unapproved New Drugs |
Vapejoose, Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
MMWTA Mothers Milk WTA |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Cigsway |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Ayuryoga, Inc. |
Unapproved New Drug |
Allure Foods LLC |
Foreign Supplier Verification Program (FSVP) |
Las Dos Californias Inc DBA Dulceria los Cuates |
Foreign Supplier Verification Program (FSVP) |
A.N.N. Imports LLC |
Foreign Supplier Verification Program (FSVP) |
Smart Smoke, Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Subhlaxmi Grocers |
Foreign Supplier Verification Program (FSVP) |
Sunny Creek Farm, Inc. |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |