FDA Cracks Down on CBD Products
FDA has issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, FDA is also indicating that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food. Federal law prohibits the use of CBD in dietary supplements, as drugs (unless approved by a drug application) and in foods and beverages. FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed.
FNS Finalizes Rule to Limit SNAP Eligibility of Able Bodied Adults without Dependents
More information here.
APHIS Publishes Rule on Garbage Feeding to Swine
APHIS amended the Swine Health Protection Act regulations by removing the State status lists from the regulations in order to maintain these lists on the Agency’s website.These changes will allow APHIS to use a notice-based, streamlined approach to update the lists while continuing to protect swine health in the United States. The list is available here. States that permit the feeding of garbage to swine include Florida, California, North Carolina, Texas, Pennsylvania, Arkansas, Colorado and Minnesota among others.
FDA Issues Guidance for Limited Modifications to Certain Tobacco Products
FDA has issued guidance entitled Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products, which sets out the FDA’s compliance policy for limited safety modifications to tobacco products on the market as of Aug. 8, 2016: (1) battery-operated tobacco products modified solely and only to the extent necessary to comply with the voluntary industry UL 8139 battery standard; and (2) e-liquid products containing nicotine modified solely and only to the extent necessary to comply with the restricted-flow requirements for liquid nicotine containers set out in the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA). This guidance explains that the FDA does not intend to enforce violations of the premarket review requirements against such modified products on the basis of these limited modifications.
FDA Updates Import Alerts
The updated import alerts may be found here.
FSIS Changes Publication Method for Lists of Foreign Countries Eligible To Export to the United States
FSIS is amending its regulations to remove lists of foreign countries eligible to export meat, poultry, and egg products to the United States. FSIS will maintain a single list of eligible foreign countries on its website instead.
FSIS Extends Comment Period on Proposed Changes to Salmonella Performance Standards for Beef Trimmings
In October, FSIS announced it was seeking comments on a proposal to update Salmonella performance standards for raw ground beef and new Salmonella performance standards for beef manufacturing trimmings, a primary component of raw ground beef (Changes to the Salmonella Verification Testing Program: Proposed Performance Standards for Salmonella in Raw Ground Beef and Beef Manufacturing Trimmings and Related Agency Verification Procedures). FSIS is proposing both standards to ensure that establishments are consistently controlling or reducing Salmonella, a harmful bacteria not ordinarily considered an adulterant in raw beef products.
FSIS received a request from an industry association for an extension of the comment period. The agency has decided to extend the comment period by an additional 30 days. This extension should provide interested members of the public with sufficient time to review the agency’s risk assessment and proposed performance standards. The comment period will now end on January 27, 2020.
FSIS Posts Quarterly Sampling Reports on Salmonella Percent Positives
The sampling reports are available here.
FDA Update on Romaine Outbreak
FDA has provided an update on the E. coli O157:H7 Outbreak Linked to Romaine from Salinas, California. FDA is advising consumers to not eat romaine lettuce harvested from Salinas, California. Additionally, consumers should not eat products identified in the recall announced by the USDA on November 21, 2019.
FSIS Notice on Chinese Poultry Product Imports
The notice provides instructions to inspection program personnel (IPP) at official import inspection establishments on actions to take when verifying the accuracy of inspection certificates for poultry products imported from the People’s Republic of China.
FSIS 2020 Rate Changes for the Basetime, Overtime, Holiday, and Laboratory Services
The new rates are:
- Basetime………………………………………… $64.84
- Overtime………………………………………… $79.88
- Holiday…………………………………………. $94.88
- Laboratory………………………………………. $82.32
- More information here.
APHIS Releases National Poultry Improvement Plan and Auxiliary Provisions Rule
APHIS is proposing to amend the regulations governing the National Poultry Improvement Plan (NPIP). These amendments would establish a U.S. Newcastle Disease Clean program within the NPIP, create an NPIP subpart specific to game birds, revise testing requirements, and clarify existing provisions of the regulations. APHIS is also proposing to amend the regulations concerning the payment of indemnity and compensation for low pathogenic avian influenza to reflect current policy and operational practices, and to allow NPIP voting delegates to represent multiple States during the Biennial Conferences. These proposed changes were voted on and approved by the voting delegates at the NPIP’s 2018 National Plan Conference.
FSIS Updates Lists of Establishments from Canada, Chile, Germany and New Zealand Eligible to Export Meat, Poultry and Egg Products to U.S.
Latest FDA Warning Letters
The latest FDA warning letters are:
Posted Date |
Company |
Issuing Office |
Subject |
12/03/2019 |
PT. SIG ASIA |
Center for Food Safety and Applied Nutrition (CFSAN) |
Seafood HACCP/CGMP for Foods/Adulterated |
12/03/2019 |
American Contract Systems, Inc. |
Office of Medical Device and Radiological Health Division 3 West |
CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
12/03/2019 |
D.A.Y. Farm |
Office of Human and Animal Foods – West Division 1 |
PHS Act/Shell Egg Regulation/Adulterated |
11/26/2019 |
Lohxa LLC |
Division of Pharmaceutical Quality Operations I |
CGMP/Finished Pharmaceuticals/Adulterated |
11/26/2019 |
EPH Technologies, Inc. |
Center for Drug Evaluation and Research | CDER |
Unapproved New Drugs/Misbranded |
11/26/2019 |
California Cereal Products |
Office of Human and Animal Foods – III East |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
11/25/2019 |
KOI CBD LLC |
Center for Drug Evaluation and Research | CDER |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Whole Leaf Organics, LLC |
Center for Drug Evaluation and Research | CDER |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Mr. Pink Collections, LLC |
Center for Drug Evaluation and Research | CDER |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Infinite Product Company LLLP DBA Infinite CBD |
Center for Drug Evaluation and Research | CDER |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Sunflora, Inc./The CBD Store, LLC dba Your CBD Store |
Center for Drug Evaluation and Research | CDER |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Bella Rose Labs |
Center for Drug Evaluation and Research | CDER |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Noli Oil, LLC |
Center for Drug Evaluation and Research | CDER |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Sabai Ventures Ltd |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Organix Industries, Inc. dba Plant Organix |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Daddy Burt Hemp Co |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Apex Hemp Oil LLC |
Center for Veterinary Medicine |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Red Pill Medical Inc. |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
CDRL Nutritional, Inc. |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Private I Salon, LLC |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Sunflora, Inc./The CBD Store, LLC dba Your CBD Store |
Center for Drug Evaluation and Research | CDER |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
11/25/2019 |
Natural Native LLC |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
Please contact Erik Lieberman at elieberman@usfoodimports.com or (202) 765-1800 if you have questions or would like additional information. |