Laws and Regulations Committee Update – November 26, 2019

Federal Register

Agricultural Marketing Service

Rules

Decreased Assessment Rate:

Marketing Order Regulating the Handling of Sweet Cherries Grown in Designated Counties in Washington

Filed on: 11/26/2019 at 8:45 am Scheduled Pub. Date: 11/27/2019

FR Document:2019-25650 PDF 16 Pages (334 KB) Permalink

Food Safety and Inspection Service

Rules

Publication Method for Lists of Foreign Countries Eligible to Export Meat, Poultry, or Egg Products to the United States

Filed on: 11/26/2019 at 8:45 am Scheduled Pub. Date: 11/27/2019

FR Document: 2019-25750  PDF  25 Pages (273 KB) Permalink

FDA

FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns

Recalls

DateBrandProduct DescriptionTypeReason/ProblemCompany
11/25/2019Tuna KingYellowfin Tuna MedallionsFood & Beverages, FishElevated Histamine LevelsNorthern Fisheries LTD

Warning Letters

Posted DateLetter Issue DateCompany NameIssuing OfficeSubject
11/25/201911/22/2019KOI CBD LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Mr. Pink Collections, LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Whole Leaf Organics, LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Infinite Product Company LLLP DBA Infinite CBDCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Sunflora, Inc./The CBD Store, LLC dba Your CBD StoreCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Bella Rose LabsCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Noli Oil, LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Organix Industries, Inc. dba Plant OrganixCenter for Food Safety and Applied Nutrition (CFSAN)Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Sabai Ventures LtdCenter for Food Safety and Applied Nutrition (CFSAN)Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Daddy Burt Hemp CoCenter for Food Safety and Applied Nutrition (CFSAN)Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019KOI CBD LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Mr. Pink Collections, LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Whole Leaf Organics, LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Infinite Product Company LLLP DBA Infinite CBDCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Apex Hemp Oil LLCCenter for Veterinary MedicineUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Red Pill Medical Inc.Center for Food Safety and Applied Nutrition (CFSAN)Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019CDRL Nutritional, Inc.Center for Food Safety and Applied Nutrition (CFSAN)Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Private I Salon, LLCCenter for Food Safety and Applied Nutrition (CFSAN)Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/201911/22/2019Natural Native LLCCenter for Food Safety and Applied Nutrition (CFSAN)Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products

FSIS

USDA’s Recommendations for a Safe Thanksgiving

OMB

The 2019 Fall Agenda was published on 11/20/2019

APHIS

USDA Seeks Comment on Proposed Changes to List of Plants for Planting Not Approved Pending Pest Risk Analysis

USDA

USDA Statement on U.S. Sugar Market

@FrankYiannasFDA

@Dr.AbernethyFDA

  • FDA is quickly working to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD. We’re doing this in line with our overarching approach like for any other substance FDA regulates.
  • In the meantime, we’re monitoring the marketplace and taking action as needed, like issuing 15 warning letters today to companies that violate the law in ways that raise public health concerns.
  • Often, people wrongly think that the myriad of CBD products on the market have been evaluated by FDA and determined to be safe, or that trying CBD can’t hurt. Aside from one prescription drug, CBD products have not been approved by FDA.
  • There are number of questions regarding CBD’s safety and there are real risks that need to be considered. There is significant interest in CBD and we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products.

@FDArecalls

@US_FDA

  • FDA took several actions today on CBD including issuing 15 warning letters, updating on safety concerns, and given the lack of scientific information, that FDA cannot conclude CBD is generally recognized as safe for use in human or animal food https://go.usa.gov/xpRXj