News Article

Laws and Regulations Committee Update - October 23 - 24, 2019

Posted on October 25, 2019

Blog: Association of Food & Drug Officials (AFDO)

October 23, 2019

Federal Register

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 10/23/2019 at 8:45 am Scheduled Pub. Date: 10/24/2019

FR Document: 2019-23195 PDF 4 Pages (90.1 KB) Permalink

  • · NAHMS Swine 2020 Study

FDA

FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease

Recalls

Date

Brand

Product Description

Type

Reason/Problem

Company

10/22/2019

Green Lumber

Dietary supplements for male sexual enhancement

Drugs

Contains Tadalafil

GL Holdings

Warning Letters

Posted Date

Letter Issue Date

Company Name

Issuing Office

Subject

10/22/2019

06/04/2019

Paisley Farms, LLC dba Paisley Farm & Crafts

Division of Human and Animal Food Operations East V

CGMP/Dietary Supplement/

Adulterated/Misbranded

10/22/2019

10/09/2019

Pollman's Bake Shops, Inc.

Division of Human and Animal Food Operations East V

CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

10/22/2019

10/10/2019

Rooted Apothecary LLC

Center for Drug Evaluation and Research

Unapproved New Drugs/ Misbranded/ Cannabidiol (CBD) Products

10/22/2019

10/11/2019

DSM Nutritional Products, LLC

Division of Human and Animal Food Operations West III

Adultered Animal Food/ Misbranded

AMS

USDA Appoints Members to National Dairy Promotion and Research Board

USDA Introduces Compliance Options for Certain Meat and Poultry Commodity Products

@FDACommissioner

  • · FDA and FTC have issued a joint warning letter to a company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease, among other conditions/diseases.
  • · We are working to protect Americans from companies marketing products with unsubstantiated claims. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children.
  • · FDA treats cannabis/cannabis-derived compounds the same as any other substance. As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting & promoting public health through sound, science-based decision-making remains our top priority.
  • · We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements.

@FrankYiannasFDA

@DrAbernethyFDA

  • · FDA’s working quickly to further clarify our regulatory approach for products with cannabis/cannabis-derivatives like CBD while using all available resources to monitor the marketplace & protect public health by taking action as needed against companies.
  • · We recognize that there is significant public interest in cannabis and cannabis-derived compounds, however we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products.
  • · We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence. We plan to provide an update on our progress in this area in the near future.

@FDAfood

October 24, 2019

Federal Register

Food and Drug Administration

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 10/24/2019 at 8:45 am Scheduled Pub. Date: 10/25/2019

FR Document: 2019-23251 PDF 2 Pages (87.4 KB) Permalink

  • · Manufactured Food Regulatory Program Standards and Medicated Feed Mill License Application

Animal and Plant Health Inspection Service

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Introduction of Organisms and Products Altered or Produced Through Genetic Engineering

Filed on: 10/24/2019 at 8:45 am Scheduled Pub. Date: 10/25/2019

FR Document: 2019-23344 PDF 4 Pages (96.8 KB) Permalink

Concurrence with OIE Risk Designations for Bovine Spongiform Encephalopathy

Filed on: 10/24/2019 at 8:45 am Scheduled Pub. Date: 10/25/2019

FR Document: 2019-23343 PDF 4 Pages (176 KB) Permalink

Agricultural Marketing Service

Proposed Rules

Removing Varietal Exemptions:

Grapes Grown in Designated Area of Southeastern California and Imported Table Grapes; Withdrawal

Filed on: 10/24/2019 at 8:45 am Scheduled Pub. Date: 10/25/2019

FR Document: 2019-23236 PDF 7 Pages (130 KB) Permalink

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 10/24/2019 at 8:45 am Scheduled Pub. Date: 10/25/2019

FR Document: 2019-23239 PDF 5 Pages (83 KB) Permalink

  • · Report Forms under Federal Milk Orders (From Milk Handlers and Milk Marketing Cooperatives).

Environmental Protection Agency

Rules

Pesticide Tolerances:

Fenbuconazole

Filed on: 10/24/2019 at 8:45 am Scheduled Pub. Date: 10/25/2019

FR Document: 2019-23380 PDF 21 Pages (244 KB) Permalink

Pendimethalin

Filed on: 10/24/2019 at 8:45 am Scheduled Pub. Date: 10/25/2019

FR Document: 2019-23382 PDF 19 Pages (184 KB) Permalink

Sulfoxaflor

Filed on: 10/24/2019 at 8:45 am Scheduled Pub. Date: 10/25/2019

FR Document: 2019-23384 PDF 11 Pages (220 KB) Permalink

Notices

Pesticide Product Registration; Receipt of Applications for New Active Ingredients (September 2019)

Filed on: 10/24/2019 at 8:45 am Scheduled Pub. Date: 10/25/2019

FR Document: 2019-23361 PDF 4 Pages (84.4 KB) Permalink

Pesticide Product Registration; Receipt of Applications for New Uses (September 2019)

Filed on: 10/24/2019 at 8:45 am Scheduled Pub. Date: 10/25/2019

FR Document: 2019-23353 PDF 4 Pages (86.9 KB) Permalink

Requests to Voluntarily Cancel Certain Pesticide Registrations and Amend Registrations to Terminate Certain Uses

Filed on: 10/24/2019 at 8:45 am Scheduled Pub. Date: 10/25/2019

FR Document: 2019-23386 PDF 11 Pages (45.2 KB) Permalink

FDA

Recalls

Date

Brand

Product Description

Type

Reason/Problem

Company

10/23/2019

Parivar

Dry Dates

Food & Beverages, Fruit/Fruit Product

High Sulfite Content

Dilips Ceramics Inc dba Shivam Distributors

AMS

USDA Reaches Consent Decision with Nicholas Meat LLC and Eugene Nicholas for Alleged Packers and Stockyards Act Violations

USDA Determines Individual Not Responsibly Connected to South Carolina Violator

USDA Settles a Packers and Stockyards Case Against Twin Lakes Calf Company, LLC

USDA Reaches a Consent Decision and Civil Penalty with Calvin Plummer, Jr., dba J&J Cattle and J-J for P&S Act Violations

USDA Section 32 Egg Products Purchase Program Announced

USDA Introduces Compliance Options for Certain Meat and Poultry Commodity Products

USDA Appoints Members to National Dairy Promotion and Research Board

USDA Announces Appointments to the Christmas Tree Promotion Board

@FDAMedia

@FrankYiannasFDA

@FDA_ORA

  • · #DYK?: Food labeling is required for most prepared foods, such as breads, canned & frozen foods, snacks, desserts, drinks, etc. Nutrition labeling for raw produce (fruits &vegetables) &fish is voluntary. LEARN MORE about how food labeling affects you: https://go.usa.gov/xVPQm


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