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Laws and Regulations Committee Update - July 24 - 25, 2019

July 26, 2019 9:55 AM | Amy Bonsell (Administrator)

July 24, 2019

Federal Register

Food and Drug Administration


Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2020

Filed on: 07/24/2019 at 8:45 am Scheduled Pub. Date: 07/25/2019

FR Document: 2019-15817  PDF 10 Pages (184 KB) Permalink


Food Safety and Inspection Service


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

Permit to Transport Undenatured Inedible Meat Products

Filed on: 07/24/2019 at 8:45 am Scheduled Pub. Date: 07/25/2019

FR Document: 2019-15786 PDF 7 Pages (216 KB) Permalink


Animal and Plant Health Inspection Service


Petition for Determination of Nonregulated Status for Enhanced Grain Yield Potential and Glufosinate-Ammonium Resistant DP202216 Maize:

Pioneer Hi-Bred International, Inc.

Filed on: 07/24/2019 at 8:45 am Scheduled Pub. Date: 07/25/2019

FR Document: 2019-15836  PDF 5 Pages (180 KB) Permalink


Petition for Determination of Nonregulated Status of Petunias Genetically Engineered for Flower Color:

Westhoff Vertriebsgesellschaft mbH

Filed on: 07/24/2019 at 8:45 am Scheduled Pub. Date: 07/25/2019

FR Document: 2019-15837 PDF 5 Pages (179 KB) Permalink



FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety

FOIA Reading Room

Record Date

FEI Number


Record Type


Establishment Type



Topway Enterprises




Warning Letters

Posted Date

Letter Issue Date


Issuing Office




AB Seafood Trading Inc

Division of Human and Animal Food Operations East I

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions



Curaleaf, Inc

Center for Drug Evaluation and Research

Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products



USDA Proposes to Close SNAP Automatic Eligibility Loophole




  • ·       FDA has issued a warning letter to Curaleaf Inc. for illegally selling unapproved #CBD (cannabidiol) products online with unsubstantiated claims that they treat cancer, Alzheimer’s disease, opioid withdrawal, pain & pet anxiety, & other conditions/diseases
  • ·       As we examine potential reg. pathways for the lawful marketing of certain CBD products, protecting & promoting public health remains our top priority. Selling unapproved products w/ unsubstantiated claims can put patients/consumers at risk by leading them to put off medical care.
  • ·       Today’s action demonstrates that FDA stands firm in its commitment to continue monitoring the marketplace and taking action as needed against firms that deceive consumers/put them at risk by illegally selling products marketed for therapeutic uses for which they aren’t approved.


  • ·       Honored to share the stage yesterday at #IAFP2019 with Dr. Mindy Brashears with @USDAFoodSafety. Whether it’s writing regulations, responding to outbreaks, or evaluating new technologies, we (FDA & USDA) work TOGETHER. The American people deserve that in their government. #FDA
  • ·       [*retweet @foodsafetynews*] Step by step, program by program, food safety leaders in government plan to make a difference #FoodSafety #FrankYiannas #IAFP2019 #MindyBrashear


  • ·       We will continue to work to protect the health & safety of American consumers from products marketed in violation of the law. At the same time, we also recognize the potential opportunities and significant interest in drugs and other consumer CBD products.
  • ·       We plan to report our progress by early this fall as we expedite our work related to CBD products. The step-wise, science-based approach we’re taking protects patients and the public health, fosters innovation for safe and appropriate products, and promotes consumer confidence.
  • ·       I’ll be testifying Thursday before the Senate Committee on Agriculture, Nutrition & Forestry on the important topic of hemp/CBD and discuss the FDA’s commitment to expediting our work to evaluate the regulatory policies related to hemp & CBD products:


  • ·       FOOD ENFORCEMENT: FDA recently suspended the food facility registration of Topway Enterprises (or Kazy’s Gourmet), preventing distribution of food into commerce. This follows a safety alert and inspections documenting repeated food safety violations
  • ·       The company has yet to implement adequate corrective actions at their facility & we continue to recommend that food retailers in TX and LA stop selling & discard recent shipments of Topway’s seafood products, including raw tuna and salmon, due to possible Listeria contamination.
  • ·       Consumers who have recently purchased seafood, particularly salmon and tuna for raw consumption, in TX and LA should contact the food retailer for more info about where the seafood was supplied. Consumers that purchased Topway products should discard them
  • ·       FDA is not aware of any confirmed illnesses related to these seafood products. However, consumers who think they may have been sickened by these products should seek the assistance of a health care professional and contact the FDA to report it:


  • ·       @FDA_Global’s Latin America Office (LAO) is engaged in an innovative program designed to rapidly increase the number of international produce exporters who are trained in how to comply with FDA’s minimum standards for safe growing, harvesting, packing & holding of produce.

July 25, 2019

Federal Register

Environmental Protection Agency


Tolerance Exemption:

Lactic Acid

Filed on: 07/25/2019 at 8:45 am Scheduled Pub. Date:  07/26/2019

FR Document: 2019-15647 PDF 13 Pages (278 KB) Permalink



FDA Announces FY2020 Fee Rates for Voluntary Qualified Importer Program and Third-Party Certification Program



FSIS Directive 6090.1: Firearms Safety In Official Livestock Establishments


Product Recalled

Date of Recall

Retail Distribution List

077-2019 CM&R Inc. Recalls Beef Stick Products due to Misbranding and Undeclared Allergens

Jul 24, 2019

No retail sales



USDA Pollock Products Purchase Program Announced



Availability of Petition for Deregulation of GE Corn




  • ·       Congratulations to Jenny Scott! Recipient of @IAFPFood Honorary Lifetime Membership Award. @FDAFood is proud of our Senior Advisor to the Director of the Office of Food Safety and her continued contributions to #foodsafety


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