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Laws and Regulations Committee Update - June 4 - 5, 2019

June 07, 2019 9:51 AM | Amy Bonsell (Administrator)

June 4, 2019

FDA

FDA Publishes Guidance Document on How to Choose Alternate Curricula for Produce Safety Training

Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine

 

AMS

Pre-Solicitation Announcement for Trade Mitigation Purchase of Dairy Products

USDA Appoints Members to National Fluid Milk Processor Promotion Board

USDA Announces $10 Million in Grants Available for the Specialty Crop Multi-State Program

 

@FDACommissioner

  • ·       #FDA is warning consumers about safety concerns with vinpocetine, an ingredient found in some dietary supplements. FDA data, along with a report issued by the National Toxicology Program (#NTP), found it can potentially cause a miscarriage or negatively impact fetal development.
  • ·       FDA hasn’t reviewed vinpocetine under safety & effectiveness standards that apply to drugs. It may be referred to as Vinca minor extract, lesser periwinkle extract, common periwinkle extract & is often marketed for memory, focus, mental acuity, energy, weight loss.
  • ·       FDA is committed to public safety and we want to make sure that we’re sharing this information about vinpocetine, especially since this health concern directly affects a vulnerable population – pregnant women or women who may become pregnant.

@FrankYiannasFDA

  • ·       #FDA is announcing new draft guidance that provides flexible recommendations for produce safety training. Education and training are key to the prevention of foodborne illness, and we know that one size doesn’t fit all for the produce industry. https://go.usa.gov/xmFjv
  • ·       Fresh fruits/vegetables are a cornerstone of a nutritious diet. We want to provide farmers tools needed to keep American produce among the safest in the world. Our new draft guidance will improve availability of training to meet the diverse needs of produce farming operations.
  • ·       #FDA is warning consumers about safety concerns with an ingredient called vinpocetine, found in certain dietary supplements. We are advising pregnant women/women who could become pregnant to NOT use vinpocetine: https://go.usa.gov/xmFBE
  • ·       Data from both FDA and #NTP suggests vinpocetine could cause a miscarriage or negatively impact fetal development. Dietary supplements containing vinpocetine are often marketed for uses that include enhanced memory, focus, or mental acuity; increased energy; and weight loss.
  • ·       Ensuring the safety of dietary supplements is a top priority. In 2016, we requested comment from stakeholders as part of an administrative proceeding to evaluate whether vinpocetine is legal for sale as a dietary supplement & we’re expediting completion of this proceeding.

@FDAfood


June 5, 2019

Federal Register

Animal and Plant Health Inspection Service

Proposed Rules

Movement of Certain Genetically Engineered Organisms

Filed on: 06/05/2019 at 8:45 am Scheduled Pub. Date: 06/06/2019

FR Document: 2019-11704 PDF 109 Pages (570 KB) Permalink

 

Environmental Protection Agency

Rules

Pesticide Tolerances:

Penthiopyrad

Filed on: 06/05/2019 at 8:45 am Scheduled Pub. Date: 06/06/2019

FR Document: 2019-11676 PDF 27 Pages (309 KB) Permalink

 

FDA

Recalls

Date

Brand

Product Description

Reason/Problem

Company

05/25/2019

Divvies

Benjamint Chocolate Bars

Undeclared Milk

Divvies, LLC

Warning Letters

Letter Issue Date

Company

Issuing Office

Letter Type

05/15/2019

ActiveHerb Technology, Inc

Division of Pharmaceutical Quality Operations IV

Warning Letter

 

FSIS

Notices

Number

Title

Date Issued

Expiration Date

17-19

Follow up Sampling in Raw Poultry Establishments not Meeting Salmonella Performance Standards

Jun 04, 2019

Jun 01, 2020

Recalls

Product Recalled

Date of Recall

Retail Distribution List

062-2019 Los Hernandez Tamales, LLC Recalls Chicken and Pork Products Produced Without Benefit of Inspection

May 31, 2019

Jun 04, 2019

 

NIH

Workshop on Metabolic Interactions between Folic Acid Excess and Vitamin B12 Deficiency

 

 

@FrankYiannasFDA

  • ·       [retweet @Deloitte_GPS_SA] #Deloitte’s Combiz Abdolrahimi will be moderating a fireside chat with FDA Deputy Commissioner @FrankYiannasFDA on how new/emerging technologies are creating new models of trust and shared value, and what the @US_FDA is doing to usher the US into a new era of smarter #foodsafety

@FDAfood

  • ·       Part of our mission @FDAFood, is being responsible for promoting & protecting the American public’s health by ensuring food supply is safe, sanitary, wholesome, & honestly labeled. https://go.usa.gov/xmsG4  #WorldFoodSafetyDay
  • ·       [retweet] What's the difference btwn PFGE vs WGS for foodborne outbreak detection? Leslie Hintz @FDAfood explains it's like looking at the moon through binoculars vs the Hubble: more specificity w/ WGS but both are valuable & both still require additional info to identify an outbreak #APHL


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