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Laws and Regulations Committee Update 4/3 - 4/4, 2019

April 05, 2019 9:17 AM | Amy Bonsell (Administrator)

April 3, 2019

Federal Register

Animal and Plant Health Inspection Service


Environmental Assessments; Availability, etc.:

BASF Plant Science, LP, Canola Genetically Engineered for Altered Oil Profile and Resistance to an Imidazolinone Herbicide

Filed on: 04/03/2019 at 8:45 am Scheduled Pub. Date: 04/04/2019

FR Document: 2019-06630  PDF 7 Pages (183 KB) Permalink



FTC Joins FDA in Sending Warning Letters to Companies Advertising and Selling Products Containing Cannabidiol (CBD) Claiming to Treat Alzheimer’s, Cancer, and Other Diseases

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

USDA, EPA, and FDA Recognize April as Winning on Reducing Food Waste Month

FDA Announces Proposed Ruling on Fluoride in Bottled Water

FDA Advancing Beneficial Animal Biotechnology Product Development




Product Description




Wholesome Pantry

Organic Nut Butters

May be contaminated with Listeria monocytogenes

Wakefern Food Corp.


Warning Letters

Letter Issue Date

Company Name

Issuing Office


Close Out Date


Nutra Pure LLC

Center for Drug Evaluation and Research

Unapproved New Drugs/Misbranded

Not Issued *


Advanced Spine and Pain, LLC (d/b/a Relievus)

Center for Drug Evaluation and Research

Unapproved New Drugs/Misbranded

Not Issued *


PotNetwork Holdings, Inc.

Center for Food Safety and Applied Nutrition

New Drug/Misbranded

Not Issued *


Bimeda Incorporated

Center for Veterinary Medicine

Unapproved New Animal Drug/Adulterated

Not Issued *




Product Recalled

Date of Recall

Retail Distribution List

040-2019 AdvancePierre Foods, Inc. Recalls Frozen Beef Patties due to Possible Foreign Matter Contamination

Apr 02, 2019

N/A (Class II Recall



  • ·        Tomorrow, we’ll be announcing partnership between FDA and U.S. Customs and Border Protection @CBP that’ll expand our ongoing collaboration. We’re working to maximize our capabilities to protect Americans from illegal and harmful products entering U.S.
  • ·        [*retweet @NBCNewsHealth*] FDA, FTC send warning letters to three CBD marketers for false medical claims
  • ·        #FDA is undertaking a process to outline pathways for the legal marketing of CBD as a food product. But we’ll continue to take enforcement action against those companies illegally marketing CBD in ways that violate current law and put consumers at risk.
  • ·        Today #FDA announced a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities:
  • ·        FDA’s steps include a public hearing on May 31 for stakeholders to share experiences/challenges w/ these products, formation of a high-level internal agency working group to explore potential product pathways, web QA updates & new warning letters for unfounded marketing claims.
  • ·        We remain committed to exploring an appropriate, efficient and predictable regulatory framework to allow product developers that meet the requirements under our authorities to lawfully market these types of products.
  • ·        At the same time, the warning letters announced today make clear that #FDA has and will continue to monitor the marketplace and use our authorities to take action against companies illegally selling these types of products when they are putting consumers at risk
  • ·        I was also concerned to hear recently that several national pharmacy chains and other major retailers have begun to sell or will soon begin to sell cannabidiol (CBD) products in several states.
  • ·        We’ll be contacting them to remind them of #FDA obligations and our commitment to protect consumers against products that can put them at risk.


  • ·        #FDA@USDA & @EPA are recognizing April as Winning on Reducing Food Waste Month & calling for greater collaboration with public, private, & nonprofit partners as well as state & local officials. Learn more here & join us.  Food is too important to waste.
  • ·        Today, the #FDA proposed updating standards for fluoride added to bottled water. It’s important to ensure that fluoride is added to bottled water at the right levels so that it can benefit consumers while also preventing dental fluorosis. Learn more at


  • ·        Ensuring animal biotech products are safe and perform as expected is critical to maintaining consumer and commercial confidence in these products and realizing their potential benefits for human and animal health. Learn more in #FDAVoices

April 4, 2019

Federal Register

Agricultural Marketing Service


Marketing Order:

Sweet Onions Grown in the Walla Walla Valley of Southeast Washington and Northeast Oregon

Filed on: 04/04/2019 at 8:45 am Scheduled Pub. Date: 04/05/2019

FR Document: 2019-06701 PDF 17 Pages (344 KB) Permalink


Food Safety and Inspection Service


Eligibility of Honduras to Export Poultry Products to the United States

Filed on: 04/04/2019 at 8:45 am Scheduled Pub. Date: 04/05/2019

FR Document: 2019-06662 PDF 23 Pages (257 KB) Permalink


Food and Nutrition Service

Proposed Rules

Providing Regulatory Flexibility for Retailers in the Supplemental Nutrition Assistance Program

Filed on: 04/04/2019 at 8:45 am Scheduled Pub. Date: 04/05/2019

FR Document: 2019-06597  PDF 31 Pages (302 KB) Permalink



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

Generic Clearance for the Development of Nutrition Education Messages and Products for the General Public

Filed on: 04/04/2019 at 8:45 am Scheduled Pub. Date: 04/05/2019

FR Document: 2019-06698 PDF 7 Pages (247 KB) Permalink


Environmental Protection Agency


Tolerance Exemption:

2-Hydroxypropyl Starch

Filed on: 04/04/2019 at 8:45 am Scheduled Pub. Date: 04/05/2019

FR Document: 2019-06689 PDF 14 Pages (395 KB) Permalink



USDA Cites Moza LLC in Pennsylvania for PACA Violations



USDA Announces Availability of Draft Environmental Assessment and Draft Plant Pest Risk Assessment for Petition to Deregulate Altered Oil Profile and Herbicide Resistant GE Canola



UrthBox Settles FTC Charges Related to Compensated Online Reviews and “Free” Trial Offer


 Of Other Claims

  • ·        Mead Johnson provided a reasonable basis for its compositional claims for its Enfamil NeuroPro  MFGM (Milk Fat Globule Membrane)-Supplemented Infant formulas but recommended modification of other claims in both consumer and healthcare professional advertisements, and discontinuance of its use of a certain bar graph in its consumer-directed commercial




  • ·        We’ve released #FDA lab tests results of 30 kratom products to determine if they contain heavy metals. The analysis found significant levels of lead and nickel at concentrations that exceed safe exposure for oral daily drug intake.
  • ·        Data suggest certain substances in the opioid kratom have potential for abuse. The findings of heavy metals in kratom strengthen our public health warnings around this substance and concern for the health and safety of Americans using it.


  • ·        FDA will hold a public meeting to discuss the draft guidance to protect food against intentional adulteration. Attend the Apr 17 meeting in our College Park, Maryland office or via the web. Sign up before April 10 >>  #Foodsafety #FSMA
  • ·        Guidance designed to address hazards intentionally introduced to foods, i.e., acts of terrorism, w/ intent to cause wide-spread harm to public health. Discussion incl: how to conduct vulnerability assessments, ID & implement mitigation strategies, food defense monitoring reqs...
  • ·        A1 -FDA’s CFSAN is a science-based regulatory organization w/responsibility to promote & protect public health by ensuring the U.S. food supply is safe, secure, sanitary, & properly labeled, along with dietary supplements & cosmetic products.  #NPHWChat
  • ·        To meet these responsibilities FDA invests significant resources in measurement and analysis, scientific methods development, original scientific research, reference database development, bioinformatics, risk analysis, and other science-based activities. #foodscience
  • ·        A6 FDA is implementing the Menu Labeling rule. You’ve probably noticed that chain restaurants, coffee shops, movie theaters, & more now have calorie information on their menus. To learn more, visit … 

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