News Article

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

Posted on April 05, 2019

Blog: Association of Food & Drug Officials (AFDO)

April 3, 2019

Federal Register

Animal and Plant Health Inspection Service

Notices

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

FDA

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

Recalls

Date	Brand	Product Description	Reason/Problem	Company
03/28/2019	Wholesome Pantry	Organic Nut Butters	May be contaminated with Listeria monocytogenes	Wakefern Food Corp.

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
03/28/2019	Nutra Pure LLC	Center for Drug Evaluation and Research	Unapproved New Drugs/Misbranded	Not Issued *
03/28/2019	Advanced Spine and Pain, LLC (d/b/a Relievus)	Center for Drug Evaluation and Research	Unapproved New Drugs/Misbranded	Not Issued *
03/28/2019	PotNetwork Holdings, Inc.	Center for Food Safety and Applied Nutrition	New Drug/Misbranded	Not Issued *
01/31/2019	Bimeda Incorporated	Center for Veterinary Medicine	Unapproved New Animal Drug/Adulterated	Not Issued *

FSIS

Recalls

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

@SGottliebFDA

· 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 https://www.nbcnews.com/health/health-news/fda-ftc-send-warning-letters-three-cbd-marketers-false-claims-n990251?cid=par-twitter-feed_20190402
· #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. https://www.businessinsider.com/are-cbd-cannabis-foods-drinks-legal-maybe-fda-2019-4
· 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: https://go.usa.gov/xm3d5
· 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.

@FrankYiannasFDA

· #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. https://go.usa.gov/xm3pq 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 https://go.usa.gov/xm3yC

@US_FDA

· 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: https://go.usa.gov/xm3d6

April 4, 2019

Federal Register

Agricultural Marketing Service

Rules

Marketing Order:

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