May 14, 2019

Federal Register

Environmental Protection Agency

Rules

Pesticide Tolerances:

Glufosinate Ammonium

Filed on: 05/14/2019 at 8:45 am Scheduled Pub. Date: 05/15/2019

FR Document: 2019-10054 PDF 10 Pages (377 KB) Permalink

Notices

Interim Registration Review Decisions and Case Closures for Several Pesticides

Filed on: 05/14/2019 at 8:45 am Scheduled Pub. Date: 05/15/2019

FR Document: 2019-10004 PDF 5 Pages (169 KB) Permalink

Pesticides:

Draft Guidance for Pesticide Registrants on Plant Regulator Label Claims, Including Plant Biostimulants; Extension of Comment Period

Filed on: 05/14/2019 at 8:45 am Scheduled Pub. Date: 05/15/2019

FR Document: 2019-10071 PDF 2 Pages (77.6 KB) Permalink

FDA

Dockets

FDA-2019-P-2239, Citizen Petition from BioNeutra North America Inc, Requests that the FDA include Isomaltooligosaccaride in the 21 CFR 101.9 (c)(6)(i) list of dietary fibers

• · A citizen petition was submitted by BioNeutra to the FDA in 2016 (the 2016 citizen petition); the petition was denied by the FDA in 2018 (2018 letter), who concluded that there was insufficient evidence demonstrating that isomalto-oligosaccharides (IMO) have a beneficial physiological effect to human health (U.S. FDA, 2018a). BioNeutra has since translated three relevant nonEnglish human studies to English (Liu et al., 1994; Lee et al., 2003; Lin et al., 2005) that were identified in the previous citizen petition. Furthermore, Bioneutra is now submitting scientific evidence to support the relationship between IMO consumption and blood cholesterol levels.

USDA

Press Release on LLP

AMS

USDA Clarifies Redirection of Assessments under Beef and Soybean Acts

@FDAfood

• · In silico safety assessment methods for food ingredients, dietary supplements, and cosmetics is the topic of the next SOT and @FDAfood colloquium on May 15. Register for the free webcast: http://bit.ly/2V9wI7s

May 15, 2019

Federal Register

Environmental Protection Agency

Notices

Meetings:

Pesticides; Draft Revised Method for National Level Endangered Species Risk Assessment Process for Biological Evaluations of Pesticides

Filed on: 05/15/2019 at 8:45 am Scheduled Pub. Date: 05/16/2019

FR Document: 2019-10177 PDF 8 Pages (175 KB) Permalink

FDA

May 14, 2019 - FDA warns manufacturers of products labeled as homeopathic for putting consumers at risk with significant violations of manufacturing quality standards

Recalls

Date	Brand	Product Description	Reason/Problem	Company
05/14/2019	Biltmore	Wild Smoked Sockeye Salmon	Listeria	Seven Seas International USA, LLC

FSIS

Recalls

Product Recalled	Date of Recall	Retail Distribution List
051-2019 Taylor Farms Texas Inc. Recalls Salad with Chicken Products due to Misbranding and Undeclared Allergens	May 14, 2019	N/A (Class II Recall)

@FrankYiannasFDA

• · [*retweet @knash99] The FDA says its AI pilot for inspecting imported food will benefit consumers, flagging the products with the highest risks https://www.wsj.com/articles/fda-launches-ai-pilot-for-inspecting-imported-food-11556789400 … via @WSJ
• · [*retweet @NewgenBiotech] U.S. Food and Drug Administration Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements.
• · [* retweet @VanessaMcConkey] FDA Deputy commissioner for Food Policy and Response @FrankYiannasFDA speaking at #regsummit2019: 75% of US consumers take dietary supplements. It’s our duty to ensure they are safe & lawful everyday. Protecting consumers is a goal FDA & the Dietary Supplements industry share.

@FDAanimalhealth

• · Today FDA issued warnings to five companies that produce homeopathic products for putting consumers, and in some cases, pets at risk with significant violations of manufacturing quality standards & marketing unapproved animal drugs
• · FDA issued a warning letter to Newton Laboratories for human drug CGMP and misbranding violations as well as unapproved new animal drug violations. For a list of affected pet products, see the warning letter
• · If your pet has experienced an adverse event after using one of Newton’s products, report it to the FDA. Visit our webpage for instructions on how to submit a report

@HeppertJoe

• · Congratulations to @MBrashears on becoming one step closer to serving as Undersecretary for @USDAFoodSafety. Thank you @SenateAgGOP for your work throughout this process. @TexasTech is proud of its world-class leaders and experts in food safety. From here, it’s possible!

May 16, 2019

Federal Register

Food and Nutrition Service

Notices

Request for Information: The Serious Deficiency Process in the Child and Adult Care Food Program

Filed on: 05/16/2019 at 8:45 am Scheduled Pub. Date: 05/17/2019

FR Document: 2019-10308 PDF 5 Pages (180 KB) Permalink

FDA

FDA Announces Public Meeting on Alternative Approaches in Clinical Investigations for New Animal Drugs

Recalls

Date	Brand	Product Description	Reason/ Problem	Company Name
05/15/2019	Karawan	Tahini	Salmonella	Broddzenatti Holding LLC
05/15/2019	GHSW, LLC	Salads, wraps and salad bar trays	Unapproved Ingredient	GHSW, LLC

FSIS

Recalls

Product Recalled	Date of Recall	Retail Distribution List
053-2019 MIBO Fresh Foods LLC Recalls Salad with Meat Products due to Misbranding and Undeclared Allergens	May 15, 2019	N/A (Class II Recall)
052-2019 Crab House Trading Corp. Recalls Siluriformes Products Produced without Benefit of Inspection	May 15, 2019

FTC

Made in USA

Closing letter to Lizbeth Levinson, Counsel for LG Hausys America, Inc. (541.13 KB)

National Academies

Organohalogen Flame Retardants Used in Consumer Products Cannot Be Assessed for Hazards as a Single Class, But Can Be Assessed in Subclasses, Says New Report

• · Offers guidance to the CPSC on how to conduct a hazard assessment of nonpolymeric, additive organohalogen flame retardants (OFRs), which are used in some consumer products.

@FrankYiannasFDA

• · Yesteday, I was privileged to represent #FDA at the Dietary Supplement Regulatory Summit in Washington, DC. FDA remains committed to working with stakeholders to modernize our efforts to ensure consumers have access to safe & lawful products. https://www.nutraingredients-usa.com/Article/2019/05/15/FDA-s-Yiannas-At-the-end-of-the-day-you-re-not-selling-products-you-re-selling-trust#.XNwW4LfssCo.twitter

@FDAfood

• · OUTBREAK US FDA w/ @CDCgov, state & local partners investigating multi-state outbreak of #Salmonella Concord illness linked to Karawan Tahini or labeled El Karawan Tahini imported from Israel. Suspect you have symptoms? Contact your healthcare provider. https://go.usa.gov/xmVsm
• · Be aware that this product has a shelf life of 2 years, so check your home for tahini w/either label. Consumers with this tahini should not eat it and should discard it. There have been 4 confirmed cases, 1 hospitalization, & 0 deaths.

@US_FDA

• · OUTBREAK ALERT: FDA along w/ @CDCgov, state & local partners are investigating a multi-state outbreak of #Salmonella Concord illness linked to Karawan Tahini (sometimes labeled El Karawan Tahini) imported from Israel.
• · FDA has requested a recall after testing confirmed contamination. Consumers should not eat it and should discard it, the product has a 2 year shelf-life. There have been 4 confirmed cases in NY, MA and TX

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