March 22nd, 2018

Federal Register

Food and Drug Administration

Notices

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

Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018

FR Document: 2018-06154 PDF 4 Pages (91.1 KB) Permalink

National Agriculture and Food Defense Strategy Survey

Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018

FR Document: 2018-06135 PDF 8 Pages (36.9 KB) Permalink

Premarket Notification for a New Dietary Ingredient

Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018

FR Document: 2018-06155 PDF 6 Pages (92.3 KB) Permalink

Animal and Plant Health Inspection Service

Notices

Determinations:

Fever Tick Status of the State of Chihuahua, Excluding the Municipalities of Guadalupe y Calvo and Morelos

Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018

FR Document: 2018-06131 PDF 4 Pages (11.3 KB) Permalink

FDA

Notice of Availability of Draft Guidance for Industry; Elemental Impurities in Animal Drug Products Questions and Answers

Recalls

Date	Brand Name	Product Description	Reason/Problem	Company
03/26/2018	Blue Ridge Beef	Complete raw pet food	May contain Salmonella and Listeria monocytogenes	Blue Ridge Beef
03/26/2018	Natural Selections and ZooLogics	Fresh raw meals for dogs	May contain Salmonella and E. coli O128	Darwin’s Natural Pet Products
03/25/2018	Mrs. Gerry's, Open Acres, Festival, Knowlan's and Market Fresh	Egg Salads and Potato Salads	Undeclared Seafood in Salad	Mrs. Gerry's Kitchen Inc.
03/25/2018	Whole Foods Market	Decorated (iced) cookies	Undeclared Egg Allergen	Whole Foods Market
03/23/2018	Kitchen's Cravings	Egg Salad Sandwich	May contain traces of Imitation Crab Meat	Kwik Trip, Inc.

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
03/13/2018	Biotek, Inc.	Denver District Office	Unapproved New Drugs/Misbranded	Not Issued *
03/16/2018	Bhavani Fruits & Vegetables LLC	New York District Office	CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions	Not Issued *
03/19/2018	Remnant Inc. DBA The Donut Stop	Kansas City District Office	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated	Not Issued *
03/21/2018	Starlight Desserts Inc	Seattle District Office	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated	Not Issued *

FSIS

Training Requirement for International Travel

AMS

USDA Restricts PACA Violators in California, Georgia and North Carolina from Operating in the Produce Industry

USDA Vegetable Purchase Program Announced

@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls

• · Help keep fruits and vegetables safe when buying and storing them. Learn the simple steps you can take to help prevent foodborne illness. #NationalNutritionMonth http://go.usa.gov/xnzKu
• · Kwik Trip, Inc. Issues Allergen Alert for Undeclared Fish or Shellfish on Premium Egg Salad Sandwich on Oat Multigrain Bread http://dlvr.it/QMRBDf
• · Stay informed on the latest guidance regarding food & nutrition labeling. Use these #FDAORA resources to LEARN MORE: https://go.usa.gov/xn6yp
• · Mrs. Gerry’s Kitchen Issues Allergen Alert on Undeclared Seafood in Salad http://dlvr.it/QMSdn3
• · Blue Ridge Beef Voluntarily Recalls BRB Complete Raw Pet Food Lot#GA0131 Because of Possible Contamination http://dlvr.it/QMSdnf
• · Store perishable fresh fruits and vegetables at 40° F or below. Use a refrigerator thermometer to check! http://go.usa.gov/xXx8n #NNM
• · Allergy Alert Issued in Select Northern California Whole Foods Market Stores for Undeclared Egg in Some Cookies http://dlvr.it/QMT70M
• · Darwin’s Natural Pet Products Issues Voluntary Recalls for Darwin’s Brand Dog Foods Due To Contamination Salmonella And Shiga Toxin-Producing Escherichia Coli O128 http://dlvr.it/QMTKKg

March 26, 2018

Federal Register

Food and Drug Administration

Notices

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

Guidance on Consultation Procedures: Foods Derived From New Plant Varieties

Filed on: 03/26/2018 at 08:45 am Scheduled Pub. Date: 03/27/2018

FR Document: 2018-06069 PDF 6 Pages (91 KB) Permalink

Guidance:

Elemental Impurities in Animal Drug Products - Questions and Answers

Filed on: 03/26/2018 at 08:45 am Scheduled Pub. Date: 03/27/2018

FR Document: 2018-06061 PDF 5 Pages (27.3 KB) Permalink

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 03/26/2018 at 08:45 am Scheduled Pub. Date: 03/27/2018

FR Document: 2018-05796 PDF 3 Pages (86.8 KB) Permalink

FDA

Recalls

Date	Brand Name	Product Description	Reason/Problem	Company
03/23/2018	Delizza	Mini Eclairs	Listeria monocytogenes	Poppies International, Inc.
03/23/2018	King Arthur	Organic Coconut Flour	May contain Salmonella	King Arthur Flour Company
03/23/2018	Eclipse	Eclipse Kratom-containing powder products	May contain Salmonella	Tamarack Inc.
03/22/2018	Milo’s Kitchen	Dog treats	Products potentially contain elevated levels of beef thyroid hormone.	J.M. Smucker Company

FSIS

Delayed Implementation of Verification of Revised Appendix A and B

• askFSIS Questions about Lethality and FSIS Appendix A
• askFSIS Questions about Stabilization and FSIS Appendix B
• askFSIS Questions about fully-cooked meat patties and compliance with 9 CFR 318.23
• askFSIS Questions about HACCP monitoring of Lethality and Stabilization CCPs

Follow-Up Sampling in Raw Poultry Establishments Not Meeting Salmonella Performance Standards

Mar 23, 2018 | PDF

• AskFSIS to Handle Questions on Siluriformes
• PHIS Quick Reference Guide Available on FSIS Website
• FSIS to Include Additional Establishment Categorization Information in PHIS
• FSIS Shares Updated Application for Export Certificate

AskFSIS

Inedible container

Containers used for inedible product

APHIS

USDA Provides Almost $70 Million in Fiscal Year 2018 to Protect Agriculture and Plants from Pests and Diseases through the 2014 Farm Bill Section 10007

• · The APHIS News and Announcements page includes articles on the individual funding amounts received for 12 states. Please let me know if you would like a breakdown of this information.

AMS

USDA Restricts PACA Violators in Florida, Tennessee and Texas from Operating in the Produce Industry

USDA Seeks Nominees for the National Sheep Industry Improvement Center

USDA Seeks Nominees for the American Lamb Board

04/25 to 04/27 April 2018 NOSB Oral Comment In-Person Registration

04/25 to 04/27 National Organic Standards Board (NOSB) Meeting - Tucson, AZ

@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls

• · #FridayFunFact #FDAORA investigators use the PREDICT risk assessment tool to identify #imports that could pose a risk to #publichealth. MORE: https://go.usa.gov/xnnyH
• · Limited Production of Two Varieties of Milo’s Kitchen® Dog Treats Voluntarily Recalled Due to Potentially Elevated Levels of Thyroid Hormone http://dlvr.it/QM7Pdd
• · King Arthur Flour Company, Inc. Voluntarily Recalls Organic Coconut Flour (16 Oz.) Because of Possible Health Risk http://dlvr.it/QM7zLg
• · Chocolate bunnies are an Easter staple but be sure they aren't on your furry friend's menu. #NationalPuppyDay https://go.usa.gov/xQabx
• · Keep chocolate away from your furry friends!
• · Poppies International, Inc. Recalls Delizza Belgian Custard Cream Mini Eclairs 30 Count, Due to Potential Health Risks http://dlvr.it/QM8p6n
• · Did you know pet food can carry germs like #Salmonella? Handwashing and proper storage can prevent illness for you, your pet, and your family. Check out our tips for pet #foodsafety #OneHealth #NationalPuppyDay http://go.usa.gov/xQaTB
• · How Many Calories Are in That Cocktail? Soon You’ll Know
• · Tamarack Inc. Recalls Eclipse Kratom Because of Possible Salmonella Contamination http://dlvr.it/QMGqbr

March 27, 2018

Federal Register

Food and Drug Administration

Notices

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

Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018

FR Document: 2018-06154 PDF 4 Pages (91.1 KB) Permalink

National Agriculture and Food Defense Strategy Survey

Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018

FR Document: 2018-06135 PDF 8 Pages (36.9 KB) Permalink

Premarket Notification for a New Dietary Ingredient

Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018

FR Document: 2018-06155 PDF 6 Pages (92.3 KB) Permalink

Animal and Plant Health Inspection Service

Notices

Determinations:

Fever Tick Status of the State of Chihuahua, Excluding the Municipalities of Guadalupe y Calvo and Morelos

Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018

FR Document: 2018-06131 PDF 4 Pages (11.3 KB) Permalink

FDA

Notice of Availability of Draft Guidance for Industry; Elemental Impurities in Animal Drug Products Questions and Answers

Recalls

Date	Brand Name	Product Description	Reason/Problem	Company
03/26/2018	Blue Ridge Beef	Complete raw pet food	May contain Salmonella and Listeria monocytogenes	Blue Ridge Beef
03/26/2018	Natural Selections and ZooLogics	Fresh raw meals for dogs	May contain Salmonella and E. coli O128	Darwin’s Natural Pet Products
03/25/2018	Mrs. Gerry's, Open Acres, Festival, Knowlan's and Market Fresh	Egg Salads and Potato Salads	Undeclared Seafood in Salad	Mrs. Gerry's Kitchen Inc.
03/25/2018	Whole Foods Market	Decorated (iced) cookies	Undeclared Egg Allergen	Whole Foods Market
03/23/2018	Kitchen's Cravings	Egg Salad Sandwich	May contain traces of Imitation Crab Meat	Kwik Trip, Inc.

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
03/13/2018	Biotek, Inc.	Denver District Office	Unapproved New Drugs/Misbranded	Not Issued *
03/16/2018	Bhavani Fruits & Vegetables LLC	New York District Office	CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions	Not Issued *
03/19/2018	Remnant Inc. DBA The Donut Stop	Kansas City District Office	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated	Not Issued *
03/21/2018	Starlight Desserts Inc	Seattle District Office	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated	Not Issued *

FSIS

Training Requirement for International Travel

AMS

USDA Restricts PACA Violators in California, Georgia and North Carolina from Operating in the Produce Industry

USDA Vegetable Purchase Program Announced

@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls

• · Help keep fruits and vegetables safe when buying and storing them. Learn the simple steps you can take to help prevent foodborne illness. #NationalNutritionMonth http://go.usa.gov/xnzKu
• · Kwik Trip, Inc. Issues Allergen Alert for Undeclared Fish or Shellfish on Premium Egg Salad Sandwich on Oat Multigrain Bread http://dlvr.it/QMRBDf
• · Stay informed on the latest guidance regarding food & nutrition labeling. Use these #FDAORA resources to LEARN MORE: https://go.usa.gov/xn6yp
• · Mrs. Gerry’s Kitchen Issues Allergen Alert on Undeclared Seafood in Salad http://dlvr.it/QMSdn3
• · Blue Ridge Beef Voluntarily Recalls BRB Complete Raw Pet Food Lot#GA0131 Because of Possible Contamination http://dlvr.it/QMSdnf
• · Store perishable fresh fruits and vegetables at 40° F or below. Use a refrigerator thermometer to check! http://go.usa.gov/xXx8n #NNM
• · Allergy Alert Issued in Select Northern California Whole Foods Market Stores for Undeclared Egg in Some Cookies http://dlvr.it/QMT70M
• · Darwin’s Natural Pet Products Issues Voluntary Recalls for Darwin’s Brand Dog Foods Due To Contamination Salmonella And Shiga Toxin-Producing Escherichia Coli O128 http://dlvr.it/QMTKKg

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