September 26, 2018

Federal Register

Food and Drug Administration

Notices

Guidance:

Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls

Filed on: 09/26/2018 at 08:45 am Scheduled Pub. Date: 09/27/2018

FR Document: 2018-21042 PDF 6 Pages (30.4 KB) Permalink

FDA

Animal Drug Safety Communication: FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events Associated with Certain Flea and Tick Products

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2019

Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2019

Recalls

Date	Brand	Product Description	Reason/Problem	Company
09/25/2018	365 Everyday Value	Tortilla Chips	Undeclared milk	Whole Foods Market
09/25/2018	Harris Teeter	Frozen yogurt	Undeclared peanut	Harris Teeter

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
09/18/2018	Rock Farm, LLC dba WholeFood Farmacy	Cincinnati District Office	Unapproved New Drugs/Misbranded	Not Issued *
08/31/2018	Independent Nutrition, Inc.	Seattle District Office	Unapproved New Animal Drug/Adultered/Misbranded/Misleading	Not Issued *
03/06/2018	Uckele Health & Nutrition, Inc.	Chicago District Office	CGMP/Dietary Supplement/Adulterated/Misbranded	Not Issued *

USDA

USDA Announces Approval of D-SNAP for North Carolina Disaster Areas

FSIS

Reporting of Negative In-Plant Kidney Inhibition Swab (Kistm) Test Results in the Public Health Information System

APHIS

USDA Outlines Next Steps for Advancing Animal Disease Traceability

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

• · September is National #FoodSafetyEducationMonth! DYK that certain groups of people have a higher risk for #foodborneillness? Although everyone is susceptible, some people are at a greater risk. LEARN MORE: http://go.usa.gov/xUByH
• · Staying clean is the first step to #foodsafety. Do you know what to wash and when? https://go.usa.gov/xPrVE
• · When pregnant women eat Mexican-style soft cheeses like Queso Fresco, they could put their unborn baby at risk http://go.usa.gov/xXhcX #HHM
• · Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product http://dlvr.it/QlMKTW
• · Attention health & food #educators! Are you looking to change consumer behavior in food handling? Don’t miss the October 4 webinar – Pulling All the Behavior Ideas Together brought to you by @Fight_BAC https://bit.ly/2QW5fR9
• · Returning to a flooded home? Check for mold and learn how to safely clean up mold after a disaster. http://bit.ly/2daayXT #Florence
• · Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips http://dlvr.it/QlMgvd
• · Making your own #juice or cider? Be sure to wash fresh fruit & vegetables appropriately! https://go.usa.gov/xU5eU #foodsafety

FTC

FTC Sending Out Refunds in Cramming Case

Court Rules in FTC’s Favor in Case against Weight-loss Supplement Marketer Roca Labs

Commissioner Maureen K. Ohlhausen Announces Departure from the FTC

Statement of Commissioner Chopra on the Departure of Maureen Ohlhausen

September 27, 2018

Federal Register

Food and Drug Administration

Rules

New Animal Drugs:

Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name

Filed on: 09/27/2018 at 08:45 am Scheduled Pub. Date: 09/28/2018

FR Document: 2018-21146 PDF 28 Pages (173 KB) Permalink

Withdrawal of Approval of New Animal Drug Applications

Filed on: 09/27/2018 at 08:45 am Scheduled Pub. Date: 09/28/2018

FR Document: 2018-21147 PDF 2 Pages (160 KB) Permalink

Proposed Rules

Label Requirement for Food that has been Refused Admission into the United States; Withdrawal

Filed on: 09/27/2018 at 08:45 am Scheduled Pub. Date: 09/28/2018

FR Document: 2018-21145 PDF 3 Pages (80.6 KB) Permalink

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 09/27/2018 at 08:45 am Scheduled Pub. Date: 09/28/2018

FR Document: 2018-21209 PDF 2 Pages (156 KB) Permalink

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

Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use

Filed on: 09/27/2018 at 08:45 am Scheduled Pub. Date: 09/28/2018

FR Document: 2018-21148 PDF 5 Pages (89.5 KB) Permalink

Food Labeling:

Use of the Names of Dairy Foods in the Labeling of Plant-Based Products

Filed on: 09/27/2018 at 08:45 am Scheduled Pub. Date: 09/28/2018

FR Document: 2018-21200 PDF 17 Pages (220 KB) Permalink

Food Safety and Inspection Service

Notices

Petition to Permit Waivers of Maximum Line Speeds:

Young Chicken Establishments Operating under the New Poultry Inspection System; Criteria for Consideration of Waiver Requests for Young Chicken Establishments to Operate at Line Speeds of up to 175 Birds Per Minute

Filed on: 09/27/2018 at 08:45 am Scheduled Pub. Date: 09/28/2018

FR Document: 2018-21143 PDF 66 Pages (392 KB) Permalink

FDA

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

Notice of Availability of Draft Guidance for Industry; Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls

USDA

Secretary Perdue Statement on Negotiations for a U.S.-Japan Trade Agreement

AMS

USDA Cites Forest City Weingart Produce Co. in Ohio for PACA Violations

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

• · DYK? Recalls are usually voluntary. Sometimes a company finds a problem & recalls a product on its own. Companies also recall products after FDA raises concerns. In all cases, FDA oversees the strategy & assesses the adequacy of the recall. https://go.usa.gov/xQjzY #FDARecalls101
• · For those who have been following our work on recalls, today #FDA issued new draft guidance on situations where we will make retail info available for food products undergoing recalls. Read today’s statement from @ScottGottliebFDA here: https://go.usa.gov/xPDNX
• · THREAD: #FDA recognizes the importance of providing consumers with actionable information on recalled food products. To promote these goals, today we’re advancing a new policy to arm consumers with information needed to avoid potentially contaminated foods https://go.usa.gov/xPDNX
• · My statement today announces a new draft guidance outlining when #FDA intends to make public retail locations that may have sold/distributed recalled human or animal food, particularly when linked to a foodborne illness outbreak and/or not easily identified as subject to a recall
• · Some examples of this may include foods sold directly to consumers with no universal product code (UPC) or bar code. This might include deli cheese, nuts, rawhide chews, or pet treats sold in bulk and fresh fruits and vegetables sold individually.
• · Knowing where a recalled product was sold during dangerous food recalls can be the difference between a consumer going to the hospital or not. While we can’t prevent every illness, we can make sure we provide information to consumers to prevent more people from becoming sick
• · This is the 2nd major policy step we’re taking as part of a broader food safety action plan. Earlier this year, I committed to further improve our recall processes and released guidance on situations where #FDA and firms would publicize public warnings to help carry out a recall
• · POLL: Before eating, you should wash your hands with soap and water for ___ seconds. https://go.usa.gov/xPDQm #NFSEM #foodsafety
• · Find out about #foodsafety today! https://go.usa.gov/xPrqN
• · Statement from FDA Commissioner @SGottliebFDA on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety https://go.usa.gov/xPDpg
• · Tyann Blessington FDA speaks about Whole Genome Sequencing and Food Safety. IFSH Annual Meeting 2018
• · Anybody can get #FoodPoisoning, but some people are more likely to get seriously ill. Learn more: #FoodSafetyMonth https://go.usa.gov/xPqv3
• · #RECALL update & reminder: Throw away Kellogg’s #HoneySmacks cereal in your cabinets w/a “best if used by” date of June 14, 2019 or earlier! @CDCgov continues to get #Salmonella illness reports linked to the cereal. 135 confirmed infections in 34 states. http://go.usa.gov/xQtc2
• · Assessment of virus adhesion to food contact surfaces-by Dr. Carol Shieh FDA at the IFSH Annual Meeting.
• · #FDA is taking new steps to make more information available to consumers in the setting of food recalls; specifically we're releasing the retail establishments that sell certain recalled items. We want to give consumers the information they need to be safe
• · 1/3 Excited to share a new & improved resource that highlights thought-provoking insights & perspectives on a variety of key topics from FDA experts & leaders. Check out #FDAVoices: https://go.usa.gov/xPDFv
• · 2/3 #FDAVoices will share perspectives on agency policy/priority areas, including how we are addressing the opioid addition crisis, leveraging innovation & competition to improve access to critical medical products, empowering consumers around their diets & health, and many more
• · 3/3 We know our audiences are diverse & may not want all the info we have to share… so we have designed #FDAVoices so that you can self-select from 5 different topic areas: Policy, Consumer Safety & Enforcement, Medical Products, Food, and Tobacco
• · Today we launched #FDAVoices with a perspective from our Commissioner @SGottliebFDA on advancing innovation in digital health. Read it here: https://go.usa.gov/xPDFG . Sign up for the new resource here: https://go.usa.gov/xPDFv
• · Today, #FDA unveiled #FDAVoices, a new and improved resource that highlights thought-provoking insights and perspectives on a variety of topics and issues from FDA experts and leaders across the agency. Sign up for #FDAVoices here: http://go.usa.gov/xPDFv
• · In the inaugural #FDAVoices, Commissioner @SGottliebFDA talks about advancing innovation in digital health. You can read it here: https://go.usa.gov/xPDFG and sign up for the new resource here: http://go.usa.gov/xPDFv
• · Did you know - Perishable food such as meat, poultry, seafood, milk, & eggs that are not kept adequately refrigerated or frozen may cause illness if consumed, even when they are thoroughly cooked. https://go.usa.gov/xP2sM #FlorenceHurricane2018 #foodsafety
• · Mauna Loa Macadamia Nut Corporation Voluntarily Recalls http://dlvr.it/QlTvxh
• · Vinetta Howard King FDA speaks about How FSMA Has Changed Compliance and Inspections. IFSH Annual Meeting 2018.
• · Mauna Loa Macadamia Nut Corporation is voluntarily recalling all of its products produced at the Keaau facility between Sept. 6 - 21, 2018 due to a potential contamination of E. coli https://go.usa.gov/xPW2Y

September 28, 2018

Federal Register

Food and Drug Administration

Notices

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

Antimicrobial Animal Drug Distribution Reports and Recordkeeping

Filed on: 09/28/2018 at 08:45 am Scheduled Pub. Date: 10/01/2018

FR Document: 2018-21208 PDF 9 Pages (39.5 KB) Permalink

Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records

Filed on: 09/28/2018 at 08:45 am Scheduled Pub. Date: 10/01/2018

FR Document: 2018-21207 PDF 9 Pages (42.9 KB) Permalink

Agriculture Department

Notices

Designation Areas:

Topeka, KS; Minot, ND; Cincinnati, OH; Pocatello, ID; Evansville, IN; Salt Lake City, UT; West Sacramento, CA; Richmond, VA; and Savage, MN

Filed on: 09/28/2018 at 08:45 am Scheduled Pub. Date: 10/01/2018

FR Document: 2018-21265 PDF 3 Pages (84.2 KB) Permalink

Agricultural Marketing Service

Proposed Rules

Change in Membership:

Honey Packers and Importers Research, Promotion, Consumer Education and Industry Information Order

Filed on: 09/28/2018 at 08:45 am Scheduled Pub. Date: 10/01/2018

FR Document: 2018-21266 PDF 16 Pages (268 KB) Permalink

Decreased Assessment Rates:

Kiwifruit Grown California

Filed on: 09/28/2018 at 08:45 am Scheduled Pub. Date: 10/01/2018

FR Document: 2018-21264 PDF 15 Pages (258 KB) Permalink

FDA

FDA Asks for Input on Use of the Names of Dairy Foods in Labeling Plant-Based Products

Notice of Agency Information Collection Activities: OMB Approvals

Notice of Withdrawal of New Animal Drug Applications

Final Rule; New Animal Drugs; Technical Amendments

Recalls

Date	Brand	Product Description	Reason/Problem	Company
09/24/2018	Mauna Loa	Macadamia Nuts	E. coli	Mauna Loa Macadamia Nut Corporation

FSIS

Import Residue Sampling Types of Inspection

AskFSIS

Labeling Buffalo produced under voluntary FSIS inspection

Labeling Bison produced under voluntary FSIS inspection

Labeling Water Buffalo produced under voluntary FSIS inspection

AMS

USDA Announces Tart Cherries Volume Regulation for the 2017–18 Crop Year

USDA Sets Referendum Dates for a Proposed Amendment to the Cranberry Marketing Order

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

• · Interested in hearing about FDA’s strategic policy and priorities areas from the experts that lead the charge? Check out #FDAVoices, a new resource from the #FDA: http://go.usa.gov/xPDFv
• · Statement from FDA Commissioner @SGottliebFDA on modernizing standards of identity and the use of dairy names for plant-based substitutes https://go.usa.gov/xPWjE
• · Recalled Kellogg’s Honey Smacks cereal was linked to 135 Salmonella infections. The investigation is over, but the advice hasn’t changed: Don’t eat Honey Smacks with “best if used by” date of June 14, 2019 or earlier. https://go.usa.gov/xQtxX
• · One of the Twittersphere's fav topics...#FDA wants to make sure labeling of plant-based products using terms like “milk” and “cheese” are not misleading to consumers. We’re soliciting public feedback to learn more about how consumers use these products. https://go.usa.gov/xPWjY
• · Vitamin D and calcium consumption has declined in the American diet, and dairy products are a leading source. When people substitute plan based products for dairy, they may not get the nutrients they expect. Our new policy process to consider these issues https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm621824.htm …
• · How can you use the #foodsafety steps to be more #foodsafe? Find out at: https://go.usa.gov/xPrK4 .
• · These issues are especially relevant for children, who typically have less diverse diets, and are therefore more dependent on dairy as a key source of these nutrients.
• · Each year, around 128,000 people are hospitalized because of foodborne illness. Watch real people’s stories about #Listeria, #Ecoli, and #Salmonella, & learn how you can put #foodsafety into practice to protect yourself & your family. https://go.usa.gov/xPryQ #NFSEM
• · Whole Foods Market has voluntarily recalled 365 Everyday Value White Corn Tortilla Chips b/c the product may contain undeclared milk not listed on the product label. All products have been removed from store shelves. https://go.usa.gov/xPWK6
• · Outbreak Investigation ended. As of 9/27/18, a total of 26 laboratory-confirmed cases of #Vibrio parahaemolyticus infection were reported in people who ate fresh #crab meat fr Venezuela; cases were reported by 7 states – CO, DE, LA, MD, NY, PA, VA, + DC. https://go.usa.gov/xPD78
• · Learn how successful your program is in preventing foodborne illness and promoting safe food handling practices by using our Educator Evaluation Toolkit. https://go.usa.gov/xPrq9 #foodsafety #NFSEM
• · Do you know how to stay #foodsafe when shopping for and storing food? Find out here: https://go.usa.gov/xPrKb
• · Who’s at risk? Certain groups of people are more likely to get sick from contaminated food & the effects are much more serious. Knowing which foods at-risk persons should avoid could help save their lives. More on how to protect them here: http://go.usa.gov/xUSa4 #FoodSafetyMonth
• · Going out to eat for dinner? Some foods are safer than others. Here’s what to watch out for. https://go.usa.gov/xPrVv
• · Was your power out for more than 4 hours? Check your freezer – if the temperature is below 40 deg. The food is safe and to can be refrozen. Otherwise, packages which still contain ice crystals are safe to refreeze or cook. https://go.usa.gov/xP2sM #FlorenceAftermath #foodsafety
• · Join @SOTtoxicology & @FDAFood on October 11 for our colloquium “The Big 8: Advances in Food #Allergy Risk Assessment and Management.” We will explore the latest issues influencing the food allergy risk assessment & management landscape. https://bit.ly/2O8Bvla
• · DYK? There are ~48 million cases of foodborne illness annually, sending more than 100K Americans to the hospital & resulting in 3K deaths. LEARN MORE about foodborne disease-causing organisms: https://go.usa.gov/xUw5C #FoodSafetyEducationMonth

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