Association of Food and Drug Officials

Laws and Regulations Committee Update 5/8 - 5/11, 2018

May 11, 2018 2:11 PM | Amy Bonsell (Administrator)

May 8, 2018

FDA

FDA Finalizes Guidance to Help Food Establishments Meet Menu Labeling Requirements 

Statement from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits from enactment of menu labeling

Food Defense Awareness for the Intentional Adulteration Rule Training

Warning Letters

Letter Issue Date

Company Name

Issuing Office

Subject

Close Out Date

04/18/2018

MC Fish Co

Cincinnati District Office

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

Not Issued *

 

askFSIS

Reimbursable Overtime associated with Animal Food

Shipment of condemned or inedible for Pet Food

Pet Food in Federal Establishment - Same Equipment

Certified Pet Food

HACCP - Metal Detectors

Why is it necessary to include cooking instructions on the label if the statement on the principal display panel includes both an endpoint temperature and the need to measure the temperature with a meat thermometer?

How can I assure Food Safety and Inspection Service that the cooking instructions have been validated? Does the validation data need to be included with the label submittal?

Why do the cooking instructions on these uncooked, breaded, boneless, poultry products need to be validated?

 

AMS

BE Disclosure & Labeling

USDA Seeks Cotton Board Nominees

Organic Integrity Through Technology Innovation (5/10)

 

National Academies

Second International Summit on Human Genome Editing Announced

 

NIH

Panel calls for improvements in research on natural experiments to combat the obesity epidemic

 

NTP

Request for Information - Technologies for Identifying Developmental Toxicants

 

CSPI

Philadelphia Takes Step Forward To Inform Consumers About High-Sodium Restaurant Meals

 

Food and Water Watch

It’s Your Move, Governor Murphy

 

@SGottliebFDA, @US_FDA

  • ·        People in the U.S. currently eat about 1/3 of their calories away from home. Research suggests that people order menu items with fewer calories when they have access to calorie information. Discover how FDA is making that info available to you. http://go.usa.gov/xQ5Na
  • ·        #FDA’s new menu labeling provision will provide a level playing field for basic health information that will help promote more competition to make menu items more healthful
  • ·        Romaine lettuce is no longer being distributed from the Yuma growing region so the potential for additional exposure to contaminated product is diminished. We will keep working to find the source of this outbreak https://go.usa.gov/xQ5w7 
  • ·        #FDA, CDC and partners continue investigating the E. coli outbreak linked to romaine. Read our “FDA Fast Facts” for key information https://go.usa.gov/xQ5w7 
  • ·        Menu labeling is part of a broader multi-year Nutrition Innovation Strategy providing all Americans with easier access to nutritious, affordable foods & encouraging food industry to innovate w/ healthier foods that today’s informed consumer wants http://go.usa.gov/xQ5Xt 
  • ·        We’re empowering consumers with reliable and actionable information about the foods they eat with today’s implementation of FDA’s menu labeling rule. http://go.usa.gov/xQ5Nw 
  • ·        Our FDA presenters are getting ready for the #FoodSafetySummit. We’ll see you there at booth #334.


May 9, 2018

Federal Register

Consumer Product Safety Commission

Notices

Meetings; Sunshine Act

Filed on: 05/08/2018 at 04:15 pm Scheduled Pub. Date: 05/10/2018

FR Document: 2018-10095  PDF 1 Page (4.33 KB)  Permalink

 

FDA

FDA Advises Consumers & Retailers to Avoid Potentially Contaminated Raw Oysters from Canada (updated)

Warning Letters

Letter Issue Date

Company Name

Issuing Office

Subject

Close Out Date

04/25/2018

Hood River Juice Company, Inc.

Seattle District Office

Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

Not Issued *

 

askFSIS

Crude oil contamination

Pet Food in Federal Establishment - Hours of Inspection

My establishment produces a not-ready-to-eat entree that contains a fully cooked, breaded boneless, chicken nugget. Does the labeling guidance for uncooked, breaded, boneless poultry products apply to the labeling of this product?

Does the endpoint internal temperature, 165°Fahrenheit (F), apply to all uncooked poultry products that require cooking for safety before being consumed? Also, does the guidance supersede any performance standards?

If the statement on the Principal Display Panel includes an internal temperature and the use of a thermometer to measure the temperature; does this information need to be included in the cooking instructions as well?

 

AMS

USDA Settles a Case with Farinelli Enterprises LLC Resulting in a $1,500 Penalty

USDA Settles a Case with Mammoth Cave Dairy Auction Inc. Resulting in a $2,750 Penalty

 

FTC

FTC Chairman Simons Names Senior Staff

 

NAD

NAD Recommends Doskocil Discontinue Certain Anti-Microbial Claims for Petmate Cat Litter Pans, Advertiser to Appeal

 

Food and Water Watch

Baltimore’s Water Crisis: Can It Get Worse?

 

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

  • ·        The Hill Op Ed: “With uniform national menu labeling guidance in place, anyone eating out will have clear, easy-to-understand information at the point of ordering – information that is presented in the same way, no matter the city or state.”

 

May 10, 2018

Federal Register

Agricultural Marketing Service

Rules

Marketing Orders: Milk in the Florida Marketing Area

Filed on: 05/10/2018 at 08:45 am Scheduled Pub. Date: 05/11/2018

FR Document: 2018-10085  PDF 11 Pages (242 KB)  Permalink

 

Marketing Orders; Amendments: Walnuts Grown in California

Filed on: 05/10/2018 at 08:45 am Scheduled Pub. Date: 05/11/2018

FR Document: 2018-10106  PDF 17 Pages (258 KB)  Permalink

 

Notices

Requests for Nominations: Peanut Standards Board

Filed on: 05/10/2018 at 08:45 am Scheduled Pub. Date: 05/11/2018

FR Document: 2018-10104  PDF 4 Pages (123 KB)  Permalink

 

FDA

Spring Unified Agenda: FDA’s Anticipated Upcoming Regulatory Work

Warning Letters

Letter Issue Date

Company Name

Issuing Office

Subject

Close Out Date

04/30/2018

Chi's Enterprise Inc

Los Angeles District Office

CGMP/Dietary Supplement/Adulterated

Not Issued *

04/18/2018

Herbs America, Inc.

Seattle District Office

New Drug/Misbranded

Not Issued *

03/22/2018

Get The Tea

Denver District Office

CGMP/Dietary Supplement/

Adulterated/Misbranded

Not Issued *

 

askFSIS

If the nutrition label were to cover most of the surface of a meat or poultry product where consumers might want to see the actual meat surface, would this be a sufficient reason to use a modified label or alternate placement?

What type of information does my establishment need to include in the labeling record to demonstrate that the cooking instructions on the label of an uncooked breaded poultry product have been validated?

If a product must be nutrition labeled, what information would be required on the label and would it be allowed to be placed on the bottom of the tray prior to assembly so that the shrink wrap could protect the integrity of the print?

 

AMS

USDA Settles a Case with Beken Livestock Inc. Resulting in a $6,000 Penalty

USDA Settles a Case with Norwood Producers Auction Yards Inc. Resulting in a $2,750 Penalty

USDA Proposes Changes to Handling Regulations for Some Irish Potatoes Grown in Idaho and Oregon

 

NAD

NAD Recommends Carma Laboratories Discontinue Certain Challenged Claims for Carmex Cold Sore Treatment

 

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

May 11, 2018

Federal Register

Food and Drug Administration

Rules

Guidance: The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification for Certain Provisions of Four Implementing Rules: What You Need to Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide

Filed on: 05/11/2018 at 08:45 am Scheduled Pub. Date:05/14/2018

FR Document: 2018-10148 PDF 6 Pages (104 KB) Permalink

 

Agricultural Marketing Service

Proposed Rules

Organic Research, Promotion, and Information Order; Termination of Rulemaking Proceeding

Filed on: 05/11/2018 at 08:45 am Scheduled Pub. Date: 05/14/2018

FR Document: 2018-10131   PDF 6 Pages (100 KB)  Permalink

 

Notices

2018 Rates Charged for Services

Filed on: 05/11/2018 at 08:45 am Scheduled Pub. Date:05/14/2018

FR Document: 2018-10132 PDF 13 Pages (293 KB) Permalink

 

FSIS

Pinnacle Foods Inc. Recalls Beef Products Due to Possible Processing Deviation

 

AskFSIS

Can selective highlighting, e.g., colored bars, or reverse printing, be used?

Is it necessary to use a nutrition display with a box shape on a round package?

Is use of Franklin Gothic Heavy or Helvetica Black and Regular type style required?

 

AMS

USDA Issues Final Rule on Reimbursement to Florida Milk Handlers and Producers Affected by Hurricane Irma

USDA Seeks Nominees for Peanut Standards Board

 

APHIS-BRS

USDA Announces Availability of Draft Environmental Impact Statement and Preliminary Pest Risk Assessment for GE Citrus Tristeza Virus Permit

 

@FDA_ORA, @US_FDA

  • ·        #FridayCaseFiles - Case 5-Hour Energy Drink: 8 people remove legitimate labels from drinks & replace w/false labels & eventually sell counterfeit drinks. This becomes one of the largest domestic food counterfeit cases: https://go.usa.gov/xQ9h9  #OCI
  • ·        Phony ”germ-killing” health products were a common therapeutic scam in the early-20th century, preying on limited public understanding of bacteriology #tbt Learn more here: https://bit.ly/2rzFkTf


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