Association of Food and Drug Officials

Laws and Regulations Committee Update 7/2 - 7/6, 2018

July 06, 2018 1:13 PM | Amy Bonsell (Administrator)

July 2, 2018

Federal Register

Food and Drug Administration

Notices

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

Regulations under Federal Import Milk Act

Filed on: 07/02/2018 at 08:45 am Scheduled Pub. Date: 07/03/2018

FR Document: 2018-14266  PDF 5 Pages (89.3 KB)  Permalink

 

Animal and Plant Health Inspection Service

Notices

Environmental Assessments; Availability, etc.:

Oral Rabies Vaccine Trial

Filed on: 07/02/2018 at 08:45 am Scheduled Pub. Date: 07/03/2018

FR Document: 2018-14307  PDF 4 Pages (98.4 KB)  Permalink

 

FDA

UPDATE: FDA Animal Drug Safety Communication: FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo

Recalls

Date

Brand Name

Product Description

Reason/Problem

Company

06/29/2018

Prescript-Assist  

Probiotic and prebiotic dietary supplement

Undeclared allergens, including almonds, crustaceans, milk, casein, eggs, and peanuts

LL’s Magnetic Clay, Inc.

06/29/2018

Whole Foods Market 

Oatmeal Cookies

Undeclared soy

Whole Foods Market

06/28/2018

Wish Bone 

House Italian Salad Dressing

Undeclared milk and egg

Pinnacle Foods Inc.

 

FSIS

Jun 29, 2018 | PDF

  • Reminder: PHIS Export Component Launches Today, June 29
  • FSIS to Implement PHR Update for Scheduling PHREs
  • Study Shows Most People Are Spreading Dangerous Bacteria Around the Kitchen and Don’t Even Realize It

L&D Market, Inc. Recalls Chicken Wrap Products Due to Misbranding and Undeclared Allergens

 

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

  • ·        Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing http://dlvr.it/QYxsff 
  • ·        LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement http://dlvr.it/QYy1k6 
  • ·        #FDA is committed to the work we do in collaboration with @USDA_APHIS and #FSIS and our shared effort to advance public health through nutrition and food safety. FDA will continue to advance these goals as part of our food center’s core mission #FoodSafety
  • ·        Allergy Alert Issued in Midwest Whole Foods Market Stores for Undeclared Soy in Oatmeal Raisin Cookies http://dlvr.it/QZ6WJY 
  • ·        Don’t forget to check your fridge/freezer for Del Monte 6 & 12oz vegetable trays withdrawn from the market on 6/8 in IA, MN, WI; consumers may still have product at home. 28oz vegetable trays also being recalled in IL, IN and should be discarded https://go.usa.gov/xQzKr 

July 3, 2018

Federal Register

Food and Drug Administration

Notices

Statements of Organizations, Functions, and Delegations of Authority

Filed on: 07/03/2018 at 08:45 am Scheduled Pub. Date: 07/05/2018

FR Document: 2018-14375  PDF 5 Pages (156 KB)  Permalink

 

FDA

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., on the ongoing risk of salmonella in kratom products

Recalls

Date

Brand Name

Product Description

Reason/Problem

Company

06/29/2018

May Flower International Inc.  

3+2 Soda Crackers

Undeclared Milk Allergens

May Flower International Inc.

06/20/2018

Kratom Powder Capsule  

Kratom Powder Capsule

Potential Salmonella Contamination  

Blissful Remedies

07/02/2018

United States Bakery  

Hamburger Buns 

Undeclared Milk

United States Bakery

 

FSIS

Approval of Official Time for Union Activities

Recall Notification Report 058-2018 (Pork Products)

 

AMS

AMS Reaches a Settlement with Robert Rawls

 

GAO

SUMMER MEALS: Actions Needed to Improve Participation Estimates and Address Program Challenges

 

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

  • ·        Getting ready for a 4th of July BBQ? Keep your guests safe from foodborne illness by following these safety tips on how to handle raw meat, poultry, and seafood: http://go.usa.gov/xQ7UY 
  • ·        It’s hard out here for a doggo scared of loud noises! If your vet has prescribed Sileo, be sure you’re comfortable with using the dosing syringe, esp locking the ring into place so you’re giving the right dose. Your vet can show you how! More info https://go.usa.gov/xUYQb 
  • ·        #FoodSafety Tip: Don’t become a repeat offender. Only use marinade as sauce once you bring it to a boil first! The raw juices from the meat you marinated will still be present if you don’t. #4thofJuly
  • ·        Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule http://dlvr.it/QZDqXC 
  • ·        Statement from FDA Commissioner @SGottliebFDA and FDA Deputy Commissioner for Foods and Veterinary Medicine Steven Ostroff, M.D., on the ongoing risk of salmonella in kratom products https://go.usa.gov/xU4Fp 
  • ·        May Flower International Inc. Issues a Allergy Alert on Undeclared Milk Allergens in “3+2 Soda Crackers” http://dlvr.it/QZFJqy 
  • ·        The FDA’s multi-state #Salmonella outbreak investigation linked to #kratom has concluded, BUT we continue to warn against consuming any kratom products. Read our full statement here: https://go.usa.gov/xU4Mg 
  • ·        ICYMI: FDA, @CDCgov and partners, initiated an environmental assessment earlier this month in the Yuma growing region to further investigate potential sources of contamination linked to the romaine outbreak. https://go.usa.gov/xUrKf 
  • ·        RECALL: Undeclared allergens in Prescript-Assist from LL’s Magnetic Clay, Inc. including almonds, crustaceans, dairy, casein, eggs, & peanuts. Risk of serious allergic reaction https://go.usa.gov/xU4sm 
  • ·        FDA's own Dr. Stephen Ostroff talks about #foodindustry investment in #foodsafety. Good for consumers & producers - it’s a #winwin https://bit.ly/2KGC6sE 
  • ·        RECALL: #Kratom capsules from Blissful Remedies #salmonella contamination found through the FDA’s sample testing. Products recalled incl. Red Maeng Da, Gold Series Ultra Enhanced Indo, & Kratom+CBD. https://go.usa.gov/xU463 
  • ·        The investigation by #FDA of salmonella in kratom products has concluded, but the risk of illness remains. My statement with Dr. Ostroff on the outbreak and #FDA’s scientific findings: http://go.usa.gov/xU4Fp 
  • ·        #FDA’s testing showed that more than 50% of kratom products were contaminated with salmonella. This contamination rate is stunningly high and is a level rarely seen in outbreak investigations of this nature. http://go.usa.gov/xU4Fp 
  • ·        United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns http://dlvr.it/QZH3Jm 
  • ·        Add some protein, complex carbs, fiber... from beans! Nutrients including antioxidants, vitamins & minerals…. from beans! #EatYourBeansDay http://go.usa.gov/xXnbS 

July 5, 2018

Federal Register

Agricultural Marketing Service

Rules

Assessment Rates:

Oranges, Grapefruit, Tangerines, and Pummelos Grown in Florida

Filed on: 07/05/2018 at 08:45 am Scheduled Pub. Date: 07/06/2018

FR Document: 2018-14514  PDF 15 Pages (253 KB)  Permalink

 

Country of Origin Labeling:

Packed Honey

Filed on: 07/05/2018 at 08:45 am Scheduled Pub. Date: 07/06/2018

FR Document: 2018-14509  PDF 4 Pages (83.8 KB)  Permalink

 

Revision of Exemption Requirements:

Tart Cherries Grown in the States of Michigan, et al.

Filed on: 07/05/2018 at 08:45 am Scheduled Pub. Date: 07/06/2018

FR Document: 2018-14516  PDF 22 Pages (263 KB)  Permalink

 

Proposed Rules

Changing of Container Requirements:

Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas

Filed on: 07/05/2018 at 08:45 am Scheduled Pub. Date: 07/06/2018

FR Document: 2018-14511  PDF 17 Pages (253 KB)  Permalink

 

Marketing Orders:

Handling of Almonds Grown in California

Filed on: 07/05/2018 at 08:45 am Scheduled Pub. Date: 07/06/2018

FR Document: 2018-14512  PDF 26 Pages (268 KB)  Permalink

 

Soybean Promotion and Research:

Amend the Order to Adjust Representation on the United Soybean Board

Filed on: 07/05/2018 at 08:45 am Scheduled Pub. Date: 07/06/2018

FR Document: 2018-14507  PDF 7 Pages (120 KB)  Permalink

 

FDA

FDA Animal Drug Safety Communication: FDA highlights potential health risks to people exposed to altrenogest products for horses or pigs

Warning Letters

Letter Issue Date

Company Name

Issuing Office

Subject

Close Out Date

06/20/2018

KPC Products Inc

Los Angeles District Office

CGMP/Dietary Supplement/Adulterated/Misbranded

Not Issued *

05/24/2018

Bimeda, Inc.

Center for Veterinary Medicine

False & Misleading Claims/Misbranded

Not Issued *

 

AMS

USDA Files Action Against Northwest Produce LLC in Idaho for Alleged PACA Violations

USDA Files Action Against Paradise Produce LLC in Nevada for Alleged PACA Violations

 

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

  • ·        FDA’s Special Agents/@TheJusticeDept: Texas vitamin shop owner found guilty of selling misbranded drugs, sold as dietary supplements, containing sibutramine. https://go.usa.gov/xQhUf 
  • ·        FDA Animal Drug Safety Communication: FDA highlights potential health risks to people exposed to altrenogest products for horses or pigs https://go.usa.gov/xU2pE 
  • ·        It’s #BBQ season! Be food safe - keep hot foods at or above 140 °F & cold foods at or below 40 °F. Discard food left out at room temp for more than 2 hours – 1 hour if the temp outside is above 90 °F: https://go.usa.gov/xQ6SJ  #BBQbasics
  • ·        Everyone loves fireworks…except maybe your pup. But if your vet has prescribed Sileo to quell his fear of loud noises, make sure you know how to lock the ring into place on the dosing syringe so you give the correct dose. More info https://go.usa.gov/xUYQb 
  • ·        Of course July is #NationalGrillingMonth. Follow some simple Barbecue Basics to keep that yummy food safe. http://go.usa.gov/xNAhN 
  • ·        E. coli outbreak linked to romaine that sickened 210 ppl in 36 states was declared over 6/28, but investigative work by @US_FDA & @CDCgov continues. We need to learn more abt how the strain entered water supply; will continue providing updates https://go.usa.gov/xUrKf 
  • ·        Post, & share our handy infographic to help avoid #foodpoisoning at your #JulyFourth2018 picnic https://www.pinterest.com/pin/381680137160383772/ …
  • ·        Planning a cookout for 4th of July? Remember to use our 4 food safety tips: clean, separate, cook and chill. https://go.usa.gov/xUY3M 
  • ·        Picnic tip #4thOfJuly2018 : Clean your cooler w/ hot soapy water especially after transporting raw seafood to prevent harmful bacteria from contaminating other foods
  • ·        Are you grilling like a pro this #JulyFourth ? Use a food thermometer to reduce the risk of food poisoning https://go.usa.gov/xNGbs 
  • ·        Happy Independence Day! #July4th Enjoy your holiday celebration & don’t forget #FoodSafety http://go.usa.gov/xNGb7 
  • ·        Firing up the grill? Here’s a mobile friendly image w/ a list of all the safe cooking temps for meat, chicken & seafood. Just pull it up when you need to check your cooking progress.
  • ·        FROM MY #JULY4TH BARBECUE TODAY! Be food safe! Keep hot foods at or above 140 °F & cold foods at or below 40 °F. Discard food left out at room temp for more than 2 hours and 1 hour if the temp outside is above 90 °F: http://go.usa.gov/xQ6SJ  #BBQbasics


July 6, 2018

Federal Register

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Title: Export Inspection and Weighing Waiver for High Quality Specialty Grains Transported in Containers Under the Authority of the United States Grain Standards Act

Filed on: 07/06/2018 at 08:45 am Scheduled Pub. Date: 07/09/2018

FR Document: 2018-14593  PDF 4 Pages (114 KB)  Permalink

 

Food and Nutrition Service

Notices

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

Assessment of Mandatory Supplemental Nutrition Assistance Program Employment and Training Programs

Filed on: 07/06/2018 at 08:45 am Scheduled Pub. Date: 07/09/2018

FR Document: 2018-14538  PDF 10 Pages (333 KB)  Permalink

 

Background Investigation Request for Contractor Employees

Filed on: 07/06/2018 at 08:45 am Scheduled Pub. Date: 07/09/2018

FR Document: 2018-14539  PDF 4 Pages (143 KB)  Permalink

 

Animal and Plant Health Inspection Service

Proposed Rules

Lacey Act Implementation Plan:

Composite Plant Materials

Filed on: 07/06/2018 at 08:45 am Scheduled Pub. Date: 07/09/2018

FR Document: 2018-14625  PDF 8 Pages (185 KB)  Permalink

 

De Minimis Exception

Filed on: 07/06/2018 at 08:45 am Scheduled Pub. Date: 07/09/2018

FR Document: 2018-14630  PDF 21 Pages (218 KB)  Permalink

 

OIRA

AGENCY: USDA-FNS

RIN: 0584-AE53

Status: Pending Review

TITLE: Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements

STAGE: Final Rule

ECONOMICALLY SIGNIFICANT: No

** RECEIVED DATE: 07/05/2018

LEGAL DEADLINE: None  

 

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

  • ·        Whether cooking inside or outside, make sure you keep your hands clean by washing them regularly. https://go.usa.gov/xNGbs  #foodsafety #grilling
  • ·        Have a problem or adverse reaction to a Food, Cosmetic, or Dietary Supplement? Contact the FDA Food & Cosmetics Information Center to make a report. http://go.usa.gov/xnafu 
  • ·        The FDA is holding a public meeting to discuss our Nutrition Innovation Strategy. Join the national conversation on food label claims, ingredient lists, standards of identity & plans for nutrition education. Register today! http://go.usa.gov/xUakt 
  • ·        My note today to my #FDA colleagues about the landmark law that laid the foundation for FDA’s modern framework for protecting and promoting American health. http://go.usa.gov/xUbb9 
  • ·        UPDATE: @CDCgov reported 212 Cyclospora illnesses linked to the recalled Del Monte veggie trays sold in IA, IN, MI, MN, and WI. FDA remains dedicated to investigating and will provide info when available. Recalled veggie trays should no longer be in stores https://go.usa.gov/xQzKr 
  • ·        Today @CDCgov reported 27 new Cyclospora illnesses linked to recalled Del Monte vegetable trays sold in IA, IN, MI, MN, WI. #FDA is investigating each component of these vegetable trays, how they became contaminated, and will continue to provide updates https://go.usa.gov/xQzKr 
  • ·        Parents – help your kids get the nutrients they need to grow. Check out these #MyPlate tips for healthy snacking! http://go.usa.gov/x9FQ6 
  • ·        How are metabolites affected by genetically engineered plants? To find out, watch the new recording of the SOT and @FDAfood colloquium “Food from Genetically Engineered Plants: What Role for Metabolomics?”: https://www.toxicology.org/events/shm/fda/fda.asp …
  • ·        Looking for up-to-date notifications on food #recalls? Outbreaks? Nutrition information? Sign-up to receive email updates on a variety of topics from the U.S. Food & Drug Administration. https://go.usa.gov/xU4wm 

 

 


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