Laws and Regulations Committee Update – March 29 – 31, 2021

March 29, 2021

FDA

Investigation of Acute Non-viral Hepatitis Illnesses – “Real Water” Brand Alkaline Water (March 2021)

  • [Note: FDA issued a Demand for Records under section 414 of the FFDCA last week because FDA investigators have been unable to complete investigations at the company’s facilities, and the company has not provided requested records.]

Recalls

DateBrand NameProductProduct TypeRecall ReasonCompany
03/27/2021TridentPacific Salmon BurgersFood & Beverages, Contaminants, Seafood/Seafood ProductMay contain small pieces of metalTrident Seafood Corporation
03/27/2021Multiple brandsDog and Cat FoodAnimal & Veterinary, Foodborne Illness, Pet Food, Food & Beverages, Foodborne Illness, Pet FoodPotential Salmonella ContaminationMidwestern Pet Foods
03/26/2021PremierZenDietary Supplement for male sexual enhancementDrugsUndeclared Sildenafil and TadalafilNamoo Enterprise LLC
03/26/2021Kareem ChefFlavored HalvaFood & Beverages, Foodborne IllnessPotential Salmonella ContaminationKareem Mart

FSIS

Constituent Update – March 26, 2021

AMS

USDA Posts Webinar Outlining the Domestic Hemp Production Final Rule

USDA Settles a Packers and Stockyards Case against Dustin Conley

AMS Issues a Complaint Against Tommy Baxley d.b.a. Tri State Cattle Marketing for Alleged Violations of the Packers and Stockyards Act

USDA Cites Imperial Frozen Foods Op Co LLC in North Carolina for PACA Violations

USDA Settles a Packers and Stockyards Case Against Ida Beef LLC

Twitter

@SecVilsack

  • This is our moment to make investments that reduce food insecurity, increase food access, and put food on the tables of struggling families. Thank you to my friend @chefjoseandres for always rising to the challenges we face. Now let’s build back better!

@FDAfood

  • FDA & @EPA have advice regarding eating fish and making informed choices.  This is especially important for women who are pregnant or may become pregnant or breastfeeding, and parents and caregivers feeding children.  http://go.usa.gov/xs9TG #FishFriday
  • OUTBREAK UPDATE: In the acute non-viral hepatitis investigation associated with “Real Water” brand alkaline water, on March 23, FDA issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act. https://go.usa.gov/xsu9g
  • Given a lack of cooperation by the firm, @US_FDA investigators have been unable to complete investigations at the “Real Water” Inc. facilities in Henderson, NV and Mesa, AZ. The FDA will provide additional updates to this advisory as more information becomes available.

March 30, 2021

Federal Register

Agriculture Department

Proposed Rules

Regulatory Agenda:

Semiannual Regulatory Agenda

Filed on: 03/30/2021 at 8:45 am Scheduled Pub. Date: 03/31/2021

FR Document: 2021-04329  PDF 16 Pages (117 KB)  Permalink

Health and Human Services Department

Proposed Rules

Regulatory Agenda:

Semiannual Regulatory Agenda

Filed on: 03/30/2021 at 8:45 am Scheduled Pub. Date: 03/31/2021

FR Document: 2021-04943  PDF 48 Pages (168 KB)  Permalink

FDA

Recalls

DateBrand NameProductProduct TypeRecall ReasonCompany
03/29/2021Harris Teeter Fresh Foods MarketCookies and Cream Cake ProductsFood & BeveragesDue to undeclared hazelnutHarris Teeter, LLC
03/29/2021SabraClassic HummusFood & BeveragesSalmonella ContaminationSabra Dipping Company LLC

AMS

USDA Restricts PACA Violators in California, Maryland, New York and Texas from Operating in the Produce Industry

AMS Issues a Complaint Against Chakota Rowdy Ray Snow, d.b.a. R&R Cattle Co. and d.b.a. Rowdy Snow Cattle for Alleged Violations of the Packers and Stockyards Act

USDA

U.S. Department of Agriculture Announces Oscar Gonzales as Assistant Secretary for Administration

  • [Note: Gonzales served in the Obama Administration in several senior positions with USDA, including as Deputy Assistant Secretary for Administration as well as Deputy Chief of Staff for Operations and Senior Advisor on Immigration Reform to Agriculture Secretary Tom Vilsack. He also served as the California State Executive Director for USDA’s Farm Service Agency (FSA), where he oversaw FSA programs across 58 counties]

NIH/ODS

 Register Now: 2021 Dietary Supplement Research Practicum through May 3

National Academies

Looking Back and Looking Ahead: Responses and Opportunities in a New Food Landscape

Twitter

@FrankYiannasFDA

@US_FDA

  • Attn pet owners and veterinary professionals: Cat and dog food recall by Midwestern Pet Foods due to possible contamination with Salmonella. These products can potentially harm pets and may pose a risk to pet caregivers. http://go.usa.gov/xsSR2
  • Retailers and distributors of recalled pet food products should immediately pull the recalled lots from their inventory and shelves and should not sell, donate, or feed these pet food products to pets or animals.

March 31, 2021

Federal Register

Food and Drug Administration

Notices

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

Substances Prohibited From Use in Animal Food or Feed

Filed on: 03/31/2021 at 8:45 am Scheduled Pub. Date: 04/01/2021

FR Document: 2021-06706  PDF 5 Pages (98.4 KB)  Permalink

FDA

FDA Extends Flexibility for Unique Facility Identifier Requirement for Food Facility Registration through December 2022

Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period

Warning Letters

Posted DateIssue DateCompany NameIssuing OfficeSubject
03/30/202103/10/2021Trippo International LLCCenter for Food Safety and Applied NutritionDietary Supplement/Adulterated
03/30/202103/16/2021Duoc Thao Tre Xanh, LLCDivision of Human and Animal Food Operations East IVNew Drug/Misbranded
03/30/202103/16/2021Anna Health, LLCDivision of Human and Animal Food Operations East IVNew Drug/Misbranded
03/30/202103/19/2021Lipotriad LLCDivision of Human and Animal Food Operations East IINew Drug/Misbranded

FSIS

FSIS to Host Eastern Laboratory Open House as Part of the Laboratory Open House Series

OMB

AGENCY: HHS-FDARIN: 0910-ZA87Status: Pending Review
TITLE: Action Levels for Lead in Juice; Draft Guidance for Industry
STAGE: NoticeECONOMICALLY SIGNIFICANT: No
** RECEIVED DATE: 03/30/2021LEGAL DEADLINE: None  
  • [Note: This has not previously been published in a Unified Agenda]

Twitter

@DrWoodcockFDA

  • FDA will continue to protect American consumers against highly concentrated caffeine products sold as dietary supplements by taking the appropriate actions necessary when companies violate the law.
    • RT: @US_FDA:
      • FDA issued a warning letter to Trippo International LLC for its 16-ounce Super Caffeine product. Based on FDA review, the product, marketed as a dietary supplement, is adulterated under the Federal Food, Drug, and Cosmetic Act. https://go.usa.gov/xshAT
      • FDA will continue taking action against highly concentrated #caffeine products that present a public health threat. FDA issued a warning letter to Trippo International LLC for their 16-ounce Super Caffeine product. https://go.usa.gov/xshAa
  • We are committed to protecting the health and safety of all pets and reacting fast when there is a food safety issue.
    • RT @FDAanimalhealth: PET FOOD RECALL: Midwestern Pet Food is recalling certain lots of cat and dog food due to possible contamination with Salmonella, which poses a health risk to pets & their human caregivers https://go.usa.gov/xsSR2
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