Laws and Regulations Committee Update – March 29 – 31, 2021
March 29, 2021
FDA
- [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
| Date | Brand Name | Product | Product Type | Recall Reason | Company |
| 03/27/2021 | Trident | Pacific Salmon Burgers | Food & Beverages, Contaminants, Seafood/Seafood Product | May contain small pieces of metal | Trident Seafood Corporation |
| 03/27/2021 | Multiple brands | Dog and Cat Food | Animal & Veterinary, Foodborne Illness, Pet Food, Food & Beverages, Foodborne Illness, Pet Food | Potential Salmonella Contamination | Midwestern Pet Foods |
| 03/26/2021 | PremierZen | Dietary Supplement for male sexual enhancement | Drugs | Undeclared Sildenafil and Tadalafil | Namoo Enterprise LLC |
| 03/26/2021 | Kareem Chef | Flavored Halva | Food & Beverages, Foodborne Illness | Potential Salmonella Contamination | Kareem 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
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
@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
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
| Date | Brand Name | Product | Product Type | Recall Reason | Company |
| 03/29/2021 | Harris Teeter Fresh Foods Market | Cookies and Cream Cake Products | Food & Beverages | Due to undeclared hazelnut | Harris Teeter, LLC |
| 03/29/2021 | Sabra | Classic Hummus | Food & Beverages | Salmonella Contamination | Sabra Dipping Company LLC |
AMS
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
@FrankYiannasFDA
- In an increasingly interconnected food system, food safety requires collaboration. The creation of ‘data trusts’ to facilitate sharing of data will ‘democratize information’ & allow participants to get smarter & safer, together. Well done @foodgov. https://www.food.gov.uk/research/research-projects/food-data-trust-a-framework-for-information-sharing
@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
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
Warning Letters
| Posted Date | Issue Date | Company Name | Issuing Office | Subject |
| 03/30/2021 | 03/10/2021 | Trippo International LLC | Center for Food Safety and Applied Nutrition | Dietary Supplement/Adulterated |
| 03/30/2021 | 03/16/2021 | Duoc Thao Tre Xanh, LLC | Division of Human and Animal Food Operations East IV | New Drug/Misbranded |
| 03/30/2021 | 03/16/2021 | Anna Health, LLC | Division of Human and Animal Food Operations East IV | New Drug/Misbranded |
| 03/30/2021 | 03/19/2021 | Lipotriad LLC | Division of Human and Animal Food Operations East II | New Drug/Misbranded |
FSIS
FSIS to Host Eastern Laboratory Open House as Part of the Laboratory Open House Series
OMB
| AGENCY: HHS-FDA | RIN: 0910-ZA87 | Status: Pending Review |
| TITLE: Action Levels for Lead in Juice; Draft Guidance for Industry | ||
| STAGE: Notice | ECONOMICALLY SIGNIFICANT: No | |
| ** RECEIVED DATE: 03/30/2021 | LEGAL DEADLINE: None |
- [Note: This has not previously been published in a Unified Agenda]
@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
- RT: @US_FDA:
- 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