Laws and Regulations Committee Update – September 8 – 10, 2021
August 8, 2021
Federal Register
Proposed Rules
Filing of Color Additive Petition:
Fermentalg
Filed on: 09/08/2021 at 8:45 am Scheduled Pub. Date:
09/09/2021 FR Document: 2021-19405 PDF 2 Pages (86.4 KB) Permalink
Filing of Food Additive Petition:
Monaghan Mushrooms Ireland Unlimited Co.
Filed on: 09/08/2021 at 8:45 am Scheduled Pub. Date: 09/09/2021
FR Document: 2021-19409 PDF 2 Pages (86.4 KB) Permalink
Meetings:
Allergenic Products Advisory Committee
Filed on: 09/08/2021 at 8:45 am Scheduled Pub. Date: 09/09/2021
FR Document: 2021-19436 PDF 3 Pages (63.1 KB) Permalink
Animal and Plant Health Inspection Service
Notices
Availability:
Pest Risk Analysis for the Importation of Fresh Mango (Mangifera indica L.) Fruit From Grenada
Filed on: 09/08/2021 at 8:45 am Scheduled Pub. Date: 09/09/2021
FR Document: 2021-19497 PDF 3 Pages (118 KB) Permalink
FDA
Warning Letters
| 09/07/2021 | 08/16/2021 | Akshar Sales LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||||
| 09/07/2021 | 08/06/2021 | Genesis Nutrition Ultra Slim dba Genesis Ultra Slim | Office of Pharmaceutical Quality Operations, Division II | Unapproved New Drugs/Misbranded | ||||||
| 09/07/2021 | 08/04/2021 | Garden Fresh Market | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | ||||||
FSIS
Extinguishing the Risk of Foodborne Illness during Wildfires
APHIS
APHIS Seeks Comment on Draft Pest Risk Assessment for the Importation of Unroasted coffee from various Central and South American Countries and Mexico to Puerto Rico
APHIS Seeks Comment on Draft Pest Risk Assessment for the Importation of Tomato from Spain (Canary Islands)
APHIS Updates Federal Domestic Soil Quarantines Map
APHIS amends entry requirements for importation of Fragaria spp., Rosa spp., and Rubus spp. plants from Canada into the United States
@US_FDA
- FDA issued a warning letter to Kaleido Biosciences, Inc. for failing to comply with federal laws & regulations to protect individuals participating in clinical trials. Kaleido’s clinical investigation involved studying a drug to mitigate & treat #COVID19.
@FDAfood
- How does @US_FDA support the call to action of World Food Safety Day? Read/listen to @FrankYiannasFDA share FDA goals in promoting a food safety culture at the National Environmental Health Association/Environmental Health Australia Event. https://go.usa.gov/xMgWH
@SecVilsack
- Farmworkers, meatpacking & front-line grocery workers took on significant personal risk to ensure Americans could feed & sustain their families throughout the pandemic. They deserve recognition for their resilience & financial support for their efforts. https://www.usda.gov/media/press-releases/2021/09/07/usda-invests-700-million-grants-provide-relief-farm-and-food
@afdonews
- Have you registered for the FREE 2021 FDA Retail Food Protection Seminar, September 13-16? Attendees will be able to connect with colleagues from the Northeast, Central, Southeast, Pacific and Southwest. Register here: http://ow.ly/N0wm50G69Gd
@FDA_ORA
- Beware of fraudulent products claiming to prevent, cure, mitigate, diagnose, or cure #COVID19. View the latest #FDAWarningLetters to individuals/companies selling unapproved & unauthorized products w/false or misleading claims. https://go.usa.gov/xAFWa #HealthFraud
August 9, 2021
White House
Addressing Concentration in the Meat-Processing Industry to Lower Food Prices for American Families
[Note: discussing increases in grocery food prices and what the administration is doing to lower prices for families]
APHIS
APHIS Seeks Comment on Draft Pest Risk Assessment for the Importation of Wheat for Consumption from Lithuania
APHIS Seeks Comment on Draft Pest Risk Assessment for the Importation of Melon from Uzbekistan
GAO
USDA Food Box Program: Key Information and Opportunities to Better Assess Performance
@FDA_ORA
- SAVE THE DATE: The 2021 FDA Retail Food Protection Seminar will be held from September 13-16, 2021. Join #FDAORA staff, @afdonews , @RFSCollab, & other regulatory leaders to engage in discussions re: retail #FoodSafety. REGISTER NOW: https://bit.ly/3hexxVG
August 10, 2021
Federal Register
Agricultural Marketing Service
Rules
Modification of Handling Regulations:
Irish Potatoes Grown in Designated Idaho and Eastern Oregon Counties
Filed on: 09/10/2021 at 8:45 am Scheduled Pub. Date: 09/13/2021
FR Document: 2021-19678 PDF 9 Pages (105 KB) Permalink
Notices
Adjustment of Appendices under the Dairy Tariff-Rate Quota Import Licensing Regulation; Correction
Filed on: 09/10/2021 at 8:45 am Scheduled Pub. Date: 09/13/2021
FR Document: 2021-19660 PDF 1 Page (78.8 KB) Permalink
Determination of Total Amounts of Fiscal Year 2022 WTO Tariff-Rate Quotas for Raw Cane Sugar and Certain Sugars, Syrups and Molasses
Filed on: 09/10/2021 at 8:45 am Scheduled Pub. Date: 09/13/2021
FR Document: 2021-19623 PDF 3 Pages (70.4 KB) Permalink
White House
Remarks by President Biden on Fighting the COVID-19 Pandemic
Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors
Executive Order on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees
FDA
Warning Letters
| Posted Date | Letter Date | Company | Issuing Office | Subject |
| 09/09/2021 | 09/07/2021 | Phytag Labs | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/09/2021 | 09/07/2021 | Nuturna International LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/09/2021 | 09/07/2021 | Pharmaganics LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/09/2021 | 09/07/2021 | Radhanite, LLC d/b/a Curalife Ltd | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/09/2021 | 09/07/2021 | Aceva, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/09/2021 | 09/07/2021 | Ar-Rahman Pharm LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/09/2021 | 09/07/2021 | Lysulin, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/09/2021 | 09/07/2021 | Live Good Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/09/2021 | 09/07/2021 | Metamune Inc | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/09/2021 | 09/07/2021 | Holistic Healer & Wellness Center, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
USDA
USDA Reminds Consumers to Handle Frozen Foods Safely This School Year
Get an A+ in Food Safety this School Year
AMS
APHIS
APHIS Publishes Pest Risk Analysis for the Import of Fresh Mango Fruit from Grenada into the United States
FTC
OEHHA
Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS) in Drinking Water
@FDAfood
- [retweet @afdonews] Ordering food online has skyrocketed during the pandemic. The FDA has scheduled a virtual learning summit October 19-21 to help understand how human and animal foods are sold through e-commerce. Attendance is free but registration is required. Do so here: http://ow.ly/Kj9D50G6a3X
- Many older adults do NOT get the recommended amounts of dietary fiber, vitamin D, calcium, and potassium. Get the facts on these nutrients and how the Nutrition Facts label can help older adults make informed food choices. https://go.usa.gov/xFz9G #HealthyAgingMonth
@SecVilsack
- USDA is committed to leveling the playing field for family farmers and ranchers, expanding meat and poultry processing capacity, and building a better, more resilient food system. https://www.reuters.com/business/biden-administration-plans-tougher-action-rein-meat-prices-2021-09-08/
@FrankYiannasFDA
- As we all know, the COVID-19 pandemic has changed the way we order food and get it delivered to our homes. We will be addressing the potential safety vulnerabilities of these foods at the upcoming public meeting from Oct 19-21 especially during the critical last mile of delivery
- We intend to use the info that we learn during this meeting and from comments submitted to the Federal Register to help determine what actions may be needed to further strengthen safeguards & keep consumers safe. I encourage you to register & participate. https://go.usa.gov/xMaRc
@DrWoodcockFDA
- There are over 1 in 10 people living with diabetes, and the FDA is committed to taking action to protect the public from unlawful dietary supplements.
- This is such an important and a timely issue to address especially now that so many of us are getting our food delivered to our homes. As new business models continue to emerge, we want to ensure that food safety plays a vital role in the process.
@US_FDA
- Today, @US_FDA& @FTCissued warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent diabetes, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). https://go.usa.gov/xM2Re
- More than 34 million Americans are living with diabetes. Dietary supplements that make fraudulent claims to treat diabetes are unapproved new drugs that could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments.