Laws and Regulations Committee Update – October 21 – 22, 2021
October 21, 2021
FDA
FDA Announces Investigation of Salmonella Outbreak Linked to Whole, Fresh Onions
Federal Judge Enters Consent Decree with Utah-based Dietary Supplement Manufacturer [Note: dietary supplements using disease claims previously received warning letters, consent decree requires the company stop marketing or manufacturing their products until they come into compliance.]
Warning Letters
| Posted Date | Issue Date | Company | Issuing Office | Subject |
| 10/19/2021 | 09/22/2021 | The Camel Milk Co. LLC dba Camel Culture | Office of Human and Animal Foods Operations – Division West 4 | New Drug/Misbranded |
FSIS
Demaiz Inc. Recalls Beef And Pork Tamale Products Due To Misbranding And Undeclared Allergen
CFSAN
CVM
FDA Announces Webinar on the Development of Animal Cells, Tissues, and Cell- and Tissue-based Products
USDA
Joint Statement from U.S. and Mexican Agriculture Secretaries [Note: affirming commitment to Mexican-US agricultural commerce.]
FTC
FTC Sends Refunds to Consumers Who Bought Deceptively Marketed Supplements to Treat Pain and Age-related Health Conditions. [Note: see Nordic Clinical, Inc. and Encore Plus Solutions, Inc. marketers of supplements Neurocet, Regenify, and Resetigen-D settled FTC charges that they deceptively promoted their products to older Americans using false claims that their products could stop pain and treat age-related ailments. Proposed order bars companies from making claims about the health benefits of their products unless substantiated.]
@FrankYiannasFDA
- Appreciated talking w/ @VickyNguyenTV & @TODAYshow to discuss the importance of the e-commerce food safety summit FDA is holding this week. There’s more food being delivered to homes than ever before & we need to keep pace when it comes to food safety. https://twitter.com/FrankYiannasFDA/status/1450852011407290371.
October 22, 2021
FDA
Recalls
| Date | Brand(s) | Product Description | Type | Reason for Recall | Company |
| 10/20/2021 | Big Bull, Peak Fresh Produce, Sierra Madre, Markon First Crop., Markon Essentials, Rio Blue, ProSource, Rio Valley, and Sysco Imperial | Whole raw red, yellow, white onions | Food & Beverages Produce Foodborne Illness | Potential Salmonella Contamination | ProSource Produce LLC |
| 10/21/2021 | Smilin’ Bob’s | Smoked Fish Dip | Food & Beverages Prepared Food Allergens | Undeclared egg allergen | Smilin’ Bob’s |
FSIS
Affco USA Recalls Frozen Raw Lamb Products Imported Without Benefit Of Import Inspection
Notice 47-21: Profile Updates in Domestic Egg Products Plants Implementing Sanitation Standard Operating Procedures or that Opt-In Early to Implement the Hazard Analysis and Critical Control Point System Requirements
USDA
askFSIS Public Q&A: California Proposition 12 Labeling Claims
@FDAFood
- @US_FDA and @Stopfoodillness are collaborating on a webinar series that explores #foodsafety culture. The first is on Thurs., Nov. 4, 2021 from 10:30 a.m. to 12 p.m. ET. “Key Concepts in Addressing Food Safety Culture as a Science – Not a Slogan” Info: https://go.usa.gov/xMJUX
@FrankYiannasFDA
- We all want safe food. We welcome new food delivery systems that meet consumers’ changing needs. Armed with what we’ve learned over the past three days, we will work with all stakeholders to address potential food safety challenges.
- Next, we’ll consider what we’ve learned during the summit from industry and government experts, and from comments submitted to the public docket until Nov. 20 to determine what actions may be needed to further strengthen consumer protections. https://regulations.gov/document/FDA-2021-N-0929-0001
- FDA, along with @CDCgov , state & local partners are investigating a multistate outbreak of Salmonella infections linked to fresh, whole onions from ProSource Inc. imported from Chihuahua, Mexico July 1 through August 27. https://fda.gov/news-events/press-announcements/fda-brief-fda-announces-investigation-salmonella-outbreak-linked-whole-fresh-onions
- This outbreak has resulted in 652 illnesses across the U.S., associated with restaurants and food service locations. That’s why we’re advising restaurants, retailers and consumers not to eat, sell, or serve the affected product.