Laws and Regulations Committee Update – December 23, 2020
December 23, 2020
Federal Register
Agricultural Marketing Service
Notices
Certification of Alabama, Virginia, Washington, and Wisconsin to Provide Official Services at Export Port Locations under a Delegation:
Cancellation of South Carolina’s Delegation
Filed on: 12/23/2020 at 8:45 am Scheduled Pub. Date: 12/28/2020
FR Document: 2020-28499 PDF 4 Pages (75.3 KB) Permalink
Animal and Plant Health Inspection Service
Proposed Rules
Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Filed on: 12/23/2020 at 8:45 am Scheduled Pub. Date: 12/28/2020
FR Document: 2020-28534 PDF 22 Pages (129 KB) Permalink
Notices
Proposed Consent Agreement: (CBD false advertising)
– Bionatrol Health, LLC
Filed on: 12/23/2020 at 8:45 am Scheduled Pub. Date: 12/28/2020
FR Document: 2020-28544 PDF 14 Pages (119 KB) Permalink
– EasyButter, LLC
Filed on: 12/23/2020 at 8:45 am Scheduled Pub. Date: 12/28/2020
FR Document: 2020-28543 PDF 14 Pages (118 KB) Permalink
– Steves Distributing, LLC
Filed on: 12/23/2020 at 8:45 am Scheduled Pub. Date: 12/28/2020
FR Document: 2020-28545 PDF 12 Pages (115 KB) Permalink
Notices
Guidance
Voluntary Disclosure of Sesame as an Allergen
Filed on: 12/23/2020 at 8:45 am Scheduled Pub. Date: 12/28/2020
FR Document: 2020-28559 PDF 4 Pages (90.7 KB) Permalink
Food Safety and Inspection Service
Proposed Rules
Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Filed on: 12/23/2020 at 8:45 am Scheduled Pub. Date: 12/28/2020
FR Document:2020-28534 PDF 22 Pages (129 KB) Permalink
FDA
FDA Warns Whole Foods Market After Repeated Food Recalls for Undeclared Allergens
Warning Letters
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject |
| 12/22/2020 | 12/11/2020 | Campimex, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| 12/22/2020 | 12/16/2020 | Whole Foods Market | Center for Food Safety and Applied Nutrition (CFSAN) | Food Labeling/Misbranded |
| 12/22/2020 | 12/22/2020 | New Leaf Pharmaceuticals, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 12/22/2020 | 12/22/2020 | NextL3vel Services Group, LLC dba This Stuff Is Good For You | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| 12/22/2020 | 12/22/2020 | Wellness BioSciences Rx | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| 12/22/2020 | 12/22/2020 | G & L Wellness, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 12/22/2020 | 12/22/2020 | Bee Delightful | Division of Human and Animal Food Operations West III | Unapproved New Drugs/Misbranded |
FTC
FTC Order Stops the Manufacturer of Superglues, and Company President, from Again Marketing Products with Misleading ‘Made in USA’ Claims
Marler Blog
Foodborne illness source attribution estimates for 2018 for Salmonella, E. coli O157, Listeria and Campylobacter are out
@FrankYiannasFDA
- Today, @cdcgov declared the multistate outbreak of E. coli O157:H7 linked to leafy greens over. FDA’s investigation is ongoing to learn the origin of contamination and prevent future outbreaks. A detailed report will be released in early 2021. https://go.usa.gov/xAbeH
@US_FDA
- Today @US_FDA posted a warning letter issued to Whole Foods Market for a pattern of receiving and offering for sale misbranded food products necessitating a series of food recalls for allergens. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whole-foods-market-610862-12162020
- Today, we issued five warning letters to companies for selling products containing cannabidiol. All five warning letters address the illegal marketing of unapproved products claiming to treat medical conditions in people and animals. https://go.usa.gov/xATMP