Laws and Regulations Committee Update – January 12 – 13, 2021
January 12, 2021
Federal Register
Agricultural Marketing Service
Rules
Pecan Promotion, Research, and Information Order
Filed on: 01/12/2021 at 8:45 am Scheduled Pub. Date: 01/13/2021
FR Document: 2021-00328 PDF 101 Pages (263 KB) Permalink
FDA
FDA Publishes Report on Focus Areas of Regulatory Science
Recalls
| Date | Brand Name | Description | Product Type | Recall Reason | Company |
| 01/11/2021 | LAVVA | Blueberry Plant-Based Yogurt | Food & Beverages | Potential for Mold | EVR Foods Inc. |
GRAS
| GRN No. | Substance | Date of Closure | FDA’s Letter |
| 942 | Whey permeate | Dec 21, 2020 | At the notifier’s request, FDA ceased to evaluate this notice (in PDF)8 (189 kB) |
APHIS
Availability of an Environmental Assessment for a Biological Control Agent of Air Potato
USDA
USDA Announces Details of the 2021 Agricultural Outlook Forum Program
@SteveFDA
- Today, we issued the Focus Areas of Regulatory Science report, which outlines areas of research that are organized by my strategic initiatives that I shared at the beginning of last year. https://go.usa.gov/xAUkA
- #2020atFDA: FDA’s Center for Veterinary Medicine (CVM) made history with the approval of the first animal biotechnology product for both food and biomedical use, a tremendous milestone for scientific innovation.
- Among the other 29 pioneer & generic approvals CVM issued are products to treat, manage or prevent serious diseases in animals, including certain mast cell tumors in dogs, weight loss in cats suffering from chronic kidney failure & severe asthma in horses.
- We’ve also provided important guidance to animal drug sponsors & to the animal food industry to promote innovation by issuing four key guidances to help facilitate the development of New Animal Drugs and one guidance on Animal Food Additive Petitions.
- We continue to monitor the marketplace through our compliance and enforcement actions, also continue to inform the public about recalls of food, drug or device products with the potential to impact the health of animals or the humans who care for them.
January 13, 2021
Federal Register
Notices
Concept Paper:
Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed
FR Document: 2021-00189 Citation: 86 FR 1979 PDF Pages 1979-1981 (3 pages) Permalink
Health and Human Services Department
Rules
Transparency and Fairness in Civil Administrative Enforcement Actions
Filed on: 01/12/2021 at 4:15 pm Scheduled Pub. Date: 01/14/2021
FR Document:2021-00592 PDF 19 Pages (156 KB) Permalink
FDA
Warning Letters
| Posted Date | Issue Date | Company | Issuing Office | Subject |
| 01/12/2021 | 11/17/2020 | Bonagens | Division of Human and Animal Food Operations East III | New Drug/Misbranded |
| 01/12/2021 | 12/22/2020 | Speedwinds Nutrition, Inc. | Division of Human and Animal Food Operations West VI | New Drug/Misbranded |
| 01/12/2021 | 12/28/2020 | Smarter Nutrition, Inc. | Division of Human and Animal Food Operations West V | New Drug/Misbranded |
HHS
HHS Improves Agency Procedures Relating to Transparency and Fairness in Civil Enforcement Actions
AMS
AMS Announces 2021 Grain Fees for Official Inspection and Weighing Services
USDA Announces Appointments to the American Egg Board
USDA
USDA Releases Agriculture Innovation Research Strategy Summary and Dashboard
OMB
| AGENCY: USDA-AMS | RIN: 0581-AD82 | Status: Concluded |
| TITLE: Establishment of a Domestic Hemp Production Program | ||
| STAGE: Final Rule | ECONOMICALLY SIGNIFICANT: Yes | |
| RECEIVED DATE: 11/30/2020 | LEGAL DEADLINE: None | |
| ** COMPLETED: 01/12/2021 | COMPLETED ACTION: Consistent with Change |
@FrankYiannasFDA
- Today, we published edits to the Food Traceability List, a list of foods for which the traceability recordkeeping requirements in the Food Traceability Proposed Rule, a key component of our #smarterfoodsafety blueprint, would apply. https://go.usa.gov/xAPyF
- In addition, we also published an FAQ to assist stakeholders who are considering providing feedback during the Food Traceability Proposed Rule comment period, which has been extended until Feb. 22.
@SteveFDA
- #2020atFDA: To proactively identify and neutralize threats to consumers, and particularly to protect consumers from fraudulent FDA-regulated products during the #COVID19 pandemic, FDA launched Operation Quack Hack in March 2020.
- To date, FDA has identified more than 1100 fraudulent & unproven medical products related to #COVID19. Operation Quack Hack led domain registrars & online marketplaces to review and take down numerous websites or listings illegally selling unproven FDA-regulated products.
- This is in addition to our normal enforcement efforts by our Office of Criminal Investigations, which last year initiated more than 600 criminal investigations targeting violations related to FDA-regulated products.