Laws and Regulations Committee Update – January 27 – 28, 2021
January 27, 2021
Federal Register
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals
Filed on: 01/27/2021 at 8:45 am Scheduled Pub. Date: 01/28/2021
FR Document: 2021-01881 PDF 3 Pages (80.4 KB) Permalink
- Title: Plan for Estimating daily Livestock Slaughter under Federal Inspection
FDA
Warning Letters
| Posted Date | Issue Date | Company Name | Issuing Office | Subject |
| 01/26/2021 | 01/08/2021 | Thai Kee Trading Co | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| 01/26/2021 | 01/14/2021 | Sage Moon Apothecary LLC | Division of Human and Animal Food Operations East I | New Drug/Misbranded |
| 01/26/2021 | 01/19/2021 | Alma Reserve | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
GRAS Notices
| GRN No. | Substance | Date of closure | FDA’s Letter |
| 949 | Bacillus coagulans strain DSM 17654 | Jan 7, 2021 | FDA has no questions (in PDF) |
| 926 | Soluble rice flour | Jan 5, 2021 | FDA has no questions (in PDF) (434 kB) |
@DrwoodcockFDA
- Today, the FDA took action to place all alcohol-based hand sanitizers from Mexico on Import Alert to help stop violative and potentially dangerous products from entering the U.S. until the agency is able to review the products’ safety. https://fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-place-all-alcohol-based-hand-sanitizers-mexico-import
- The FDA has seen a sharp increase in hand sanitizer products from Mexico labeled to contain ethanol but that tested positive for methanol. FDA’s analyses found 84% of samples from Mexico were not in compliance with FDA regulations and more than half contained toxic ingredients.
- Under the import alert, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and FDA staff may detain them. This marks the first time the FDA has issued a countrywide import alert for any category of drug product.
- Poor-quality products with dangerous and unacceptable ingredients will not be tolerated. The FDA will continue to work with stakeholders to ensure the availability of safe hand sanitizers and to communicate vital information with the health and safety of U.S. consumers in mind.
- We don’t take this action lightly. Methanol is poisonous, even when absorbed through the skin. Ingesting small amounts of methanol can be fatal, especially in young children. There have already been adult fatalities from ingestion. Methanol cannot contaminate our hand sanitizers.
@FDAFood
- You won’t want to miss the opening session featuring Federal agency leaders discussing food safety and health at the 2021 Consumer #FoodSafety Education Virtual Conference! Register by Feb. 5 for just $99 — a $30 savings! http://fightbac.org/virtual #foodsafety2021 #CFSEVirtual
- Stay up-to-date on how to protect your food and water in case of weather emergencies. Find out what to have on hand before extreme weather and what to do during and after. https://go.usa.gov/x7fVT
- This New Year, resolve to reduce food waste, save money, and help protect the environment. Our new video has tips to help. https://fda.gov/food/consumers/food-waste-animations
January 28, 2021
FDA
Recalls
| Date | Brand Name | Description | Product Type | Recall Reason | Company |
| 01/27/2021 | Maine Grains, GrowNYC | Organic yellow peas | Food & Beverages | Undeclared soy | Main Grains, Inc. |
USDA
U.S. Department of Agriculture Announces Key Staff Appointments
@FrankYiannasFDA
- FDA has completed our investigation of the 2020 leafy greens E.coli outbreak and found the presence of a recurring outbreak strain on adjacent land. https://go.usa.gov/xA6TD
- We continue to recommend that growers of leafy greens assess and mitigate risks associated with adjacent and nearby land use practices, particularly as it relates to the presence of livestock, which are a persistent reservoir of E. coli O157:H7.
- Increasing awareness around adjacent land use is one of the specific goals of FDA’s Leafy Greens Action Plan released last March. We remain dedicated to working together with our state partners and the produce industry to bend the curve of these foodborne illnesses.
@FDAfood
- Read about lessons learned by FDA’s Coordinated Outbreak Response and Evaluation Network (CORE) in @foodsafetynews article “Outbreak Investigations of Foodborne Illnesses Linked to Atypical Food-Pathogen Pairs.” https://bit.ly/3cdVVFe
- These pathogen reduction efforts and lessons learned drive future response and prevention efforts. Authors are from FDA’s CORE team: Stelios Viazis, Ph.D., Michael C. Bazaco, Ph.D., and Douglas Karas, M.A.
@DrAbernathyFDA
- Today I gave a talk for @FNLM on the history of real-world data/evidence (RWD/E). RWD/E is healthcare data & clinical evidence generated outside of the traditional clinical trial setting, eg electronic health records, administrative claims, patient reported data, social media
- Real-world data/evidence is the contemporary iteration of observational research (OR) / outcomes research / clinical epidemiology. The name evolved as data/analytic capabilities evolved, the focus of the research question shifted, and new outcomes were variables added.
- Real-world data/evidence (RWD/E) isn’t a new field rather an updated name/concept for an evolving field & specific areas of focus. Observational/outcomes research -> comparative effectiveness research/ pharmacoepidemiology -> patient-centered outcomes research/etc -> RWD/E
- National Library of Medicine’s Pubmed, released in 1996, is a great example of how government action accelerates progress. Pubmed made searching the medical literature easy and free – a catalytic event in the application of research-based evidence to patient care. @FNLM #EBM