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  • February 22, 2019 1:15 PM | Amy Bonsell (Administrator)

    February 19, 2019

    Federal Register

    Food and Drug Administration

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals:

    Sanitary Transportation of Human and Animal Food

    Filed on: 02/19/2019 at 8:45 am Scheduled Pub. Date: 02/20/2019

    FR Document: 2019-02751 PDF 8 Pages (38.5 KB) Permalink

    • Ø  21 CFR 1.900

     

    Agricultural Marketing Service

    Rules

    Processed Raspberry Promotion, Research, and Information Order; Termination of Assessments

    Filed on: 02/19/2019 at 8:45 am Scheduled Pub. Date: 02/20/2019

    FR Document: 2019-02775 PDF 12 Pages (141 KB) Permalink

     

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals

    Filed on: 02/19/2019 at 8:45 am Scheduled Pub. Date: 02/20/2019

    FR Document: 2019-02700 PDF 7 Pages (132 KB) Permalink

    • Ø  Export Fruit Regulations – Export Apple Act (7 CFR 33) and Export Grape and Plum Act (7 CFR 35)

     

    International Trade Administration

    Notices

    Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

    Certain Pasta from Italy

    Filed on: 02/19/2019 at 8:45 am Scheduled Pub. Date: 02/20/2019

    FR Document: 2019-02786 PDF 4 Pages (85.6 KB) Permalink

     

    Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty

    Filed on: 02/19/2019 at 8:45 am Scheduled Pub. Date: 02/20/2019

    FR Document: 2019-02785 PDF 4 Pages (161 KB) Permalink

     

    U.S. Codex Office

    Notices

    Meetings:

    Codex Committee on Contaminants in Foods

    Filed on:  02/19/2019 at 8:45 am Scheduled Pub. Date: 02/20/2019

    FR Document: 2019-02743 PDF 6 Pages (258 KB) Permalink

     

    FDA

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    02/18/2019

    Chukar Cherries

    Ultra Dark Chocolate Cherries

    Undeclared milk

    Chukar Cherries

    02/15/2019

    EnviroKidz

    Choco Chimps, Gorilla Munch and Jungle Munch cereals

    May contain undeclared gluten (wheat and barley)

    Nature’s Path Foods

    02/15/2019

    DG™

    Baby Gripe Water herbal supplement

    Undissolved ingredient, citrus flavonoid

    Kingston Pharma, LLC

    02/15/2019

    Smoked Alaska

    Smoked Silver Salmon

    Potential for Clostridium botulinum

    Smoked Alaska Seafoods, Inc

    02/15/2019

    Jansal Valley

    Dukkah 2.5oz

    May contain glass pieces

    Sid Wainer and Son

     

    USDA

    United States Issues WTO Counter Notification Concerning India’s Market Price Support for Various Pulses

     

    FSIS

    Feb 15, 2019 | PDF

    • FSIS Posts Updated Quarterly Sampling Results
    • FSIS Posts Updated Dataset on Imports
    • FSIS Posts Next Set of Establishment Specific Datasets
    • FSIS Posts Individual Category Status and Aggregate Results for Poultry Carcasses, Chicken Parts, and Comminuted Poultry Tested for Salmonella

    Recalls

    Product Recalled

    Date of Recall

    Retail Distribution List

    015-2019 Panola County Processing, LLC Recalls Sausage Products Due to Possible Processing Deviation | En Español

    Feb 11, 2019

    Feb 14, 2019

    015-2019 Panola County Processing, LLC Recalls Sausage Products Due to Possible Processing Deviation | En Español

    Feb 11, 2019

    Feb 14, 2019

     

    AMS

    AMS Issues Complaint against R & W Farms LLC, Wanda Thompson and Rickey G. Thompson for Alleged Violations of the P&S Act

    AMS Reaches a Consent Decision and Civil Penalty with Gary Wedel

     

    APHIS

    USDA Provides $66 Million in Fiscal Year 2019 to Protect Agriculture and Natural Resources from Plant Pests and Diseases

     

    @SGottliebFDA

    • Ø  Dietary supplements such as vitamins, minerals or herbs are regularly used by 3 out of 4 consumers and can be beneficial. In today’s #FDA #SundayTweetorial I review FDA’s efforts to ensure safety of these products through steps to modernize our oversight https://go.usa.gov/xEny3 .
    • Ø  Some background: Under the Dietary Supplement Health and Education Act (DSHEA) supplements are a type of food. Companies are subject to a number of requirements around manufacturing and product labeling but #FDA review isn't needed to market their product https://go.usa.gov/xEQzr .
    • Ø  Since DSHEA was enacted in 1994 the supplement industry has evolved in more ways than envisioned; expanding from $4 billion in sales and 4,000 products to $40 billion in sales and about 80,000 products. This growth offers new opportunities but also creates the potential for risks
    • Ø  As supplements have grown in popularity so too have the number of products on the market that are potentially dangerous or make unproven or misleading health benefit claims. For these reasons #FDA is implementing new steps to modernize our oversight, and considering other actions
    • Ø  Although the vast majority of manufacturers in the supplement market act responsibly; a small number of bad actors are exploiting the halo created by the quality work of legitimate companies and promulgating products with inappropriate claims or potentially harmful ingredients.
    • Ø  I’m concerned that changes in the supplement market are outpacing the evolution of our own policies to ensure safety and our capacity to manage emerging risks. So, I’ve concluded that we will take new steps to modernize and strengthen our overall approach to these products.
    • Ø  At my direction, the #FDA established an internal Dietary Supplement Working group tasked with taking a close look at our organizational structures, processes, procedures and practices to identify new ways to modernize and strengthen our regulatory oversight to ensure safety.
    • Ø  Last week I unveiled our initial efforts to help advance the group’s three policy priorities for dietary supplements as part of our new work stream: Protecting consumers from unsafe products; ensuring product integrity and quality; and promoting informed consumer decision making.
    • Ø  One important new step is developing a rapid-response communications tool that will more quickly alert consumers to avoid buying or using products with unlawful or potentially dangerous ingredients and notify industry that they should avoid making or selling these products.
    • Ø  Another is providing guidance on submitting required safety notifications for new dietary ingredients (NDIs), ingredients introduced after DSHEA. These submissions are #FDA’s only opportunity to review the safety of an NDI before they reach consumers https://go.usa.gov/xEQtA .
    • Ø  Knowing we don’t have all the answers, we’ll also be holding an open meeting this spring to hear from the public about other steps we might consider for advancing responsible innovation - such as clarifying the scope of permitted ingredients or opening a dialogue on exclusivity.
    • Ø  As we move forward, we’ll also reinforce important existing activities. This includes collaborative research with industry, academia, and government partners, such as our new Botanical Safety Consortium, which we formed to look at novel ways for using toxicology tools….
    • Ø  …and our continued efforts to protect public health through enforcement action. Last week we posted letters to 17 companies illegally marketing Alzheimer’s disease products, often sold on websites and social media platforms. Other actions are in the works https://go.usa.gov/xEQMp
    • Ø  These health fraud products haven't been proven to be safe and effective for diseases and health conditions they claim to treat. They prey on vulnerable populations, cause consumers to waste money on unproven products, and often delay proper medical care https://go.usa.gov/xEQME
    • Ø  Some believe that modifying DSHEA to add a product listing requirement could improve transparency, promote risk-based regulation and establish a mechanism to easily ID bad actors without overly burdening responsible firms. We look forward to future dialogue on this matter.
    • Ø  Dietary supplements can play an important role in our lives as we strive to stay healthy. With modernization of our oversight, our goal is to preserve consumers’ access to lawful supplements while upholding our obligation to protect the public from unsafe and unlawful products.

     

    @FrankYiannasFDA

    • Ø  Standards (such as GS1) + New Enabling Technologies (such as blockchain) = a New Era of Scalable & Interoperable Food Traceability solutions. It CAN be done. @GS1_US #blockchain #traceability https://www.forbes.com/
    • Ø  THREAD: This week, FDA released findings from the agency’s investigation of the November 2018 outbreak of E. coli O157:H7 in California-linked romaine lettuce. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631290.htm …
    • Ø  While the report doesn’t explain the totality of what happened, it’s more than what we had before and it provides insights to inform future preventive efforts.
    • Ø  1) Survivability - finding the outbreak strain in sediment of the water reservoir is significant, as studies have shown E. coli can survive in sediments longer than in water. It’s possible outbreak strain may have been present in on-farm water reservoir for months or even years.
    • Ø  2) Verification - while the one farm had a procedure in place to treat the agricultural water with a sanitizer before use, the investigation team noted verification records did not document sufficient sanitizer to adequately reduce any pathogens present.
    • Ø  3) Traceability - without the ability of industry to rapidly trace origin of products to growing region or source, public health advisories issued during outbreaks will continue to be - out of necessity - broad & likely to include farms & regions that may not be responsible.
    • Ø  Fresh leafy greens are an important part of an overall healthy diet. Let’s work “together” and with a “shared sense of urgency” to make sure they’re safe.

     

    @FDAfood


  • February 15, 2019 2:28 PM | Amy Bonsell (Administrator)

    This session will introduce emerging issues pertaining to the commercialization and regulation of Cell-Cultured products derived from meats, seafood or poultry. Included is an overview of the production process of cell-cultured proteins,  labeling of the new products as well as other regulatory issues of this new poultry and meat-based protein products. These products are on the verge of being market-ready, and discussed are whether existing regulations are adequate for emerging safety concerns of these technologies. Join Susan Burns of Burns LLC and Barbara Kowalcyk for a webinar on Animal Cell Culture Technology from Meats Products.

    Date: February 22, 2019
    Time: 2:00PM ET


    Register Now!

  • February 15, 2019 1:55 PM | Amy Bonsell (Administrator)

    February 13, 2019

    Federal Register

    Environmental Protection Agency

    Notices

    Pesticide Emergency Exemptions; Agency Decisions and State and Federal Agency Crisis Declarations

    Filed on: 02/13/2019 at 8:45 am Scheduled Pub. Date: 02/14/2019

    FR Document: 2019-02354 PDF 17 Pages (112 KB) Permalink

     

    Product Cancellation Order for Certain Pesticide Registrations and Amendments to Terminate Uses

    Filed on: 02/13/2019 at 8:45 am Scheduled Pub. Date: 02/14/2019

    FR Document: 2019-02385 PDF 9 Pages (38 KB) Permalink

     

    USDA

    USDA Seeks Nominees for the Mushroom Council

     

    FSIS

    Notices

    Number

    Title

    Date Issued

    Expiration Date

    03-19

    Actions to Take When Raw Poultry Establishments Receive Campylobacter Test Results

    Feb 12, 2019

    Feb 01, 2020

     

    @FrankYiannasFDA

    @USDAFoodSafety

    • ·        Registration for the 2019 Consumer Food Safety Education Conference has officially opened! Join us March 7-8, 2019, in Orlando, FL for a 2 day conference filled with take-away strategies for changing people’s #FoodSafety knowledge & behaviors. https://cfsec2019.fightbac.org

     

    February 14, 2019

    Federal Register

    Agriculture Department

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals

    Filed on: 02/14/2019 at 8:45 am Scheduled Pub. Date: 02/15/2019

    FR Document: 2019-02457 PDF 4 Pages (88.6 KB) Permalink

    • Ø  National Animal Health Monitoring System; Goat 2019 Study

     

    Agricultural Marketing Service

    Rules

    Establish Procedures to Meet Via Electronic Communications:

    Olives Grown in California

    Filed on: 02/14/2019 at 8:45 am Scheduled Pub. Date: 02/15/2019

    FR Document: 2019-02517  PDF 12 Pages (256 KB) Permalink

     

    Proposed Rules

    Marketing Order: Spearmint Oil Produced in the Far West; Salable Quantities and Allotment Percentages for the 2019-2020 Marketing Year

    Filed on: 02/14/2019 at 8:45 am Scheduled Pub. Date: 02/15/2019

    FR Document: 2019-02514 PDF 33 Pages (408 KB) Permalink

     

    National Organic Program:

    National List of Allowed and Prohibited Substances for April 2018 NOSB Recommendations (Crops and Handling)

    Filed on: 02/14/2019 at 8:45 am Scheduled Pub. Date: 02/15/2019

    FR Document: 2019-02518 PDF 18 Pages (262 KB) Permalink

     

    Environmental Protection Agency

    Rules

    Pesticide Tolerances:

    Trifloxystrobin

    Filed on: 02/14/2019 at 8:45 am  Scheduled Pub. Date: 02/15/2019

    FR Document: 2019-02523 PDF 22 Pages (350 KB) Permalink

     

    Trifluralin

    Filed on: 02/14/2019 at 8:45 am Scheduled Pub. Date: 02/15/2019

    FR Document: 2019-02535 PDF 23 Pages (353 KB) Permalink

     

    FDA

    FDA Releases Report on Investigation into the Fall 2018 Outbreak of Illnesses Tied to Romaine Lettuce

    Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas on findings from the agency’s investigation of the November 2018 outbreak of E. coli O157:H7 in California-linked romaine lettuce

    Salmonella Linked to Tahini

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    02/12/2019

    Ottogi

    JIN JJAMBBONG’ and Jin Ramen

    Undeclared egg

    Ottogi America, Inc

    Warning Letters

    Letter Issue Date

    Company Name

    Issuing Office

    Subject

    Close Out Date

    02/01/2019

    Panther James LLC.

    Center for Food Safety and Applied Nutrition

    Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

    Not Issued *

     

    FTC

    2018 Annual Report on Refunds to Consumers

     

    OEHHA

    Amendment to Section 25705 No Significant Risk Level for Bromochloroacetic Acid: The regulation will be effective on April 1, 2019.  This regulation establishes a No Significant Risk Level of 0.70 micrograms per day for bromochloroacetic acid for purposes of Proposition 65.

    Amendment to Section 25705 No Significant Risk Level for Bromodichloroacetic Acid: The regulation will be effective on April 1, 2019.  This regulation establishes a No Significant Risk Level of 0.95 micrograms per day for bromodichloroacetic acid for purposes of Proposition 65.

     

    @SGottliebFDA

    • Ø  Today #FDA released our investigation report for the November E. coli outbreak linked to romaine from CA. It reinforces recommendations for romaine growers to help prevent this from happening again https://go.usa.gov/xEQvw
    • Ø  Advancing the safety of fresh leafy greens requires ongoing collaboration. We’ll continue to work with states, federal partners, and industry to explore better ways to assure quick, accurate and easy access to key traceability information.

     

    @FrankYiannasFDA

    • Ø  Today’s investigation report provides more information than we had before. And it reinforces the fact that implementation of preventive measures based on the best available science is the most effective means to ensure the safety of produce

    @US_FDA

    • Ø  Cyclospora is a parasite, with a complicated lifecycle, not a bacterial pathogen, like Salmonella or E. coli. Discover how an FDA-developed test detects Cyclospora and how its development detected a significant outbreak last summer. https://go.usa.gov/xERKc

    February 15, 2019

    Federal Register

    Food and Drug Administration

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals:

    Food Additive Petitions and Investigational Food Additive Exemptions

    Filed on: 02/15/2019 at 8:45 am Scheduled Pub. Date: 02/19/2019

    FR Document: 2019-02596 PDF 5 Pages (17.5 KB) Permalink

     

    Agricultural Marketing Service

    Rules

    Termination of Marketing Order:

    Irish Potatoes Grown in Southeastern States

    Filed on: 02/15/2019 at 8:45 am Scheduled Pub. Date: 02/19/2019

    FR Document: 2019-02581 PDF 13 Pages (251 KB) Permalink

     

    Food and Nutrition Service

    Rules

    Supplemental Nutrition Assistance Program:

    Eligibility, Certification, and Employment and Training Provisions of the Food, Conservation and Energy Act

    Filed on: 02/15/2019 at 8:45 am Scheduled Pub. Date:02/19/2019

    FR Document: 2019-02551 PDF 18 Pages (292 KB) Permalink

     

    Environmental Protection Agency

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals:

    Agricultural Worker Protection Standard Training, Notification, and Recordkeeping

    Filed on: 02/15/2019 at 8:45 am Scheduled Pub. Date: 02/19/2019

    FR Document: 2019-02583 PDF 4 Pages (181 KB) Permalink

     

    International Trade Administration

    Notices

    Fresh Garlic from the People's Republic of China

    Filed on: 02/15/2019 at 8:45 am Scheduled Pub. Date: 02/19/2019

    FR Document: 2019-02585  PDF 5 Pages (284 KB) Permalink

     

    AMS

    USDA Restricts PACA Violators in California and New York from Operating in the Produce Industry

     

    NIH

    Healthy Infants Harbor Intestinal Bacteria That Protect Against Food Allergy

     

    FTC

    FTC Announces March 2019 Session on International Engagement as Part of its Hearings on Competition and Consumer Protection in the 21st Century

    FTC Announces New Sessions of its Hearings on Competition and Consumer Protection in the 21st Century


  • February 15, 2019 1:54 PM | Amy Bonsell (Administrator)

    February 12, 2019

    Federal Register

    Risk Management Agency

    Notices

    Meetings:

    2018 Farm Bill Implementation Listening Session

    Filed on: 02/11/2019 at 4:15 pm Scheduled Pub. Date: 02/14/2019

    FR Document: 2019-02360 PDF 18 Pages (319 KB) Permalink

    FDA

    FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

    Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

    FTC and FDA Send Warning Letters to Companies Selling Dietary Supplements Claiming to Treat Alzheimer’s Disease and Remediate or Cure Other Serious Illnesses Such as Parkinson’s, Heart Disease, and Cancer

    Recalls

    Date Brand Product Description Reason/Problem Company

    02/08/2019 WTRMLN WTR

    Cold pressed juiced watermelon potential presence of soft plastic World Waters, LLC

    Warning Letters

    Letter Issue Date Company Name Issuing Office Subject Close Out Date

    02/05/2019 Pure Nootropics, LLC

    Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

    02/05/2019 TEK Naturals

    Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

    02/05/2019 John Gray’s Mars Venus LLC

    Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

    02/05/2019 Nutrition Coalition Inc

    Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

    02/05/2019 Blue Ridge Silver

    Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

    02/05/2019 Sovereign Laboratories, LLC

    Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

    02/05/2019 DK Vitamins

    Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

    02/05/2019 Peak Nootropics LLC (aka Advanced Nootropics)

    Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

    02/05/2019 Gold Crown Natural Products

    Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

    02/05/2019 Emmbros Overseas Lifestyle PVT LTD.

    Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

    02/05/2019 Earth Turns, LLC

    Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

    02/05/2019 Capris Associates Inc. / BR Naturals

    Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *

    USDA

    USDA to Release Complete Set of Tables for Agricultural Projections to 2028

    FSIS

    Recalls

    Product Recalled Date of Recall

    015-2019 Panola County Processing, LLC Recalls Sausage Products Due to Possible Processing Deviation

    Feb 11, 2019

    AMS

    USDA Dairy Product Purchase Program Announced

    USDA Seeks Nominees for United Sorghum Checkoff Program Board

    USDA Seeks Nominees for the National Peanut Board

    USDA Seeks Nominees for the Highbush Blueberry Council

    FTC

    FTC Returns Almost $3.5 Million to Consumers Who Bought Deceptively Marketed “Weight-Loss” Supplements from Direct Alternatives and Original Organics, LLC

    @SGottliebFDA

    • We’re committed to helping beneficial products and innovation advance in the dietary supplement space; but to protect consumers from a small number of bad actors in this burgeoning industry, we need to modernize our framework for overseeing these products: www.washingtonpost.com

    • THREAD: Today, the #FDA announced a new plan for implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years. At the same time, we executed a major enforcement action to protect consumers: https://go.usa.gov/xEnDj

    • My goal is to achieve the right balance between preserving consumers’ access to lawful supplements, while upholding our solemn obligation to protect the public from unsafe/unlawful products. Today’s announcement reflects new steps by FDA to achieve these twin goals

    • Among FDA’s new steps, we will be communicating to the public as soon as possible when there’s a concern about a dietary supplement. Our new rapid-response tool will tell consumers to avoid buying or using suspect products, and notify industry to avoid making/selling them.

    • We’ll also need to ensure that our regulatory framework is flexible enough to adequately evaluate product safety while promoting innovation. The key to this effort will be important new steps to foster the submission of new dietary ingredient notifications

    • Today, #FDA also issued warning and advisory letters to 17 companies illegally selling products claiming to cure Alzheimer’s. We partnered with the #FTC on three letters and we’ll working to end the violative practices we cited: https://go.usa.gov/xEnDZ

    • We’ll hold a public meeting this spring on new steps we can consider to help advance responsible innovation in the dietary supplement industry. We’ll address challenges that may be barriers to innovation, including incentives like exclusivity as a way to promote safe innovation

    • [*retweet @jonathanrockoff*] 17 dietary supplement makers are getting letters from @US_FDA alleging they are illegally selling products for Alzheimer’s and other diseases with improper claims, @JaredSHopkins reports https://www.wsj.com/

    • FDA finalizes guidance to strengthen its recall processes https://www.medtechdive.com

    @FrankYiannasFDA

    • THREAD: Since the Dietary Supplement Health and Education Act (DSHEA) was created over 25 years ago, the dietary supplement industry has evolved in more ways than imagined. And with those changes, #FDA’s policies, regulations and enforcements must change as well.

    • Today, @SGottliebFDA announced new plans that #FDA will be rolling out soon to address how we plan to take DSHEA into the 21st century with new efforts that will keep the American public safe from dishonest supplement claims: https://go.usa.gov/xEnDj

    • #FDA’s new efforts focus on communicating to the public as soon as possible when there is a concern about a dietary supplement & ensuring our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation.

    • We’ll also continue working closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.

    • As part of these efforts, today #FDA also warned consumers to watch out for products falsely claiming to cure Alzheimer’s disease and other, serious conditions. We’ll continue to take such actions to protect public health: https://go.usa.gov/xEnDZ

    • [*retweet @Zlatimeyer] Your dietary supplements are about to get safer, as FDA does first overhaul in 25+ years https://www.usatoday.com/story/money/2019/02/11/dietary-supplements-grow-safer-first-fda-overhaul-25-years/2835763002/ … via @usatodaymoney

    • [*retweet @NYTHealth*] The F.D.A. warns dietary supplement sellers to stop claiming their powders and pills can cure Alzheimer's and other diseases. It wants Congress to toughen current laws to regulate the booming industry.https://www.nytimes.com/

    @FDASpox

    • 3 in 4 American consumers take a dietary supplement, spending $40 billion annually on those products. Today, #FDA is announcing new & reformed efforts to strengthen regulation of dietary supplements to protect the public from unsafe products: https://go.usa.gov/xEnDj

    • As part of our efforts, today #FDA also warned 17 companies for products falsely claiming to cure Alzheimer’s disease & other serious diseases/health conditions, including diabetes & cancer. We’ll continue working to end this practice: https://go.usa.gov/xEnDZ

    @FDArecalls

    • World Waters Issues Voluntary Recall of Select WTRMLN WTR Original 12 Packs Due To The Possible Presence of Soft Plastic Pieces. Company Urges Consumers to Check Packages Prior to Consumption http://dlvr.it/QygPqn

    @US_FDA

    • FDA posted 12 #warningletters & 3 #advisoryletters to companies illegally selling products making unproven drug claims to prevent, treat/cure #Alzheimers disease. Products are marketed & sold online & on social media without FDA approval. #healthfraud https://go.usa.gov/xEnB5


  • February 15, 2019 1:52 PM | Amy Bonsell (Administrator)

    February 11, 2019

    Federal Register

    Food and Drug Administration

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals:

    Food Contact Substance Notification Program

    Filed on: 02/11/2019 at 8:45 am Scheduled Pub. Date: 02/12/2019

    FR Document: 2019-01977 PDF 7 Pages (97.9 KB) Permalink

     

    FDA

    Additional Resources Support Compliance with the Produce Safety Rule

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    02/08/2019

    Bird Seed Food Co.

    Granola-Goldenola Turmeric & Ginger

    Undeclared cashews

    Bird Seed Food Co.

    02/08/2019

    McDaniel Life-Line

    Indian Herb (topical)

    marketed without an approved NDA/ANDA

    McDaniel Life-Line LLC

     

    FSIS

    AskFSIS: Noncompliance records (NR) association - enforcement

    Feb 08, 2019 | PDF

    • FSIS Names New Deputy Chief Financial Officer
    • FSIS Posts Updated Dataset on Imports
    • Establishment Specific Datasets Now Available
    • Reminder: Consumer Food Safety Education Conference to Be Held March 6-8, 2019

     

    Recalls

    Product Recalled

    Date of Recall

    Retail Distribution List

    014-2019 VICS Acquisition, LLC Recalls Chicken Products due to Misbranding and Undeclared Allergens

    Feb 10, 2019

     

    008-2019 Perdue Foods, LLC Recalls Refrigerated Fun Shapes Chicken Breast Nuggets Due to Misbranding and Undeclared Allergens | En Español

    Jan 28, 2019

    Feb 08, 2019

     

    @FrankYiannasFDA

    @FDAfood

    • ·        #RECALL UPDATE: Additional products linked to #tahini products with #Salmonella. Voluntarily recall includes Soom Foods 12 oz. Chocolate Sweet Tahini Halva Spread & Baron’s brand tahini. For list of recalled products >> http://go.usa.gov/xP6va
    • ·        [*retweet @SOToxicology] SOT and @FDAfood holding colloquium on redesigning rodent bioassays for risk assessment on Feb 20. Register to attend on-site or via webcast: http://bit.ly/2ShpAol

    @FDArecalls

    • ·        McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Indian Herb http://dlvr.it/QyVkb5
    • ·        Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger http://dlvr.it/QyW39c


  • February 08, 2019 3:47 PM | Amy Bonsell (Administrator)

    February 7, 2019

    Federal Register

    Food and Drug Administration

    Notices

    Guidance:

    Public Warning and Notification of Recalls

    Filed on: 02/07/2019 at 8:45 am Scheduled Pub. Date: 02/08/2019

    FR Document: 2019-01603 PDF 6 Pages (101 KB) Permalink

     

    Environmental Protection Agency

    Notices

    Certain New Chemicals or Significant New Uses:

    Statements of Findings for September 2018

    Filed on: 02/07/2019 at 8:45 am  Scheduled Pub. Date: 02/08/2019

    FR Document: 2019-01535 PDF 6 Pages (104 KB) Permalink

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    Retail Distribution List

    006-2019 Stino Da Napoli Recalls Various Meat Products Produced without Benefit of Inspection | En Español

    Jan 23, 2019

    Feb 06, 2019

    002-2019 Perdue Foods LLC Recalls Simplysmart Organics Gluten Free Chicken Nugget Products Due to Possible Foreign Matter Contamination | En Español

    Jan 17, 2019

    Feb 06, 2019

     

    GRAS Notices

    GRAS No.

    Substance

    827

    Preparation containing three bacterial phages specific to several Escherichia coli serotypes

    826

    Dihydroquercetin

    825

    Beta-galactosidase from Kluyveromyces lactis

    824

    Salmocin

    823

    Rebaudioside E

    822

    Curcumin

    821

    Glucosylated steviol glycosides

    820

    Lactobacillus fermentum CECT5716

     

    OMB

    AGENCY: USDA-APHIS

    RIN: 0579-AE47

    Status: Pending Review

    TITLE:Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms

    STAGE: Proposed Rule

    ECONOMICALLY SIGNIFICANT: No

    ** RECEIVED DATE: 02/06/2019

    LEGAL DEADLINE: None  

     

    @FDAfood

    • ·        Registered for the Consumer Food Safety Education Conference (CFSEC 2019)? We’re looking at you > academia, government, industry, consumer advocacy groups & professional organizations! Sign-up before Feb 7 for 12% discount! http://cfsec2019.fightbac.org  #foodsafety2019

    @FDA_ORA

    • ·        The Nutrition Facts label that you see on packaged foods or when preparing a meal has undergone a makeover. Last fall, FDA made changes to these labels to reflect updated scientific findings to help you make more informed choices about the foods you eat. https://go.usa.gov/xPHeJ 

    February 8, 2019

    Federal Register

    Food and Drug Administration

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals

    Filed on: 02/08/2019 at 8:45 am Scheduled Pub. Date: 02/11/2019

    FR Document: 2019-01812 PDF 2 Pages (86.2 KB) Permalink

    • ·        Several OMB approved information collections, including “Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use”

     

    Food and Nutrition Service

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals:

    Annual State Report on Verification of Supplemental Nutrition Assistance Program Participation

    Filed on: 02/08/2019 at 8:45 am Scheduled Pub. Date: 02/11/2019

    FR Document: 2019-01726 PDF 5 Pages (147 KB) Permalink

     

    FDA

    Paving the Road to Produce Safety Rule Inspections

    Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    Retail Distribution List

    007-2019 Harvest Food Group, Inc. Recalls Poultry Products Due to Misbranding and Undeclared Allergen | En Español

    Jan 25, 2019

    Feb 07, 2019

    004-2019 H & T Seafood, Inc. Recalls Siluriformes Products Produced without Benefit of Import Inspection | En Español

    Jan 18, 2019

    Feb 07, 2019

     

    AMS

    USDA Restricts PACA Violators in California, Florida and Georgia from Operating in the Produce Industry

    USDA Cites Sarita Ranch Provission Inc. in California for PACA Violations

    USDA Settles a Case with Beltex Corporation dba Frontier Meats Resulting in a $8,400 Penalty

    USDA Proposes Amendments to Regulations Governing Meats, Prepared Meats, and Meat Products (Grading, Certification, and Standards)

     

     

    @SGottliebFDA

    • ·        Today, we took another important step by issuing final guidance on public warnings and notifications of many FDA-regulated product recalls. It outlines situations where #FDA will more actively warn the public of recalls/safety issues https://go.usa.gov/xENQh
    • ·        FDA finalizes guidance on public recall warnings - POLITICO

     

    @FrankYiannasFDA

     

    @FDASpox

    • ·        Today, the #FDA took yet another meaningful step in improving our recall processes of many FDA-regulated products by announcing final guidance on public warnings and notifications of recalls. Read more about it in a statement from @SGottliebFDA https://go.usa.gov/xENQh
    • ·        In our latest #FDAVoices, read more about FDA’s unprecedented amount of outreach, visiting farms and regulatory partners all over the world to get feedback and insights on the most effective and feasible ways to prevent produce contamination. https://go.usa.gov/xEN2T

     

    @FDAanimalhealth

    • ·        In recent months, there have been multiple pet food recalls due to potentially toxic levels of vitamin D in dog food.
    • ·        In November 2018, 9 brands of dry dog food were recalled https://go.usa.gov/xENUa
    • ·        In January 2019, >20 varieties of Hill’s Science Diet & Prescription Diet canned (not dry) dog food were recalled https://go.usa.gov/xENUK
    • ·        Pet owners should STOP FEEDING these recalled products immediately & contact a vet if their dog shows symptoms of vitamin D toxicity.
    • ·        FDA is working with manufacturers to investigate the issue & make sure corrective steps are taken.
    • ·        Contact your vet if your dog shows symptoms such as: vomiting, ↓appetite, ↑thirst, ↑urination, excessive drooling, weight loss. These may be signs of vitamin D toxicity, which can lead to kidney failure & death.
    • ·        If a vet determines that your dog has vit. D toxicity & suspects it’s related to dog food, report it to FDA. Here’s how: https://go.usa.gov/xENH5  Be sure to include brand, lot #, best by date.
    • ·        When reporting a pet food-related issue to FDA, please be sure to include as much detail as possible – especially the LOT NUMBER & BEST BY DATE from the packaging https://go.usa.gov/xENH5 . This critical info can help us save lives!
    • ·        Tip: When you purchase new pet food, use your phone to snap a photo of the lot number and best by date – just in case.


  • February 08, 2019 3:45 PM | Amy Bonsell (Administrator)

    February, 4, 2019

    Federal Register

    Agriculture Department

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals

    Filed on: 02/04/2019 at 8:45 am Scheduled Pub. Date: 02/05/2019

    FR Document: 2019-01040  PDF  4 Pages (115 KB) Permalink

    • Ø  Export certificate request forms under Dairy Grading Branch

    Filed on: 02/04/2019 at 8:45 am Scheduled Pub. Date: 02/05/2019

    FR Document: 2019-01054 PDF 5 Pages (118 KB) Permalink

    • Ø  Regarding pasteurized eggs and FSIS compliance

     

    Agricultural Marketing Service

    Proposed Rules

    Meats, Prepared Meats, and Meat Products (Grading, Certification, and Standards)

    Filed on: 02/04/2019 at 8:45 am Scheduled Pub. Date: 02/05/2019

    FR Document: 2019-00869  PDF  36 Pages (471 KB)  Permalink

     

    Environmental Protection Agency

    Proposed Rules

    Tolerance and Tolerance Exemption Actions:

    Fenoxaprop-ethyl, Flufenpyr-ethyl, Imazapyr, Maleic hydrazide, Pyrazon, Quinclorac, Triflumizole, et. al.

    Filed on: 02/04/2019 at 8:45 am Scheduled Pub. Date: 02/05/2019

    FR Document: 2019-00787 PDF 25 Pages (439 KB) Permalink

     

    USDA

    Canadian, Mexican Agriculture Leaders to Take Part in USDA’s 2019 Outlook Forum

     

    FSIS

    Feb 01, 2019 | PDF

    • FSIS Welcomes New Deputy Under Secretary for Food Safety
    • Label Backlog Update and Tips for the Label Approval Process
    • Delay in FSIS’ Plans to Discontinue PFGE for E. coli and Move to WGS as the Primary Characterization Tool
    • Updates to the FSIS Microbiology Laboratory Guidebook
    • FSIS Posts Individual Category Status and Aggregate Results for Poultry Carcasses, Chicken Parts, and Comminuted Poultry Tested for Salmonella

    Recalls

    Product Recalled

    Date of Recall

    Retail Distribution List

    011-2019 Taylor Farms TX, Inc. Recalls Chicken Products Due To Misbranding And Undeclared Allergens

    Feb 02, 2019

    N/A (Class II Recall)

    010-2019 Pilgrim’s Pride Corporation Recalls Breaded Popcorn Chicken Products Due To Possible Foreign Matter Contamination

    Feb 01, 2019

    No retail sales

    009-2019 Tyson Foods, Inc. Recalls Chicken Nugget Products due to Possible Foreign Matter Contamination

    Jan 29, 2019

    Feb 01, 2019

    003-2019 Johnsonville, LLC Recalls Raw Ground Frozen Cheddar Cheese and Bacon Flavored Pork Patty Products Due to Possible Foreign Matter Contamination | En Español

    Jan 18, 2019

    Feb 01, 2019

     

    APHIS

    APHIS Requests Public Comment on the Draft Environmental Impact Statement for the Grasshopper and Mormon Cricket Suppression Program

     

    FTC

    FTC Returns More Than $6 Million to Consumers Who Bought Deceptively Marketed Health Products from Tarr, Inc. (dietary supplements and skincare products)

     

    @FrankYiannasFDA

    @FDA_ORA

    • Ø  To Eat or Not to Eat? That is the question! Are all the decorative glitters and dusts you use on cakes & cookies safe to eat? Sometimes they are, sometimes they are not. LEARN MORE in this #FDAConsumerUpdate: https://go.usa.gov/xE3Dz

    February 5, 2019

    Federal Register

    Agriculture Department

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals

    Filed on: 02/05/2019 at 8:45 am Scheduled Pub. Date:02/06/2019

    FR Document: 2019-01148 PDF 3 Pages (114 KB) Permalink

    • ·        National Agricultural Statistics Service: Egg, Chicken, and Turkey Surveys

     

    Filed on: 02/05/2019 at 8:45 am Scheduled Pub. Date: 02/06/2019

    FR Document: 2019-01305 PDF 3 Pages (86.9 KB) Permalink

    • ·        National Agricultural Statistics Service: On-farm and Off-farm Stock Reports

     

    Agricultural Marketing Service

    Rules

    Assessment Rates:

    Oranges, Grapefruit, Tangerines, and Pummelos Grown in Florida

    Filed on: 02/05/2019 at 8:45 am Scheduled Pub. Date: 02/06/2019

    FR Document: 2019-01141 PDF 14 Pages (246 KB) Permalink

     

    Raisins Produced from Grapes Grown in California

    Filed on: 02/05/2019 at 8:45 am Scheduled Pub. Date: 02/06/2019

    FR Document: 2019-01139 PDF 13 Pages (142 KB) Permalink

     

    Environmental Protection Agency

    Proposed Rules

    Pesticide Petitions:

    Residues of Pesticide Chemicals in or on Various Commodities

    Filed on: 02/05/2019 at 8:45 am Scheduled Pub. Date: 02/06/2019

    FR Document: 2019-01108 PDF 6 Pages (166 KB) Permalink

    • ·        5 pesticide petitions, including one of each: amended tolerance for non-inert, new tolerance exemption for inert, new tolerance exemption for non-inert, new tolerance for inert, new tolerance for non-inert

     

    Animal and Plant Health Inspection Service

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals:

    Federal Plant Pest and Noxious Weeds Regulations

    Filed on: 02/05/2019 at 8:45 am Scheduled Pub. Date: 02/06/2019

    FR Document: 2019-01144 PDF 4 Pages (96.6 KB) Permalink

    • ·        Reinstatement of Information Collection
    •  

    Standards for Privately Owned Quarantine Facilities for Ruminants

    Filed on: 02/05/2019 at 8:45 am Scheduled Pub. Date: 02/06/2019

    FR Document: 2019-01145 PDF 4 Pages (174 KB) Permalink

    • ·        Reinstatement of Information Collection

     

    FDA

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    02/04/2019

    Stacy's

    Pita Chips

    Undeclared milk

    Frito-Lay

    02/04/2019

    Whole Foods Market

    Hipster Chipster Cookies

    Undeclared Milk, Egg, Walnuts

    Whole Foods Market

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    012-2019 Q's American Best Trading Inc. Recalls Siluriformes Products Produced Without Benefit of Import Inspection

    Feb 04, 2019

     

    AMS

    USDA Announces the Availability of Support for States to Improve Agricultural Marketing Efforts

     

    @FrankYiannasFDA

    • ·        Enhanced supply chain traceability & transparency is the equivalent to ‘shining a light’ on each segment of the food system. It will drive accountability & help deter undesired behaviors & practices. Better traceability can’t wait. #traceability https://www.optelgroup.com/tracabilite

     

    @FDArecalls

    • ·        Allergy Alert Issued by Santa Rosa Whole Foods Market for Undeclared Walnut, Milk and Eggs in “Hipster Chipster” Cookies http://dlvr.it/QyBZLx

    Frito-Lay Issues Voluntary Allergy Alert on Undeclared Milk In Small Number of Stacy’s Simply Naked Pita Chips http://dlvr.it/QyBvLZ


  • February 01, 2019 3:02 PM | Amy Bonsell (Administrator)

    January 28, 2019

    FDA

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    01/24/2019

    Jac. Vandenberg, Inc.

    Peaches, nectarines, plums

    Listeria monocytogenes

    Jac. Vandenberg, Inc.

    01/24/2019

    Thrive Market

    Several varieties of nut butters

    Potentially contaminated with Listeria monocytogenes

    Thrive Market Inc.

    01/18/2019

    Mrs. Grissom’s Select

    Old Fashioned Pimento Cheese

    Undeclared Milk

    Mrs. Grissom’s Salads

     

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    007-2019 Harvest Food Group, Inc. Recalls Poultry Products Due to Misbranding and Undeclared Allergen

    Jan 25, 2019

     

    @FrankYiannasFDA

    @FDArecalls

    • ·        Jac. Vandenberg, Inc. Recalls Fresh Peaches, Fresh Nectarines and Fresh Plums Because They May Be Contaminted with Listeria Monocytogenes http://dlvr.it/QxTJ1m
    • ·        Mrs. Grissom’s Salads Issues a Voluntary Recall http://dlvr.it/QxVV6t

    January 29, 2019

    USDA

    Perdue Selects Three Senior Leaders at USDA

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    008-2019 Perdue Foods, LLC Recalls Refrigerated Fun Shapes Chicken Breast Nuggets Due to Misbranding and Undeclared Allergens

    Jan 28, 2019

     

    @FrankYiannasFDA

    Congratulations to Dr. Mindy Brashears for being appointed by @SecretarySonny to serve as Deputy Under Secretary for Food Safety @USDA. We @US_FDA look forward to working with you. Advancing food safety requires collaboration. https://www.usda.gov/media/press-releases/2019/01/28/perdue-selects-three-senior-leaders-usda … @SGottliebFDA @FDAfood

    January 30, 2019

    Federal Register

    Agricultural Marketing Service

    Proposed Rules

    Irish Potatoes Grown in Colorado:

    Handling Regulation for Area No. 2

    Filed on: 01/30/2019 at 8:45 am Scheduled Pub. Date: 01/31/2019

    FR Document: 2019-00553  PDF 17 Pages (271 KB) Permalink

     

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals:

    Commodities Covered by the Livestock Mandatory Reporting Act of 1999

    Filed on: 01/30/2019 at 8:45 am Scheduled Pub. Date: 01/31/2019

    FR Document: 2019-00548  PDF  5 Pages (116 KB) Permalink

     

    FDA

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    01/28/2019

    Oskri

    Nut Butters

    Listeria monocytogenes

    Oskri Organics Corporation

    12/28/2018

    Purina

    Lamb chow

    Elevated copper level

    Purina Animal Nutrition

     

    Warning Letters

    Letter Issue Date

    Company Name

    Issuing Office

    Subject

    Close Out Date

    11/29/2018

    Gonzalez and Nietos, LLC

    San Juan District Office

    Seafood HACCP/CGMP for Foods/Adulterated

    Not Issued *

    11/15/2018

    H & H Products Company

    San Juan District Office

    Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

    Not Issued *

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    009-2019 Tyson Foods, Inc. Recalls Chicken Nugget Products due to Possible Foreign Matter Contamination

    Jan 29, 2019

     

    FTC

    Court Rules in FTC’s Favor in Case against Weight-loss Supplement Marketer Roca Labs

     

    @FrankYiannasFDA

    • ·        AI system, couple with video cameras & automated analysis, successful in identifying desired and undesired behaviors in kitchens in China. Digital 24/7 monitoring. A new era of Smarter Food Safety is dawning. https://sc.mp/4xae3  #AI #IoT #smarterfoodsafety

    @USDAFoodSafety

    • ·        #Recall: Tyson Foods, Inc. Recalls Chicken Nugget Products due to Possible Foreign Matter Contamination http://bit.ly/2MJEYnu

    @FDArecalls

    • ·        Purina Animal Nutrition Voluntarily Recalling Purina® Honor® Show Chow® Showlamb Grower Due to Elevated Copper Level http://dlvr.it/Qxm2J8 
    • ·        Oskri Organics Corporation Recalls All Nut Butters because of Possible Health Risk http://dlvr.it/Qxm2FH 

     


  • January 25, 2019 1:21 PM | Amy Bonsell (Administrator)

    January 22, 2019

    FDA

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    01/17/2019

    Ottogi

    Various noodle products

    Undeclared egg

    Ottogi America, Inc.

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    005-2019 Custom Made Meals, LLC Recalls Chicken Skewer Products Due to Misbranding and Undeclared Allergens

    Jan 18, 2019

    004-2019 H & T Seafood, Inc. Recalls Siluriformes Products Produced without Benefit of Import Inspection

    Jan 18, 2019

    003-2019 Johnsonville, LLC Recalls Raw Ground Frozen Cheddar Cheese and Bacon Flavored Pork Patty Products Due to Possible Foreign Matter Contamination

    Jan 18, 2019

    002-2019 Perdue Foods LLC Recalls Simplysmart Organics Gluten Free Chicken Nugget Products Due to Possible Foreign Matter Contamination

    Jan 17, 2019

     

    APHIS

    USDA Confirms Virulent Newcastle Disease in Backyard Exhibition Birds in Utah, Not a Food Safety Concern

     

    @SGottliebFDA

    • ·        THREAD: We've received multiple inquiries about which critical food operations continue during the shutdown. Examples of the work that we're still doing include: 1) High-risk domestic food surveillance inspections; 2) foodborne illness surveillance and outbreak investigations;
    • ·        3) Execution of high-risk food recalls; 4) Inspection of foreign food facilities; and 5) Sampling of imported food samples (including sampling for antibiotic residue contamination and decomposition analysis). These are among critical activities ongoing by dedicated, unpaid staff.
    • ·        SHUTDOWN UPDATE: We’ve been recalling inspectors to perform critical, high risk food safety inspections. We’ve been asked how many dedicated colleagues are currently working on these unpaid assignments. More people are on the way. Here’s a current snapshot of our field resources:
    • ·        So far we’ve called back about 100 investigators and 35 supervisors to conduct and support domestic food surveillance inspections of high risk products. These professionals are in addition to FDA staff who were already working high-risk inspections, like foreign food assignments.
    • ·        In addition, at #FDA’s Office of Import and Enforcement Operations, which cover International Mail Facilities and ports of entry, we have about 450 FDA staff in the field - including investigators, compliance experts and supervisors - supporting these critical safety operations
    • ·        More staff could be on the way depending on needs. This is a snapshot of some of our current inspection work on high-risk assignments. Taken together, it's smaller than our usual footprint. But we’re targeting the riskiest products to make sure that Americans remain protected.

    @FrankYiannasFDA

    @SecretarySonny

    • ·        There's understandable concern about child nutrition programs, but this needs to be clear: USDA’s child nutrition programs are funded quarterly and are fully funded through the end of March. Includes National School Lunch, School Breakfast, and Child & Adult Care Food programs.

    @FDArecalls

    Ottogi America, Inc. Issues Allergy Alert on Undeclared Egg in Products http://dlvr.it/Qx15Q9

    January 24, 2019

    FDA

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    01/23/2019

    Satur Farms

    Baby Spinach and Mesclun

    Product potentially contaminated with Salmonella

    Satur Farms

    01/23/2019

    Gold Medal

    Unbleached Flour

    Potential Salmonella contamination

    General Mills

    01/23/2019

    Simple Truth Organic

    Fruit Puree with Nonfat Greek Yogurt pouch

    Undeclared Milk

    Perrigo Company

     

    FSIS

    Notices

    Number

    Title

    Date Issued

    Expiration Date

    01-19

    Extension of Delayed Implementation of Verification of Revised Appendix A and B

    Jan 23, 2019

    Feb 01, 2020

    Recalls

    Product Recalled

    Date of Recall

    006-2019 Stino Da Napoli Recalls Various Meat Products Produced without Benefit of Inspection

    Jan 23, 2019

     

    APHIS

    USDA Restricts PACA Violators in Florida and New York from Operating in the Produce Industry

     

    Food & Water Watch

    "Inspected and Passed"? No, Despite What Labels Say

     

    @SGottliebFDA

    • ·        General Mills is conducting a voluntary national recall of five-pound bags of Gold Medal Unbleached Flour with a better if used by date of April 20, 2020. The recall is because of potential presence of Salmonella. FDA is investigating and working with General Mills on the recall.

    @FrankYiannasFDA

    • ·        During the partial shutdown, @US_FDA continues to promptly respond to recalls. General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour. More info at http://dlvr.it/QxLqWc

    @FDArecalls

    • ·        Perrigo Issues Allergy Alert For Simple Truth Organic Banana, Strawberry & Apple Puree With Nonfat Greek Yogurt http://dlvr.it/QxLqW1
    • ·        General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour http://dlvr.it/QxLqWc
    • ·        Product Recall Because of Possible Health Risk http://dlvr.it/QxLqWv

     

    January 25, 2019

    FDA

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    01/24/2019

    Whole Foods market

    Pizza, sandwiches, wraps, etc.

    Product potentially contaminated with Salmonella

    Whole Foods Market

     

    FSIS

    FSIS Directive 9900.5 Revision 1: Label Verification of Imported Meat Poultry and Egg Products

     

    APHIS

    USDA Continues Restrictions of a PACA Violator in South Dakota from Operating in the Produce Industry

     

     

    CVM

    FDA Cautions Pet Owners Not to Feed One Lot of Hare Today Gone Tomorrow Due to Salmonella and Listeria monocytogenes

     

    @SGottliebFDA

    • ·        General Mills is conducting a voluntary national recall of five-pound bags of Gold Medal Unbleached Flour with a better if used by date of April 20, 2020. The recall is because of potential presence of Salmonella. FDA is investigating and working with General Mills on the recall.
    • ·        #FDA is cautioning pet owners not to use lot 12.04.2018 of Hare Today Gone Tomorrow Ground Chicken/Bones/Organs after it tested positive Salmonella and Listeria monocytogenes. https://go.usa.gov/xEBDj
    • ·        The affected product is labeled as Ground Chicken and sold online as Ground Chicken/Bones/Organs. Salmonella and Listeria monocytogenes can affect both human and animal health.
    • ·        If you have symptoms of infection, consult your health care providers. Consult a veterinarian if your pet has symptoms. #FDA has info on the symptoms here: https://go.usa.gov/xEBDj
    • ·        Pets can get sick from bacteria and may also be carriers of it and pass it onto their human companions without appearing to be ill. #FDA is aware of recent cases in which humans and/or animals have gotten sick from exposure to contaminated pet foods.
    • ·        #FDA is concerned about pathogens like these in any pet food. This lot of pet food poses a serious threat to human/animal health. If you have Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, lot 12.04.2018, stop feeding it to your pets.
    • ·        There are several steps consumers should take to reduce the risk of infection to human and animal health. Start by throwing away the product in a secure container where other animals cannot access it.
    • ·        Clean where product was stored; clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors and any other surfaces that the food or pet may have had contact with. Also, clean up pet’s feces in yards or parks where people or other animals may be exposed

    @FrankYiannasFDA

    • ·        Study, ‘machine learning’ may help determine authenticity of tested honey samples. A New Era of Smarter Food Safety & Food Testing is dawning. #AI #MachineLearning #technology

    @FDArecalls

    • ·        Satur Farms’ Recall of Baby Spinach Affects Prepared Food Items from Whole Foods Market Stores in Eight States http://dlvr.it/QxRH9h

     


  • January 18, 2019 1:12 PM | Amy Bonsell (Administrator)

    January 14, 2019

    AMS

    USDA Cites Farmers Best of NYC Inc in New York for PACA Violations

     

    @SGottliebFDA

    • ·        THREAD - SHUTDOWN UPDATE: The lapse in funding represents one of the most significant operational challenges in FDA’s recent history. But as an agency, we’re committed to fulfilling our consumer protection mandate, to the best of our abilities, under our current configuration.
    • ·        We analyzed activities with close input from senior career leaders & public health experts. Our plans always included activities to address immediate threats to human life & safety. But as lapse continues we’re evaluating additional activities we need to except to prevent threats
    • ·        FDA determined after careful analysis and in close consultation with senior career leaders and public health experts that the following activities should be considered excepted, unpaid work because they’re necessary to identify and respond to threats to safety of human life:
    • ·        The additional activities may be considered excepted work during a shutdown. Given the prolonged shutdown and compounding risk as time accrues; FDA is working to operationalize additional activities that exceed what we’ve done in past shutdown situations. Activities include:
    • ·        Expanded inspection activities beyond “for-cause” inspections to also include foreign and domestic food, drug, medical, device and pharmacy compounding surveillance inspections focused on the highest risk products and facilities;
    • ·        Expanded monitoring and analysis by the Coordinated Outbreak and Response Evaluation (CORE) Network to include additional food safety and foodborne illness outbreak surveillance, detection, and response activities;
    • ·        Surveillance sampling of imported high-risk foods, drugs, and devices, and the logistical coordination and laboratory support for allowable inspections and evaluation;
    • ·        Expanded monitoring and evaluating medical device adverse event and malfunction reports to include additional types of medical devices;
    • ·        Expanded activities related to surveillance and response for recalls (including Class I and Class II) as necessary to identify and respond to threats to the safety of human life;
    • ·        It is not business as usual at FDA. Many key functions aren't getting done. But we're focused on maintaining core activities that directly impact consumer safety and save lives. My priority is to our consumer protection mission and the people executing mission critical functions
    • ·        In the coming days, we’ll update on some additional activities that the #FDA plans to continue undertaking, especially activities related to veterinary health issues that have a direct impact on human life and safety.

     

    @FrankYiannasFDA

     

    January 15, 2019

    @SGottliebFDA

    • ·        UPDATE ON FOOD INSPECTIONS AND OTHER INSPECTION ACTIVITY: The response from our outstanding field force and inspectorate has been overwhelming and outstanding. They're among the finest, most dedicated professionals in our federal workforce and we're grateful for their service ->
    • ·        We re-starting high risk food inspections as early as tomorrow. We'll also do compounding inspections this week. And we started sampling high risk imported produce in the northeast region today. We'll expand our footprint as the week progresses. Our teams are working.
    • ·        This work is being done by an inspectorate that's largely going unpaid. These men and women are the tip of the spear in our consumer protection mission. They're the very front line. And they're on the job. The entire nation owes them gratitude. I'm inspired by their dedication.
    • ·        With the support of our dedicated field force, we're recalling hundreds of furloughed colleagues to conduct inspections of high risk food facilities and other entities; working on mostly unpaid inspection assignments, led by #FDA's outstanding inspectorate https://www.nbcnews.com/
    • ·        Behind the efforts of our dedicated field force, we'll be restarting inspections of high risk food and medical product facilities as early as tomorrow. And sampling assignments at ports of entry re-started today. https://www.bloomberg.com/
    • ·        This was a major functional accomplishment amidst one of the biggest operational challenges in FDA’s modern history and it was fully enabled by the leadership of FDA’s field force and the colleagues who serve the country on the front lines of that mission. https://www.nytimes.com/
    • ·        #FDA is alerting pet owners not to feed their dogs certain A+ Answers Straight Beef Formula because it may be contaminated with Salmonella. Specifically, Lot 2018 20/08 20, tested positive for Salmonella by Nebraska state officials. Salmonella can be harmful to humans and animals. The company recalled the product from distribution and retail locations in Nebraska late last month but has not recalled the product nationwide. Read more here: https://go.usa.gov/xEjGn .

     

    @FrankYiannasFDA

     

    CVM

    FDA Cautions Pet Owners Not to Feed One Lot of A+ Answers Straight Beef Formula for Dogs Due to Salmonella

    FDA

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    01/15/2019

    RXBAR

    RXBAR bars-several varieties

    Undeclared Peanut

    RXBAR

    01/15/2019

    El Guapo

    Chile Habanero and Pasilla-Ancho Chile Pods

    unlabeled peanut allergen

    Mohave Foods Corporation

     

    GAO

    SNAP: Actions Needed to Better Measure and Address Retailer Trafficking

     

    NTP

    NTP Update - January 2019

     

    @FDArecalls

    • ·        RXBAR Recalls Certain Varieties of Bars Due to a Potential Undeclared Peanut Allergen http://dlvr.it/QwmZNl
    • ·        Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen http://dlvr.it/QwmZNB

    January 17, 2019

    @Scott Gottlieb, M.D.

    • ·        THREAD: Some of the dedicated FDA staff of our Office of Regulatory Affairs at work, unpaid, in our Philadelphia lab. We’ve restarted high risk food sampling assignments and other critical surveillance activity. Among many hardships our people are overcoming right now ....
    • ·        .... one of the hardest challenges is to find yourself on furlough. All of our colleagues are critical; all do critical work to advance public health. I highly value each and every one of you, the institution depends on all of you....
    • ·        .... You’re valued each day. But it’s even more the case that in moments of challenge, when some of our work stops, that your critical role becomes so obvious. FDA can’t achieve its full mission without each of you; whether you’re exempt, excepted, or on furlough. We’re one FDA.

     

    @FrankYiannasFDA

     

    January 18, 2019

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    002-2019 Perdue Foods LLC Recalls Simplysmart Organics Gluten Free Chicken Nugget Products Due to Possible Foreign Matter Contamination

    Jan 17, 2019

     

     

    @SGottliebFDA

    • ·        .@US_FDA continues to take actions to prevent future foodborne outbreaks through surveillance sampling. Here, an #FDA Consumer Safety Officer in Nogales, AZ, collects a sample of fresh produce (sweet peppers) to be analyzed by an FDA laboratory for microbiological contamination.
    • ·        THREAD: We appreciate US PIRG’s interest in the safety of the nation’s food system and we always welcome a larger conversation on the topic. Public health is our top priority and FDA is working hard to ensure the U.S. food supply remains among the safest in the world.
    • ·        While we agree with the premise that prevention is always better than a corrective action, such as executing a recall, there should be caution in using recall numbers alone as the sole metric for gauging long-term performance trends in food safety.
    • ·        Dramatic improvements in new tools to detect foodborne pathogens has likely resulted in an increased # of recalls. The complexity of supply chain for foods has also increased so one contaminated ingredient can trigger many recalls, which can affect the overall number of recalls.
    • ·        FDA ensures that recalls by companies – voluntary or involuntary – are initiated, overseen, and completed promptly and effectively, and that consumers have timely, actionable information to protect themselves and their families.
    • ·        Even during the lapse in funding, we're continuing to support recalls as necessary to identify and respond to threats to the safety of human life, and activities for the surveillance and inspection of high-risk foods.
    • ·        Over the past year, #FDA has made several key policy changes to improve and modernize its food recall processes -- with a focus on providing more meaningful information to consumers.
    • ·        More actions to improve our recall policies are planned, including ways to further improve our ability to track and trace products through the supply chain. We’ll continue to communicate on these efforts in the coming year.


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