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  • June 21, 2019 8:43 AM | Amy Bonsell (Administrator)

    June 19, 2019

    Federal Register

    Food and Drug Administration

    Notices

    Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds

    Filed on: 06/19/2019 at 8:45 am Scheduled Pub. Date: 06/20/2019

    FR Document: 2019-13122 PDF 5 Pages (34.6 KB) Permalink

     

    Animal and Plant Health Inspection Service

    Proposed Rules

    Swine Health Protection Act; Amendments to Garbage Feeding Regulations

    Filed on: 06/19/2019 at 8:45 am Scheduled Pub. Date: 06/20/2019

    FR Document: 2019-13154 PDF 7 Pages (186 KB) Permalink

     

    Environmental Protection Agency

    Rules

    Tolerance Exemptions:

    Melamine formaldehyde polycondensate resin

    Filed on: 06/19/2019 at 8:45 am Scheduled Pub. Date: 06/20/2019

    FR Document: 2019-12994 PDF 12 Pages (242 KB) Permalink

     

    FDA

    Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products

    Statement on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    06/17/2019

    Mai sushi my way

    Spicy shrimp tempura crunch roll, Spicy shrimp tempura roll

    Undeclared eggs

    Mai Cuisine Inc.

    Warning Letters

    Posted Date

    Letter Issue Date

    Company

    Issuing Office

    Subject

    06/18/2019

    06/06/2019

    PRL Inc

    Division of Human and Animal Food Operations East V

    CGMP/Dietary Supplement/Adulterated/Misbranded

    06/18/2019

    06/07/2019

    Earthworks Health

    Office of Human and Animal Food- West Division II

    Unapproved New Drugs/Misbranded

     

    AMS

    USDA Partners with U.S. Farmers and Ranchers Alliance to Promote U.S. Agriculture

    AMS Issues Complaint against Clinton Livestock Auction LLC, Sandra Berry and Jack Blake Berry

    AMS Reaches a Consent Decision and Civil Penalty with Cargill Meat Solutions Corporation

    AMS Issues Complaint against Michael J. Rogers

     

    FNS

    USDA Applauds Recent Settlement Regarding SNAP Quality Control Misconduct

     

    @FrankYiannasFDA

    • ·       Smarter Food Safety = People-led + FSMA-based + Technology-enabled. Thanks @QAMagazine for your interest in this new era. It will require all of us - public & private sectors - working together. https://t.co/mFrgcbb2i2
    • ·       Today, #FDA is providing guidance for the declaration of added #sugars for single-ingredients sugars & syrup & certain cranberry products as part of the process of updating the Nutrition Facts Label. Background & my full statement are here > https://go.usa.gov/xy33z

    @FDAMedia

    • ·       1/5 FDA issued final guidance to provide labeling clarification for the Added Sugars declaration on single-ingredient sugars, syrups & certain cranberry products: https://go.usa.gov/xyqSm
    • ·       2/5 For single-ingredient sugars and syrups, the Nutrition Facts label will now only provide a percent Daily Value for Added Sugars.
    • ·       3/5 Manufacturers may add a “†” symbol on packages & containers of single-ingredient sugars & syrups immediately following the percent Daily Value declaration for Added Sugars.
    • ·       4/5 This symbol leads consumers to info about the gram amount of Added Sugars, as well as info about how that amount of sugar contributes to the percent Daily Value.
    • ·       5/5 For certain cranberry products, where sugar is added and does not exceed the level in a comparable fruit product, the label may indicate that sugar has been added because cranberries are naturally tart. To learn more, check out our new video!

    @US_FDA

    • ·       Sugar is added to a lot of foods & it can be hard not to eat too much of it. It’s important to get less than 10% of your total daily calories from added sugars. Changes to the Nutrition Facts label will let you know how much added sugar you’re eating.

    @FDAfood

    @FDAanimalhealth

    There’s a lot of talk on the internet about CBD for treating dogs who react to loud noises. You should be aware that FDA has NOT evaluated these products and can’t say whether they are safe or effective, how they are manufactured, or whether they contain CBD. https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

    June 20, 2019

    Federal Register

    Food and Drug Administration

    Rules

    Guidance:

    Determining the Number of Employees for Purposes of the Small Business Definition (Current Good Manufacturing Practices and Preventive Controls Regulations for Human and Animal Food)

    Filed on: 06/20/2019 at 8:45 am Scheduled Pub. Date: 06/21/2019

    FR Document: 2019-13223 PDF 6 Pages (179 KB) Permalink

     

    Notices

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

    Substances Generally Recognized as Safe: Notification Procedure

    Filed on: 06/20/2019 at 8:45 am Scheduled Pub. Date: 06/21/2019

    FR Document: 2019-13220 PDF 3 Pages (83.4 KB) Permalink

     

    Threshold of Regulation for Substances Used in Food-Contact Articles

    Filed on: 06/20/2019 at 8:45 am Scheduled Pub. Date: 06/21/2019

    FR Document: 2019-13117 PDF 8 Pages (109 KB) Permalink

     

    Food and Nutrition Service

    Rules

    Supplemental Nutrition Assistance Program:

    Student Eligibility, Convicted Felons, Lottery and Gambling, and State Verification Provisions of the Agricultural Act; Correction

    Filed on: 06/20/2019 at 8:45 am Scheduled Pub. Date: 06/21/2019

    FR Document: 2019-12910 PDF 7 Pages (173 KB) Permalink

     

     

    FDA

    FDA Announces New Qualified Health Claims for EPA and DHA Omega-3 Consumption and the Risk of Hypertension and Coronary Heart Disease

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    06/18/2019

    Signature Select

    Avocado Chunks

    Listeria monocytogenes

    Nature’s Touch Frozen Foods West Inc.

     

    USDA

    USDA World Agricultural Outlook Board Chair Dr. Seth Meyer to Depart

     

    FSIS

    Notices

    Number

    Title

    Date Issued

    Expiration Date

    19-19

    Label Verification of Imported Raw Beef Products Labeled “For Cooking Only” or “For Full Lethality Treatment”

    Jun 19, 2019

    Jul 01, 2020

     

    @FDAMedia


  • June 21, 2019 8:42 AM | Amy Bonsell (Administrator)

    June 18, 2019

    Federal Register

    Environmental Protection Agency

    Notices

    Pesticide Product Registration:

    Applications for New Active Ingredients

    Filed on: 06/18/2019 at 8:45 am Scheduled Pub. Date: 06/19/2019

    FR Document: 2019-12949 PDF 5 Pages (181 KB) Permalink

     

    FDA

    USDA and HHS Invite Oral Public Comments at the Second Meeting of the 2020 Dietary Guidelines Advisory Committee

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    06/17/2019

    Sprouts Farmers Market

    Frozen Cut Leaf Spinach

    Listeria monocytogenes

    Sprouts Farmers Market

     

    FOIA Releases

    Record Date

    FEI Number

    Company

    Record Type

    State

    Establishment Type

    Publish Date

    07/23/2015

    3003051915

    nSpired Natural Foods, Division of the Hain Celestial Group

    483

    Oregon

    Manufacturer

    06/15/2019

    07/24/2015

    2117605

    Plainview Milk Products Cooperative

    483

    Minnesota

    Manufacturer

    06/15/2019

    07/11/2015

    2433583

    Setton International Foods, Inc.

    483

    New York

    Manufacturer and Repacker

    06/15/2019

    07/11/2015

    1832630

    Aunt Mid's Produce Company

    Sample Record

    Michigan

    Ready-to-Eat Produce Manufacturer

    06/15/2019

    07/11/2015

    3002119179

    Peregrina Cheese Company

    483

    New York

    Cheese Manufacturer

    06/15/2019

     

     

    Sparboe Farms Inc.

    483

    Colorado

    Shell Egg Producer

    06/15/2019

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    Retail Distribution List

    068-2019 Pasture Raised Foods, LLC Recalls Raw Whole Poultry Products Produced Without Benefit of Inspection

    Jun 12, 2019

    Jun 17, 2019

    060-2019 Richwell Group, Inc. Recalls Siluriformes Products Produced Without Benefit of Import Inspection | En Español

    May 28, 2019

    Jun 17, 2019

     

    @HHSGov

    • ·       MORE FLOUR RECALLED: Check your home for recalled 5 lb. bags of Pillsbury Best Bread Flour; the flour may be contaminated with E. coli. Return recalled flour to the store or throw it away. Info to identify recalled flour: https://go.usa.gov/xm7YA

    @SecretarySonny

    • ·       Dairy producers have endured a disproportionate amount of stress the last couple of years, but the new Dairy Margin Coverage program will help many better weather the ups and downs of the market. Signup begins today on @FarmersGov: http://ow.ly/sSos50uG6wY

     

     


  • June 21, 2019 8:40 AM | Amy Bonsell (Administrator)

    June 17, 2019

    Federal Register

    Animal and Plant Health Inspection Service

    Rules

    Scrapie in Sheep and Goats; Correction

    Filed on: 06/17/2019 at 8:45 am Scheduled Pub. Date: 06/18/2019

    FR Document: 2019-12820 PDF 2 Pages (156 KB)  Permalink

     

    Environmental Protection Agency

    Rules

    Tolerance Exemption:

    Bacillus amyloliquefaciens subspecies plantarum strain FZB42

    Filed on: 06/17/2019 at 8:45 am Scheduled Pub. Date: 06/18/2019

    FR Document: 2019-12748  PDF 9 Pages (166 KB)  Permalink

     

    Food and Nutrition Service

    Notices

    Meetings:

    2020 Dietary Guidelines Advisory Committee

    Filed on: 06/17/2019 at 8:45 am Scheduled Pub. Date: 06/18/2019

    FR Document: 2019-12806  PDF 7 Pages (203 KB)  Permalink

     

     

    Federal Register

    NOTE federal register website has not yet updated. I will circulate an update in the afternoon if relevant documents are posted.

     

    FDA

    FDA is Committed to Sound, Science-based Policy on CBD

    FDA Releases Decoding the Food Code: Information to Assist the User, an Online Based Training Module

    Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    06/14/2019

    WinCo Foods

    Frozen Red Raspberries

    Norovirus

    WinCo Foods, LLC

    06/14/2019

    Pillsbury BEST

    Flour

    E.coli

    Hometown Food Company

    06/14/2019

    Lay’s

    Potato Chips

    Undeclared Milk

    Frito-Lay North America

    06/14/2019

    Parivar

    Dry Dates

    High Sulfite Content

    SHIVAM DISTRIBUTORS

    GRAS Notices

    GRN No.

    Substance

    847

    Lactobacillus plantarum ECGC 13110402

    846

    Rebaudioside M

    845

    Lactobacillus rhamnosus LGG

    844

    Algal oil (55% docosahexaenoic acid) from Schizochytrium sp. strain FCC-3204

    843

    Algal oil (35% docosahexaenoic acid) from Schizochytrium sp. strain FCC-1324

    842

    Maltogenic alpha-amylase

    841

    Saccharomyces cerevisiae expressing L-lactate dehydrogenase from Rhizopus oryzae

    840

    Lactobacillus paracasei strain F19

    839

    Purified steviol glycosides

    838

    Purified steviol glycosides

    837

    Hydroxytyrosol

    836

    Algal oil (50-60% docosahexaenoic acid) from Schizochytrium sp. HS01

    835

    Ilex guayusa leaf extract

    834

    Preparation containing bacterial phages specific to shiga-toxin producing Escherichia coli

    833

    Lacto-N-tetraose

    832

    Acid prolyl endopeptidase produced by Aspergillus niger

    831

    Bacillus subtilis DE111

    830

    Chicory flour

    829

    Dried biomass of Aspergillus oryzae fermented with minerals

    828

    D-psicose

     

    FSIS

    Jun 14, 2019 | PDF

    • FSIS to Post Individual Category Status and Aggregate Results for Poultry Carcasses, Chicken Parts, and Comminuted Poultry Tested for Salmonella
    • FSIS to Post Updated Dataset on Imports
    • Label Backlog Update and Tips for the Label Approval Process

    Recalls

    Product Recalled

    Date of Recall

    069-2019 Ruiz Foods Products Inc. Recalls Bacon Breakfast Wrap Products Due to Possible Foreign Matter Contamination

    Jun 14, 2019

    065-2019 EXP Table 87 Frozen, LLC Recalls Pork and Beef Pizza Products Produced without Benefit of Inspection

    Jun 14, 2019

     

    AMS

    USDA Announces Grain Inspection Advisory Committee Appointments

     

    @FDACommissioner

    • ·       As part of our effort to address the global health challenge of antimicrobial resistance (AMR), @US_FDA supports the development of next-generation sequencing (NGS)-based diagnostics to help health care providers identify and treat the right pathogen.
    • ·       To help build NGS infrastructure, our database called FDA-ARGOS, makes publicly available quality-controlled microbial reference genomes for diagnostic use. https://bit.ly/31np2y2
    • ·       The FDA team is looking for unique, hard-to-source microbes like biothreat organisms, emerging pathogens & AMR-related pathogens to help improve the database. We encourage the community to share microbe samples here: https://bit.ly/2WISMXz
    • ·       More work needs to be done to address AMR concerns and together we can harness genomic data to help in this fight.

    @FrankYiannasFDA

    @US_FDA

    • ·       Today, at the FDA’s request, @USMarshalsHQ seized 300,000+ containers of dietary supplements from Life Rising Corporation, due to good manufacturing practice violations. FDA is discouraging consumers from purchasing/using these products. More: https://go.usa.gov/xmhDg

    @DrAbernethyFDA

    • ·       Science-based policy and deliberate, thoughtful, and quick-as-possible decision-making are critical as FDA evaluates the way forward for CBD. Safety, public health & public access all need to be considered. To learn more:

    @CDCgov

    • ·       Nearly 300 people sick in 41 states from Salmonella outbreaks linked to chickens and ducks in backyard flocks. Wash hands and handle them appropriately. https://go.usa.gov/xmpnE
  • June 21, 2019 8:36 AM | Amy Bonsell (Administrator)

    Statement from Director Susan T. Mayne Ph.D., Center for Food Safety and Applied Nutrition

    June 18, 2019

    Dear International Colleague,

    Three years ago, the U.S. Food and Drug Administration announced the most comprehensive reform to the Nutrition Facts label since its introduction in 1993. The changes to the label reflect the l Three years ago, the U.S. Food and Drug Administration announced the most comprehensive reform to the Nutrition Facts label since its introduction in 1993. The changes to the label reflect the latest nutritional science available, emphasizing the information that consumers need to make better-informed decisions about their eating habits.

     

    In updating the label, we saw a need to acknowledge that Americans are eating differently than two decades ago when the labeling requirements were first introduced, or even in 2006, when we last updated the label with added information about trans fats.  Among other changes, the new label requires that the amount of and percent Daily Value for Added Sugars be declared; the latter of which is based on 50 grams of added sugar per day, or about 12.5 teaspoons, for those consuming 2,000-calories a day. These changes take into account that Americans on average are consuming Added Sugars in amounts that exceed recommended limits. atest nutritional science available, emphasizing the information that consumers need to make better-informed decisions about their eating habits.

     

    In updating the label, we saw a need to acknowledge that Americans are eating differently than two decades ago when the labeling requirements were first introduced, or even in 2006, when we last updated the label with added information about trans fats.  Among other changes, the new label requires that the amount of and percent Daily Value for Added Sugars be declared; the latter of which is based on 50 grams of added sugar per day, or about 12.5 teaspoons, for those consuming 2,000-calories a day. These changes take into account that Americans on average are consuming Added Sugars in amounts that exceed recommended limits.  

    Last year, we continued this important work with the launch of the agency’s Nutrition Innovation Strategy, which has as one of its hallmarks to empower consumers with information, enabling them to construct diets more consistent with the Dietary Guidelines for Americans. Today we’re taking another important step with the issuance of a final guidance with the goal of helping consumers better understand the amount of sugar in single-ingredient products like powdered sugar, pure maple syrup and honey.

    This final guidance, “Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products ,” provides clarification for companies that produce single-ingredient sugars and syrups, in addition to those who produce cranberry products. Single-ingredient sugars are intended to be consumed alone or added to foods by consumers, and thus will be an added sugar to the diet when consumed. As companies who produce these products began to look at how they would implement the new label, they raised concerns about how consumers would perceive the Added Sugars declaration on their product labels. Additionally, the Agriculture Improvement Act of 2018, commonly referred to as the “Farm Bill,” stated that Nutrition Facts labels cannot require the declaration of the gram amount of Added Sugars for single-ingredient sugars, honey, agave and syrups, including maple syrup. For maple syrup and honey especially, we heard concerns that consumers might misinterpret the Added Sugars label declaration to mean that manufacturers had added additional sugars to them, such as corn syrup or cane sugar.

    After reviewing and considering the comments made to our February 2018 draft guidance, as well as fulfilling the legislative requirement in the 2018 Farm Bill, we are finalizing this guidance in a way that provides consumers with information as to how consumption of these products can be accommodated within the recommendations of the dietary guidelines, while at the same time reducing the potential for consumers to misinterpret single-ingredient sugars and syrups as having additional sugars added to them.

    The final guidance issued today explains that for single-ingredient sugars, the Nutrition Facts label will still include a line for Total Sugars with the amount per serving expressed in grams; however, the line below it – which has been reserved for Added Sugars – will only provide a percent Daily Value for Added Sugars.  We are exercising enforcement discretion to allow for the use of a “†” symbol immediately following the percent Daily Value declaration for Added Sugars, which leads consumers to a statement that provides information about the gram amount of Added Sugars, as well as information about how that amount of sugar contributes to the percent Daily Value. As an example, for a single-ingredient sugar that provides 10 grams of sugar per serving, manufacturers are encouraged to include a “†” symbol after the percent Daily Value declaration for Added Sugars that refers the consumer to information that reads: ‘One serving adds 10g of sugar to your diet and represents 20% of the Daily Value for Added Sugars.’ Our goal with this final guidance is to help consumers understand that these single-ingredient sugars have no additional sugars added to them, while also conveying how their consumption will contribute to the amount of Added Sugars consumed in a day.

    Additionally, the final guidance provides information related to the labeling of Added Sugars on certain cranberry products. Since cranberries are naturally tart and contain very little natural sugar, the manufacturers of these products frequently add sugar to make them more palatable. The makers of these products have stated that even after adding sugar, their products typically have the equivalent total sugar content of other fruit products that do not have sugars added. Therefore, in instances where sugar is added and it does not exceed the level in a comparable fruit product, such as cranberry juice cocktail as compared to unsweetened grape juice, we are stating our intent to exercise enforcement discretion to allow the Nutrition Facts label to include a symbol that leads the consumer to a statement outside the Nutrition Facts label indicating that sugar has been added because cranberries are naturally tart. The statement can also indicate that the 2015-2020 Dietary Guidelines for Americans includes language that there is room for limited amounts of added sugars in the diet, including from nutrient-dense foods like naturally tart fruit. Alternatively, the statement could refer to the 2015-2020 Dietary Guidelines for Americans recommended limit for Added Sugars of no more than 10% of calories. Our intent with this additional information is to help American consumers more easily understand how certain sweetened cranberry products can be part of a healthy dietary pattern.

    In implementing this final guidance today, we have made sure to allow ample time for manufacturers to comply. Therefore, this guidance states our intent to exercise enforcement discretion so that any single-ingredient sugar or cranberry product that is impacted by this guidance will have until July 1, 2021 to switch to the new label. We want to ensure that manufacturers have time to redesign their packaging and adhere to the new labeling requirements.

    In updating the Nutrition Facts label and later releasing the Nutrition Innovation Strategy, the goal has been to provide consumers with the information they need to make informed decisions about their diet and health, including with the products they are eating every day. Other changes that consumers are seeing on the new label include adjusted serving sizes so that the amounts of calories and nutrients listed on the label more accurately reflect what is customarily consumed. Additionally, Americans are seeing a change in which nutrients are declared, as vitamin D and potassium are now required on the label because Americans do not always get the recommended amounts.

    The Added Sugars declaration is one more piece of information that consumers can use to make informed decisions about their diet. Our goal in issuing this final guidance is to help consumers better understand how consumption of single-ingredient sugars and certain cranberry products can be accommodated within recommended limits for Added Sugars in healthy diets.

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


  • June 14, 2019 9:22 AM | Amy Bonsell (Administrator)

    June 13, 2019

    Federal Register

    Food and Nutrition Service

    Proposed Rules

    Providing Regulatory Flexibility for Retailers in the Supplemental Nutrition Assistance Program; Reopening of Comment Period

    Filed on: 06/13/2019 at 8:45 am Scheduled Pub. Date: 06/14/2019

    FR Document: 2019-12630 PDF  4 Pages (88.6 KB) Permalink

     

    HHS

    HHS Secretary Azar Statement on Agricultural Biotechnology Executive Order

     

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    068-2019 Pasture Raised Foods, LLC Recalls Raw Whole Poultry Products Produced Without Benefit of Inspection

    Jun 12, 2019

     

    AMS

    AMS Issues Complaint against Sugarcreek Livestock Auction Inc. and Leroy H. Baker, Jr.

    AMS Settles a Case with Windsor Livestock Auction Co. Inc.

    USDA Determines Individuals Not Responsibly Connected to California Violator

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

    Christmas Tree Industry Votes to Continue Research and Promotion Program

     

    OMB

    AGENCY: USDA-AMS

    RIN: 0581-AD87

    Status: Pending Review

    TITLE:Establishment of a Milk Donation Program

    STAGE: Final Rule

    ECONOMICALLY SIGNIFICANT: No

    ** RECEIVED DATE: 06/12/2019

    LEGAL DEADLINE: None  

     

    CSPI

    Trump Administration Proposes Deregulatory Shift on Agricultural Biotechnology

     

    @USDA

    @US_FDA

    • ·       The phrase "Best if Used By" helps clarify that the date label is about quality, not safety, and that if stored properly, products do not necessarily have to be discarded after the date. Learn more about reducing food waste: https://go.usa.gov/xmtnT


  • June 14, 2019 9:19 AM | Amy Bonsell (Administrator)

    June 10, 2019

    Federal Register

    Food and Drug Administration

    Notices

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

    Agency Information Collection Activities; Proposals, Submissions, and Approvals

    Filed on: 06/10/2019 at 8:45 am Scheduled Pub. Date: 06/11/2019

    FR Document: 2019-12278 PDF 2 Pages (155 KB) Permalink

    • ·       List of information collections approved by OMB including Food Additive Petitions and Investigational Food Additive Exemptions; FSVP Programs for Importers of Food for Humans and Animals

    Mitigation Strategies to Protect Food Against Intentional Adulteration

    Filed on: 06/10/2019 at 8:45 am Scheduled Pub. Date: 06/11/2019

    FR Document: 2019-12288 PDF 7 Pages (110 KB) Permalink

     

    Food Safety and Inspection Service

    Notices

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

    Egg Products

    Filed on: 06/10/2019 at 8:45 am Scheduled Pub. Date: 06/11/2019

    FR Document: 2019-12258 PDF 7 Pages (219 KB) Permalink

     

    Permit to Obtain Specimens of Condemned or Other Inedible Materials from Official Establishments

    Filed on: 06/10/2019 at 8:45 am Scheduled Pub. Date: 06/11/2019

    FR Document: 2019-12260 PDF 7 Pages (220 KB) Permalink

     

    FDA

    Public Health Alert Concerning Hepatitis A Virus Contamination of Kroger Brand Frozen Blackberries

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    06/07/2019

    Private Selection

    Frozen Triple Berry Medley

    Possible Hepatitis A Contamination

    The Kroger Co.

     

    FSIS

    Jun 07, 2019 | PDF

    • FSIS Posts Annual Summaries of Consumer Complaints 
    • Label Updates on Removal of Jambalaya from Policy Book

    Recalls

    Product Recalled

    Date of Recall

    067-2019 Taylor Farms Illinois, Inc. Recalls Bacon Quiche Products due to Misbranding and Undeclared Allergens

    Jun 09, 2019

    066-2019 Tyson Foods, Inc. Recalls Ready-To-Eat Chicken Fritter Products due to Possible Foreign Matter Contamination

    Jun 07, 2019

     

    APHIS

    USDA Investigating Detection of Genetically Engineered (GE) Wheat in Washington State

     

    AMS

    AMS Settles Packers and Stockyards Act Case with Randy Freeman

    USDA Cites Spiech Farms LLC in Michigan for PACA Violations

    Peanut Industry Votes to Continue Research and Promotion Program

     

    OEHHA

    Notice of Adoption – Section 25704 Exposures to Listed Chemicals in Coffee Posing No Significant Risk

     

    @FrankYiannasFDA

    • ·       ALERT: FDA informing consumers to a hepatitis A virus (HAV) contamination of frozen blackberries under the Kroger grocery store “Private Selection” brand. Consumers advised not to eat & throw away select, recalled products identified at this link
    • ·       Earlier today, I was at the UN representing @US_FDA in the inaugural World Food Safety Day. In a global food system, when it comes to food safety, we all win or lose together. Read my entire speech here https://bit.ly/2I1b2Cq  & let’s make EVERY day a World Food Safety Day!
    • ·       There’s a role for everyone in this important work. Check out #FDA’s new #WorldFoodSafetyDay page for valuable information about how to participate in spreading the word about food safety & avoid foodborne illnesses https://go.usa.gov/xmtkJ
    • ·       I would like to acknowledge & thank the @FAO and @WHO for all that they do to advance food safety worldwide. As we look towards the future, there’s no question that we must all continue to work on creating a stronger, global culture of food safety, together.
    • ·       Today, I’m @UN to discuss how food safety is everyone’s business. It’s an issue that transcends international borders. We must foster, support and strengthen food safety cultures on our farms, in our facilities, and in our nations. #FDA #WorldFoodSafetyDay
    • ·       Our work towards these goals are set in the framework of three missions set forth by Congress and @US_FDA to prevent foodborne illnesses, create a modern food safety system, and empower consumers to make informed choices about their diet.
    • ·       First, there is the FDA Food Safety Modernization Act that #FDA has been implementing since it was signed into law in 2011. Under FSMA, science & risk-based standards have been put in place for the production, packing, holding and transportation of foods
    • ·       Second, @FDACommissioner Sharpless & I recently announced a New Era of Smarter Food Safety to leverage new & emerging technologies to further food safety goals. It creates shared value for all - farmers, food producers, regulators, consumers, the planet https://go.usa.gov/xmtYW
    • ·       Third, there’s #FDA’s Nutrition Innovation Strategy announced in 2018 to empower consumers with information & facilitate industry innovation to create healthier products, help combat the growing burden of chronic disease

    @US_FDA

    • ·       #SafetyAlert: STOP using bobbie Milk-Based Powder Companion Formula from & sold by Bobbie Baby Inc., mfg in Germany, imported & sold online. FDA has found products non-compliant w/ infant #formula regs & inadequate nutrient levels for some #infants https://go.usa.gov/xmteu

    June 11, 2019

    Federal Register

    Food and Drug Administration

    Notices

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

    Establishing and Maintaining Lists of United States Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products

    Filed on: 06/11/2019 at 8:45 am Scheduled Pub. Date: 06/12/2019

    FR Document: 2019-12321 PDF 8 Pages (98 KB)  Permalink

     

    Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species

    Filed on: 06/11/2019 at 8:45 am Scheduled Pub. Date: 06/12/2019

    FR Document: 2019-12316 PDF 7 Pages (36.5 KB) Permalink

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    Retail Distribution List

    057-2019 Aurora Packing Company, Inc. Recalls Beef Products Due to Possible E. coli O157:H7 Contamination | En Español

    May 22, 2019

    Jun 10, 2019

    054-2019 Caito Foods LLC. Recalls Salads with Chicken Products due to Misbranding and Undeclared Allergens

    May 17, 2019

    Jun 10, 2019

    034-2019 EXP Tyson Foods, Inc. Recalls Chicken Strip Products Due to Possible Foreign Matter Contamination | En Español

    May 04, 2019

    Jun 10, 2019

     

    FNS

    FNS Blog: Louisiana Tour Highlights Making a Difference One Meal and One Life at a Time

     

    @FrankYiannasFDA

    @FDAfood

    @FDA_ORA

    • ·       ORA’s core mission is to protect consumers and public health. #FDAORA uses statutory authority to exclude bad actors that are responsible for misdeeds from participation in FDA regulated industry. I am Kenny Shade, a debarment specialist. MORE: https://go.usa.gov/xmuVd  #IAmORA

     


  • June 07, 2019 9:52 AM | Amy Bonsell (Administrator)

    June 6, 2019

    Federal Register

    Agricultural Marketing Service

    Notices

    Proposed Posting, Posting, and De-posting of Stockyards

    Filed on: 06/06/2019 at 8:45 am Scheduled Pub. Date: 06/07/2019

    FR Document: 2019-12014 PDF 5 Pages (129 KB) Permalink

     

    Animal and Plant Health Inspection Service

    Notices

    Environmental Assessments; Availability, etc.:

    Importation of Plants in Approved Growing Media into the United States

    Filed on: 06/06/2019 at 8:45 am Scheduled Pub. Date: 06/07/2019

    FR Document: 2019-12020 PDF 3 Pages (93.5 KB) Permalink

     

    Environmental Protection Agency

    Proposed Rules

    Pesticide Petitions:

    Residues of Pesticide Chemicals in or on Various Commodities

    Filed on: 06/06/2019 at 8:45 am Scheduled Pub. Date: 06/07/2019

    FR Document: 2019-11930 PDF 9 Pages (166 KB) Permalink

     

    Notices

    Pesticide Product Registration:

    Receipt of New Use Applications in April 2019

    Filed on: 06/06/2019 at 8:45 am Scheduled Pub. Date: 06/07/2019

    FR Document: 2019-11929 PDF 6 Pages (94.5 KB) Permalink

    • ·       Requests to remove established tolerances for certain pesticides on various raw agricultural commodities and food products
    •  

    Consumer Product Safety Commission

    Notices

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

    Flammability Standards for Children's Sleepwear

    Filed on: 06/06/2019 at 8:45 am Scheduled Pub. Date: 06/07/2019

    FR Document: 2019-11972 PDF  4 Pages (172 KB) Permalink  

     

    Requirements Pertaining to Third Party Conformity Assessment Bodies

    Filed on: 06/06/2019 at 8:45 am Scheduled Pub. Date: 06/07/2019

    FR Document: 2019-11965 PDF 6 Pages (183 KB) Permalink

     

    Safety Standard for Automatic Residential Garage Door Operators

    Filed on: 06/06/2019 at 8:45 am Scheduled Pub. Date: 06/07/2019

    FR Document: 2019-11966 PDF 3 Pages (166 KB) Permalink

     

    Safety Standard for Omnidirectional Citizens Band Base Station Antennas

    Filed on: 06/06/2019 at 8:45 am Scheduled Pub. Date:  06/07/2019

    FR Document: 2019-11974 PDF 3 Pages (166 KB) Permalink

     

    Safety Standard for Walk-Behind Power Lawn Mowers

    Filed on: 06/06/2019 at 8:45 am Scheduled Pub. Date: 06/07/2019

    FR Document: 2019-11973 PDF  3 Pages (126 KB)  Permalink

     

    Third Party Testing of Children's Products

    Filed on: 06/06/2019 at 8:45 am Scheduled Pub. Date: 06/07/2019

    FR Document: 2019-11967 PDF 12 Pages (242 KB) Permalink

     

     

    FDA

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    06/05/2019

    Whole Foods Market

    Specialty Pestos

    Undeclared Milk, Pine Nuts, Walnuts

    North Atlantic Whole Foods Market

     

    FSIS

    AskFSIS

    Export Certification Signatures - PHIS Export Module

     

    APHIS

    USDA Proposes New SECURE Biotechnology Regulations to Protect Plant Health and Promote Agricultural Innovation

     

    NARB

    NARB Recommends Eli Nutrition Discontinue Certain Antacid Claims Made for TummyZen Dietary Supplement, Approves Other Claims

     

    If 

    @FrankYiannasFDA

    @US_FDA

    • ·       June 13 FDA Grand Rounds reveals methods to identify food-borne pathogen tied to eating imported fresh produce. Register: https://go.usa.gov/xmABN

    @FDAfood

    @FDA_ORA

     

    June 7, 2019

    Federal Register

    Food and Drug Administration

    Notices

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

    Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

    Filed on: 06/07/2019 at 8:45 am Scheduled Pub. Date: 06/10/2019

    FR Document: 2019-12108  PDF 8 Pages (102 KB) Permalink

    • ·       Responses to some comments received

     

    Animal and Plant Health Inspection Service

    Notices

    Addition of Mongolia to the List of Regions Affected by African Swine Fever

    Filed on: 06/07/2019 at 8:45 am Scheduled Pub. Date: 06/10/2019

    FR Document: 2019-12067 PDF 3 Pages (157 KB) Permalink

     

    Environmental Impact Statements; Availability, etc.:

    Predator Damage Management in Idaho

    Filed on: 06/07/2019 at 8:45 am Scheduled Pub. Date: 06/10/2019

    FR Document: 2019-12066 PDF 7 Pages (108 KB) Permalink

     

    FDA

    Letter to State Agricultural Directors

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    Retail Distribution List

    065-2019 Table 87 Frozen, LLC Recalls Pork Pizza Products Produced Without Benefit of Inspection

    Jun 06, 2019

    Posted

     

    @FDACommissioner

    • ·       SAFETY ALERT: Do not use 2 additional products that tested positive for asbestos & have been recalled: Claire’s JoJo Siwa Makeup Set (SKU #888711136337, Batch/Lot No. S180109) & Beauty Plus Global Contour Effects Palette 2 (Batch No. S1603002/PD-C1179) https://go.usa.gov/xmtxa
    • ·       The FDA takes these findings and our obligation to protect consumers seriously. These results are part of our ongoing survey of cosmetic products for asbestos & our commitment to take regulatory and enforcement action as needed. https://go.usa.gov/xmt3g
    • ·       The FDA will continue to update its Safety Alert with new information as it becomes available. Consumers may subscribe to receive updates at the bottom of the Cosmetics Recalls and Alerts page.

    @FrankYiannasFDA

    @DrAbernethyFDA

    • ·       I saw an interesting news report suggesting FDA’s main concern re CBD is to ensure drug development continues. This is an impt issue but we are also concerned about the need for population-level data to inform safe levels, etc. CBD reg strategy must take all issues into account.

    @FDAfood

    @US_FDA

    • ·       Today, FDA sent a letter to the state agricultural directors about how we are modernizing our approach to a new era of smarter food safety where we'll use new and emerging technologies to create a more digital, traceable, and safer food system https://go.usa.gov/xmeH5

    @FDAanimalhealth

    • ·       Did you know FDA regulates foods from genetically engineered & genome-edited crops in conjunction w/ the USDA & EPA? Each federal partner plays an integral role in ensuring the safety of biotechnology plant products in the marketplace.
    • ·       FDA ensures the safety of human & animal foods; EPA regulates pesticides incl. new plant varieties developed using biotechnology; & USDA protects agriculture from pests & diseases that may result from new plant varieties developed through biotechnology.
    • ·       Under FDA regulations, human/animal foods from new plant varieties developed through biotechnology must meet the same food safety requirements as foods derived from traditionally bred plants
    • ·       FDA encourages developers of biotech plants to consult w/ the agency before marketing their products to ensure they are safe & lawful. Check out FDA’s blog on the agency’s Voluntary Plant Biotechnology Consultation Program for more info: https://t.co/T8QzQm7BJn
    • ·       FDA is committed to helping foster innovation in the field of plant biotechnology by working with developers to ensure that consumers can be confident that foods developed through the use of biotechnology meet the FDA’s high safety standards.


  • June 07, 2019 9:51 AM | Amy Bonsell (Administrator)

    June 4, 2019

    FDA

    FDA Publishes Guidance Document on How to Choose Alternate Curricula for Produce Safety Training

    Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

    Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine

     

    AMS

    Pre-Solicitation Announcement for Trade Mitigation Purchase of Dairy Products

    USDA Appoints Members to National Fluid Milk Processor Promotion Board

    USDA Announces $10 Million in Grants Available for the Specialty Crop Multi-State Program

     

    @FDACommissioner

    • ·       #FDA is warning consumers about safety concerns with vinpocetine, an ingredient found in some dietary supplements. FDA data, along with a report issued by the National Toxicology Program (#NTP), found it can potentially cause a miscarriage or negatively impact fetal development.
    • ·       FDA hasn’t reviewed vinpocetine under safety & effectiveness standards that apply to drugs. It may be referred to as Vinca minor extract, lesser periwinkle extract, common periwinkle extract & is often marketed for memory, focus, mental acuity, energy, weight loss.
    • ·       FDA is committed to public safety and we want to make sure that we’re sharing this information about vinpocetine, especially since this health concern directly affects a vulnerable population – pregnant women or women who may become pregnant.

    @FrankYiannasFDA

    • ·       #FDA is announcing new draft guidance that provides flexible recommendations for produce safety training. Education and training are key to the prevention of foodborne illness, and we know that one size doesn’t fit all for the produce industry. https://go.usa.gov/xmFjv
    • ·       Fresh fruits/vegetables are a cornerstone of a nutritious diet. We want to provide farmers tools needed to keep American produce among the safest in the world. Our new draft guidance will improve availability of training to meet the diverse needs of produce farming operations.
    • ·       #FDA is warning consumers about safety concerns with an ingredient called vinpocetine, found in certain dietary supplements. We are advising pregnant women/women who could become pregnant to NOT use vinpocetine: https://go.usa.gov/xmFBE
    • ·       Data from both FDA and #NTP suggests vinpocetine could cause a miscarriage or negatively impact fetal development. Dietary supplements containing vinpocetine are often marketed for uses that include enhanced memory, focus, or mental acuity; increased energy; and weight loss.
    • ·       Ensuring the safety of dietary supplements is a top priority. In 2016, we requested comment from stakeholders as part of an administrative proceeding to evaluate whether vinpocetine is legal for sale as a dietary supplement & we’re expediting completion of this proceeding.

    @FDAfood


    June 5, 2019

    Federal Register

    Animal and Plant Health Inspection Service

    Proposed Rules

    Movement of Certain Genetically Engineered Organisms

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

    FR Document: 2019-11704 PDF 109 Pages (570 KB) Permalink

     

    Environmental Protection Agency

    Rules

    Pesticide Tolerances:

    Penthiopyrad

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

    FR Document: 2019-11676 PDF 27 Pages (309 KB) Permalink

     

    FDA

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    05/25/2019

    Divvies

    Benjamint Chocolate Bars

    Undeclared Milk

    Divvies, LLC

    Warning Letters

    Letter Issue Date

    Company

    Issuing Office

    Letter Type

    05/15/2019

    ActiveHerb Technology, Inc

    Division of Pharmaceutical Quality Operations IV

    Warning Letter

     

    FSIS

    Notices

    Number

    Title

    Date Issued

    Expiration Date

    17-19

    Follow up Sampling in Raw Poultry Establishments not Meeting Salmonella Performance Standards

    Jun 04, 2019

    Jun 01, 2020

    Recalls

    Product Recalled

    Date of Recall

    Retail Distribution List

    062-2019 Los Hernandez Tamales, LLC Recalls Chicken and Pork Products Produced Without Benefit of Inspection

    May 31, 2019

    Jun 04, 2019

     

    NIH

    Workshop on Metabolic Interactions between Folic Acid Excess and Vitamin B12 Deficiency

     

     

    @FrankYiannasFDA

    • ·       [retweet @Deloitte_GPS_SA] #Deloitte’s Combiz Abdolrahimi will be moderating a fireside chat with FDA Deputy Commissioner @FrankYiannasFDA on how new/emerging technologies are creating new models of trust and shared value, and what the @US_FDA is doing to usher the US into a new era of smarter #foodsafety

    @FDAfood

    • ·       Part of our mission @FDAFood, is being responsible for promoting & protecting the American public’s health by ensuring food supply is safe, sanitary, wholesome, & honestly labeled. https://go.usa.gov/xmsG4  #WorldFoodSafetyDay
    • ·       [retweet] What's the difference btwn PFGE vs WGS for foodborne outbreak detection? Leslie Hintz @FDAfood explains it's like looking at the moon through binoculars vs the Hubble: more specificity w/ WGS but both are valuable & both still require additional info to identify an outbreak #APHL


  • June 06, 2019 4:41 PM | Amy Bonsell (Administrator)

    May 31, 2019

    Federal Register

    Agriculture Department

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals

    Filed on: 05/31/2019 at 8:45 am Scheduled Pub. Date: 06/03/2019

    FR Document: 2019-11469 PDF 4 Pages (115 KB) Permalink

    • ·       Importation and Transportation of Meat, Poultry and Egg Products

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    Retail Distribution List

    059-2019 Sikorski Sausages Co., Ltd. Recalls Meat and Poultry Sausage Products Produced without Benefit of Import Inspection

    May 24, 2019

    May 30, 2019

     

    @FDACommissioner

    • ·       Today, FDA is holding a public hearing to obtain scientific data & info about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis/cannabis-derived compounds. Read my opening remarks: https://go.usa.gov/xmHnY
    • ·       There are lots of questions, including many related to safety we will need to answer to ensure that FDA is taking an appropriate, well-informed, and science-based approach to the regulation of cannabis and cannabis derivatives, including CBD.
    • ·       We encourage all stakeholders – presenters, attendees, and those unable to participate in today’s hearing – to submit comments to our docket on this topic, which is open until July 2. Watch the webcast/submit comments: https://go.usa.gov/xmTR8
    • ·       We hope that this meeting, and the comments submitted to our public docket, will help us as we try to approach this issue in an informed way. This hearing is an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.

    @FrankYiannasFDA

    • ·       Study, 84% of consumers occasionally discard food near the package date. https://bit.ly/2HMAH1J  We’re helping to fix that by supporting efforts to standardize the term “Best if Used By” as related to #quality of food NOT safety. Learn more http://go.usa.gov/xmG9n  #NoWastedFood
    • ·       New digital technologies hold great promise to strengthen food safety & facilitate trade for firms of all sizes. Thank you @WTO for your role in providing a platform for this important, global conversation. http://newsvideo.su/video/10801389

    @FDAfood

    • ·       Attend the first @AmerChemSociety & @FDAfood colloquium “Frontiers in Flavor Chemistry” in person or watch live. The focus is on taste perception in humans & its impact on nutrient intake plus recent advances in food flavors incl discovery of new ones. https://go.usa.gov/xmAWp

    @FDA_ORA

    • ·       Health fraud scams can do more than waste your money; they can cause serious injury or even death. Using unproven treatments can delay getting a potentially life-saving diagnosis & medication that works. LEARN MORE: https://go.usa.gov/xm5T4  #FDAConsumerUpdate

    June 3, 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: 06/03/2019 at 8:45 am Scheduled Pub. Date: 06/04/2019

    FR Document: 2019-11532 PDF 4 Pages (15.4 KB) Permalink

     

    Guidance:

    Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

    Filed on: 06/03/2019 at 8:45 am Scheduled Pub. Date: 06/04/2019

    FR Document: 2019-11603 PDF 5 Pages (106 KB) Permalink

     

    FDA

    Recalls

    Date

    Brand

    Product Description

    Reason/Problem

    Company

    05/30/2019

    Deep Foods, Inc.

    Deep Golden Raisins

    Undeclared Sulfites

    Deep Foods Inc.

     

    FSIS

    FSIS Officials' Calendar of Meetings

    May 31, 2019 | PDF

    • FSIS Removes Jambalaya from the Food Standards and Labeling Policy Book
    • FSIS Names New Director for International Liaison Office in Beijing
    • Label Backlog Update and Tips for the Label Approval Process
    • Signatures for Vietnam Export Certification Documents
    • FSIS to Expand Establishment Specific Datasets

    AskFSIS

    Shipping Unmarked Livestock Primals, Livers, Hearts, and Tongues in Commerce

    Recalls

    Product Recalled

    Date of Recall

    064-2019 Perdue Foods LLC Recalls Perdue Simply Smart Organics Poultry Products Due to Possible Foreign Matter Contamination

    May 31, 2019

    063-2019 Johnsonville, LLC. Recalls Ready-To-Eat Jalapeño Cheddar Smoked Sausage Links Due to Possible Foreign Matter Contamination

    May 31, 2019

    062-2019 Los Hernandez Tamales, LLC Recalls Chicken and Pork Products Produced Without Benefit of Inspection

    May 31, 2019

     

    AMS

    USDA Restricts PACA Violators in California, Florida, Ohio, Texas and Washington from Operating in the Produce Industry

    AMS Settles a Case with Javier Juarez, d.b.a JJ Meats

    AMS Issues Complaint against Ashville Stockyard Inc., Bradley M. Plunkett and Tilda Plunkett

    AMS Issues Complaint against Mitchell Lee Barthel dba Rock’n M Cattle

    USDA Seeks Cotton Board Nominees

     

    @FrankYiannasFDA

    • ·       A tech-enabled, future food system holds great promise to be a safer, more efficient, & sustainable food system. Let’s not simply try to predict it; let’s create it, together. #smarterfoodsafety https://t.co/2bmJE0ehiN

    @DrAbernethyFDA

    • ·       Thanks again to all who contributed to today’s public meeting on cannabis/cannabis-derived products/CBD. We all want a way forward. Here is some more about what I have heard today about this quickly evolving space…
    • ·       Many people use these products. For CBD, info presented suggests that many consumers think that regulatory pathways are fully in place to keep products safe. Meanwhile speakers reinforced that regulatory pathways are unclear. We must sort this out in service of public health.
    • ·       One speaker suggested: “Distinguish between medication setting with physician oversight vs safe use in mass market setting without physician oversight. Need clear differentiation between FDA-approved medicines and consumer-focused foods and supplements.”
    • ·       Today’s meeting illuminated many different issues encountered by manufacturers, researchers, local governments, etc (e.g., labeling, marketing, access to research product, terminology, manufacturing, standards).
    • ·       New research was presented today; researchers are asked to submit the data to the public docket - thank you. This information will be included in our ongoing review of literature & databases to develop a summary of what we reliably know and where new research is needed.
    • ·       Systematic studies are needed. It sounds like a number of studies are available or underway. We also wonder if real-world evidence derived from electronic health records, personal monitors, administrative data, etc, can be used to address critical questions in this space.
    • ·       I want to clarify a question from today: FDA supports cannabis researchers in a variety of ways and has issued detailed guidance on submitting IND applications to conduct human studies with drugs derived from plants like cannabis. See questions 16 & 17 https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers
    • ·       I suspect that the public docket will expand our understanding, add new information, and reinforce observations today. We will work as quickly as possible to define a way forward. Appreciate a speaker’s observation: “You guys have a tough job. Good luck with that.” Indeed.
    • ·       Appreciate the many comments at today’s public hearing at FDA. Important messages, data and stories are coming throughout the day and via public docket. I’m impressed by all of the members of the public that have traveled to FDA to share their comments.
    • ·       Here is some of what I am hearing… First, there is a need to further clarify the regulatory framework to reduce confusion in the market. The product questions apply to people and animals.
    • ·       Given the rapid expansion of the market, timely clarification of the path forward is critical, but it’s our responsibility to ensure that the regulatory path is scientifically sound and in the interest of public health.
    • ·       Key questions about product safety need to be addressed. Data are needed to determine safety thresholds for CBD; datasets/information should be objective, of adequate quality and available for transparent review. Lab testing and data analyses need to be replicable.
    • ·       There are both positive supporters of cannabis-cannabis derived products including CBD and also concerned citizens worried that widely available products can be harmful
    • ·       Consumers need consistent information and labeling. State/government entities need support in knowing what to do. And we really need to understand the implications for children when they take CBD-containing products at different dosage ranges. More updates later today.

     


  • May 31, 2019 9:34 AM | Amy Bonsell (Administrator)

    May 30, 2019

    Federal Register

    Food and Drug Administration

    Notices

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

    Food Labeling; Notification Procedures for Statements on Dietary Supplements

    Filed on: 05/30/2019 at 8:45 am Scheduled Pub. Date: 05/31/2019

    FR Document: 2019-11419 PDF 4 Pages (14.2 KB) Permalink

     

    Agriculture Department

    Notices

    Agency Information Collection Activities; Proposals, Submissions, and Approvals

    Filed on: 05/30/2019 at 8:45 am Scheduled Pub. Date: 05/31/2019

    FR Document: 2019-11372 PDF 10 Pages (107 KB) Permalink

    • ·       Restricted, Prohibited, and Controlled Importation of Animal and Poultry Products and Byproducts, Into the United States

     

    International Trade Administration

    Notices

    Certain Frozen Warmwater Shrimp from the Socialist Republic of Vietnam

    Filed on: 05/30/2019 at 8:45 am Scheduled Pub. Date: 05/31/2019

    FR Document: 2019-11396 PDF 8 Pages (97.8 KB) Permalink

     

    FSIS

    Recalls

    Product Recalled

    Date of Recall

    061-2019 J Deluca Fish Company Inc. Recalls Siluriformes Products Produced Without Benefit of Import Inspection

    May 29, 2019

     

    AMS

    AMS Issues Complaint against John B. Hagler

     

    APHIS

    USDA Proposes to Consolidate Regulations for Laboratory Testing

     

    OMB

    AGENCY: USDA-APHIS

    RIN: 0579-AE47

    Status: Concluded

    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  

    ** COMPLETED: 05/29/2019

    COMPLETED ACTION: Consistent with Change

     

     

    @FrankYiannasFDA

    @SecretarySonny

    • ·       In Geneva, New York this morning with @RepTomReed visiting Ravines Wine Cellars, owned and operated by the Hallgren family. We had a great tour then discussion with local producers about the importance of trade and passing USMCA.
    • ·       Joined @RepBrindisi for a tour of @Chobani headquarters, before we sat down with stakeholders, producers and employees to talk about dairy in the school lunch program, the farm bill, ag labor and trade - specifically the need to pass #USMCA for NY dairies as soon as possible.

    @FDAfood

    @FDA_ORA


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