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.

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