Laws and Regulations Committee Update 4/16 – 4/17, 2018
April 16, 2018
FDA Investigates Salmonella Braenderup Infections Linked to Shell Eggs from Rose Acre Farms
Labeling & Nutrition: Highly Concentrated Caffeine in Dietary Supplements (April 2018)
FDA to Extend Comment Period on Draft Guidance Regarding Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products
FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine
|Date||Brand Name||Product Description||Reason/Problem||Company|
|04/13/2018||Country Daybreak, Food Lion and more||Shell eggs||Salmonella Braenderup||Rose Acre Farms|
|04/13/2018||Formagere de la Brie||Cheese||Listeria monocytogenes||Seacrest Foods International, Inc.|
|04/13/2018||K9 Natural||Pet food||Listeria monocytogenes||K9 Natural Ltd|
|04/12/2018||AMA Wholesale Inc.||Rhino 69 Extreme 50000 capsules||Unapproved New Drug (Presence of Tadalafil)||AMA Wholesale Inc.|
- FSIS Extends Comment Period on Petition on Beef and Meat Labeling Requirements
- FSIS Posts Updated Dataset on Import Refusals
- FSIS Announces Second Webinar on the Modernization of Swine Slaughter Inspection Proposed Rule
Fresh Foods Manufacturing Co. Recalls Ready-To-Eat Salad Products Due to Possible E. coli O157:H7 Contamination
How do I determine if the country requires prior plant approval?
How is Meat and Poultry Exporting Regulated?
Must plants comply with facility/production export requirements?
Imported Raw Beef Product utilized for grinding
Are military shipments required to stamped with the export stamp?
Does FSIS allow deviations from U.S. Standards for export?
What certification is required for ships’ stores product?
On FSIS Form 9060-5, must “Consigned To” entry show a complete address?
Is it ever necessary to place the export stamp on a certificate or use an embossed seal?
On FSIS Form 9060-5, what goes in the “exported from” and “exported by” blocks?
On FSIS Form 9060-5, what goes in the “Consigned To” block?
What is expected in the “Product As Labeled” block?
On FSIS Form 9060-5, can similar products be grouped?
On FSIS Form 9060-5, what are “shipping marks” and are they always required?
Do military shipments have to meet foreign language requirements?
On FSIS Form 9060-5, what is entered in the “Est./Plant Number on Product” block?
What can be done when product is detained because additional certification is required?
On FSIS Form 9060-5, what is allowed in the “Remarks” section?
When countries require a USDA seal, who is allowed to remove it?
On FSIS Form 9060-5, can similar products be grouped under a generic name on certificates?
On FSIS Form 9060-5, is the signing official’s name required to be printed above the signature?
On FSIS Form 9060-5, can weights be listed only in metric weight on certificates?
On FSIS Form 9060-5, what Est. no. is required in the “EST / PLANT NUMBER ON PRODUCT” block?
Samples for research and evaluative testing purposes
How does a plant determine their approval status after a plant review?
What is the Best Way to Prepare for a Plant Review?
Verifying casings processed outside the United States were derived from animals that received ante-mortem and post-mortem inspection
If a label bears a Halal or Kosher statement, does FSIS have to monitor the production of the product?
Products for personal consumption
Can FSIS certify “by-products” for export?
Can a Noncompliance Record (NR) be issued for failing to label “For Export Only” when required?
Is there any restriction on size of type on certificates?
What can be done if product is detained because a plant is not listed on a plant list?
If plants are listed with an “M” or “P,” how will this affect entry of product?
If the store does not slice the products but sells them whole or in chunks, are they still exempt from nutrition labeling?
If a product with a nutrition claim in the brand name is sold in chubs intended for slicing in a Super market deli where it will be displayed or promoted by brand name, how can the nutrition information be conveyed by the retailer?
Does the definition of processing as it pertains to retail outlets include repackaging of food sold in bulk packages into retail size packages at the store level?
Are items exempt that are tray-packed at a plant versus a supermarket and intended to be sold in the deli department as ready-to-consume?
Can the labeling of product that has been fabricated into cuts or ground products from carcasses and parts bear retained water statements with lesser values or no value?
PHIS FSIS Authority to Access Establishment Records
What is the order of appearance of the optional vitamins and minerals?
Does FSIS recognize FDA’s “less than 12 square inch” package size exemption policy or only the “40 or less square inch” policy?
AMS Adds Export Verification Program for Pork Exports to Argentina
Organic Integrity Through Technology Innovation
Food Industry Split on Disclosing Sesame, an Allergen
New FDA Guidance Declaring Bulk Caffeine Products Illegal Is an Unqualified Victory for Public Safety
@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls
- FDA issues guidance for industry to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine http://go.usa.gov/xQb4A
- FDA issues guidance to protect public from dangers of pure or highly concentrated caffeine supplements, clarifying that these powders & liquids are considered unlawful when sold in bulk quantities to consumers https://go.usa.gov/xQb4A
- Risk of overuse & misuse is high when highly concentrated caffeine is sold in bulk. Difference between a heaping vs. level scoop can be dangerous when an average recommended serving is 1/16 tsp of powder https://go.usa.gov/xQb4A
- Today #FDA takes critical step to protect consumers from dangers of highly concentrated or pure caffeine supplements marketed in bulk quantities https://go.usa.gov/xQb4A FDA makes clear pure or highly concentrated caffeine sold in bulk quantities directly to consumers are illegal
- FDA will take action when dietary supplement products with potentially dangerous amounts of caffeine put consumers at risk https://go.usa.gov/xQb4A Just a single teaspoon of powdered pure caffeine product can contain 2.5 times a toxic dose of caffeine; 2 tablespoons can be deadly
- Today FDA issued guidance for industry on ways to formulate & market dietary supplements containing caffeine such that these products do not present significant or unreasonable risk of illness or injury https://go.usa.gov/xQbEA
- Deciding what’s the right portion size for you to eat? The Nutrition Facts Label is a great resource! https://go.usa.gov/xQTUR
- #FDAORA issues #warningletter to Seattle bakery for violating regulations for human food that was prepared, packed, or held under insanitary conditions https://go.usa.gov/xQYSR #youvebeenwarned
- #FDA is taking new action today to address the significant public health risks associated with pure caffeine being marketed to consumers in bulk packaging and in extremely high doses that creates an unreasonable risk of potentially lethal overdoses.
- FDA’s investigation finds that chopped romaine lettuce from the Yuma AZ region is likely source of ongoing E. coli O157:H7 outbreak that sickened 35 people. No specific brands identified yet, but FDA continuing to investigate. https://go.usa.gov/xQbsC
- Current E. coli outbreak linked to chopped romaine lettuce from Yuma AZ is NOT related to earlier outbreak linked to leafy greens.
- Winter lettuce growing season in Yuma is just about over & in the coming weeks the romaine lettuce will be sourced from California instead.
- FDA to extend comment period for 45 Days on Draft Guidance Regarding Declaration of #AddedSugars of honey, maple syrup, & certain cranberry products https://go.usa.gov/xQbsR
- #FDA’s action today addresses the significant public health risks associated with pure caffeine that’s being marketed to consumers in bulk packaging and in extremely high doses. These products create an unreasonable risk of potentially lethal overdoses
- #FDA is working hard to identify brands, but for now: chopped romaine lettuce from Yuma, AZ area is likely source of ongoing illness outbreak. 35 people got sick. Unless you know your chopped romaine is not from Yuma area, don’t eat it. https://go.usa.gov/xQbAz
- This current E. coli outbreak is likely linked to chopped romaine lettuce from Yuma, AZ area. This outbreak is different from an earlier one linked to leafy greens. Confirm source of chopped romaine before eating. https://go.usa.gov/xQbAz
- Lettuce illnesses may lessen: The growing season in Yuma, AZ – where the chopped romaine that likely sickened 35 people – is ending, then CA’s season begins. https://go.usa.gov/xQbAz
- OUTBREAK: FDA’s investigation finds that chopped #romaine lettuce from Yuma AZ region likely source of ongoing #EColi O157:H7 outbreak that sickened 35 people. No specific brands identified yet, FDA continuing to investigate. http://go.usa.gov/xQbsC
- Outbreak Alert: 35 people sick in 11 states with E. coli infections linked to chopped romaine lettuce. Don’t eat any store-bought chopped romaine, including salad mixes with romaine, in your fridge. Throw it away. http://go.usa.gov/xQbwT
- Updated with comment from @CRN_Supplements @US_FDA may block consumer sales of pure or near pure bulk caffeine to consumers after two deaths. @SGottliebFDA warns of teens using it in “workout cocktails.” https://usat.ly/2GVixMd via @usatoday
- ‘Rhino 69 Extreme 50000’ Recalled due to Presence of Active Ingredient ‘Tadalafil’ http://dlvr.it/QPSvt4
- Seacrest Foods Recalls l’Explorateur Soft Ripened Cheese Due to Possible Health Risk http://dlvr.it/QPSvtD
- Rose Acre Farms Recalls Shell Eggs Due to Possible Health Risk http://dlvr.it/QPTRdy
- Planning to start a new food business? You need to know about FDA regulatory requirements http://go.usa.gov/3BhZd
- #FDA took action to address significant public health risks associated with pure, highly concentrated caffeine that’s marketed to consumers in bulk packaging and in extremely high doses. These products create a risk for potentially lethal overdoses3
- #FDA is advising consumers not to eat recalled eggs produced by Rose Acre Farms’ Hyde County farm. Eggs sold under multiple brand names in 9 states https://go.usa.gov/xQjqt FDA testing determined that these eggs are connected to 22 illnesses caused by Salmonella Braenderup
- Recalled eggs sold under multiple brand including Coburn Farms, Country Daybreak, Food Lion, Glenview, Great Value, Nelms, Sunshine Farms https://go.usa.gov/xQjqt Consumers with these eggs shouldn’t eat them. Throw them away or return them to place of purchase for credit or refund
- CDC, FDA, and states are investigating an outbreak of E. coli O157:H7 infections linked to chopped romaine lettuce from the Yuma, Arizona growing region. Thirty-five people are sick in 11 states. Read the advice on what to do to protect yourself: http://go.usa.gov/xQbwb
- E.coli Outbreak: Check your fridge! Throw away all chopped romaine lettuce, including salad mixes containing romaine. Clean all fridge, counter, and food surfaces with warm soapy water. http://go.usa.gov/xQbwT
- K9 Natural Ltd Voluntarily Recalls K9 Natural Frozen Chicken Feast Raw Pet Food 2.2lb And 11lb Bags Because Of Possible Listeria Monocytogenes http://dlvr.it/QPdwzW
April 17, 2018
Agricultural Marketing Service
Jamestown, North Dakota; Lincoln, Nebraska; and Memphis, Tennessee Areas
Filed on: 04/17/2018 at 08:45 am Scheduled Pub. Date: 04/18/2018
FR Document: 2018-08102 PDF 7 Pages (92.8 KB) Permalink
|Letter Issue Date||Company Name||Issuing Office||Subject||Close Out Date|
|04/04/2018||Amerigo Labs LLC||Kansas City District Office||Dietary Supplement/New Drug/Misbranded||Not Issued *|
|Date||Brand Name||Product Description||Reason/Problem||Company|
|04/16/2018||Euphoric||Marketed as dietary supplement- capsules||tainted with undeclared sildenafil and tadalafil||Epic Products, LLC|
|04/14/2018||Sunseed Vita Prima||Sugar Glider Formula||It has the potential to be contaminated with Salmonella||Vitakraft Sun Seed Inc|
|04/13/2018||Various: Raw Form Organics, Molecule, Chameleon, Naturally, Lifted, Live Well, Third Eye||Powdered kratom products||MANDATORY RECALL ordered for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC||Triangle Pharmanaturals LLC|
FSIS Notice 21-18 Scientific Integrity Training at FSIS
Mid-shift Cleaning of Facility
On FSIS Form 9060-5, do we always need shipping marks?
Jurisdiction for Meat, Poultry, and Egg products
How do I obtain plant approval when required?
Can an average be used for the retained water statement when meat or poultry with different retained water levels is packaged together and labeled?
What Daily Reference Values (DRV) and Recommended Intakes (RDI) are established for protein for the purpose of listing protein as a percent of Daily Value (DV)?
Must International Units (IU) be used in calculating a Reference Daily Intake (RDI) for vitamin A and how is Retinol Equivalents (RE) converted to IU?
Terms with No Official Definition
Egg Products – Pasteurized Egg Products Recognized Laboratory (PEPRLab) Program
Federal Efforts to Manage the Risk of Arsenic in Rice
@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls
- Risk of overuse & misuse is high when highly concentrated caffeine is sold in bulk. Difference between a heaping vs. level scoop can be dangerous when an average recommended serving is 1/16 tsp of powder. Learn more here: https://go.usa.gov/xQbQy
- unapproved new drugs, which company’s website claimed combated various diseases, and incorrectly labeled & adulterated dietary supplements https://go.usa.gov/xQYSp #youvebeenwarned
- Vitakraft Sun Seed Recalls of Sunseed Vita Prima Sugar Glider Food Due to Possible Salmonella Health Risk http://dlvr.it/QPk6nW
- How many arrests did #OCI make last year? How many warning letters were issued? Learn all about #FDAORA 2017 achievements: https://go.usa.gov/xntmK
- FDA has issued guidance for industry on ways to formulate & market dietary supplements containing pure or highly concentrated #caffeine so they do not present significant or unreasonable risk of illness or injury https://go.usa.gov/xQbEA
- Salmonella outbreak: Several brands of shell eggs recalled after 23 people sick in 9 states. Do not eat, serve or sell recalled eggs. Brand names here: http://go.usa.gov/xQjdC
- FDA orders mandatory recall for kratom products due to risk of salmonella http://dlvr.it/QPm2YD
- Do you have recalled eggs at home? Throw them out or return them. Wash and sanitize refrigerator drawers and shelves that held recalled eggs. http://go.usa.gov/xQjd4
- Like our efforts around tobacco, #FDA’s comprehensive nutrition strategy is one of our greatest opportunities to have a profound and generational impact on human health https://go.usa.gov/xQrB5
- Epic Products, LLC, Issues Voluntary Nationwide Recall of All Lots of Euphoric Capsules Due to Presence of Undeclared Sildenafil and Tadalafil http://dlvr.it/QPmbFr
- What do you truly know about dietary supplements? #FDAORA wants to make sure consumers know the benefits AND the risks when it comes to dietary supplements. LEARN MORE: https://go.usa.gov/xnJB6
FTC Commissioner Terrell McSweeny to Resign
Resignation Statement of Commissioner Terrell McSweeny (62.94 KB)