Laws and Regulations Committee Update 4/2 – 4/4, 2018
April 2, 2018
Federal Register
Notices
Privacy Act; Systems of Records
Filed on: 04/02/2018 at 08:45 am Scheduled Pub. Date: 04/03/2018
FR Document: 2018-06759 PDF 7 Pages (176 KB) Permalink
Rules
Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Correction
Filed on: 04/02/2018 at 08:45 am Scheduled Pub. Date: 04/03/2018
FR Document: 2018-06519 PDF 9 Pages (158 KB) Permalink
Notices
Special Supplemental Nutrition Program for Women, Infants and Children:
2018/2019 Income Eligibility Guidelines
Filed on: 04/02/2018 at 08:45 am Scheduled Pub. Date: 04/03/2018
FR Document: 2018-06178 PDF 6 Pages (190 KB) Permalink
Agricultural Marketing Service
Proposed Rules
Oranges, Grapefruit, Tangerines, and Pummelos Grown in Florida:
Increased Assessment Rate
Filed on: 04/02/2018 at 08:45 am Scheduled Pub. Date: 04/03/2018
FR Document: 2018-06726 PDF 15 Pages (249 KB) Permalink
FDA
Recalls
| Date | Brand Name | Product Description | Reason/Problem | Company |
| 03/29/2018 | PASTA DE LASSAR ANDROMACO | Pasta De Lassar Andromaco Skin Protectant | Potential for contamination with yeast, mold, and bacteria | MarcasUSA, LLC |
FSIS
PFP Enterprises LLC Recalls Raw Beef Products Produced Without Benefit of Inspection
Mar 30, 2018 | PDF
- FSIS Releases Fiscal Year 2017 Year in Review
- FSIS Announces Availability of Fiscal Year 2017 Residue Testing Results
- FSIS Updates Two Chemistry Methods
- E. coli Testing Update
@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls
- Is your furry friend a healthy weight? #Obesity is a problem for Rover and Felix too! About 58% of cats & 54% of dogs in the US are overweight. READ MORE in this #FDAconsumerupdate: https://go.usa.gov/xnwug
- DYK? You can sign up to receive email notification of new recalls, market withdrawals, & safety alerts! Sign up today to keep up-to-date on the #recalls that could affect you https://go.usa.gov/xn6Xf
- You made a food shopping plan. When in the store, compare similar items using the Nutritional Facts Label to select the healthier food. https://go.usa.gov/xQrvm #NationalNutritionMonth
- Keep your Easter egg hunt fun & safe with these half a dozen tips! https://go.usa.gov/xQqm3
- Find great #FoodSafety tips for #Passover meals here: http://go.usa.gov/cu42v
- MarcasUSA, LLC Issues Voluntary Nationwide Recall of Pasta De Lassar Andromaco Skin Protectant 25% Zinc Oxide 60g Due to Potential Contamination http://dlvr.it/QMwzxj
- If you are interested in food policy & #equity, worth reading @SGottliebFDA on the nutrition priorities of @US_FDA Full speech: https://goo.gl/TZuETP
- Planning an #Easter egg hunt? Learn how to keep it bacteria-free with these tips ⇛ http://go.usa.gov/3XnhP
- While fixated on #MarchMadness #FinalFour2018 don’t forget #foodsafety! http://go.usa.gov/xnZYn
- The #FDA’s new nutrition strategy aims to leverage the tools of diet and nutrition as a way to better address the burden of chronic disease, troubling disparities when it comes to diet, and inequality in health and medical outcomes http://go.usa.gov/xQrB5
- Last week, I laid out #FDA‘s new plan to leverage nutrition as a tool to reduce chronic disease. Among other things, we commit to define label terms in new regs. Today’s WSJ Edit Page calls on us to do the same. For those who missed the plan, here’s it is https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm603090.htm …
- FDA’s new “Nutrition Innovation Strategy” aims to instigate healthful food innovation that can help reduce the burden of chronic disease; close dietary disparities that also contribute to health inequality. Read the plan here: …
- ICYMI: LEARN MORE about the FDA recall process in this #FDAORA #consumerupdate: https://go.usa.gov/xn6jP
April 3, 2018
Federal Register
Agricultural Marketing Service
Rules
Cranberries Grown in States of Massachusetts, et al.; Free and Restricted Percentages for the 2017-18 Crop Year for Cranberries
Filed on: 04/03/2018 at 08:45 am Scheduled Pub. Date: 04/04/2018
FR Document: 2018-06875 PDF 44 Pages (302 KB) Permalink
Decreased Assessment Rates:
Tomatoes Grown in Florida
Filed on: 04/03/2018 at 08:45 am Scheduled Pub. Date: 04/04/2018
FR Document: 2018-06883 PDF 15 Pages (254 KB) Permalink
National Organic Program:
USDA Organic Regulations
Filed on: 04/03/2018 at 08:45 am Scheduled Pub. Date: 04/04/2018
FR Document: 2018-06867 PDF 5 Pages (322 KB) Permalink
Size Requirements for Oranges:
Oranges, Grapefruit, Tangerines, and Pummelos Grown in Florida
Filed on: 04/03/2018 at 08:45 am Scheduled Pub. Date: 04/04/2018
FR Document: 2018-06874 PDF 10 Pages (245 KB) Permalink
Proposed Rules
Olives Grown in California; Decreased Assessment Rate
Filed on: 04/03/2018 at 08:45 am Scheduled Pub. Date: 04/04/2018
FR Document: 2018-06877 PDF 14 Pages (249 KB) Permalink
FDA
In Forum and On Farms, FDA and Partners Work to Harvest Agreement on Water Issues
Recalls
| Date | Brand Name | Product Description | Reason/Problem | Company |
| 03/30/2018 | Nirvanio, Pain Out | Dietary Supplement Capsules | Salmonella | NutriZone, LLC |
Warning Letters
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
| 03/26/2018 | Schmidt, James | Minneapolis District Office | Illegal Drug Residue | Not Issued * |
AskFSIS
Preventive Measure of Retraining Employees
APHIS
USDA Warns Dangerous Pests are Emerging, Adds Cherry Fruit Fly to Alert List
@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls
- Want cook a more nutritious meal? Look What’s Cooking at https://go.usa.gov/xQrvV
- The FDA is working with growers & exploring ways to simplify #AgWaterStandards #FSMAFutureisNow https://go.usa.gov/xQYp7
- New York raw milk cheese company ordered to stop sales for food safety violations: http://go.usa.gov/xQYdJ
- Nutrizone Recalls Various Lots of Multiple Dietary Supplements Because of Possible Salmonella Health Risk http://dlvr.it/QNB2BL
- Part of the #FDANutritionInnovation is finalizing the guidances for nutritional facts label – 1st overhaul in 20 years – plus new #menulabeling reqs #NPHW https://go.usa.gov/xQYdv
- FDA had 117 educational farm visits in 2017; most recently to 2 farms in Florida to discuss #AgWaterStandards #FSMA https://go.usa.gov/xQYp7
- Salmonella outbreak update: Do not eat recalled dried coconut from International Harvest, Inc., Natural Grocers, and Healthy Nut Factory. Throw away or return to the place of purchase. https://go.usa.gov/xQYxe
- RECALL UPDATE – FDA identifies 16 retail locations that were potentially supplied with contaminated bulk dried #coconut possible #Salmonella. Do not consume. Throw away or return. http://go.usa.gov/xQxdX
- #Easter or #Passover leftovers? Remember to use or freeze within 4 days! Leftovers can be frozen for up to 3 months for best quality. #FoodSafety #Foodwaste
- TODAY! #FDAORA speaks at @MMFEHA Annual Education Conference about food product labeling requirements for manufacturers, distributors & imports to ensure consumers remain informed about the foods they eat.
- #Pregnant women avoid foods w/ a higher risk of a foodborne disease often found in #unpasteurized milk products & deli meats. #Listeria can severely affect you & your unborn child. Review our guide for #foodsafety http://go.usa.gov/xQCq9
April 4, 2018
Federal Register
Rules
New Animal Drugs:
Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor’s Name and Address
Filed on: 04/04/2018 at 08:45 am Scheduled Pub. Date: 04/05/2018
FR Document: 2018-06961 PDF 13 Pages (117 KB) Permalink
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals
Filed on: 04/04/2018 at 08:45 am Scheduled Pub. Date: 04/05/2018
FR Document: 2018-06927 PDF 4 Pages (114 KB) Permalink
Intents to Certify:
Virginia Department of Agriculture and Consumer Services
Filed on: 04/04/2018 at 08:45 am Scheduled Pub. Date: 04/05/2018
FR Document: 2018-06969 PDF 3 Pages (96 KB) Permalink
FDA
CVM releases eSubmitter Webinar Series
New York raw milk cheese company ordered to stop sales for food safety violations
FDA orders mandatory recall for kratom products due to risk of salmonella
Mandatory Recall Order sent to Triangle Pharmanaturals LLC Concerning Products Containing Powdered Kratom (PDF – 508KB)
Recalls
| Date | Brand Name | Product Description | Reason/Problem | Company |
| 04/03/2018 | Nirvanio | Special Reserve Kratom Blend | Salmonella | NutriZone, LLC |
| 04/03/2018 | Raw Form Organics | 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 |
Warning Letters
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
| 04/02/2018 | Arrow Reliance Inc | Center for Veterinary Medicine | Adulterated Animal Food/Misbranded | Not Issued * |
FSIS
Good Foods Group, LLC Recalls Ready-To-Eat Chicken Products Due to Misbranding and Undeclared Allergen
AskFSIS
Countries and Regulations Not Identified in the Export Library
How do I notify someone that there is an error in the export information?
Are “poultry feet” and “poultry paws” the same?
AMS
USDA Highlights Feedback from Stakeholders in Review of Livestock Mandatory Reporting Program
USDA Seeks Nominees for the Cattlemen’s Beef Promotion and Research Board
ORA FOIA
| Record Date | FEI Number | Firm Name | Record Type | State | Establishment Type | Date Posted |
| 03/30/2018 | 3013760469 | Triangle Pharmanaturals, LLC | FDA Requested Recall Letter | NV | Manufacturer | 04/03/2018 |
| 03/31/2018 | 3013760469 | Triangle Pharmanaturals, LLC | Other Correspondence | NV | Manufacturer | 04/03/2018 |
| 04/02/2018 | 3013760469 | Triangle Pharmanaturals, LLC | Other Correspondence | NV | Manufacturer | 04/03/2018 |
@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls
- FDA orders mandatory recall for kratom products due to risk of salmonella: http://go.usa.gov/xQggw
- @US_FDA launching External Stakeholder Meeting Request (“ESMR”) system for stakeholders outside industry to request meetings with FDA. https://bit.ly/2Gxh62a
- Read the FDA press annoucement here: https://go.usa.gov/xQg4c https://twitter.com/SGottliebFDA/status/981177095635308544
- #FDA ordered a mandatory recall for kratom products from Triangle Pharmanaturals due to risk of salmonella. This first ever mandatory recall order is based on imminent health risk; company’s refusal to conduct a voluntarily recall despite repeated requests https://go.usa.gov/xQggv
- We continue to also have serious concerns about the safety of any kratom-containing product and are pursuing these concerns separately. This action is based on risks posed by the contamination of this particular product w/ a potentially dangerous pathogen: https://go.usa.gov/xQggv
- This action regarding Kratom is the first time #FDA has ordered a mandatory recall because a company has opted not to recall a potentially dangerous product after repeated notifications by FDA of an opportunity to initiate a voluntary recall: https://go.usa.gov/xQggv
- #FDA’s first approach is to encourage voluntary compliance, but when we have a company, which refuses to cooperate, is violating the law, and is endangering consumers, the agency will pursue all avenues of enforcement under our current authority: https://go.usa.gov/xQggv #FSMA
- #FDA signed an order to effectuate the first ever mandatory recall, under #FSMA authorities, to address an imminent hazard related to an ongoing outbreak of salmonella associated with a Kratom product. We advise consumers not to consume this product.
- FDA’s first ever mandatory recall was issued for kratom products from Triangle Pharmanaturals due to risk of salmonella. This first ever order is based on imminent health risk; company’s refusal to conduct a voluntarily recall despite repeated requests …
- Do you have leftover eggs from your Easter egg hunts or egg dyeing projects? #FDAORA wants you to play it safe with eggs! LEARN MORE: https://go.usa.gov/xnJXj
- FDA Orders Mandatory Recall for Kratom Products Due to Risk of Salmonella http://dlvr.it/QNJ8sd
- For the first time, FDA uses the mandatory recall authority it got under the food safety bill. It orders a Las Vegas company to recall powdered kratom products after samples tested positive for salmonella.
- The FDA ordered a mandatory recall for kratom products due to risk of salmonella. Our first approach is to encourage voluntary compliance, but if a company doesn’t cooperate, the agency will pursue all avenues of enforcement under our current authority https://go.usa.gov/xQggv
- Nutrizone Expands Recall of Various Lots of Multiple Dietary Supplements Because of Possible Salmonella Health Risk http://dlvr.it/QNJL6w
- FDA is actively working with produce experts to make our agricultural water standards for harvestable fruits and vegetables easier to understand and follow, while still protecting consumers. https://go.usa.gov/xQYVP
- “In a speech that seemed designed to signal that nutrition is still a priority… @SGottliebFDA said his agency would launch a comprehensive, multi-year package of nutrition initiatives… with the goal of tackling health conditions such as obesity.” http://ow.ly/5t5E30ji9VL
- The Nutrition Facts Label is a great resource for when deciding what is the right portion size for you to eat. https://go.usa.gov/xQrvm
- ust like @US_FDA‘s @SGottliebFDA, @PHAnews believes all Americans deserve the opportunity to live a healthy life, no matter where they live, work or play: http://www.ahealthieramerica.org
- #FDA issues first ever order to effect a mandatory recall, in this case for a Kratom contaminated with a dangerous pathogen; after sponsor refused to issue a voluntarily recall. Consumers are advised not use product, stores urged to remove it from shelves
- Check out #FDA’s new External Stakeholder Meeting Request (“ESMR”) system to more easily enable stakeholders outside of industry (such as patient and provider groups) to request meetings with the agency’s drug review program http://bit.ly/2Gxh62a