FDA Discusses Standards of Identity and Geographic Indications of Foods
Ravi Bharwani of FDA discussed FDA’s Standards of Identity versus the European Union’s geographical indications. The article is here.
USDA Offers Tribal Students Career-Track Scholarships in Agriculture
USDA announced the opening of the 2020 scholarship application cycle for the USDA 1994 Tribal Scholars Program. The program aims to increase the number of tribal college and university students studying agriculture, food, natural resource sciences, and other agriculture-related disciplines. The program is available through the USDA Office of Partnerships and Public Engagement (OPPE). More information here.
Latest FDA Import Alerts
FDA has released its latest import alerts. Alerts have been updated for soft ripened cheese from France, seafood products, products with illegal color additives, salmonella, allergen labeling and more.
AMS Seeking Feedback on Draft Instructions for Validating GMOs Removed from Foods
In the final rule establishing the National Bioengineered Food Disclosure Standard (Standard), published December 21, 2018, AMS indicated it would provide industry stakeholders further instructions on how to validate a refining process. The regulations implementing the Standard identify the requirements for a validated refining process at 7 CFR 66.9(b)-(c). A validated refining process is included in the regulations because the definition of bioengineered food excludes foods in which the modified genetic material is not detectable. A validated refining process is one way a regulated entity can demonstrate that modified genetic material is undetectable.
The draft instructions are available on the AMS website at https://www.ams.usda.gov/rules-regulations/be/validation-process. AMS invites public comments on the draft instructions by January 16, 2020. Comments should be submitted online at www.regulations.gov.
FDA Approves Reduced Nicotine Cigarettes
FDA authorized the marketing of two new tobacco products manufactured by 22nd Century Group Inc. – Moonlight and Moonlight Menthol, which are combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes. More information here.
FSIS Releases Korea Audit Report
The audit report is available here.
NACCHO and FDA Announce the Ninth Year of the Retail Program Standards Mentorship Program
The Mentorship Program is funded through a Cooperative Agreement between FDA and National Association of County and City Health Officials (NACCHO). The peer mentorship program provides opportunities to learn, share experiences, and acquire tools and resources related to the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards). The program pairs retail food regulatory program practitioners who are experienced in applying the Retail Program Standards with those newly enrolled and/or looking for assistance, guidance, tools, resources, and recommendations for continued success. More information here.
FDA Releases Materials from Oct. Public Meeting on Deemed Tobacco Product Applications
This meeting was intended to provide information on the agency’s process for tobacco product application review with a particular focus on deemed tobacco products (e.g., cigars, waterpipe, and Electronic nicotine Delivery Systems (ENDS) including e-liquids and electronic cigarettes) including product review policies, procedures, and general scientific principles. The materials are available here.
FDA Denies Color Additive Petition by Center for Food Safety on Soy Leghemoglobin (i.e. heme in Impossible Burger)
The Center for Food Safety had objected to the final FDA rule amending the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products. More information here.
FSIS Highlights Accomplishments in Protecting Public Health in 2019
More information here.
Latest FDA Warning Letters
Posted Date |
Company Name |
Issuing Office |
Subject |
12/17/2019 |
Delfino Battista SRL |
Center for Food Safety and Applied Nutrition (CFSAN) |
Seafood HACCP/CGMP for Foods/Adulterated |
12/17/2019 |
Dercher Enterprises, Inc., DBA Gordon Laboratories |
Division of Pharmaceutical Quality Operations I |
CGMP/Finished Pharmaceuticals/Adulterated |
12/17/2019 |
LNK International, Inc. |
Division of Pharmaceutical Quality Operations I |
CGMP/Finished Pharmaceuticals/Adulterated |
12/17/2019 |
Unipharma, LLC |
Office of Pharmaceutical Quality Operations, Division II |
CGMP/Finished Pharmaceuticals/Adulterated |
12/17/2019 |
U.S. Dairy Unlimited, LLC |
Office of Human and Animal Foods Division 4 East |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
12/17/2019 |
Ee Hui Food Manufacture PTE Ltd |
Center for Food Safety and Applied Nutrition (CFSAN) |
Seafood HACCP/CGMP for Foods/Adulterated |
12/17/2019 |
Wild Child WA Pty Ltd. |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
12/17/2019 |
Conformis Inc. |
Office of Medical Device and Radiological Health Operations |
CGMP/QSR/Medical Devices/Adulterated |
12/17/2019 |
Pharmalab Enterprises, Inc. |
Office of Pharmaceutical Quality Operations, Division II |
CGMP/Finished Pharmaceuticals/Adulterated |
12/13/2019 |
Soaptronic LLC |
Division of Pharmaceutical Quality Operations IV |
Unapproved New Drugs/Misbranded |
For more information about any of these matters please contact Erik Lieberman at elieberman@usfoodimports.com or 202-765-1800. |