FDA Suspends Domestic Inspections
FDA has announced that the Agency has temporarily postponed all routine domestic facility inspections. All domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. The Agency will continue to respond to natural disasters, outbreaks, and other public health emergencies involving FDA-regulated products.
FDA Waives FSVP & Preventive Controls Supplier Verification Onsite Audit Requirement
FDA is temporarily waiving the requirements under supplier verification provisions of the FSVP and Preventive Controls for Human and Animal Food Rules for annual onsite audits. FDA will not take enforcement action for firms that use alternative verification methods because COVID-19 makes onsite audits not practicable.
National Marine Fisheries Service Expands Ban on Certain Mexican Seafood
The National Marine Fisheries Service announced they will expand the ban on the importation of certain fish and fish products from Mexican fisheries operating in the upper Gulf of California beginning April 3.
The announcement came after NOAA Fisheries revoked comparability findings, under the import provisions of the Marine Mammal Protection Act, for several Mexican fisheries within the range of the vaquita (an endangered porpoise) in the Upper Gulf of California. NOAA already restricts shrimp, curvina, sierra and chano fish and fish products from that area caught in gillnets within the range of the vaquita. Effective April 3, the import restrictions will be expanded to include these same fish caught with other gear types (in addition to gillnets). It will also include anchovy, herrings, sardines, mackerels, croaker, and pilchard caught within the affected Upper Gulf of California fisheries.
FSIS Publishes Notice on UK Raw Beef Imports
Notice 11-20 is available here.
FDA Publishes Final Rule on Tobacco Warning Labels; Final Guidance on Submission of Label Plans
The rule is available here and guidance available here.
APHIS Seeks Comment on List of Agents and Toxins Posing Severe Threat to U.S. Agriculture
The list is required to be maintained under the Agricultural Bioterrorism Protection Act of 2002. More information here.
FAS Releases Trade Safeguard List
The notice lists the updated quantity-based trigger levels for products which may be subject to additional import duties under the safeguard provisions of the WTO Agreement on Agriculture. The notice also includes the relevant period applicable for the trigger levels on each of the listed products.
FDA Import Operations and COVID-19
FDA’s Import Operations currently remain functional and operational. Activities including FDA Prior Notice review, FDA entry processing, FDA sampling/examination of high risk shipments, FSVP inspections, filer assessments, and compliance activities are all ongoing.
While most import operations are not currently experiencing delays, the import community should expect delays in the receipt of hard copy notices. FDA will have a lessened capacity to generate and mail hard-copy Notices of FDA Action (release notices, sampling notices, etc.). FDA strongly encourages all members of the import community who deal in FDA-regulated articles to utilize the FDA Import Trade Auxiliary Communication System (ITACS) for current entry status and to receive FDA notices electronically.
FDA Guidance for Pharmacies Producing Hand Sanitizer
The guidance Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), is immediately in effect and outlines that the agency does not intend to take action against manufacturing firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs during this ongoing public health emergency as described in the guidance .
The second guidance, Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, is in effect for the temporary compounding of certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities. Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a tailor-made medication. The temporary policy outlined by the agency does not require compounders to obtain a patient-specific prescription.
FDA Sprout E. coli Outbreak Update
Consumers should not eat Chicago Indoor Garden’s recalled products. CDC reports additional cases in this outbreak.
FDA Cancels Cosmetics Meeting
FDA has canceled the public meeting “International Cooperation on Cosmetics Regulation (ICCR) – Preparation for ICCR-14 Meeting” scheduled for April 14, 2020 due to the Coronavirus Disease 2019 (COVID-19) outbreak.
FSIS Expands Healthy Claim Criteria
FSIS is announcing that it will allow establishments to use the implied nutrient content claim “healthy” on their labels which: (1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or (2) contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D. FSIS is making this announcement to maintain consistent requirements for food labels by allowing the same uses of the claim “healthy” for meat and poultry products as are currently allowed for food products under FDA’s jurisdiction.
Latest FDA Import Alerts
The latest FDA import alerts are available here.
Latest FDA Warning Letters
Posted Date |
Company |
Issuing Office |
Subject |
03/18/2020 |
Invitrx Therapeutics Inc. |
Center for Biologics Evaluation and Research (CBER) |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
03/17/2020 |
Commonwealth Vapes |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/17/2020 |
Vapstor Distribution |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/17/2020 |
Sweet Ann Cake, Inc. |
Office of Human and Animal Food Operations East Division IV |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
03/17/2020 |
Vaping Studio |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/17/2020 |
Sunrise Distributors Inc |
Division of Northern Border Imports |
Foreign Supplier Verification Program (FSVP) |
03/17/2020 |
Nature Essence Small Molecule Co., LTD |
Division of Human and Animal Food Operations East V |
Cosmetics/Adulterated/Misbranded |
03/17/2020 |
Warner Herb Co. |
Office of Human and Animal Foods Operations-East |
Unapproved New Drugs/Misbranded |
03/17/2020 |
Cipla Limited |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
03/17/2020 |
City Vapes Premium eJuice Inc. |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/17/2020 |
Dianne’s Fine Desserts |
Office of Human and Animal Food Operations East Division 1 |
Food Labeling/Misbranded |
03/17/2020 |
Banco Vida Corp. |
Office of Biological Product Operations |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
03/17/2020 |
Windlas Healthcare Private Limited |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
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