In This Week’s Edition:
- FDA Sends Warning Letters to Amazon and Walmart for Third Party Fulfillment of Supplement with Active Pharmaceutical Ingredients; Unapproved Drug Claims
- FDA Announces Effective Date of Supplier Verification Provisions of FSMA Preventive Controls Rules
- FSIS-FOIA Request Monthly Report
- FDA Updates Manufactured Food Regulatory Program State Standards
- FDA Proposes Increase in Color Certification Fees
- AMS Proposing to Adjust Mango Board Representation
- AMS Reduces Assessments for Pork Promotion Order
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
FDA Sends Warning Letters to Amazon and Walmart for Third Party Fulfillment of Supplement with Active Pharmaceutical Ingredients; Unapproved Drug Claims
FDA this week published warning letters it had sent to Walmart and Amazon for offering a dietary supplement through their websites that contained an active pharmaceutical ingredient and made unapproved drug claims. FDA asserted in the letters that Walmart and Amazon were introducing the prohibited supplement into interstate commerce by providing third-party fulfillment services for it. This position will have significant consequences for retailers who offer third-party fulfillment services as FDA is holding Walmart and Amazon responsible for items sold by third-party sellers which violate the Federal Food, Drug and Cosmetic Act. Please contact Erik Lieberman at elieberman@usfoodimports.com if you have any questions about this matter. We offer verification services that can reduce the compliance risks of retailers who provide third-party fulfillment services.
FDA Announces Effective Date of Supplier Verification Provisions of FSMA Preventive Controls Rules
FDA is announcing the effective date of October 31, 2022, for requirements related to establishing and implementing supply-chain programs, records documenting supply-chain programs, and onsite audits in two final rules, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.
FSIS-FOIA Request Monthly Report
See the full October report on FSIS-FOIA requests here.
FDA Updates Manufactured Food Regulatory Program State Standards
FDA has issued revised food safety standards for state regulatory programs that oversee food facilities that manufacture, process, pack, or hold foods. These regulatory program standards, known as the Manufactured Food Regulatory Program Standards, were first issued by the agency in May 2007. The 2022 changes include updates to defined terms, new job aides, as well as updates to the current standards.
FDA Proposes Increase in Color Certification Fees
FDA issued a proposed rule to amend the color additive regulations to increase the fees for certification services. If finalized, the proposed rule will implement a 10 cent per pound increase in color certification fees.
AMS Proposing to Adjust Mango Board Representation
This proposal invites comments on changes to the representation of the National Mango Board under the Mango Promotion, Research and Information Order. This action would allocate the seven foreign producer Board seats to the top five mango exporting countries, based on mango volume exported to the United States, with an additional seat allocated to the top exporting country, and one at-large seat. In addition, the proposal would require no more than one Board member be employed by or be affiliated with the same company.
AMS Reduces Assessments for Pork Promotion Order
The AMS rulemaking for the Pork Promotion order decreases the current rate of assessment of 0.40 percent of the market value of live porcine animals to 0.35 percent and decreases the amount of assessment per pound due on imported pork and pork products (one- to three-hundredths of a cent per pound).
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the outbreak of Listeria monocytogenes (reference #1057) in Ice Cream, the outbreak has ended, and FDA’s investigation has closed.
- For the outbreak of E. coli (reference #1121) in a not yet identified food, the case count has increased from 10 to 11 cases.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include foods containing undeclared major food allergens or foods that fail to properly label major food allergens, foods imported by foreign suppliers who are not in compliance with FSVP, and more.
FDA Warning Letters
Vape King, Inc |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Rogue Vapers, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Juicemafia Inc. d/b/a ECIG-Works |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Cloud X Vapes Forest Lake LLC d/b/a CloudXVapes |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Alternative Health Distribution LLC d/b/a CannaAid |
Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |
Bakkavor Foods USA Inc. |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
Facema, LLC. |
Foreign Supplier Verification Program (FSVP) |
Sovereign Pharmaceuticals, LLC |
CGMP/Finished Pharmaceuticals/Adulterated |
McConnell Labs Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |
ARYZ Trading LLC |
Foreign Supplier Verification Program (FSVP) |
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC |
Compounding Pharmacy/Adulterated Drug Products |
Minuti Coffee LLC |
Foreign Supplier Verification Program (FSVP) |
Amazon.com, Inc. |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
Walmart Inc. |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
Lupin Limited |
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
Latin Foods Market |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded |