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From: Policy Canary <alerts@policycanary.io>
Your Marine Collagen Powder — Action Required
March 4, 2026 · 7:14 AM
Marine Collagen Powder
The FDA cited three companies for identity-testing failures on marine-sourced collagen in the last 90 days. Your product's ingredient profile matches the cited substances. Lab protocols need updating.
Action Items
- Verify identity-testing protocols for marine collagen
- Request updated CoA from supplier
- Document compliance review for FDA inspection readiness
Deadline
Q2 2026
Source
21 CFR 111.75(a)(1)(ii)
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From: Policy Canary
Your Marine Collagen Powder — Action Required
Marine Collagen Powder
Identity-testing warning mapped to your ingredient profile.
Action required by Q2 2026
21 CFR 111.75(a)(1)(ii)
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Monitored Products
Marine Collagen Powder
BHA Eye Cream SPF 15
Biotin Complex 5000mcg
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Monitored Products
Marine Collagen Powder
NovaBiotics failed identity testing for marine collagen. COA-only documentation was deemed insufficient by the FDA. Your product uses the same ingredient — this warning applies to your formulation.
Recommended Actions
- 1Audit identity testing protocols against 21 CFR 111.75(a)(1)(ii)
- 2Verify COA includes marine collagen-specific identity tests, not generic protein analysis
- 3Confirm per-batch testing with your contract manufacturer
Action required by Q2 2026
Source: FDA CFSAN Warning Letters · 21 CFR 111.75(a)(1)(ii)
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WEEKLY INTELLIGENCE
The FDA This Week
Jul 6–Jul 10, 2026
The FDA issued 14 warning letters to online vendors for the illegal sale of unapproved ketamine, esketamine, and arketamine products. Medical device manufacturers Fresenius Kabi and Windstone Medical Packaging initiated Class I corrections for infusion pump malfunctions and contaminated surgical convenience kits. Food importers faced enforcement for Foreign Supplier Verification Program violations, specifically regarding soybean meal imports by Bushman Organic Farms.
Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec
The FDA is announcing a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee to discuss Biologics License Application (BLA) 125827, submitted by Replimune, Inc. for Vusolimogene Oderparepvec. The FDA is also establishing a public docket to receive comments regarding this application.
Ketamine Store / www.ketaminestore.org — Unapproved New Drugs/Misbranded
Ketamine Store / www.ketaminestore.org
The FDA issued a Warning Letter to Ketamine Store for illegally selling unapproved and misbranded ketamine and esketamine products, including liquids, troches, and nasal sprays, directly to U.S. consumers without requiring a prescription. These products lack FDA approval, fail to meet compounding exemptions under sections 503A and 503B of the FD&C Act, and bypass strict REMS requirements designed to mitigate serious safety risks. The FDA requested the immediate cessation of these sales.
Bushman Organic Farms, Inc. — Foreign Supplier Verification Program (FSVP)
Bushman Organic Farms, Inc.
The FDA issued a Warning Letter to Bushman Organic Farms, Inc. for significant violations of the Foreign Supplier Verification Program (FSVP) regulation. The company failed to develop, maintain, and follow an FSVP for imported foods, specifically organic soybean meal imported from multiple foreign suppliers.
Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
Fresenius Kabi has issued a Class I correction for its Ivenix Large Volume Infusion Pumps due to a risk of touchscreen malfunction (random touches or lack of responsiveness) after the device is dropped or jarred. This mechanical issue, caused by a loosened touchscreen input cable, can lead to therapy interruption or delay. The FDA classifies this as a high-risk recall with potential for serious injury or death.
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32 SKUs · 40+ active ingredients
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Moisturizer line · Next audit: Q2 2026
“Does the new BHA guidance apply to our moisturizer line? I need to know before our next audit.”
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Q3 launch timeline · Collagen SKU at risk
“What does this collagen identity testing warning mean for our Q3 launch timeline?”
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