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From: Policy Canary <alerts@policycanary.io>

Your Marine Collagen Powder — Action Required

March 4, 2026 · 7:14 AM

Urgent · Action Required

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

  1. Verify identity-testing protocols for marine collagen
  2. Request updated CoA from supplier
  3. 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)

Ingredient Match

Matched by formula

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Marine Collagen Powder
Vitamin D3Marine CollagenHyaluronic Acid

Matched to FDA Warning Letter WL-2025-1847

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Monitored Products

Marine Collagen Powder

BHA Eye Cream SPF 15

Biotin Complex 5000mcg

Coverage

7 FDA data sources

Federal Register, guidance documents, warning letters, import alerts, Regulations.gov, openFDA, and RSS — all in one pipeline.

Federal Register

847

Warning Letters

1,247

openFDA

169K

Guidance Docs

2,761

Import Alerts

154

Regulations.gov

1,178

RSS Feeds

12

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Monitored Products

Intelligence Report2h ago

Marine Collagen Powder

21 CFR 111.75(a)(1)(ii)

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)

Interactive demo · click any product to see its intelligence

WEEKLY INTELLIGENCE

The FDA This Week

Apr 6–Apr 10, 2026

FDA investigators executed a coordinated enforcement sweep against online distributors marketing unapproved injectable peptides, including Semaglutide, Tirzepatide, and Retatrutide. Warning letters issued to Mile High Compounds, Prime Sciences, and PekCura Labs signal a focused crackdown on the illicit weight-management supply chain. Concurrent actions against Pure Indulgence Aesthetics for DSCSA violations and Medline Industries for CGMP failures highlight a week of intensified manufacturing and distribution oversight.

0items tracked
0sectors active
0substances flagged
0deadlines identified
Pharma14Supplements5Devices3Food2Tobacco1Biologics1
Safety Alert

Ventilator Correction: Baxter Updates Use Instructions for Volara Single-Patient Use Circuits

FDA has classified Baxter Healthcare's correction of Volara Single-Patient Use Circuits as a Class I recall. The issue involves interference between the Volara system and home care ventilators, potentially leading to oxygen desaturation or barotrauma. Users are instructed to follow a new Instructions for Use (IFU) addendum and monitor for signs of respiratory distress.

Class Ii Devices
Warning Letter
botulinum neurotoxin type AonabotulinumtoxinA

Pure Indulgence Aesthetics — Drug Supply Chain Security Act (DSCSA) Violations

Pure Indulgence Aesthetics

The FDA issued a Warning Letter to Pure Indulgence Aesthetics for violating the Drug Supply Chain Security Act (DSCSA). The firm was found dispensing significantly more units of Botox than it documented purchasing from an authorized trading partner and was discovered to possess an unlabeled vial containing botulinum neurotoxin type A, indicating the use of unauthorized and potentially unsafe sources for prescription injectables.

Prescription Drugs
Source
Warning Letter
RetatrutideTirzepatide+2

Mile High Compounds LLC — Unapproved New Drugs Sold Over the Internet

Mile High Compounds LLC

FDA Warning Letter issued to Mile High Compounds LLC for selling unapproved, injectable peptide drugs (Semaglutide, Tirzepatide, Retatrutide) and bacteriostatic water online. The FDA considers these products drugs because they are marketed for weight loss and addiction recovery, violating the FD&C Act's requirements for new drug approvals.

Injectable Drugs
Source
Warning Letter

Medline Industries, LP — CGMP/QSR/Medical Devices/Adulterated

Medline Industries, LP

The FDA issued a warning letter to Medline Industries, LP for CGMP/QSR violations at its Glen Falls, NY manufacturing facility. The agency found the firm's devices adulterated due to failures in establishing adequate CAPA procedures to address syringe and manifold disconnections linked to excess silicone. The firm also failed to maintain appropriate cleaning schedules for cleanroom manufacturing equipment, resulting in visible particulate matter, and did not properly verify design changes for luer connectors to ensure compliance with ISO standards. The firm has initiated a product removal (recall) but must further address systemic quality system deficiencies.

Class Ii Devices
Source

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