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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)

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WEEKLY INTELLIGENCE

The FDA This Week

Apr 27–May 1, 2026

The FDA proposed excluding GLP-1 receptor agonists semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substance list. Concurrent Class I recalls for Insulet’s Omnipod 5 and Trividia Health’s TRUE METRIX systems signal heightened surveillance of diabetes management hardware. Manufacturing oversight remains a priority, evidenced by CGMP warning letters to Intas Pharmaceuticals and Lexia LLC for inadequate laboratory testing.

0items tracked
0sectors active
0substances flagged
0deadlines identified
Pharma14Devices7Food5Biologics4Cosmetics2Supplements1Veterinary1
Press ReleaseDue: 2026-06-29
semaglutidetirzepatideliraglutide

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List

FDA has issued a proposal to exclude three GLP-1 receptor agonists—semaglutide, tirzepatide, and liraglutide—from the list of bulk drug substances that outsourcing facilities (503B) can use in compounding. The agency determined there is no clinical need for such compounding from bulk substances when FDA-approved versions are available, unless the drug is on the official FDA drug shortage list.

Compounded DrugsPrescription DrugsInjectable Drugs
Press Release
dextromethorphan hydrobromidebupropion hydrochloride

FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia

The FDA approved Axsome Therapeutics' Auvelity for the treatment of agitation associated with Alzheimer’s dementia, making it the first non-antipsychotic drug approved for this use. The drug, previously approved for major depressive disorder, carries a Boxed Warning regarding suicidal thoughts and behaviors in young patients and requires monitoring for seizures and hypertension.

Prescription Drugs
Source
Safety Alert

Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods

The FDA has classified the recall of specific lots of Insulet's Omnipod 5 Pods as a Class I recall, its most serious level. The devices contain a defect where internal tubing may tear, causing insulin to leak inside the pod instead of being delivered to the patient. This can result in significant insulin under-delivery, leading to hyperglycemia and potentially life-threatening diabetic ketoacidosis (DKA). Over 470 serious injuries have been reported in connection with this defect.

Class Ii Devices
Source
Safety Alert

Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication

The FDA has classified Trividia Health's recall of its TRUE METRIX Blood Glucose Monitoring Systems as Class I, following reports of 114 serious injuries and one death. The systems' software incorrectly uses the same 'E-5' error code for both critically high blood glucose levels (>600 mg/dL) and test strip errors, which can lead to life-threatening treatment delays or improper self-administration of insulin.

In Vitro Diagnostics
Source

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