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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

Jun 22–Jun 26, 2026

Unapproved sexual health and prostate drugs sold via e-commerce triggered enforcement actions against Amazon.com and multiple specialty retailers. The agency simultaneously finalized nine harmonized guidances establishing effectiveness standards for veterinary anthelmintic drugs across livestock and companion animal species. Food and device sectors saw critical actions, including Class I recalls for GE HealthCare resuscitation systems and multiple Foreign Supplier Verification Program violations.

0items tracked
0sectors active
0substances flagged
0deadlines identified
Pharma19Veterinary9Supplements7Food6Biologics4Devices4Tobacco1
anthelmintics

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: General Recommendations; Guidance for Industry; Availability

The FDA is announcing the availability of a final guidance for industry titled 'Effectiveness of Anthelmintics: General Recommendations' (VICH GL7). This guidance, developed by the VICH, provides recommendations for the design and conduct of clinical trials to demonstrate the effectiveness of anthelmintic medicinal products in various animal species.

Veterinary Drugs
Warning Letter

Amazon.com, Inc. — Unapproved New Drugs/Misbranded

Amazon.com, Inc.

The FDA issued a Warning Letter to Amazon.com, Inc. for distributing unapproved new drugs via its Fulfillment by Amazon (FBA) network. The products, marketed for the treatment of phimosis and balanitis, are classified as unapproved new drugs because they make disease treatment claims without having an approved FDA application or complying with the relevant OTC monograph.

Otc Drugs
Source
Warning Letter

Huons Co., Ltd. — CGMP/Finished Pharmaceuticals/Adulterated

Huons Co., Ltd.

FDA issued a Warning Letter to Huons Co., Ltd. for severe CGMP violations at its South Korean drug manufacturing facility. Violations include egregious data integrity breaches in the microbiology lab (such as discarded failing bioburden plates and backdated records), inadequate out-of-specification investigations, and severe contamination hazards in aseptic processing operations. Consequently, the firm was placed on Import Alert 66-40, suspended U.S. production, and committed to a voluntary recall of all unexpired drugs in the U.S. market.

Injectable Drugs
Source
Warning Letter

Pamex Foods Incorporated — Foreign Supplier Verification Program (FSVP)

Pamex Foods Incorporated

The FDA issued a Warning Letter to Pamex Foods Incorporated for failing to comply with Foreign Supplier Verification Program (FSVP) requirements (21 CFR part 1, subpart L). The firm did not develop an FSVP for imported foods, including Worcestershire sauce, frozen stuffed corn tortillas, and corn flour. Furthermore, the firm failed to register its facility as required under section 415 of the FD&C Act. The FDA gave the firm 15 working days to respond and warned that continued non-compliance could lead to the imported foods being placed on Detention Without Physical Examination (DWPE).

Gravies Sauces
Source

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