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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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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
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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
Oct 5–Oct 9, 2026
The FDA executed a significant administrative purge of the generic drug market this week, withdrawing approval for 53 abbreviated new drug applications from manufacturers including Par Health USA and Amneal Pharmaceuticals. Food sector focus shifted to traceability compliance with new draft guidance on enforcement policies for retail establishments and restaurants regarding FSMA recordkeeping. Parallel enforcement in the supplement and device categories addressed acute safety risks, specifically banned DMAA in pre-workout powders and particulate matter in ICU Medical IV tubing.
Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications
FDA is withdrawing approval of 37 Abbreviated New Drug Applications (ANDAs) held by Par Health USA LLC and other entities. This administrative action removes the legal authorization to market these generic drug products in the United States.
Guidance for Industry: Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants
The FDA's Human Foods Program issued a draft guidance outlining an enforcement policy for the FSMA final rule on Requirements for Additional Traceability Records for Certain Foods. The agency states it currently does not intend to enforce certain traceability requirements for specific retail food establishments and restaurants.
Leader Formulas, LLC. Issues Voluntary Nationwide Recall of RAPTURE Preworkout Due to the Presence of 1,3-Dimethylamylamine (DMAA)
Leader Formulas, LLC. has initiated a voluntary nationwide recall of one lot of RAPTURE Preworkout dietary supplement powder (Lot 260327-4) due to the presence of 1,3-Dimethylamylamine (DMAA). DMAA is associated with serious cardiovascular risks, including heart attack and elevated blood pressure. The product was distributed nationwide through retail stores and the company's website.
IV Tubing Set Correction: ICU Medical Updates Use Instructions for IV Tubing Sets
ICU Medical has issued a Class II recall for several types of IV tubing sets, including Plum, Gravity, and Oncology administration sets, due to the presence of black specks and particulate matter in the drip chambers. A subsequent investigation by the company and the FDA determined that the discoloration is intrinsic to the PVC material and does not enter the fluid path or pose a safety risk to patients. While product returns are not required, healthcare providers are instructed to inspect devices before use and segregate any units containing loose particulate matter.
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32 SKUs · 40+ active ingredients
“Which of my 32 SKUs is affected? I can’t cross-reference 40+ ingredients manually after every FDA notice.”
QA Manager
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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47 products · 3 categories
“I have 47 products. Show me which ones are affected — not a 500-page Federal Register summary.”
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