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We refer readers to the CY 2022 and CY 2023 PFS final rules (86 FR 65415 through 65418 and 87 FR 70040 through 70041) for previously finalized MVP subgroup registration requirements

The micro-channels created by the needles allow the peptide to penetrate deeper layers of the skin, significantly boosting collagen remodeling and speeding up recovery time

At a glance Drug / isotretinoin (Accutane), oral retinoid for severe nodular acne Supplement / green tea extract (GTE), standardized to EGCG (epigallocatechin gallate) Primary concern / additive hepatotoxicity at GTE doses 400 mg EGCG/day Secondary concern / CYP1A2 and CYP3A4 modulation may shift isotretinoin metabolism Dietary green tea risk / low, typical brewed cup contains 50 to 100 mg EGCG Monitoring required / LFTs (ALT, AST) at baseline and weeks 4, 8 per iPLEDGE protocol FDA DILI signal / GTE linked to drug-induced liver injury in 29 case reports reviewed by NIH LiverTox Recommendation / avoid concentrated GTE supplements during isotretinoin

Addressing these knowledge gaps will be essential in translating the scientific promise of PSYs into viable, evidence-based therapies for people living with MS (Figure 2)

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