We are launching a mushroom coffee dietary supplement and need a licensed U.S. attorney or regulatory consultant with specific expertise in FDA dietary supplement labeling under DSHEA to review our completed label, website, and claims package before first sale.
• Final label design (front panel + back panel with Supplement Facts)
• 4-page website (index, ingredients, disclaimer, terms)
• Formula ingredient list with doses and COAs
• *What we need:**
• Legal review of all 15 structure/function claims under 21 CFR 101.93
• Confirmation that no claims cross into disease claim territory under 21 CFR 101.93(g)
• Review of Supplement Facts panel for 21 CFR 101.36 compliance
• Review of website copy for FTC advertising compliance
• Guidance on 30-day 403(r)(6) COSM notification filing
• Written legal opinion or review memo we can retain on file
• *Requirements**
• Must be a licensed U.S. attorney OR credentialed FDA regulatory consultant
• Must have specific experience with DSHEA dietary supplement labeling
• Must be familiar with 21 CFR 101.93, 101.36, and FTC guidelines for supplements