REGULATORY & REP GUARDRAILS

Compliant. Legal in All 50 States. No Special License Required.

MAKE Wellness Bioactive Precision Peptides™ are orally delivered, food-derived dietary supplements governed by DSHEA and GRAS. Know the rules before you detail.

Regulatory Summary Overview

Governed by DSHEA & GRAS: Formulated from natural food-protein hydrolysates with Generally Recognized As Safe (GRAS) status under the Dietary Supplement Health and Education Act.
No 503A / 503B Compounding Conflict: FDA's 2023–2025 enforcement actions targeted compounded injectable synthetic peptides. Oral bioactive dietary supplements are completely exempt from compounding restrictions.
Standard Retail License Only: An existing retail pharmacy or OTC retail license is all that is required for accounts to offer these products.

Rep Compliance Guardrails

Always Say

“Supports healthy…” / “designed to support…”
“Dietary supplement under DSHEA”
“Oral bioactive peptides”
“Part of a healthy lifestyle”
“Cash-pay wellness category”

Never Say

“Treats / cures / prevents…”
“FDA-approved drug”
“Replaces your medication”
“Works like a GLP-1 / peptide drug”
“Guaranteed results”

Rule of thumb: describe what the product supports, never what it treats. If a prospect asks “does this treat X?”, redirect to “it's designed to support healthy [pathway] as part of a wellness routine.”

Download Full 3-Page Compliance PDF

Keep on file for account owners, legal counsel, or state board inspectors.

Download Official PDF