Reviewed by Peptide Treatments Medical Advisory Board (Medical Advisory Board)

Argireline: Regulatory Status

Current legal and regulatory status for Argireline across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.

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United States

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Gray Area

Compounding status: not applicable (cosmeceutical). WADA: not listed. marketed in 50+ countries as cosmetic ingredient. Most commercially successful anti-wrinkle peptide. Ingredient in thousands of consumer skincare products. The Ordinary's Argireline Solution 10% is a top-selling product in this category.

Last verified:

What This Means

Reclassification is not the same as FDA approval.

Even if Argireline moves to Category 1, it remains an off-label therapeutic that requires physician supervision. Category 1 means it can be compounded under section 503A — it does not confer approved-drug status.

Argireline Overview

Uses, benefits, evidence, and monitoring.

Contraindications

Safety profile and drug interactions.

Evidence Summary

Clinical trial data and evidence tiers.