Psyched downplays FDA's safety comments on AME-1

Executive Summary

• Completed an initial production run of the “Santa” dietary supplement shot on Sept. 15, 2025, with a soft launch planned for Oct. 1, 2025 and a second run scheduled for mid‑October.
• Submitted a scaled‑up extraction process patent application (U.S. Application No. 19/157,676) on Aug. 18, 2025; the filing is now pending in the U.S. and Canada.
• Voluntarily filed an NDIN with the FDA for AME‑1 in July 2025; although the FDA did not affirm safety, the company asserts compliance under the FFDCA and continues to market its products.

Key Details

• Product Development:
• “Santa” dietary supplement shot pilot run announced Apr. 10, 2025; initial production completed Sept. 15, 2025.

• Soft launch targeted for Oct. 1, 2025; second production run slated for mid‑October to support holiday inventory.

• Scientific Studies:

• Genotoxicity study on AME‑1 started Mar. 14, 2025 (AMES test, in‑vitro TK‑MLA assay, micronucleus assay). Ongoing with results to be disclosed later.

• Six‑month accelerated stability study by third‑party lab shows AME‑1 retains muscimol content up to 18 months and exhibits no microbial growth; product “Calm” now labeled with an 18‑month shelf life.

• Patents:

• Filed a “scaled‑up extraction process” patent application in the USPTO on Aug. 18, 2025 (U.S. Application No. 19/157,676).

• Application pending in both United States and Canada.

• Regulatory Update:

• Submitted a New Dietary Ingredient Notification (NDIN) for AME‑1 to the FDA in July 2025, including historical use data and company‑conducted toxicology studies.

• FDA response (Sept. 2025) indicated the filing did not demonstrate that AME‑1 “will reasonably be expected to be safe.” Company notes NDIN does not require FDA approval for market entry; compliance remains under FFDCA.

• Market Expansion:

• Company plans to grow route‑to‑market partnerships nationwide as additional AME‑1 products are introduced.

Notable Quotes

(No direct quotes were provided in the release.)