Mironova Labs

L-Ergothioneine for Dietary Supplements

The "longevity vitamin" — GRAS (self-affirmed), EU Novel Food authorized

For supplement brands and formulators developing longevity, cognitive health, and antioxidant products

GRAS

FDA Status (Self-Affirmed)

≥99%

Purity (HPLC)

30 mg/day

EU Supplement Ceiling

21 yr

Epidemiology Cohort

Supported by peer-reviewed researchGRAS (self-affirmed)EU Novel Food authorizedUS-manufacturedPeer-reviewed evidence

L-Ergothioneine is a naturally occurring amino acid uniquely accumulated via the dedicated OCTN1/SLC22A4 transporter — distinguishing it from passively distributed antioxidants. Mironova produces synthetic ergothioneine at ≥99% purity with GRAS (self-affirmed) and EU Novel Food authorization, providing consistent quality for supplement formulations.

Challenges & Solutions

Your Challenge. Our Answer.

We understand the specific problems you face — and we built solutions for each one.

The Problem

Consumer demand for science-backed longevity ingredients is growing, but most antioxidants have undifferentiated positioning

Mironova’s Answer

L-Ergothioneine has a dedicated transporter (OCTN1) — it’s actively accumulated in tissues, unlike passively absorbed antioxidants. The “longevity vitamin” positioning is peer-reviewed.

The Problem

Regulatory pathway for novel ingredients is complex — brands need ingredients with established safety dossiers

Mironova’s Answer

EGT has GRAS status (self-affirmed) and EU Novel Food authorization (EFSA, up to 30 mg/day). Clear regulatory pathway.

The Problem

Dietary intake of EGT is very low in Western diets (mushrooms are the primary source), creating a supplementation opportunity

Mironova’s Answer

Estimated US dietary intake is far below levels associated with benefit in epidemiological studies — strong rationale for supplementation

Published Research

Published Evidence

Key findings from peer-reviewed literature relevant to your application.

Reduced Mortality & CV Risk

Prospective study (n = 3,236): higher plasma EGT independently associated with reduced all-cause mortality and lower cardiovascular events.

Smith et al., Heart 2020

"Longevity Vitamin" Hypothesis

EGT proposed as a “longevity vitamin” — insufficient dietary EGT may accelerate aging-associated damage.

Ames, PNAS 2018

Cognitive Decline Association

Plasma EGT levels decline significantly beyond age 60 and are lower in individuals with mild cognitive impairment.

Cheah et al., Biochem. Biophys. Res. Commun. 2016

Longitudinal Cognitive Cohort

In 470 memory clinic participants followed up to 5 years, lower baseline plasma EGT was associated with faster cognitive decline across multiple domains.

Cheah et al., Free Radic. Biol. Med. 2022

16-Week RCT in Older Adults

RCT (n=147, ages 55–79) testing 10 and 25 mg daily EGT. Clear dose-dependent pharmacokinetics. Signals in subjective memory and sleep initiation at 25 mg. No adverse events.

Halliwell, Cheah et al., Clinical Nutrition 2024

GRAS (Self-Affirmed) Status

L-Ergothioneine has established GRAS status for specified food uses in the US, with EU Novel Food authorization under Regulation (EU) 2018/462.

GRAS Self-Affirmation Framework; EU Reg. 2018/462

Market Context

Ergothioneine Is Emerging as a Longevity Ingredient

Bruce Ames’ “longevity vitamins” framework positioned ergothioneine alongside PQQ and taurine as compounds essential for long-term health. A 21-year epidemiology cohort (Malmö Diet and Cancer, ~3,236 subjects) found ergothioneine most strongly associated with a healthier dietary pattern, with lower coronary disease and all-cause mortality per SD increase. A 2025 Cell Metabolism study linked ergothioneine to H₂S/persulfidation signaling and higher NAD⁺ in aged muscle tissue. These are observational and mechanistic findings — not proof that supplementation treats any disease.

Malmö Diet and Cancer Study; Ames (2018); Cell Metabolism (2025)

~3,236

Cohort participants

2025

Cell Metabolism study

GRAS

FDA Self-Affirmed

Application Notes

Supplement Formulation Notes

Recommended dose: up to 30 mg/day (EU authorized level).
Compatible with capsule, tablet, and powder formats.
Stable under standard supplement storage conditions.
Complementary antioxidant chemistry alongside vitamin C and other antioxidants.
For full mechanism data, transporter science, and peer-reviewed studies, please visit our Ergothioneine Science Hub.

Why Mironova

Your Advantage with Mironova

01

Synthetic, Not Fermentation

Produced via defined synthetic route with ≥99% purity (HPLC). Consistent composition batch to batch — no variability from biological production systems.

02

GRAS + EU Novel Food

Self-affirmed GRAS status for food and supplement use in the US. EU Novel Food authorized (EFSA opinion) with defined maximum levels: 30 mg/day for adult supplements.

03

Transporter-Targeted Biology

Ergothioneine is actively accumulated via the dedicated OCTN1/SLC22A4 transporter — not passively distributed. This selective uptake distinguishes it from generic antioxidants.

04

US Manufacturing with Documentation

Full analytical documentation suitable for supplement product dossiers. Produced in Fairfield, NJ with raw material traceability.

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FAQ

Frequently Asked Questions

Common technical questions about this product line, answered by our scientific team.

In the US, ergothioneine has self-affirmed GRAS status for specified food and supplement uses. In the EU, it is authorized as a Novel Food ingredient (Reg. 2018/462) with maximum supplement dose of 30 mg/day for adults. Not authorized for pregnant/lactating women or children under 3.
A 16-week RCT (n=147, 10 vs 25 mg/day) showed large plasma increases and signals in subjective memory and sleep initiation at 25 mg, but the composite memory primary endpoint was not sustained vs placebo. Epidemiological associations are strong but observational. We present these as what they are — not as proof of efficacy.
Mushrooms are rich in ergothioneine but deliver variable doses depending on species, growing conditions, and preparation. Synthetic production provides controlled purity (≥99%) and precise dosing for supplement formulations. The molecule is identical — the difference is consistency and documentation.
Prefer “mechanistically complementary” framing unless combination RCTs exist. The 2025 Cell Metabolism data links ergothioneine to NAD⁺ levels through cGPDH/persulfidation pathways, but this is a single preclinical study. Synergy claims require clinical evidence.
Antioxidant support and cellular protection are standard structure-function claim categories for supplements. Disease claims (treats, cures, prevents any condition) are not permitted. Frame mechanisms around “supports cellular health” and “contributes to antioxidant defense.”

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Related Resources

Technical data, product specifications, and application guidance.