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brainAdvanced7 IngredientsBotanical Extract

Brain & Mood Mushroom Complex

Compliant with FDA 21 CFR 101.36 Labeling Rules

FDA Label Layout PreviewStandard Vertical

Supplement Facts

Serving Size 2 Capsules

Servings Per Container 30

Amount Per Serving

%DV

Lion's Mane Extract (fruiting body) (Hericium erinaceus)

500 mg

†

Ashwagandha Extract (root) (Withania somnifera)

300 mg

†

Cordyceps Extract (fruiting body) (Cordyceps militaris)

250 mg

†

Rhodiola Rosea Extract (root) (Rhodiola rosea)

150 mg

†

Bacopa Monnieri Extract (leaf) (Bacopa monnieri)

150 mg

†

Phosphatidylserine (from Soy)

50 mg

†

Alpha-GPC

50 mg

†

† Daily Value not established.

Other Ingredients: Vegetable capsule, rice flour, magnesium stearate.

Contains: Soy.

Other Ingredients: Vegetable capsule, rice flour, magnesium stearate.

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Form Factor

Capsule

Serving Size

2 Capsules

Active Constituents

7 Total

Proprietary Blends

N/A

Applied FDA 21 CFR Compliance Rules

3 Pre-built Guardrails

✓

Botanical Latin Binomial Declaration21 CFR 101.4(h)

Per 21 CFR 101.4(h), botanical ingredients must declare the Latin binomial (e.g., Hericium erinaceus) and plant part (e.g., fruiting body) in parentheses after the common name. Omitting the Latin name is a top FDA Form 483 observation.

✓

Standardized Extract Declaration21 CFR 101.36(b)(2)

When an extract is standardized to a marker compound (e.g., Ashwagandha standardized to 5% withanolides), the standardization must be declared on the label — typically in parentheses after the extract name.

✓

Extract Ratio vs Raw Material21 CFR 101.4(h)

A 10:1 extract ratio means 10 parts raw material yielded 1 part extract. The amount declared on the label is the final extract weight (e.g., 500 mg of 10:1 extract), NOT the equivalent raw material weight (which would be 5000 mg).

Key Ingredients in This Formula

2 ReferencedBrowse all 15 →

AshwagandhaBotanicals

Adaptogenic herb used in Ayurvedic medicine. No FDA RDI; declared with † symbol. Standardized extracts typically contain 5% withanolides.

Lion's ManeBotanicals

Medicinal mushroom used for cognitive support. No FDA RDI; declared with † symbol. Common extracts: 10:1, 8:1 dual extract.

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FDA Label Formatting Guide for Brain & Mood Mushroom Complex

Mushroom and adaptogen complexes present some of the most nuanced FDA Supplement Facts labeling challenges under 21 CFR 101.4(h) and 21 CFR 101.36. This template demonstrates correct formatting for standardized botanical extracts — including 10:1 extract ratios, 5% withanolide standardization for Ashwagandha, and mandatory Latin binomial declarations for Lion's Mane, Cordyceps, and Reishi.

Common mushroom label failures include: omitting the plant part (fruiting body vs mycelium), failing to declare standardization percentages for active compounds, and confusing "extract ratio" (e.g., 10:1) with "concentration" — they are not interchangeable. This template formats all three correctly per FDA 21 CFR 101.4(h) botanical declaration rules.

Frequently Asked Questions

How to list a 10:1 mushroom extract on a supplement facts label?

List the extract name (e.g. Lion's Mane Extract), the plant part (fruiting body), the Latin name (Hericium erinaceus), and the extract ratio (10:1) in parentheses. The amount shown is the final extract weight, not the raw material weight.

How to show standardized active compounds on a label?

Per FDA 21 CFR 101.36(d), standardized compounds are shown in parentheses after the ingredient name. For example: "Ashwagandha Extract (root) (Withania somnifera) (standardized to 5% withanolides) 300 mg". The standardization percentage is part of the ingredient declaration, not the amount.

Do mushroom extracts need Latin names on supplement labels?

Yes. Per FDA 21 CFR 101.4(h), botanical ingredients must include the Latin binomial in parentheses. For example, Lion's Mane must show "(Hericium erinaceus)" and Ashwagandha must show "(Withania somnifera)".

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