Pomegranate Extract

About

What it is and where it shows up.

Pomegranate extract is a concentrated, polyphenol-rich powder derived from the whole fruit of Punica granatum L., typically containing ≥50% total polyphenols including punicalagins. It is used as a functional food ingredient and nutraceutical for its antioxidant properties in dairy products, beverages, and confectionery.

Safety summary

The regulatory and scientific consensus.

No adverse events were reported in human studies with orally administered whole fruit pomegranate extract, and no treatment-related adverse effects were observed at the highest doses in subchronic animal studies. Allergic reactions to pomegranate are rare and it is not classified as a major allergen. The ingredient is not intended for use in infant formula or foods for infants and young children, and typical dietary exposure is estimated at 60–130 mg/person/day at mean to 90th percentile in the US population aged 2 and older.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Pomegranate extract does not carry a dedicated E-number as a food additive. It may be used as a food ingredient or novel food in the EU under applicable regulations (Regulation (EU) 2015/2283 for novel foods); no specific EFSA opinion restricting or banning it for general use has been identified. Use for specific health claims requires EFSA authorisation.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Fruits and vegetables listed in Indian Food Composition Tables (NIN/ICMR) may be used as processed ingredients including extracts in supplements or nutraceuticals per FSSAI Health Supplement Regulations 2017. Specific health benefit claims require prior FSSAI approval. Pomegranate infusion (a related form) received product-level approval under FSS (NSF & FI) Reg. 2017.source
FDA (Food and Drug Administration) (United States)	Approved	GRAS Notice GRN 001064 filed by Verdure Sciences; approved for use in dairy products, non-alcoholic beverages, and chocolate candy at 50 mg per serving. Not intended for infant formula, foods for infants/young children, or USDA-regulated meat and poultry products.source

Who should approach with care

Whose guidance would steer them away.

Infants — The FDA GRAS notice (GRN 001064) explicitly states that pomegranate extract is not intended for use in infant formula or foods formulated for infants and young children due to insufficient safety data in this population.

Kidney Disease — Pomegranate is high in potassium and contains oxalates; concentrated extracts may pose a risk for individuals with impaired kidney function who require potassium or oxalate restriction.

Heart Disease — Pomegranate extract may interact with blood pressure medications (e.g., ACE inhibitors) and blood thinners (e.g., warfarin) due to its potent polyphenol content; patients on such medications should seek medical guidance.

Liver Disease — Highly concentrated polyphenol extracts have theoretical hepatic metabolism interactions; individuals with liver disease should consult a physician before consuming pomegranate extract as a supplement ingredient.

Research citations

The sources behind this verdict.

1EFSA. Food Additives – EFSA Panel on Food Additives and Flavourings (FAF) Overview. efsa.europa.eu
2FDA. GRAS Notice No. GRN 001064 – Whole Fruit Pomegranate Extract (Verdure Sciences / Pomella®), 2023. fda.gov
3FSSAI. List of Product(s)/Ingredient(s) Applications Approved under FSS (NSF & FI) Regulations, 2017 – FSSAI Product Approval List, 2022. fssai.gov.in
4FDA. Pomella® Pomegranate Extract GRAS Notification – Verdure Sciences Submission Dossier, 2022. fda.gov
5FSSAI. Implementation of Health Supplements and Nutraceuticals Regulations – FSSAI Advisory (2017/2018), 2018. fssai.gov.in

Independently researched5 citations