Black Pepper Extract

About

What it is and where it shows up.

Black pepper extract is a concentrated preparation derived from the dried berries of Piper nigrum L., standardised primarily for its alkaloid piperine content; it is used as a flavouring agent and, in food supplements, as a bioavailability enhancer for co-administered nutrients and drugs. The piperine content in commercial extracts typically ranges from 3–9% in oleoresins up to ≥95% in highly purified supplement-grade material.

Safety summary

The regulatory and scientific consensus.

At normal culinary seasoning levels black pepper extract is broadly considered safe and poses no adverse health risk; EFSA established a NOAEL of 5 mg/kg body weight/day for piperine based on increased serum cholesterol in animal studies, while estimated dietary per-capita intake from flavouring use is only ~6.2 µg/day—far below the NOAEL. Concentrated supplement-grade doses (5–100 mg piperine/day) significantly inhibit CYP3A4 and P-glycoprotein, increasing bioavailability of numerous co-administered drugs and thereby carrying a meaningful drug-interaction risk. Animal studies at high bolus piperine doses indicate potential disturbance of spermatogenesis and embryotoxic effects, and regulatory bodies in several jurisdictions require cautionary labelling for pregnant and breastfeeding women using piperine-containing supplements.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Piperine (FL-no: 14.003), the primary bioactive alkaloid in black pepper extract, was evaluated as a flavouring substance in EFSA FGE.86Rev2 (2015). A NOAEL of 5 mg/kg bw/day was established; estimated EU per-capita flavouring intake via the MSDI method is ~6.2 µg/day, well below the NOAEL. No formal ADI set. Black pepper oleoresin and supercritical extract were also assessed safe as animal feed additives at ≤5 mg/kg complete feed (EFSA FEEDAP, 2022).source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Piper nigrum L. is a regulated spice under FSSAI Food Product Standards Chapter 2.9 (Salt, Spices, Condiments and Related Products) under the FSS (Food Products Standards and Food Additives) Regulations 2011. Pepper extracts are permissible as nutraceutical or supplement ingredients per FSS (Health Supplements, Nutraceuticals) Regulations; specific health-benefit claims for extracts require prior FSSAI approval.source
FDA (Food and Drug Administration) (United States)	Approved	Black pepper (Piper nigrum) and its oleoresin are GRAS under 21 CFR 182.10 (spices and natural seasonings) and 21 CFR 182.20 (essential oils, oleoresins, and natural extractives). Also evaluated as FEMA GRAS for use as a flavouring substance. No formal ADI established.source

Who should approach with care

Whose guidance would steer them away.

Pregnancy — Animal studies at high bolus piperine doses demonstrate maternal reproductive and embryotoxic effects; multiple regulatory bodies require cautionary labelling on piperine-containing supplements advising pregnant women to consult a healthcare professional before use.

Lactation — Concentrated piperine has not been adequately studied in breastfeeding women and may alter drug metabolism in both mother and infant; cautionary labelling is required in some jurisdictions for lactating women using piperine supplements.

Other — Piperine potently inhibits CYP3A4 and P-glycoprotein, significantly increasing bioavailability of co-administered drugs including anticoagulants, immunosuppressants, antiretrovirals, and many others; individuals on any regular prescription medication should consult a doctor before consuming concentrated black pepper extract or piperine supplements.

Research citations

The sources behind this verdict.

1FSSAI. Food Safety and Standards (Food Product Standards) Chapter 2.9: Salt, Spices, Condiments and Related Products – Version 2 (04.11.2024), 2024. fssai.gov.in
2EFSA. Safety and efficacy of feed additives prepared from Piper nigrum L.: black pepper oil and black pepper oleoresin for use in all animal species and a supercritical extract for use in dogs and cats (FEFANA asbl), 2022. efsa.europa.eu
3PubMed. Health Benefits and Risks of Consuming Spices on the Example of Black Pepper and Cinnamon, 2022. pmc.ncbi.nlm.nih.gov
4PubMed. Safety Aspects of the Use of Isolated Piperine Ingested as a Bolus, 2021. pubmed.ncbi.nlm.nih.gov
5PubMed. Determination and risk characterisation of bio-active piperine in black pepper and selected food containing black pepper consumed in Korea, 2021. pmc.ncbi.nlm.nih.gov
6EFSA. , 2015.

Independently researched6 citations