Quinine Hydrochloride

About

What it is and where it shows up.

Quinine hydrochloride is the hydrochloride salt of quinine, an alkaloid extracted from the bark of the cinchona tree. It imparts the characteristic bitter taste to tonic water and certain bitters-style beverages, and is approved strictly as a flavouring substance in non-alcoholic and some alcoholic drinks.

Safety summary

The regulatory and scientific consensus.

At the low concentrations used in food flavouring (typically ≤85 mg/L in soft drinks in the EU), EFSA concluded quinine salts are not expected to pose a safety concern for the general population. However, quinine has a well-established pharmacological profile at higher doses — including cardiac arrhythmia, thrombocytopenia (immune-mediated platelet destruction), and haemolytic reactions in G6PD-deficient individuals — making sensitive populations a key concern. The EU restricts its use exclusively to beverages with a maximum permitted level of 85 mg/L (expressed as quinine base).

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
FSANZ (Food Standards Australia New Zealand) (Australia)	Restricted	Permitted as a flavouring substance in beverages under the Australia New Zealand Food Standards Code. Maximum use level aligns broadly with Codex and EU limits.source
EFSA (European Food Safety Authority) (European Union)	Restricted	Permitted only in non-alcoholic flavoured drinks and certain alcoholic drinks at a maximum of 85 mg/L expressed as quinine base, under Annex II to Regulation (EC) No 1333/2008. EFSA FGE.35Rev1 (2015) concluded no safety concern at flavouring-level intakes. No formal ADI has been established for food use.source
FSSAI (Food Safety and Standards Authority of India) (India)	Restricted	Quinine (INS 591) is listed in FSSAI Food Safety and Standards (Food Products Standards and Food Additives) Regulations as a permitted flavouring agent in carbonated water and tonic-style beverages; exact MPL follows Codex Alimentarius guidance.source
FDA (Food and Drug Administration) (United States)	Restricted	Permitted as a flavouring agent in carbonated beverages only, at a maximum level of 83 ppm (approximately 83 mg/L) under 21 CFR 172.575. Use as an over-the-counter drug for leg cramps was banned by FDA in 1994 due to safety concerns at therapeutic doses.source

Who should approach with care

Whose guidance would steer them away.

Pregnancy — Quinine has oxytocic properties and has been associated with foetal harm including congenital malformations and hypoglycaemia in newborns even at sub-therapeutic doses found in tonic water with frequent consumption.

G6pd Deficiency — Quinine can trigger acute haemolytic anaemia in individuals with G6PD deficiency by inducing oxidative stress in red blood cells, even at the concentrations present in tonic water.

Heart Disease — Quinine prolongs the QT interval and can potentiate arrhythmias; individuals with pre-existing cardiac conditions or those on QT-prolonging medications should seek medical advice before regular tonic water consumption.

Infants — Quinine-containing beverages are not appropriate for infants due to the alkaloid's pharmacological activity and the immature capacity of the infant liver to metabolise it safely.

Children — Children have lower body weight and proportionally higher beverage intake relative to bodyweight, raising potential exposure concerns; quinine-containing drinks are not recommended for young children.

Research citations

The sources behind this verdict.

1FDA. 21 CFR 172.575 — Quinine. accessdata.fda.gov
2WHO. JECFA Monograph: Quinine Hydrochloride — WHO Food Additives Series. apps.who.int
3EFSA. Flavouring Group Evaluation 35 Revision 1 (FGE.35Rev1): Consideration of quinine hydrochloride, quinine sulphate and quinine monohydrochloride dihydrate, 2015. efsa.europa.eu
4PubMed. Quinine, an old anti-malarial drug in a modern world: role in the treatment of malaria, 2011. pubmed.ncbi.nlm.nih.gov
5PubMed. Quinine-induced thrombocytopenia: drug-dependent GPIb/IX antibodies inhibit megakaryocyte and platelet production in vitro, 1999. pubmed.ncbi.nlm.nih.gov

Independently researched5 citations