Our Verdict: SAFE

Quinine Bisulfate

CAS549-56-4

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Quinine Bisulfate โ€” food additive

Quinine bisulfate is a salt form of quinine, a bitter alkaloid compound derived from cinchona bark, used as a flavoring agent in beverages and food products. It imparts a characteristic bitter taste and has been utilized in food manufacturing for decades, most notably in tonic water and other carbonated beverages.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Quinine Bisulfate?

Quinine bisulfate (CAS Number: 549-56-4) is a chemical salt formed by combining quinine, a naturally occurring alkaloid alkaloid derived from the bark of cinchona trees native to South America, with bisulfate. The compound appears as a white to off-white crystalline powder and is highly soluble in water. Quinine itself has a long history of use in food and beverages, dating back centuries when cinchona bark was first discovered and utilized in traditional medicine and later in food flavoring applications.

Common Uses

Quinine bisulfate functions primarily as a flavoring agent and flavoring adjuvant in the food and beverage industry. Its most prominent application is in the production of tonic water, where it provides the distinctive bitter taste characteristic of the beverage. Beyond tonic water, quinine bisulfate appears in various carbonated soft drinks, flavored waters, and other beverages marketed to consumers seeking bitter flavor profiles. The compound is valued in food manufacturing for its potencyโ€”only small quantities are needed to achieve the desired bitter taste, making it cost-effective for producers. Some food manufacturers also utilize it in pharmaceutical applications and as a food additive in select confectionery and flavoring preparations.

Safety Assessment

Quinine bisulfate has not been approved by the FDA as a Generally Recognized as Safe (GRAS) substance, meaning it does not have blanket approval for use in all food categories without specific authorization. However, this classification does not necessarily indicate a safety concern; rather, it reflects that the compound has not undergone the formal GRAS notification process or petition for FDA approval. According to FDA records, there have been zero adverse events reported and zero recalls associated with quinine bisulfate, indicating no documented safety incidents in the food supply. The European Food Safety Authority (EFSA) has established acceptable daily intake (ADI) values for quinine in food applications. Typical exposure levels from dietary sources, particularly tonic water consumption, remain well below established safety thresholds for the general population. Certain populations, including pregnant women and individuals with specific medical conditions or sensitivities, should exercise caution with quinine-containing products, as quinine can have pharmacological effects beyond simple flavoring.

Regulatory Status

In the United States, quinine is permitted as a food additive in specific beverages, most notably tonic water, where it is recognized for its traditional use. The FDA permits quinine in carbonated soft drinks and other beverages at levels not exceeding 15 mg/L. However, the specific regulatory pathway for quinine bisulfate versus other quinine salts may vary, and manufacturers must ensure compliance with applicable food additive regulations in their respective jurisdictions. In the European Union, quinine is listed as a permitted food additive under Regulation (EC) No 1333/2008. Many countries have established specific limits on quinine content in food and beverages, reflecting both historical use patterns and safety considerations.

Key Studies

Scientific literature on quinine and its salts has primarily focused on pharmacological effects rather than food safety applications. Research has established quinine's chemical properties, metabolism, and bioavailability in humans. Studies examining typical dietary exposure to quinine through beverages like tonic water have consistently shown that consumption at normal levels poses minimal health risk to the general population. Toxicological studies on quinine compounds have contributed to the establishment of safety guidelines and acceptable daily intake levels by regulatory agencies. The long historical use of quinine in foods and beverages, combined with the absence of documented adverse events from food-level exposures, provides additional evidence supporting its safety profile in culinary applications.

Frequently Asked Questions

What is Quinine Bisulfate?

Quinine bisulfate is a salt form of quinine, a bitter alkaloid compound derived from cinchona bark, used as a flavoring agent in beverages and food products. It imparts a characteristic bitter taste and has been utilized in food manufacturing for decades, most notably in tonic water and other carbonated beverages.

Is Quinine Bisulfate safe?

Quinine Bisulfate is currently rated "safe" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Quinine Bisulfate banned in any country?

Quinine Bisulfate is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.