Our Verdict: SAFE

Choline Bitartrate

CAS87-67-2

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

Choline Bitartrate — food additive

Choline bitartrate is a salt form of choline, an essential nutrient, combined with tartaric acid for stability. It is used as a nutrient supplement in foods and dietary supplements to support choline intake, which plays roles in cognitive function, liver health, and cell membrane structure.

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 Choline Bitartrate?

Choline bitartrate is a compound formed by combining choline, an essential nutrient, with bitartrate (a salt derived from tartaric acid). Choline itself is a water-soluble nutrient that the body requires for multiple physiological functions. The bitartrate form improves the stability and shelf-life of choline in food and supplement formulations, making it a practical choice for manufacturers seeking to deliver this nutrient in stable products.

Choline is classified as an essential nutrient by the National Academies of Sciences, Engineering, and Medicine, meaning the human body cannot synthesize adequate amounts and must obtain it through diet or supplementation. It is naturally present in foods such as eggs, liver, fish, and cruciferous vegetables.

Common Uses

Choline bitartrate is primarily used as a nutritional supplement ingredient in:

- Dietary supplements targeting cognitive health and memory support

- Fortified beverages and functional foods

- Prenatal and postnatal nutritional products

- Sports nutrition and performance supplements

- Brain health and nootropic formulations

The bitartrate form is preferred in many commercial applications because tartaric acid acts as a stabilizing agent, helping choline remain effective over extended shelf-life. This makes it particularly useful in liquid and powder formulations where moisture exposure is a concern.

Safety Assessment

Choline bitartrate has not been associated with adverse events reported to the FDA, and there are no FDA recalls linked to this ingredient. The safety profile of choline itself is well-established; the Institute of Medicine established an Adequate Intake (AI) for choline and identified an Upper Level (UL) of 3,500 mg per day for adults based on animal studies showing liver effects at higher doses.

The bitartrate component adds minimal safety concern, as tartaric acid is widely recognized as safe and is naturally present in grapes and other fruits. Tartaric acid and its salts have a long history of safe use in food and beverages.

No significant toxicity concerns have been identified for choline bitartrate at typical supplementation levels. Some individuals may experience minor gastrointestinal effects such as nausea or fishy body odor at very high doses, but these are generally associated with excessive choline intake rather than the bitartrate form specifically.

Regulatory Status

Choline bitartrate is not on the FDA's Generally Recognized as Safe (GRAS) list, which means it was not formally affirmed through the GRAS notification process. However, this does not indicate safety concerns; rather, many supplement ingredients function under the Dietary Supplement Health and Education Act (DSHEA) framework, where they are permitted in dietary supplements without requiring GRAS status.

In the United States, choline bitartrate is permitted for use in dietary supplements and may be added to conventional foods as a nutrient supplement ingredient. The FDA recognizes choline as a nutrient and permits nutrient supplementation in foods under applicable regulations.

International regulatory bodies, including those in Canada, Australia, and the European Union, similarly permit choline compounds in supplement and fortified food applications.

Key Studies

Research on choline supports its role in cognitive development, particularly during pregnancy and infancy. Studies have demonstrated associations between adequate choline intake and improved memory and attention span. The nutrient is essential for the synthesis of acetylcholine, a neurotransmitter critical for cognitive function.

Choline is also recognized for its role in methylation reactions and liver health. Research published in peer-reviewed journals supports the nutritional importance of adequate choline intake across the lifespan.

While extensive research exists on choline's nutritional benefits, specific clinical studies comparing the bioavailability and efficacy of choline bitartrate versus other choline forms (such as choline citrate or alpha-GPC) are limited, though the bitartrate form is considered a reliable delivery method.

Frequently Asked Questions

What is Choline Bitartrate?

Choline bitartrate is a salt form of choline, an essential nutrient, combined with tartaric acid for stability. It is used as a nutrient supplement in foods and dietary supplements to support choline intake, which plays roles in cognitive function, liver health, and cell membrane structure.

Is Choline Bitartrate safe?

Choline Bitartrate 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 Choline Bitartrate banned in any country?

Choline Bitartrate 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.