Why did lithium get banned? A look at the historical salt substitute tragedy

October 13, 2025 •

3 min read

In 1949, the U.S. Food and Drug Administration (FDA) banned the sale of lithium, but not for its modern use in treating mental illness. The ban stemmed from a tragic series of deaths among heart disease patients who were using lithium chloride as a supposedly safe salt substitute. The critical answer to why did lithium get banned lies in a misunderstanding of its toxicity and metabolism.

Quick Summary

Lithium was banned by the FDA in 1949 due to fatalities from its use as an unregulated salt substitute. The danger arose when patients on low-sodium diets experienced toxic lithium buildup. The ban was lifted decades later for specific, carefully monitored psychiatric applications.

Key Points

1949 FDA Ban: {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium}
Cause of Toxicity: {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium}
Re-approval in 1970: {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium}
Crucial Monitoring: {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium}
Historical Misuse vs. Modern Use: {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium}
Legacy of Safety: {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium}

Early Medical Applications and Misguided Enthusiasm

Historically, lithium was used in various applications, from mineral springs treatments in the 19th century to being an ingredient in popular soft drinks like 7 Up until 1948. This led to a public perception of lithium as a beneficial substance. In the 1940s, with growing awareness of the dangers of high sodium intake, lithium chloride was introduced as a salt substitute under brand names like Westsal and Milosal. These products were marketed as safe alternatives for heart patients, often without adequate understanding of the risks.

The Tragedy of Lithium Chloride Intoxication

Reports of severe illness and death began appearing in the late 1940s among heart disease patients using lithium salt substitutes. Published case studies in 1949 detailed symptoms of lithium toxicity, including nausea, vomiting, tremors, confusion, kidney damage, and death. The danger arose because the kidneys process lithium and sodium similarly. Patients on low-sodium diets retained more lithium, leading to toxic accumulation, a risk compounded by the unknown narrow therapeutic index of lithium at the time.

The FDA Ban and Subsequent Re-evaluation

The alarming reports prompted the FDA to ban the sale of lithium chloride as a salt substitute in 1949. This action addressed a public health crisis caused by the substance's misuse. Despite the ban in the US, research into lithium's psychiatric uses continued internationally, particularly in Australia and Denmark. {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium} With international research and advancements in monitoring blood levels, lithium was re-evaluated for medical use in the US.

Modern Lithium: From Ban to Breakthrough

In 1970, the FDA approved lithium carbonate for treating acute mania in bipolar disorder. {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium}


Historical Misuse vs. Modern Therapeutic Use	Aspect	Historical Salt Substitute Use (1940s)	Modern Therapeutic Use (Post-1970)
Formulation	Lithium Chloride	Lithium Carbonate, Lithium Citrate
Indication	Sodium-free salt for heart patients	Bipolar Disorder (Acute Mania, Maintenance)
Regulation	Unregulated food additive	FDA-approved psychiatric medication
Monitoring	None	Regular blood level checks required
Risk of Toxicity	High, especially with low sodium intake	Managed and minimized with monitoring
Sodium Intake	Restricted (low-sodium diet)	Sodium intake must be consistent

Safe and Effective Use Today

Today, lithium is a crucial medication for bipolar disorder, known for its effectiveness in preventing manic and depressive episodes. Its use is carefully managed with strict protocols, including regular blood tests to maintain safe therapeutic levels. Understanding lithium's narrow therapeutic index is key to its safe use, with dosages adjusted based on blood concentrations and patient response. The history of lithium highlights the importance of rigorous research and regulation in pharmacology, demonstrating how a dangerous, uncontrolled application led to a ban, which in turn paved the way for its safe and effective medical use under controlled conditions. For detailed information on its modern clinical application, the {Link: NCBI https://www.ncbi.nlm.nih.gov/books/NBK519062/} is an authoritative resource.

Understanding the Historical Context

The Problem: Unregulated lithium chloride was marketed as a salt substitute in the 1940s for people on low-sodium diets due to conditions like hypertension.
The Fatal Flaw: Lithium and sodium are processed similarly by the body. {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium}
The FDA's Action: {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium}
The Therapeutic Rebirth: {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium}
Modern Safety: {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium}

Conclusion

So, why did lithium get banned in the past? {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium} This pivotal moment in medical history forced regulators to acknowledge the dangers of an uncontrolled substance and catalyzed the development of modern protocols. The lessons learned from that incident, combined with controlled scientific research, ultimately allowed for lithium's safe and effective re-introduction as a life-saving treatment for bipolar disorder under strict medical supervision. {Link: Dr.Oracle AI https://www.droracle.ai/articles/83050/fda-approval-indications-for-lithium}

Frequently Asked Questions

No, lithium was not banned from all medicine permanently. The ban issued by the U.S. Food and Drug Administration (FDA) in 1949 was specifically for its use as an unregulated salt substitute, not for all medicinal applications.

In the 1940s, lithium chloride was marketed as a salt substitute for people with high blood pressure or heart disease who needed to reduce their sodium intake. It was believed to be a safe alternative to table salt.

Patients on low-sodium diets inadvertently caused a build-up of lithium in their systems. The kidneys, which regulate both sodium and lithium, retained the lithium in the absence of sufficient sodium, leading to toxic levels.

Yes, lithium is still widely used today and is considered a highly effective medication for treating bipolar disorder, under strict medical supervision. The FDA approved its use for this purpose in 1970.

Today, lithium is used in regulated doses and with strict protocols that include regular monitoring of blood levels. This ensures the level remains within a narrow, therapeutic window, preventing toxicity.

Lithium has a narrow therapeutic index, meaning the difference between a safe, effective dose and a toxic, unsafe dose is very small. This is why careful blood level monitoring is so crucial for patients using it.

The historical incident is a direct reason for the stringent safety protocols used today. The tragic lessons from the 1940s salt substitute misuse led to a deeper understanding of lithium's pharmacology and the essential need for blood monitoring.