Is citicoline banned in the US? Unpacking the Status of This Cognitive Supplement

October 6, 2025 •

4 min read

While citicoline is a prescription medication in some countries like Japan and parts of Europe, in the United States, it is widely available over-the-counter as a dietary supplement. The key to understanding its status is recognizing the difference in regulatory pathways for dietary supplements versus prescription drugs, which has led to confusion regarding whether is citicoline banned in the US.

Quick Summary

Citicoline is not a banned substance in the United States; rather, it is legally sold and regulated by the FDA as an over-the-counter dietary supplement, unlike its status as a prescription medication in other parts of the world. Its availability is a result of a different regulatory framework, allowing its use for supporting cognitive function and memory.

Key Points

Not Banned in the US: Citicoline is not a prohibited substance but is legally sold as an over-the-counter dietary supplement in the United States.
Dietary Supplement vs. Prescription Drug: The legal status of citicoline differs globally; it is a dietary supplement in the US but a prescription drug in countries like Japan and Spain.
GRAS Status: The FDA recognizes citicoline (specifically, the inner salt form) as Generally Recognized As Safe (GRAS), allowing its use in supplements and food products.
Regulatory Enforcement: The FDA and FTC can take action against companies that make unproven or illegal disease-related health claims about citicoline, but this does not constitute a ban on the ingredient itself.
Supports Cognitive Health: Citicoline is widely used in the US for general cognitive support, including memory, focus, and overall brain function, not for treating specific diseases.
Importance of Reputable Brands: Because supplements are not pre-approved, consumers should choose high-quality brands that use ingredients like Cognizin® and undergo third-party testing.

What is Citicoline?

Citicoline, or cytidine 5'-diphosphocholine (CDP-choline), is an endogenous compound naturally occurring in the human body. It serves as an essential precursor in the biosynthesis of phosphatidylcholine, a critical component of neural cell membranes. This means it provides the necessary building blocks for maintaining the structure and function of brain cells. Beyond its role in cellular membrane repair, citicoline is also a source of choline, which the body can use to produce the neurotransmitter acetylcholine, a chemical messenger vital for memory and cognitive function.

The Misconception: Is Citicoline Banned in the US?

The widespread misconception that citicoline is banned in the US likely stems from several factors:

Regulatory Differences: Citicoline's legal status varies significantly worldwide. In some countries, it is classified and sold as a prescription drug, often for treating neurological disorders such as stroke and traumatic brain injuries. This has created confusion for those comparing international regulations to US laws.
Outdated Information: Some sources, including older academic literature, have cited a 2009 event in which there was a temporary halt or ban on some specific uses or formulations of citicoline. This was not a permanent, sweeping ban on the substance itself but rather a regulatory event concerning how it was marketed or classified. Subsequent self-affirmation as Generally Recognized As Safe (GRAS) has since clarified its status for use as a food ingredient or supplement.
Online Rumors: In the age of misinformation, it's easy for outdated or incorrect information to persist and circulate online, particularly within forums discussing nootropics and supplements. Without access to accurate regulatory information, these rumors can become entrenched.

The Real Story: FDA Regulation and GRAS Status

The US Food and Drug Administration (FDA) regulates citicoline not as a prescription drug but as a dietary supplement. Its journey to becoming a widely available supplement was formalized through the Generally Recognized As Safe (GRAS) process.

GRAS Self-Affirmation: In 2009, a Japanese company, Kyowa-Hakko, submitted a self-affirmation of citicoline (inner salt form) as GRAS. This process allows for an ingredient to be used in food and dietary supplements without pre-market FDA approval, provided that there is a scientific consensus among experts that it is safe under the intended conditions of use.
FDA Enforcement, Not Ban: While the FDA does not approve dietary supplements before they are marketed, it does monitor them and can issue warnings or take action against companies that make illegal or unsubstantiated health claims. For example, the FDA and FTC have issued warning letters to supplement companies making unproven claims that citicoline could treat diseases like Alzheimer's. This is about regulating marketing practices, not banning the ingredient itself.
Key Distinction: The critical difference is that in the US, citicoline is not marketed or prescribed as a drug for treating specific diseases but as a supplement intended to support general cognitive function, memory, and brain health.

Citicoline in the US vs. International Market

To further clarify the context surrounding citicoline's status, a comparison between its regulation in the US and other countries is useful:


Aspect	United States	Japan and European Countries
Regulatory Class	Dietary Supplement	Prescription Drug
FDA Regulation	Monitored, but not pre-approved. Falls under GRAS status for use in supplements.	Approved and regulated as a pharmaceutical product.
Availability	Over-the-counter in supplement form at various stores and online.	Requires a doctor's prescription for sale and use as a medicine.
Intended Use	Marketed for supporting cognitive function, memory, and overall brain health. Claims must be general, not disease-specific.	Used medically for treating conditions like acute ischemic stroke, traumatic brain injuries, and certain neurological disorders.
Forms	Predominantly available in oral forms (capsules, tablets).	Available in oral formulations, injections, and intravenous preparations under medical supervision.
Potential Concerns	Supplement quality and consistency can vary. Important to choose reputable brands.	Potential side effects and drug interactions are managed by a healthcare provider.

Why Choose a Reputable Citicoline Supplement?

Because dietary supplements are not subject to the same stringent pre-market testing as prescription drugs in the US, it is essential for consumers to be vigilant when selecting a product. Opting for supplements from reputable brands is crucial for ensuring product quality, purity, and proper formulation. Many well-regarded brands use branded forms of citicoline, such as Cognizin® Citicoline, which have undergone specific testing for safety and efficacy. Looking for certifications from independent third-party testing organizations, such as NSF International or USP, can also provide an additional layer of assurance regarding product standards.

Conclusion

To definitively answer the question, no, citicoline is not banned in the US. The confusion surrounding its legal status stems from the vast differences in pharmaceutical and supplement regulation globally. In the United States, citicoline is a legally available dietary supplement, thanks to its Generally Recognized As Safe (GRAS) status, which allows for its over-the-counter sale for general cognitive and brain health support. This contrasts with its status as a prescription drug for specific neurological treatments in other countries. Consumers should be mindful of these regulatory distinctions and prioritize reputable brands to ensure product quality and safety when choosing to use citicoline to support their cognitive health.

For more detailed regulatory information, refer to the FDA's Dietary Supplement Guidance, which outlines the rules governing the sale and marketing of supplements in the US.

Frequently Asked Questions

This claim likely stems from a misunderstanding or misinterpretation of a specific regulatory event. While some older academic sources mentioned a 2009 ban, this was not a widespread, permanent ban on the substance. The confusion arises from the difference between its status as a dietary supplement in the US and a prescription drug in other countries.

As a prescription drug (outside the US), citicoline is used to treat specific neurological conditions under medical supervision, with its safety and efficacy backed by pharmaceutical-level clinical trials. As a dietary supplement (in the US), it is marketed for general health support, such as cognitive function, and does not require the same level of pre-market approval.

The chemical compound (CDP-choline) is the same. However, the form and purity can differ. In the US, the inner salt form of citicoline has been self-affirmed as GRAS for use in supplements. Pharmaceutical-grade citicoline, often used in injections, undergoes more rigorous testing and regulation.

No, citicoline is not available as a prescription drug in the US. It is only sold as an over-the-counter dietary supplement. In a clinical setting, healthcare providers may use intravenous (IV) formulations, but this is a separate medical procedure.

The FDA regulates citicoline as a dietary supplement, meaning it does not need pre-market approval. However, the FDA can enforce rules regarding manufacturing quality and can take action against companies for making unsubstantiated health claims, especially if they are marketed as treating or curing diseases.

Yes. While the active ingredient is the same, different manufacturers may sell different forms, such as citicoline free-base or citicoline sodium. Many reputable brands use a specific patented form called Cognizin® Citicoline.

You should look for products from reputable manufacturers. Many reliable brands use branded ingredients like Cognizin® Citicoline and have their products certified by independent third-party organizations like USP or NSF to ensure quality, purity, and accurate labeling.