The use of Titanium Dioxide in Tylenol is approved by regulatory bodies and the drug is safe to use as prescribed.

Tylenol is a widely used over-the-counter (OTC) medication primarily used to relieve pain and reduce fever. Its active ingredient is acetaminophen which is also known as paracetamol. Apart from this the medication also contains few other ingredients. 

The presence of one such ingredient called Titanium Dioxide has raised concern among the consumers. Social media users are claiming that Titanium Dioxide has been banned in many countries as it has been proved to be harmful for humans. 

However, Fact Crescendo found the claim to be misleading. Titanium Dioxide has been approved to be used in medications as well as in other products. 

What’s the claim?

Social media users are claiming that Tylenol contains titanium dioxide and red dye which are considered harmful additives. Titanium dioxide is used to whiten products and has been banned or removed in other countries and from food items like Dunkin’ Donuts and Skittles. It has been claimed to worsen ADHD symptoms. 

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Fact Check- 

Ingredients in Tylenol and Warnings with it: 

Tylenol primarily contains Acetaminophen as an active ingredient. Apart from this various inactive ingredient like caranuba wax, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide, polysorbate 80, titanium dioxide etc. 

This medicine contains acetaminophen, which can harm the liver if taken more than 4,000 mg in one day. It can also be dangerous if it is consumed with other medicines that have acetaminophen or if one drinks three or more alcoholic drinks every day while using it. Some people may also have a serious skin reaction to acetaminophen, which could cause redness, blisters, or a rash. Details about the product can be read here. 

Is Titanium Dioxide Harmful?

Titanium dioxide (TiO₂) is currently approved for use in medicines in many countries, including the United States and the European Union, primarily as a colorant and opacifying agent in tablets, capsules etc. The FDA allows for the safe use of TiO2 as a color additive in foods according to the specifications and conditions, including that the quantity of titanium does not exceed 1% by weight of the food, as stated in FDA regulations. The FDA has reviewed scientific data and found no safety concerns when titanium dioxide is used within the approved limits.

In 2023, the Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) re-evaluated the safety of titanium dioxide. In its summary report, JECFA concluded that TiO₂ added to food is safe. Based on the available data (toxicological, biochemical, and other), the total daily intake of the substance does not represent a hazard to health.

The UK Committee of Toxicity (COT) reviewed the European Food Safety Authority’s 2021 findings and conducted its own detailed evaluation. It concluded that, at current exposure levels in the UK, titanium dioxide (E 171) is unlikely to pose a health risk. However, the committee acknowledged the potential harmful effects of nano-sized TiO₂ and is currently examining whether it can damage DNA. 

The European Medicines Agency (EMA) reviewed the role of titanium dioxide in human medicines and confirmed that it’s widely used for its unique properties like providing a bright white color to the product, blocking harmful light, and protecting sensitive ingredients. EMA acknowledged that currently there are no alternatives to Titanium Dioxide that will match its effectiveness and replacing it could require significant reformulation and testing of thousands of medicines. Although the EU banned TiO₂ in food in 2022 due to safety uncertainties, EMA allowed its continued use in medicines. 

Conclusion: 

Although there are harmful effects of Titanium Dioxide and it has been banned by the European Union, the amount used in medicines is within safety limits and does not possess threat and has been approved by regulatory bodies. Further research is going on to find alternatives to TiO₂.