Certain ‘Misbranded’ Tylenol Products Contain Harmful Titanium Dioxide, Class Action Says

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A proposed class action alleges the maker of Tylenol has failed to properly disclose that the ubiquitous pain reliever contains titanium dioxide, a heavy metal that can accumulate in and harm the human body. 

The 26-page filing alleges Johnson & Johnson Consumer’s failure to disclose on product labels the safety concerns linked to consuming titanium dioxide is “likely to deceive reasonable consumers.” 

The lawsuit claims that the Tylenol labeling violates the Federal Food, Drug and Cosmetic Act in that the pain reliever is touted as “safe when used as directed” despite the fact that an ingredient, titanium dioxide, can have detrimental health effects. 

Be sure to scroll down to see which Tylenol products allegedly contain harmful titanium dioxide. 

Per the case, titanium dioxide is often used to enhance the whiteness of paint, plastics, paper goods and certain foods and drugs. Studies have shown, however, that titanium dioxide exposure can cause pathological lesions of the liver, spleen, kidneys and brain; lung tumors; and inflammation, cell necrosis and dysfunction in the kidneys, the lawsuit states. 

Although the Food and Drug Administration (FDA) last looked into the risks of titanium dioxide more than 50 years ago, consumer advocacy groups more recently have called on the agency to consider banning the ingredient from use in food entirely, the suit relays. In May 2019, France banned titanium dioxide as a food additive, and in May 2021, the European Food Safety Authority proclaimed that the substance is no longer considered a safe food additive, the complaint shares. 

Research has shown that titanium dioxide nanoparticles, which accumulate in the human body, are genotoxic, meaning they can damage a person’s DNA, the lawsuit states. The nanoparticles are also recognized and taken up by immune cells, which can trigger an inflammatory response, and solid particles, once they reach sub-mucosal tissue, are able to enter lymphatic and blood circulation, according to the case. 

“In sum, TiO2 particles are ‘without doubt’ associated with the hazardous properties of cell damage, genotoxic effects, inflammatory responses, and changes in cell signaling. Researchers have thus cautioned that TiO2 should be used with great care, particularly in food and cosmetics: ‘The least that should be done for the consumer is that a declaration of nano-sized TiO2 in [ ] products is obligatory, so that we will have the choice whether to use it or not.’” 

As a global consumer health corporation, the defendant has been aware of the safety concerns posed by titanium dioxide since at least 2013, when a study published by a “medical professional” with the company found that the inhalation of titanium dioxide nanoparticles in a group of mice led to “considerable systemic inflammation, endothelial dysfunction and lipid metabolism dysfunction,” the complaint says. 

According to the lawsuit, at least the following Tylenol products contain titanium dioxide as an active ingredient:

• Tylenol Extra Strength;
• Tylenol Extended Release; 
• Tylenol Cold + Flu Multi-Action;
• Tylenol Cold + Flu Severe;
• Tylenol PM;
• Tylenol Rapid Release Gels; and 
• Tylenol Regular Strength Liquid Gels.

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The suit charges that Johnson & Johnson Consumer has knowingly and intentionally left information about the safety concerns associated with titanium dioxide consumption off product labels, despite touting the medications as “safe and effective when used as directed.” The case contends that the company has an obligation to disclose this information to the public. 

The lawsuit looks to cover all consumers in the United States who, at any time within the last four years, bought any of the Tylenol products listed on this page for personal or household use.

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