Titanium Dioxide in Oral Care Products: History, Safety, and Regulatory Landscape

Recently, Mars Inc., the maker of Skittles, announced it would be removing titanium dioxide from its iconic candy in the United States. This decision made headlines and sparked renewed public interest in the safety of food additives. But did you know that titanium dioxide isn’t just found in colorful candies - it’s also a common ingredient in many of the oral care products we use every day, including toothpaste? As regulatory agencies, consumer advocates, and manufacturers debate the future of this ingredient, it’s important to understand why titanium dioxide is so widely used, what the scientific community says about its safety, and how its regulatory status is evolving both in the U.S. and abroad.

What Is Titanium Dioxide and Why Is It Used in Oral Care?

Titanium dioxide (TiO₂) is a naturally occurring mineral compound used for its brilliant white color and ability to scatter light (the appearance of whiter teeth based on the reflection of light). After extraction from minerals like ilmenite and rutile, it’s processed into a fine, highly purified powder. In toothpaste and other oral care products, its primary function is as a whitening agent and colorant. That bright, opaque white paste on your toothbrush? Titanium dioxide is likely responsible for that clean, appealing look.

Since the mid-20th century, as commercial toothpaste brands sought to deliver not just oral health benefits but also visual cues of cleanliness and freshness, titanium dioxide became a staple. Its use is not limited to toothpaste; you’ll also find it in some mouthwashes, dental polishes, and cosmetic products. The form used in oral care is typically non-nano (meaning the particles are larger than 100 nanometers) which is considered less likely to pose inhalation or absorption risks compared to nanoparticles.

Claims and Perceived Benefits in Toothpaste

The main reason manufacturers include titanium dioxide in toothpaste is simple: aesthetics. Consumers expect toothpaste to be a uniform, bright white, which is often associated with purity and efficacy. Some research has explored whether titanium dioxide, particularly when combined with other minerals, might offer additional benefits like reducing dentin hypersensitivity or increasing resistance to acid erosion. However, these potential advantages are not the primary reason for its widespread use, and most toothpaste brands rely on it for its visual impact rather than any direct oral health benefit.

Safety Profile: What Does the Science Say?

For decades, titanium dioxide was considered nonreactive and safe for use in food, cosmetics, and oral care products. The U.S. Food and Drug Administration (FDA) approved it as a colorant for these applications, and it remains listed as an approved additive under specific regulations for cosmetics, drugs, and food. In food, the FDA limits its use to no more than 1% by weight, while in toothpaste, it’s typically present in much smaller amounts; just enough to achieve that signature white color.

However, recent years have brought increased scrutiny, especially regarding its use as a food additive. The main concern centers on the possibility that nano-sized particles of titanium dioxide could accumulate in the body and cause genotoxic effects (damage to DNA that could potentially lead to cancer). In 2021, the European Food Safety Authority (EFSA) concluded that titanium dioxide could no longer be considered safe as a food additive, citing these concerns. This led to a ban on its use in food products in the European Union, effective February 2022, and a similar ban in France in 2020.

Despite these developments, regulatory agencies in the United States, United Kingdom, Canada, Australia, and New Zealand have reviewed the same scientific evidence and chosen not to impose a ban, citing a lack of conclusive proof of harm at the levels typically consumed. In the U.S., the FDA continues to permit titanium dioxide in food and oral care products, though it is now actively reviewing its safety in response to public and political pressure.

It’s important to note that the risk assessment for toothpaste differs from that for food, as toothpaste is generally not swallowed in significant quantities. However, young children may ingest more toothpaste than adults, prompting some researchers to estimate daily intake levels and assess potential risks, especially from the nanoparticle fraction. Most studies have found that the levels ingested from toothpaste are well within established safety limits.

Regulatory Actions and Public Pressure

The Skittles decision by Mars Inc. didn’t happen overnight. It followed years of advocacy from consumer groups, legal petitions to the FDA, and growing concern from the public about the safety of titanium dioxide in food. In the U.S., the Center for Food Safety and other organizations have petitioned the FDA to ban the use of titanium dioxide in food, citing studies on potential DNA damage and cancer risk. The FDA, in response to these petitions and increased scrutiny, has opened a formal review of titanium dioxide’s safety as a food additive and is accepting public comments before making a final determination.

At the state level, Arizona became the first state to ban titanium dioxide in school lunches, reflecting a growing willingness among local governments to act where federal agencies have not. Meanwhile, the FDA’s ongoing review process could ultimately lead to new regulations or restrictions, depending on the outcome of its scientific and public review.

International Bans and Regulatory Divergence

The European Union’s ban on titanium dioxide as a food additive marked a significant shift in global regulatory approaches. The ban was based on concerns about the potential for nanoparticles to cause DNA damage, even though direct evidence of harm in humans remains limited. France led the way with a national ban in 2020, and the EU followed suit in 2022. These actions have influenced regulatory debates in other countries and spurred advocacy groups in the U.S. to push for similar restrictions.

Despite the EU’s action, other major regulatory agencies—including those in the UK, Canada, Australia, and New Zealand—have not banned titanium dioxide in food or oral care products, citing insufficient evidence of harm. In the U.S., the FDA’s review remains ongoing, but titanium dioxide is still widely permitted in both food and oral care.

Which Toothpastes Still Use Titanium Dioxide?

Despite the growing controversy, titanium dioxide remains a common ingredient in many leading U.S. toothpaste brands. Crest, Colgate, Sensodyne, Arm & Hammer, Tom’s of Maine, and various store brands continue to use it, particularly in mainstream and whitening varieties. Crest has noted that most of its toothpastes contain titanium dioxide, except for certain children’s products like Crest Pro-Health Stages Toothpaste, which are formulated without it. Tom’s of Maine offers both titanium dioxide-containing and titanium dioxide-free options, reflecting consumer demand for alternatives.

Consumers can identify titanium dioxide in toothpaste by looking for “titanium dioxide” or “CI77891” on the ingredient list. As awareness grows, more brands are introducing titanium dioxide-free products, especially in the natural and organic segments.

Industry Trends and the Future of Whitening Agents

The scrutiny of titanium dioxide has prompted toothpaste manufacturers to explore alternative whitening agents such as hydrated silica, sodium bicarbonate, kaolin, and chalk. These ingredients are often marketed as more natural or environmentally friendly, appealing to consumers who wish to avoid synthetic additives or ingredients banned in other regions.

The oral care industry is closely watching the FDA’s ongoing review and the outcome of public comments and scientific evaluations. Should the FDA decide to restrict or ban titanium dioxide in oral care products, manufacturers will need to reformulate their products, just as Mars has done with Skittles, and as many European food producers have already done.

Titanium dioxide has been a central ingredient in toothpaste and other oral care products for decades, valued for its whitening properties and visual appeal. Its safety has been supported by regulatory approval and scientific research, but recent concerns about nanoparticles and potential genotoxicity have led to bans in food products in Europe and increased scrutiny in the United States. The decision by Mars to remove titanium dioxide from Skittles, following advocacy, regulatory pressure, and high-profile political attention, has accelerated the debate and prompted the FDA to open a formal review of the additive’s safety.

As the regulatory landscape evolves and consumer preferences shift, the oral care industry is adapting by offering titanium dioxide-free alternatives and exploring new whitening technologies. Consumers now have more choices than ever, and the future of toothpaste ingredients will likely be shaped by ongoing research, regulatory decisions, and the growing demand for transparency and safety in everyday products.

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