On Thursday, March 27, 2025, the Agência Nacional de Vigilância Sanitária (Anvisa) announced a nationwide suspension of the sale of Colgate Clean Mint toothpaste in Brazil. This decision, published in the Diário Oficial da União, comes in response to 13 reports of adverse events associated with the product's use, including significant oral health issues.
The reported reactions to Colgate Clean Mint include swelling in the tonsils, lips, and oral mucosa, as well as burning sensations, numbness in the mouth, irritated gums, and dry mouth. The toothpaste in question is a new formulation of the Colgate Total 12 line, which has undergone changes in both its formula and its name.
Colgate Total Prevenção Ativa, the reformulated toothpaste, was introduced to the market in July 2024. The new formula replaced sodium fluoride with stannous fluoride, a change that has since raised concerns among consumers. Between January 1 and March 19, 2025, Anvisa received eight formal notifications regarding adverse effects linked to this product. On March 27 alone, more than one hundred complaints were registered on Reclame Aqui, a platform where consumers voice their grievances about products and services.
In a statement, Colgate-Palmolive defended the safety of stannous fluoride, asserting it is widely used and recognized globally. The company emphasized that the new formula underwent over a decade of research and rigorous testing before its release. However, they acknowledged that a small segment of the population might exhibit sensitivity to certain ingredients, including stannous fluoride, dyes, or flavorings. Colgate's guidance for consumers experiencing adverse reactions is to discontinue use immediately.
Aline Laignier, a dentist specializing in pediatric dentistry and orthodontics, noted that allergic reactions do not affect everyone and can manifest in various ways, including burning sensations, canker sores, and swelling in the gums. "It could be a flavoring or a detergent present in the formula. Some patients may react even to other toothpaste brands, not just those containing stannous fluoride," she explained.
The Conselho Regional de Odontologia de São Paulo (CROSP) also commented on the issue, stating that adverse reactions to toothpaste typically cease once the product is no longer used. They advised consumers experiencing oral sensitivities to stop using any toothpaste they have not used before and to seek alternatives.
The CROSP further explained that the only way to determine whether a specific component of the toothpaste is responsible for an allergic reaction is through skin sensitivity tests. They emphasized that adverse reactions should not be attributed solely to fluoride ions, as both stannous fluoride (SnF2) and sodium fluoride (NaF) are effective in preventing cavities due to their fluoride content.
Both forms of fluoride are beneficial for dental health, as they strengthen tooth enamel and help remineralize weakened areas. However, they differ in their antibacterial properties. The sodium (Na) in NaF does not provide any preventive effect, while the stannous ion (Sn2+) possesses antibacterial qualities, which not only helps reduce cavities but also improves gum health, according to CROSP.
The legal framework surrounding this precautionary ban allows for a 90-day suspension of the product, during which time Anvisa will assess whether the toothpaste poses health risks. Colgate has the right to appeal this decision, and depending on the outcome of the evaluation, the agency may determine whether to extend the suspension of manufacturing and sales.
As of now, the Colgate Clean Mint toothpaste remains listed on the company's website, although it is not available for purchase. The recent developments have led to increased public interest, with Colgate being among the most searched terms in Brazil according to Google Trends.
This situation highlights the ongoing concerns regarding product safety and consumer health, particularly in the realm of personal care items. With the rising number of complaints and adverse reactions reported, both consumers and regulatory agencies are on high alert.
In summary, the suspension of Colgate Clean Mint toothpaste serves as a critical reminder of the importance of vigilant monitoring of consumer products, especially those that directly impact health and well-being. As investigations continue, consumers are advised to remain informed and cautious about the products they use.
