The Agência Nacional de Vigilância Sanitária (Anvisa) has suspended the sale of Colgate Clean Mint toothpaste throughout Brazil due to numerous reports of adverse reactions from consumers. The decision, published in the Diário Oficial da União on Thursday, March 27, 2025, follows a significant number of notifications regarding health concerns associated with the product.
According to Anvisa, the suspension was prompted by eight reports involving 13 adverse effects linked to the use of the toothpaste. The symptoms reported by consumers include swelling in the tonsils, lips, and oral mucosa, a burning sensation, numbness in the lips and mouth, dry mouth, irritated gums, and redness. These reactions have raised alarms about the product's safety, leading to the precautionary measure.
Colgate Clean Mint is an updated version of the previously popular Colgate Total 12 toothpaste. The change in formulation, which took place at the end of 2024, involved replacing sodium fluoride with stannous fluoride. This new formula was marketed as an improvement, but it seems to have triggered unexpected side effects in some users.
In a statement to the press, Colgate-Palmolive acknowledged the decision made by Anvisa but emphasized that the product does not pose health risks. The company stated, "We are aware of Anvisa's decision for a precautionary interdiction of Colgate Clean Mint toothpaste, which does not imply a recall of the product. We are taking all necessary measures to interact with Anvisa and demonstrate the product's safety." They also mentioned that stannous fluoride is safe, effective, and widely used in toothpastes globally.
Despite this assurance, the company recognized that a small minority of individuals might have sensitivities to certain ingredients, such as stannous fluoride, dyes, or flavors. In light of this, Colgate has advised consumers experiencing adverse reactions to discontinue use of the toothpaste to alleviate symptoms.
As part of its commitment to consumer safety, Colgate has been monitoring reports related to the product closely. They are following each situation individually, ensuring that any issues are addressed promptly. The company has also encouraged consumers to seek medical attention if they experience any adverse effects after using the toothpaste.
This suspension is legally stipulated to last for 90 days, during which time Anvisa will conduct a thorough investigation into the safety of the product. The agency has stated that the sale of Colgate Clean Mint will remain halted until the investigation is complete and the product's safety is confirmed.
Since its launch in July 2024, Colgate Clean Mint has been marketed as a modern solution for oral care. However, the recent adverse reports have raised concerns among consumers, prompting them to question the safety of the new formulation. The company had previously claimed that the new formula was the result of over a decade of research and development, along with extensive testing with consumers, including trials in Brazil.
In light of the current situation, consumers who have experienced any symptoms after using the Colgate Clean Mint toothpaste are urged to report their experiences to Anvisa's notification system. This feedback is crucial for ensuring the safety of products sold in Brazil and helps regulatory agencies respond effectively to potential health risks.
As the investigation unfolds, it remains to be seen how Colgate will address the concerns raised by consumers and regulatory authorities. The company's commitment to quality and safety will be under scrutiny as they navigate this challenging situation.
In summary, the suspension of Colgate Clean Mint toothpaste serves as a reminder of the importance of consumer safety and regulatory oversight in the health and personal care industry. As the investigation progresses, both consumers and the industry will be watching closely for updates and resolutions.
