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Alert to Consumers! Anvisa Banned Colgate Total Clean Mint Toothpaste After Reports of Adverse Reactions Such as Mouth Ulcers, Swelling, and Burning. The New Formula with Stannous Fluoride May Be the Cause of the Problems. Procon Notified the Company, and Consumers Should Stay Alert! Learn Everything About the Case and How to Protect Yourself.
The National Health Surveillance Agency (Anvisa) determined, on March 27, 2025, the precautionary ban of all batches of Colgate Total Clean Mint toothpaste.
The decision was made after the agency received a significant number of reports of adverse events associated with the use of the product, which contains stannous fluoride in its formulation.
Consumer Reports
Various consumers reported adverse reactions after using Colgate Total Clean Mint. Among the symptoms mentioned are oral lesions such as mouth ulcers, sores, and blisters; tongue problems; painful sensations such as pain, burning, and stinging; swelling of the tonsils, lips, and oral mucosa; numbness in the lips and mouth; and gum irritations. These reports were recorded on complaint platforms and directly to Anvisa.
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Change in Product Formula
In July 2024, Colgate launched a new version of the toothpaste, replacing sodium fluoride with stannous fluoride as the main active ingredient.
Stannous fluoride is known for its anticavity and antimicrobial properties. However, this change may be related to the adverse reactions observed in some users.
Colgate’s Position
Colgate stated that the new formula is the result of more than a decade of research and development, being safe for use.
The company acknowledges that some people may be sensitive to certain ingredients, such as stannous fluoride, colorants, or flavorings, and recommends that, in these cases, use of the product be discontinued.
Colgate provides a consumer support channel to address questions and record incidents.
Measures Taken by Anvisa
The precautionary ban imposed by Anvisa is valid for 90 days and is preventive in nature, aiming to protect consumer health while more in-depth investigations into the reports of adverse reactions are conducted. During this period, the sale and use of Colgate Total Clean Mint are suspended.
Guidelines for Consumers
Consumers who experience adverse symptoms after using the toothpaste should immediately stop using the product and seek medical advice.
Additionally, it is important to report the occurrence to Colgate’s support channels and Anvisa, contributing to the investigation and monitoring of cases.
Procon-SP Action
Procon-SP notified Colgate, requesting clarifications regarding the measures taken in response to the suspension.
The entity seeks information on how consumers can identify the banned products, which batches are affected, and what measures are being taken to assist those who had adverse reactions. The company has 24 hours to respond.
Importance of Health Surveillance
Cases like this highlight the importance of health surveillance and the continuous monitoring of products available in the market.
Anvisa’s actions are crucial to ensure the safety and health of the population, ensuring that products sold meet established quality and safety standards.
Update: Suspension of the Ban
On March 31, 2025, Anvisa suspended the ban on Colgate Total Clean Mint toothpaste after the company filed an appeal.
Despite the release, Anvisa issued a warning about the possibility of unwanted reactions to the use of toothpastes containing stannous fluoride in their formulation.
The ban and subsequent release of Colgate Total Clean Mint toothpaste by Anvisa highlight the need for consumer attention to everyday products.
It is essential to be alert to possible adverse reactions and seek professional guidance whenever necessary. Collaboration between regulatory bodies, companies, and consumers is vital to maintain safety and trust in the products available in the market.
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