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With Renewed Ban by Anvisa, Colgate Total Clean Mint Formula Raises Suspicions About Adverse Reactions and Oral Health Impacts, While Authorities Investigate Risks Associated with Stannous Fluoride Still Present in the Product on Shelves.
According to the portal UNITV, the National Health Surveillance Agency (Anvisa) has once again determined the precautionary ban of Colgate Total Clean Mint toothpaste, after the company itself withdrew its appeal to suspend the previous decision.
The measure was taken in response to numerous reports from consumers regarding adverse reactions, such as lip swelling, inflammation, and oral lesions.
The ban, published on March 27, 2025, prohibits the commercialization of the product until its safety is proven.
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Stannous Fluoride: The Component Under Suspicion
The focus of the investigations is on stannous fluoride, a substance present in the new formulation of the product launched in July 2024.
Although recognized for its anticaries and antimicrobial properties, stannous fluoride may be associated with the unwanted reactions reported by some users.
Anvisa emphasizes that the ban is a preventive and temporary measure aimed at protecting public health while further tests and analyses are conducted.
Recommendations to Consumers
Anvisa advises consumers to immediately stop using Colgate Total Clean Mint toothpaste upon noticing any signs of irritation or oral discomfort.
In cases of persistent symptoms, it is essential to seek a health professional.
Additionally, the agency requests that consumers report adverse event notifications in the e-Notivisa system, contributing to the investigation and monitoring of the product.
Guidelines for Points of Sale
Despite the ban, there is no requirement to withdraw the product from shelves.
However, commercial establishments must ensure that Colgate Total Clean Mint toothpaste is not displayed or sold until its safety is confirmed.
Anvisa reiterates that the measure is restricted to the Clean Mint variant, and other versions of the product may continue to be sold normally.
Alert to Healthcare Professionals
Healthcare professionals should be alert to possible oral reactions in their patients, especially those using Colgate Total Clean Mint toothpaste.
It is important to educate patients about the signs of adverse reactions and recommend safe alternatives for oral hygiene.
Manufacturers, for their part, should ensure that product labels contain clear information about possible risks and proper usage instructions.
Colgate’s Position
Colgate reaffirms that the product is safe and meets the standards of regulatory agencies.
However, it acknowledges that reports of discomfort need to be individually investigated.
The company states that it is collaborating with Anvisa to expedite technical investigations and ensure consumer safety.
Data on Reports of Adverse Reactions
Between January 1 and March 19, 2025, Anvisa registered eight notifications involving 13 cases of adverse events related to the use of Colgate Total Clean Mint toothpaste.
The main reported symptoms include:
- Oral Lesions (sores, wounds, and blisters);
- Painful Sensations (pain, burning, stinging);
- Gingival Inflammation;
- Lip Edema;
- Feeling of Numbness (lips/mouth).
The Anvisa highlights that these symptoms significantly impact consumers’ quality of life, resulting, in some cases, in medical costs, missed work, difficulties in eating and communicating, and emotional distress.
The ban on Colgate Total Clean Mint toothpaste by Anvisa is a preventive measure based on reports of adverse reactions from consumers.
While investigations are ongoing, it is essential for consumers to be vigilant about signs of oral irritation and follow the guidance of health authorities.
Collaboration between Anvisa, Colgate, and consumers is crucial to ensure the safety and well-being of all.
