The Agência Nacional de Vigilância Sanitária (Anvisa) has once again placed a precautionary ban on Colgate's Total Clean Mint toothpaste, effective April 30, 2025. This decision follows the withdrawal of an appeal by the manufacturer, Colgate-Palmolive, which had sought to lift the ban that was initially imposed on March 27, 2025. The suspension of the product was prompted by numerous consumer complaints regarding adverse reactions, including swelling of the lips and oral lesions.
Initially, Anvisa had decided to suspend the commercialization of the toothpaste for a period of 90 days after receiving eight notifications of adverse events associated with its use. These reports detailed symptoms such as burning sensations, gum inflammation, and oral lesions, which significantly impacted the quality of life for some consumers. In response to these complaints, Anvisa clarified that while there was no mandatory recall of the product, it should not be available for sale.
In a statement, Anvisa noted, "The agency received reports of adverse events that indicate the presence of stannous fluoride in the formulation may be associated with undesirable reactions in some users." This particular ingredient, while known for its antimicrobial and anti-cavity benefits, has raised concerns among certain consumers.
Colgate had initially filed an appeal against the suspension, which temporarily allowed the toothpaste to return to store shelves on March 30, 2025. However, the company later withdrew this appeal, leading to the reinstatement of the ban. In a statement to the press, Colgate emphasized its commitment to consumer safety and quality, asserting that the Total Clean Mint product adheres to rigorous regulatory standards. The company stated, "We believe in a timely resolution of this issue and are dedicated to addressing any consumer concerns through our official contact channels."
The adverse reactions reported by users have included a variety of symptoms, such as:
- Oral lesions
- Painful sensations
- Burning sensations
- Gingival inflammation
- Lip edema
These issues have prompted Anvisa to issue a public alert, advising consumers to monitor for signs of irritation and to discontinue use if discomfort persists. Health professionals are also encouraged to observe for any oral changes in patients using the product and to advise them accordingly.
Colgate's Total Clean Mint toothpaste is a newer formulation, having replaced the previous Total 12 line. The key change in this new version was the substitution of sodium fluoride with stannous fluoride, which has been touted for its enhanced effectiveness against dental plaque. However, this change has also been linked to the reported adverse reactions.
In a social media response, Colgate Brasil reiterated its mission to provide excellent oral health products, stating, "We understand and recognize that these cases can cause discomfort and we are available to address each one through our contact platform." The company has also assured consumers that its products adhere to stringent safety and quality standards set by regulatory agencies.
Despite the assurances from Colgate, the adverse reports have raised eyebrows among consumers and health professionals alike. Many users have taken to social media to share their experiences, reporting a range of discomforts including swelling, burning sensations, and even canker sores. These reactions have sparked a debate about the safety of the new formulation and whether consumers should be concerned about the ingredients used.
Anvisa's decision to reinstate the ban reflects its ongoing commitment to consumer safety and the necessity of thorough investigations into the safety of products in the market. The agency has highlighted the importance of reporting adverse reactions, encouraging consumers to utilize its e-Notivisa system to report any issues they encounter with health products.
As this situation develops, both Anvisa and Colgate are expected to continue their collaboration in investigating the safety of the Total Clean Mint toothpaste. The outcome of these investigations may lead to further changes in the product's formulation or additional measures to ensure consumer safety.
For now, the toothpaste remains off the shelves as Anvisa continues to monitor the situation. Consumers are advised to remain vigilant and report any adverse reactions they experience while using dental products. The agency's proactive approach aims to safeguard public health and ensure that all products meet the necessary safety standards.
