The Agência Nacional de Vigilância Sanitária (Anvisa) has taken a significant step by ordering the precautionary ban of all units of Colgate Clean Mint toothpaste, following numerous reports of adverse reactions from consumers. This decision, published in the Diário Oficial da União on March 27, 2025, is valid for a period of 90 days and comes amidst growing concerns over the safety of the product.
Between January 1 and March 19, 2025, Anvisa received eight notifications involving 13 cases where consumers reported symptoms such as swelling of the lips, oral mucosa, and tonsils, as well as burning sensations, numbness in the mouth, dry mouth, irritated gums, and redness. These alarming reports have raised questions about the safety of the newly formulated toothpaste.
Colgate Total Prevenção Ativa, the toothpaste in question, is a reformulated version of the popular Colgate Total 12. The primary change in this formulation was the replacement of sodium fluoride with stannous fluoride, a compound known for its antimicrobial properties. Colgate has publicly defended this change, asserting that it is safe and the result of over a decade of research and consumer testing, including studies conducted in Brazil.
Despite the company's assurances, Anvisa's decision reflects the serious nature of the complaints. The agency stated that it would continue to monitor the situation and may consider a permanent suspension of the product's manufacturing and sale if further evaluations deem it hazardous to health. Colgate has the opportunity to appeal the decision within the 90-day period.
The controversy surrounding the reformulated toothpaste has not gone unnoticed. Reports of allergic and inflammatory reactions have been widespread, with consumers expressing their frustrations on various platforms, including the ReclameAqui website, where more than a thousand complaints have been logged. Many users have reported experiencing oral lesions, canker sores, and other distressing symptoms after switching to the new formula.
One consumer from Curitiba shared her experience, stating that she had used Colgate Total for years without issues until she switched to the new formula. She began experiencing recurring canker sores, which she initially attributed to dietary changes or low immunity. However, upon researching online, she found that many others were having similar problems. After discontinuing use of the toothpaste, her symptoms subsided within days, reinforcing her belief that the product was the cause.
Another case involved a 25-year-old student who suffered severe symptoms, including dozens of canker sores that lasted nearly a month. He sought medical advice from four different doctors, but without a clear diagnosis. Ultimately, he decided to stop using the toothpaste, and relief came almost immediately. His experience highlights the potential severity of the reactions some consumers are facing.
The symptoms reported by users include swelling in the tonsils, lips, and oral mucosa; burning sensations; mouth numbness; dry mouth; gum irritation; and redness in sensitive areas of the mouth. These reactions have prompted Anvisa to classify the reported incidents as adverse events related to the use of the newly formulated toothpaste.
Colgate's decision to change the formula was presented as an advancement in dental care. The company claimed that the new formulation would provide superior protection against bacteria and strengthen tooth enamel. However, dental professionals have pointed out that while stannous fluoride is effective against cavities and has antibacterial properties, it can trigger reactions in sensitive individuals.
In response to the ban, Colgate-Palmolive has reiterated the safety of its product, emphasizing that stannous fluoride is a well-established ingredient in oral hygiene products worldwide. The company stated that extensive testing, including trials with Brazilian consumers, confirmed the efficacy and safety of the new formulation. They have also established a customer service channel at 0800 703 7722 for consumers seeking more information or experiencing adverse effects.
The implications of this ban extend beyond consumer safety; they also affect the competitive landscape of the oral hygiene market. Colgate-Palmolive holds a substantial share of the global toothpaste market, with 41% in the first half of 2024, and Latin America accounting for 25% of its revenue. This ban may provide an opportunity for competitors like Oral-B and Sensodyne to capture market share among consumers seeking alternatives.
As the investigation into the safety of Colgate Clean Mint continues, Anvisa is expected to assess the reports and data provided by Colgate-Palmolive. The agency's swift action underscores its commitment to public health and consumer safety. The situation serves as a critical reminder of the importance of vigilance in monitoring the safety of everyday products and the need for transparency from manufacturers.
In light of the ongoing investigation, consumers are advised to discontinue use of Colgate Clean Mint and consult a healthcare professional if they experience any adverse reactions. Anvisa encourages consumers to report any side effects through its online system, which is crucial for ongoing safety assessments.
This incident not only raises concerns about the safety of Colgate Clean Mint but also highlights the broader issues surrounding the introduction of new formulations in widely used products. As the case unfolds, it will be essential for both consumers and regulatory agencies to remain vigilant in ensuring that safety standards are upheld in the marketplace.
Ultimately, the fate of Colgate Clean Mint will depend on the outcomes of the ongoing evaluations and the company's response to the findings. The next 90 days will be critical in determining whether the toothpaste can return to shelves or if it will be permanently withdrawn, reshaping the landscape of dental care products in Brazil.
