Brazil Bans Popular Colgate Toothpaste Due to Adverse Effects
Authorities Investigate Potential Risks with the Toothpaste After Reports of Adverse Effects Associated with Its New Formula with Stannous Fluoride
The Brazilian National Health Surveillance Agency (Anvisa) announced a precautionary ban on all batches of Colgate Total Clean Mint toothpaste containing stannous fluoride, an active ingredient in oral care. The measure, officially published Tuesday, was taken after detecting a significant increase in adverse effects among Brazilian consumers who used the product.
According to Anvisa, the decision was made following a risk assessment related to the new toothpaste formula, launched in July 2024 under the name Colgate Total Active Prevention. Users reported various symptoms such as:
Oral lesions
Painful or burning sensations
Inflammation of the gums
Swelling of the lips and tonsils
Dry mouth and reddened gums
In total, eight reports were recorded involving 13 adverse events. These effects have caused everything from medical costs to missed work, in addition to difficulties eating, speaking, and emotional distress, according to the Anvisa statement.
Which product is affected?
The measure affects only Colgate Total Clean Mint toothpaste with stannous fluoride (case 25351.159395/2024-82). Other versions of the Colgate Total line are not subject to the restriction and can continue to be sold normally.
The ban is temporary and preventative in nature and will remain in effect while additional analyses are conducted to determine the product's safety. Anvisa emphasizes that the toothpaste should not be consumed or sold during the investigation.
Is it available in other countries?
Colgate Total Clean Mint toothpaste, with this formula, is also available in several Latin American countries, which could cause concern among consumers outside of Brazil. It is recommended to check if the purchased product contains "stannous fluoride" in the ingredient list.
What the Colgate brand says
On its official website, Colgate confirms the use of stannous fluoride, highlighting that it is an active ingredient recognized by the American Dental Association (ADA) for its effectiveness against cavities, bacteria, and hypersensitivity.
Following Anvisa's ruling, the company issued a statement stating that it had already filed a legal appeal that resulted in the automatic suspension of the measure.
"We continue to take all reasonable measures to interact with Anvisa and demonstrate the safety of the product," Colgate stated.
"It is important to note that the product does not pose any general health risks, but some people may be more sensitive to certain ingredients, such as stannous fluoride, colorants, or flavors."
Colgate
Colgate, founded in 1806 in New York, is today the world's best-selling toothpaste brand, present in 200 countries and controlling nearly 40% of the global market. Its parent company, Colgate-Palmolive, reported revenues of more than $18 billion in 2023.
The Clean Mint variant, now under scrutiny, is part of the successful Colgate Total 12 range, which has recently undergone a change in formula and packaging.