News Category: Regulatory news
Public urged not to use products, which may be unsafe
The Health Products Regulatory Authority (HPRA) and the Health Service Executive (HSE) today advised members of the public of a recall of the ToothFaerie brand of toothpaste products. These toothpastes are considered unsafe, and consumers are advised to stop using these products immediately.
The products are not believed to have been made widely available. However, the HPRA understands that some of the recalled products may still be available to Irish consumers, including via online supply or at local markets.
The HPRA previously requested retailers to stop selling these toothpastes as they do not meet the requirements of the European Cosmetics Regulations. For this reason, they are considered unsafe. For example;
- The products listed an ingredient which is prohibited from use in cosmetic products. This ingredient, sodium tetraborate (borax), may cause damage to the reproductive system which may affect fertility.
- One batch was tested and found to contain lead which should also not be used in cosmetics as it can damage fertility or the unborn child and can cause damage to organs through prolonged or repeated exposure.
- Some batches of product were tested and found to have microbial contamination at levels which may cause infection or irritation.
- No assurance was received that a Cosmetic Product Safety Report had been carried out for the products in question. Such safety reports are a legal requirement for all cosmetics on the Irish market in order to protect public health.
- Unfounded medical claims are made in the product advertising material.
To date, the company has not addressed these safety concerns. Therefore, these products are still considered non-compliant and unsafe, and are being recalled to consumer level. Any retailers who may have stock of these products are requested to remove the products from sale and contact the HPRA at cosmetics@hpra.ie.
Aoife Farrell, HPRA, advised the public not to continue to use these products.
“Unfortunately, these products do not meet the quality and safety requirements that the European legislation requires. These laws are in place to protect the public from unsafe products. It is concerning that the products contain a banned ingredient, and also bacteria, at levels that could cause infection. Our advice is for consumers to immediately stop using these products. These products were possibly purchased at small local retailers, or ordered online, and were available in six different flavours. If you are concerned about any medical issues, please contact your GP. Shoppers are also advised not to purchase any of these products, even if they find them available for sale.”
The HPRA also reminds consumers to always check that any cosmetic product they buy, whether in a shop or ordered online, has a name and address within the EU on the label. This is a legal requirement, and its absence may indicate the safety standards have not been met.
Cosmetic products on the market must meet the requirements of Regulation (EC) No. 1223/2009. In Ireland, the market surveillance of cosmetic products is carried out by the HPRA and the Environmental Health Service and Public Analysts’ Laboratories of the HSE. Neither the HPRA nor the HSE has any role in refunds of recalled cosmetic products.
For Further Information:
HPRA Product Recall - ToothFaerie Toothpaste Range
Media queries:
Káno Communications (01) 679 8600
Kathryn Moley (086) 733 4438
About the Health Products Regulatory Authority:
The Health Products Regulatory Authority (HPRA) protects and enhances public and animal health by regulating medicines, medical devices and other health products. The products under its remit include human and veterinary medicines, medical devices, blood and blood components, tissues and cells, organs for transplantation and cosmetics.
About The Health Service Executive:
The Health Service Executive’s role in cosmetic products involves activities such as conducting inspections, sampling and analysis. These market surveillance activities are carried out by the Environmental Health Service and Public Analyst’s Laboratories of the HSE in cooperation with the Health Products Regulatory Authority (HPRA).
Images of ToothFaerie toothpaste products:
