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Advocates Philippines
FDA Warns Public About Unnotified Toy And Childcare Article 'PRO-CLACKERS (LATO-LATO WITH LIGHTS)'
Photo credit: FDA
Manila - The Food and Drug Administration (FDA) has issued a public warning regarding the purchase and use of an unnotified toy and childcare article (TCCA) product known as "PRO-CLACKERS (LATO-LATO WITH LIGHTS)." The FDA's postmarketing surveillance has revealed that the product does not possess a valid Certificate of Product Notification (CPN) as of 05 June 2023. Consequently, the sale, distribution, and use of this product without proper authorization from the FDA are strictly prohibited under the regulations implementing Republic Act No. 9711, also known as the "Food and Drug Administration Act of 2009."
As the aforementioned product has not undergone the FDA notification process, its quality and safety cannot be assured by the agency. The use of this violative product may pose health risks to consumers.
The potential hazards associated with such unnotified toy and childcare article products include the presence of ingredients not permitted in these items. The use of substandard and potentially adulterated products of this nature can result in health risks such as endocrine disruption, reproductive or developmental effects, as well as the risk of injury, choking, or suffocation due to small or broken parts.
To ensure public safety, the FDA advises against purchasing the mentioned violative toy and childcare article product. Consumers are urged to always check if a product is notified with the FDA by using the FDA Verification Portal accessible at https://verification.fda.gov.ph before making a purchase or using toy and childcare article products.
All establishments concerned are warned against distributing the violative toy and childcare article product until they have fully complied with FDA rules and regulations.
The FDA calls on its regional field offices, regulatory enforcement units, law enforcement agencies, and local government units to collaborate in preventing the sale or availability of these violative products within their respective jurisdictions.
To report any sale, distribution, complaints, or adverse events related to the use of the violative toy and childcare articles, consumers are encouraged to utilize the online reporting facility called eReport, accessible at ereport@fda.gov.ph. Additionally, they may contact the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) hotline at (02) 8857-1900 loc. 8113 or 8107.
As the aforementioned product has not undergone the FDA notification process, its quality and safety cannot be assured by the agency. The use of this violative product may pose health risks to consumers.
The potential hazards associated with such unnotified toy and childcare article products include the presence of ingredients not permitted in these items. The use of substandard and potentially adulterated products of this nature can result in health risks such as endocrine disruption, reproductive or developmental effects, as well as the risk of injury, choking, or suffocation due to small or broken parts.
To ensure public safety, the FDA advises against purchasing the mentioned violative toy and childcare article product. Consumers are urged to always check if a product is notified with the FDA by using the FDA Verification Portal accessible at https://verification.fda.gov.ph before making a purchase or using toy and childcare article products.
All establishments concerned are warned against distributing the violative toy and childcare article product until they have fully complied with FDA rules and regulations.
The FDA calls on its regional field offices, regulatory enforcement units, law enforcement agencies, and local government units to collaborate in preventing the sale or availability of these violative products within their respective jurisdictions.
To report any sale, distribution, complaints, or adverse events related to the use of the violative toy and childcare articles, consumers are encouraged to utilize the online reporting facility called eReport, accessible at ereport@fda.gov.ph. Additionally, they may contact the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) hotline at (02) 8857-1900 loc. 8113 or 8107.
Jun 16, 2023
