The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified and adulterated toy and childcare article (TCCA) product, “BATHTUB DOG PLAYSET”.
The FDA laboratory test report showed that the product contains concentrations of 19.4% for di-(2-ethylhexyl) phthalate (DEHP) and 0.5% for dibutyl phthalate (DBP).
Pursuant to Department of Health Administrative Order (DOH-AO) No. 2009-0005-A issued on 14 December 2011, “It shall be unlawful for any person to manufacture for sale, offer for sale, distribute in commerce, or import into the country any children’s toy that contains concentrations of more than 0.1 percent of di-(2-ethylhexyl) phthalate, dibutyl phthalate (DBP) or benzyl butyl phthalate (BBP)”.
Potential hazards may come from ingredients that are found to contain beyond the allowable limit of an ingredient such as Phthalates to be part of TCCA products. The use of substandard and possibly adulterated TCCA products may result to health risks including but not limited to endocrine disruption and reproductive or developmental effects in relation to exposure to these compounds.
In light of the foregoing, the public is advised not to purchase the aforementioned unnotified and adulterated TCCA product. Always check if a health product is notified and/or registered with the FDA by using the FDA Verification Portal feature accessible at https://verification.fda.gov.ph which may be used by typing in the name of the product before the purchase and/or using the health products.
All concerned establishments are warned not to distribute unnotified and adulterated health products.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.
To report any sale, distribution, complaint and/or adverse event on the use of the violative TCCA product, please access the online reporting facility, eReport, at [email protected], or call us at the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) hotline (02) 8857-1900 loc. 8113 or 8107.
Dissemination of this advisory to all concerned is hereby requested.