The Food and Drug Administration (FDA) warns the public from purchasing and using the adulterated cosmetic product BABY Q™ BABY WIPES which tested positive for the presence of METHYLISOTHIAZOLINONE. Such ingredient is prohibited to be used in leave-on cosmetic products as per Annex VI, Reference No. 57 of the ASEAN Cosmetic Directive.
Methylisothiazolinone has been listed in Annex VI/57 of the ASEAN Cosmetic Directive to be used as a preservative in the finished cosmetic products. However, the use of the said ingredient have been prohibited for leave-on cosmetic products (including ‘wet wipes’) in the Philippines through the issuance of FDA Circular No. 2017-006 as a product of the 25th ASEAN Cosmetic Committee Meeting and Its Related Events.
The ban of the aforementioned ingredient for leave-on cosmetic products has been ordered due to clinical data which indicates that, no safe concentrations of Methylisothiazolinone for induction of contact allergy or elicitation have been adequately demonstrated.
The aforementioned adulterated product is found to be non-compliant with the existing standards, and, thus pose potential hazards to the consuming public. The use of adulterated cosmetic products may result to adverse reactions, including but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.
In light of the foregoing, the public is advised not to purchase the aforementioned adulterated product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph.) has a Search feature which may be used by typing in the name of the product before purchasing.
All concerned establishments are warned not to distribute adulterated cosmetic 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.
Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8113 or 8107.
To report any sale or distribution of the afore-mentioned cosmetic product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:-> FDA Advisory No.2020-206