FDA releases warning vs. Ever Bilena Lip, Cheek Stain Night Berry

The Food and Drug Administration (FDA) warns the public from purchasing and using the adulterated cosmetic product EB EVER BILENA LIP & CHEEK STAIN NIGHT BERRY.

The said Ever Bilena products tested and found to contain MICROBIAL CONTAMINANTS beyond the 1000 cfu/g limit set by the FDA, and as published in the ASEAN Cosmetic Directive (ACD). The table below indicates the particulars of the adulterated cosmetic product/s:

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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 cosmetic product. Always check if a product is notified 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 cosmetic products.

All concerned establishments are warned not to distribute adulterated cosmetic products.

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FDA releases warning vs. Ever Bilena Lip, Cheek Stain Night Berry

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic product, the online reporting facility, eReport can be accessed at ereport@fda.gov.ph, 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.

Meanwhile, Ever Bilena said on Twitter that its products undergo microbial testing prior to release and are FDA compliant.

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Ever Bilena also said it is doing its own internal testing which will take five to seven days along with a third-party lab.
“Our Product Development & FDA compliance team are also in coordination with FDA for our Corrective Actions/Preventive Actions,” Ever Bilena added.