In furtherance to FDA Advisory No. 2021-0581 “Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “BODYXPERT SHAPE FIRMING LOTION” dated 12 March 2021, the Food and Drug Administration (FDA) reiterates its advice to the public against the purchase and use of the cosmetic product, BODYXPERT SHAPE FIRMING LOTION.
The FDA has coordinated with the Market Authorization Holder (MAH), Lifestrong Marketing Inc., and has verified that the aforementioned cosmetic product is COUNTERFEIT. According to the company, Lifestrong Marketing Inc., the LOT No. GW04041017 does not belong to any batches of products that they distributed, released, and sold to their consumers/sellers that same year and thereafter.
Counterfeit products did not go through the required safety assessment and the FDA verification process. These products pose potential health hazards to the consuming public since their safety and purity cannot be guaranteed. Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or restricted ingredients that in excessive amount as per ASEAN Cosmetic Directive (ACD). The use of substandard and possibly 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 violative cosmetic product. Moreover, the public is advised to always check if a cosmetic 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 purchasing.
All concerned establishments are warned not to distribute counterfeit 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 and Household/Urban Hazardous Substances Regulation and Research through e-mail at [email protected] or call (02) 8857-1900 local 8113 or 8107.
To report any sale or distribution of unnotified cosmetic products, the online reporting facility, eReport can be accessed at [email protected].
Dissemination of this advisory to all concerned is hereby requested.