The Food and Drug Administration (FDA) warns the public from purchasing and using the non-compliant cosmetic product imported by and distributed by the Market Authorization Holder (MAH), ELEGANT FUMES BEAUTY PRODUCTS INC.:
According to Republic Act 3720, a cosmetic shall be deemed to be misbranded if its labeling is false or misleading in any particular. Furthermore, IRR of Republic Act 9711 defines “misbranding” as giving unsubstantiated claims, misinformation or misleading information on the label or other information materials.
The aforementioned product was found to have misleading information on the label reflecting the local company address as “Manila Province, P.R. China” which is inconsistent with the information declared in the acknowledged product notification rendering the product as being misbranded. Furthermore, the MAH, Elegant Fumes Beauty Product Inc. in its letter to FDA dated 24 August 2020 admitted error and misprinting of local company address on the label of the aforementioned product.
In light of the foregoing, the public is advised not to purchase the aforementioned violative 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 violative cosmetic product until they have fully complied with the rules and regulation of the FDA.
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 cosmetic product, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:-> FDA-Advisory-No.2020-1650