The Food and Drug Administration (FDA) warns the public against the purchase and use of the following unregistered drug products:
- Beauty OrganicsTM HAIR VITA (Gugo+Aloe Vera+Minoxidil) HAIR GROWER SHAMPOO 150 mL
- METHYL SALICYLATE+CAMPHOR KUTO-ALIS Herbal Oil 50 mL
The FDA has verified through post-marketing surveillance that the abovementioned drug products are not registered and no Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of these health products without the proper authorization is prohibited.
Since these unregistered drug products have not gone through evaluation process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative products may pose health risks to consumers.
In light of the foregoing, the public is advised not to purchase these violative products. Moreover, the public is advised to always check if a dug product is registered 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 the violative drug products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment and a CPR for the drug product.
All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.
For more information kindly contact the FDA Center for Drug Regulation and Research through e-mail at [email protected], or call (02) 809-5596.
To report any sale or distribution of unregistered drug product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.
Dissemination of this advisory to all concerned is hereby requested.