The Food and Drug Administration (FDA) warns the public from purchasing and using the unregistered household/urban pesticide (H/UP) product:
- SESOU® NATURE SOURCE EXTRA-GENTLE BUZZ OFF! BUG REPELLENT LOTION FOR BABIES BABY CARE CITRONELLA
The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Registration (CPR) as of 08 July 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “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 any health product without the proper authorization from the FDA is prohibited.
Since the abovementioned unregistered household/urban pesticide product has not gone through the registration process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative product may pose health risks to consumers.
Potential hazards may come from harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage and organ failure.
In light of the foregoing, the public is advised not to purchase the aforementioned violative household/urban pesticide product. Moreover, the public is advised to always check if a household/urban pesticide product is registered with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.
All concerned establishments are warned not to distribute violative household/urban pesticides 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 their jurisdiction.
To report any sale, distribution, complaint and/or adverse event on the use of the violative household/urban pesticides, email us 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.2020-1327