QuestionsQuestions (FDA CIRCULAR NO. 2010-015)
The circular cites Section 12 of Republic Act (RA) No. 9711, which authorizes the FDA to take actions such as seizure when products are found to be imminently injurious, unsafe, or dangerous.
The FDA found through laboratory examination that the samples contain heavy metal (mercury) exceeding the allowable limit of 1 ppm.
Because the products contain mercury above the allowable limit (1 ppm), the circular declares them as posing imminent danger or injury to the consuming public.
The circular expressly declares the identified cosmetic products to be imminently injurious, unsafe, or dangerous based on laboratory findings.
FDA Regulation Officers (central and regional) were ordered to seize immediately the listed cosmetic products for custody from all outlets or establishments where they may be found.
It states that the importation, selling, or offering for sale of such products is in direct violation of RA 9711 or the Food and Drug Administration Act of 2009.
The circular states that mercury exceeding the allowable limit of 1 ppm violates the regulatory limit.
It supports the reliability of the finding and demonstrates that the presence of contaminated products was observed across different outlets and times.
It identifies with specificity the exact products covered by the ban/seizure order, which helps prevent ambiguity in enforcement.
LGUs and consumers are asked to assist by reporting outlets found selling the above products.
The circular is dated/issued August 13, 2010 and states it was adopted on 31 August 2010.
Their importation, selling, or offering for sale is considered a direct violation of RA 9711 / FDA Act, and the FDA is authorized to seize them from public sale or distribution.
They may question chain of custody, sampling validity, accuracy of laboratory analysis, whether the exact product matches the circular’s identifiers, or whether proper FDA procedures for seizure and handling were followed.
It indicates urgency and immediate compliance; retailers must avoid selling the listed products and must cooperate with seizure orders and related investigations.