FDA CIRCULAR NO. 2018-009

: The Circular aims to provide updates and amendments to the ASEAN Cosmetic Directive as adopted during the 28th ASEAN Cosmetic Committee meeting, guiding establishments involved with cosmetic products in manufacturing, importation, exportation, sale, and related activities to ensure safety, quality, and compliance.
: It covers manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, and, where applicable, use, testing, promotion, advertising, or sponsorship of cosmetic products.
: Sanctions and penalties prescribed by Republic Act No. 9711, known as the Food and Drug Administration Act of 2009, shall be imposed on violators.
: The Circular took effect immediately upon its release on September 11, 2018.
: The maximum concentration must not exceed 8% calculated as Thioglycolic acid.
: Yes, only compliant products can be placed in the market after that date; non-compliant products must be withdrawn.
: The maximum trace limit is 25 parts per million (ppm).
: The latest revision is accessible on the FDA website.
: Republic Act No. 9711, the Food and Drug Administration Act of 2009, provides the legal basis for imposing sanctions and penalties.