Cosmetic FDA Registration: Requirement for Prohibited Substance Testing
Question
When applying for cosmetic FDA notification in Thailand, is it mandatory for the applicant to submit test results for prohibited substances from a medical science center beforehand? This question arises because an FDA officer reportedly indicated this requirement, which seems to contradict common practice and the high cost of such testing.
Answer
Based on the conversation you shared, it appears there might be some confusion regarding the requirement for pre-application testing of prohibited substances when applying for FDA approval for cosmetics in Thailand.
Typically, the standard process for applying for cosmetic FDA notification (แจ้งรายละเอียดเครื่องสำอาง) does not require the applicant to submit test results for prohibited substances from a medical science center beforehand. The responsibility for conducting tests, if the FDA suspects the presence of prohibited substances or wants to verify compliance, usually lies with the FDA after the notification has been submitted and the product is on the market. They may randomly sample products for testing.
The information you received from the FDA official seems to contradict the standard understanding and the experience shared by cosmeceutical7. It is understandable that this would cause confusion, especially given the high cost of such testing.
Based on the common practice and the information from cosmeceutical7, you would typically proceed with submitting the required documents for FDA notification without needing to provide pre-application test results for prohibited substances. However, it is always best to ensure your formulation does not contain any prohibited ingredients as listed by the FDA.