Using Tester Formulation for Commercial Sale and FDA Registration

Asked by: naasuaysai On: October 20, 2014 Product Type: Cosmetics

Question

Can a "tester" formulation be used for commercial sale and FDA registration? What is the purpose of a tester formulation, and when should FDA registration be pursued for a cosmetic product?

Answer

Based on the previous discussion, a "tester" in this context refers to a small-scale prototype formulation mixed by a lab.

  • Its primary purpose is for testing ingredients, developing product prototypes, and evaluating performance before scaling up for commercial production.
  • It already contains preservatives added by the lab.
  • Testers are generally not recommended for direct commercial sale and subsequent อย. (FDA) registration because they are produced on a small scale and can be costly.
  • อย. registration is typically done for the final product formulation produced at a suitable commercial scale after the prototype development is complete and satisfactory.