FDA Registration for Lipstick: Clarifying the Term "Organic Color"
Question
I am trying to register a lipstick product with the FDA and used the term "สีออร์แกนิค" (Organic Color) for the colorants. The FDA is asking for certification that the color is truly organic. I understood "organic color" to mean color from natural plants. However, the colorants I purchased from myskinrecipes are not from natural plants. Could you please clarify:
- Why the FDA is asking for this certification?
- Is my understanding of "organic color" correct in this context?
- What should I do to resolve this issue with the FDA, given that the colorants are not from natural plants?
Answer
Subject: Regarding FDA approval for lipstick using "Organic Color" term
Hello,
Thank you for your inquiry regarding FDA approval for your lipstick product using the term "สีออร์แกนิค" (Organic Color) and the FDA's request for certification.
Based on the information provided by our staff, there seems to be a misunderstanding regarding the term "organic color". In chemistry, "organic color" refers to the chemical structure of the colorant, which contains carbon atoms. It does not necessarily mean that the color is derived from natural plants.
The staff has confirmed that the colorants you purchased from myskinrecipes are not derived from natural plants. Therefore, you cannot claim that these colors are from natural plants to the FDA. The FDA's request for verification is correct because your claim (implying natural plant origin) is not accurate for the colorants you are using.
To resolve this issue with the FDA, you will likely need to:
- Clarify the meaning of "organic color" with the FDA based on the chemical definition, but be aware that if your intention was to imply natural origin, this claim is incorrect for the colors you purchased.
- Avoid using the term "สีออร์แกนิค" if you intended it to mean "from natural plants", as this is misleading and cannot be supported by the source of the colorants.
- Consider changing your product name or description to accurately reflect the nature of the colorants used, in compliance with FDA regulations.
Unfortunately, myskinrecipes cannot provide a certificate stating that the colors are from natural plants because they are not. You should discuss the acceptable terminology and required documentation for the actual colorants you are using with the FDA directly.