Legal & Regulatory Considerations for Vitamin C E Ferulic and Pitera Products

ถามโดย: teddy_fai เมื่อ: May 07, 2014 ประเภทผลิตภัณฑ์: เครื่องสำอาง

คำถาม

I am developing cosmetic products, specifically a Vitamin C E Ferulic formula and a product containing 'Pitera'. What are the key legal and regulatory aspects I need to consider for commercial production and sale? This includes FDA registration requirements (e.g., selling ingredients vs. finished product), patent issues (especially regarding formulas like Skinceuticals' Vitamin C E Ferulic, including whether changing ingredient ratios avoids infringement), and trademark issues related to using the name 'Pitera'.

คำตอบ

Information Regarding Commercial Cosmetic Production: Vitamin C E Ferulic and Pitera

1. Vitamin C E Ferulic Acid Formula

  • FDA Registration and Selling Separately: Based on the information received, cosmetic product registration with the FDA (อย.) generally requires the product to be registered as a finished, ready-to-use formula. Selling ingredients like Vitamin C powder separately from a base may not comply with the FDA's requirements for finished cosmetic products intended for consumers. The original formula is sold combined in a single product, and controlling stability and shelf life is crucial.
  • Patent Issues: The Vitamin C E Ferulic Acid formula is patented in the United States by Skinceuticals. It is uncertain whether this patent is valid or enforceable in Thailand, but it is certain that products with this formula cannot be sold in the United States. Adjusting the ratio of ingredients may not avoid patent infringement if the new ratios still fall within the range covered by the patent. It is recommended to consult with a legal expert on patent law in Thailand for accurate advice.

2. Pitera

  • Patent and Trademark Issues: The name "Pitera" is a registered trademark of SK-II. Therefore, you cannot use the name "Pitera" when selling your product, regardless of the concentration you use.
  • Ingredient Naming: To avoid trademark issues, you must use the INCI (International Nomenclature of Cosmetic Ingredients) name for this ingredient, which is Galactomyces Ferment Filtrate, or use another name that describes the ingredient. Using the INCI name is the correct and safe way to avoid trademark problems.

In summary, for the Vitamin C E Ferulic formula, it should be registered as a finished product, and you should check patent issues in Thailand. For Pitera, absolutely do not use the name "Pitera" commercially; use the name Galactomyces Ferment Filtrate instead.

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