FDA Approval for Home Cosmetic Production
Question
Is it possible to obtain FDA approval (เลข อย.) for cosmetics manufactured at home for sale? What are the key requirements for the production location, process, and equipment?
Answer
Yes, it is possible to apply for FDA approval (เลข อย.) for products you manufacture at home and wish to sell.
However, obtaining approval requires that your production location, process, and equipment meet the specific standards set by the FDA. These standards are primarily focused on ensuring cleanliness, preventing contamination, and maintaining overall product safety and quality.
Based on advice from FDA officials, key considerations often include:
- Having a separate production area, ideally with its own entrance, distinct from your living space or home kitchen.
- Using equipment solely dedicated to production, kept separate from household items.
- Ensuring the production environment is clean and hygienic.
- Potentially using equipment for sterilizing tools.
While it is possible, it is crucial to ensure your setup and procedures comply fully with FDA regulations.
Therefore, the best course of action is to contact the FDA directly for the most accurate and detailed information regarding the requirements and application process for home-based production.