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How do you file a supplement product with the FDA???
I am planning to put out a product that has supplement ingredients in it for energy - an energy drink.
1. Does anyone know what the process is for this with regards to the FDA?
2. Is a supplement product like this considered a drug?
3. Does it have its own category?
4. Does anyone know what the filing process is with the FDA?
The FDA's site is not particularly easy to understand, so I thank you for helping me out.
- Anonymous1 decade agoFavorite Answer
The FDA does not currently regulate supplements. Filing a pharmaceutically active product with the FDA is not something any individual can (or can afford) to do, it basically involves doing widespread and thorough trials with the product and monitoring large representative samples of 'patients' (first rats, then people, typically) to ascertain any toxicity or side-effects. Then you store about half your product and test batches of it on a regular schedule to monitor what sold product might degrade into in someone's medicine cabinet over time. The FDA will want to come and inspect your manufacturing process, your QA/QC processes, and review your metrology records from time to time, too....