Yahoo Answers is shutting down on May 4th, 2021 (Eastern Time) and beginning April 20th, 2021 (Eastern Time) the Yahoo Answers website will be in read-only mode. There will be no changes to other Yahoo properties or services, or your Yahoo account. You can find more information about the Yahoo Answers shutdown and how to download your data on this help page.

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.

Thank you!

1 Answer

  • Anonymous
    1 decade ago
    Favorite 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....

    Good luck...

Still have questions? Get your answers by asking now.