How to Get FDA Approval for a Supplement？

The Dietary Supplement Health and Education Act of 1994 (DSHEA) gives the FDA authority to regulate dietary supplements, but it does not require them to be approved by the agency before they are marketed. This means that manufacturers of dietary supplements are responsible for ensuring that their products are safe and that their labeling is truthful and not misleading.

If you are considering developing a dietary supplement, you should be aware of the FDA's regulations and requirements. Here are some steps you can take to get FDA approval for your supplement:

Choose your ingredients carefully.

The FDA has a list of Generally Recognized As Safe (GRAS) ingredients. You can use these ingredients without having to provide any safety data to the FDA. However, if you want to use an ingredient that is not on the GRAS list, you will need to submit safety data to the FDA.

Perform security tests.

The FDA does not require that dietary supplements be shown to be safe before they are marketed. However, you should conduct your own safety tests to ensure that your product is safe for human consumption. These tests should include toxicity studies, as well as studies to assess the potential for interactions with other medications or supplements.

Develop a label.

The label on your dietary supplement must be truthful and not misleading. You must also include the following information:

Product name

the ingredients

The amount of each ingredient

The intended use of the product.

Any warning or caution

Register with the FDA. 

You must register your dietary supplement facility with the FDA before you can market your product. You can do this online at the FDA's website.

Submit a notification to the FDA. Once you have registered your facility, you must submit a notification to the FDA for each dietary supplement you want to market. This notification must include the following information:

The name of the product

The ingredients

The amount of each ingredient

The intended use of the product

Any warnings or precautions

The FDA will review your notification and may request additional information. If the FDA does not object to your notification within 90 days, you can begin marketing your dietary supplement.

It is important to note that the FDA's approval of a dietary supplement does not mean that the product is effective. The FDA only reviews the safety of dietary supplements, not their effectiveness. If you are considering taking a dietary supplement, you should talk to your doctor first.

Additional Resources

FDA's Dietary Supplements website: https://www.fda.gov/food/dietary-supplements

NIH Office of Dietary Supplements: https://ods.od.nih.gov/

ConsumerLab.com: https://www.consumerlab.com/

NSF International: https://www.nsf.org/