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Are the products approved by FDA?

The KETO/OS product is a dietary supplement and therefore, does not carry FDA approval. It is regulated instead under the Dietary Supplement Health and Education Act. The facility the product is made in is an FDA registered facility as a food manufacturer and complies with Good Manufacturing Practices.

 

For more information, please visit the FDA website:

https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm109760.htm

 

Who is responsible for the safety of dietary supplements?

FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.

The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market.

 

If the dietary supplement contains a NEW ingredient, manufacturers must notify FDA about that ingredient prior to marketing. However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness.

Manufacturers are required to produce dietary supplements in a quality manner and ensure that they do not contain contaminants or impurities, and are accurately labeled according to current Good Manufacturing Practice (cGMP) and labeling regulations.

 

If a serious problem associated with a dietary supplement occurs, manufacturers must report it to FDA as an adverse event. FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.

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