The FDA does not approve food or individual supplements, but sets rules and guidelines that all companies must adhere to. This is why no food or supplement carries the FDA seal on its label. The products that the FDA approves on an individual basis are medicinal drugs. We can assure you that VIVRI strictly follows the guidelines established by the FDA for the categories of their products, which are sold freely throughout the United States. If you want information on the role of the FDA, please visit their website at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm