Is Calocurb FDA Approved?Updated 2 months ago

Calocurb is a natural dietary supplement, not a prescription medication. As such, it is not “FDA approved” in the way that prescription drugs or medical devices are. The U.S. Food and Drug Administration (FDA) does not “approve” dietary supplements for safety or effectiveness before they reach the market. Instead, supplements like Calocurb must comply with FDA regulations for labeling, manufacturing, and ingredient safety.

GRAS-Certified Ingredients

Calocurb’s key ingredients, including Amarasate® (a hops extract) and canola oil, are classified as GRAS—Generally Recognized As Safe—according to FDA standards for food ingredients. This means they have a long history of safe use in foods or are supported by scientific evidence and expert consensus.

Quality and Safety

Calocurb is manufactured in facilities that follow Good Manufacturing Practices (GMP), as required by the FDA for dietary supplements. Each batch is routinely tested for purity, potency, and contaminants. Additionally, Calocurb’s canola oil is certified Glyphosate Residue Free by The Detox Project.

What “FDA Approval” Really Means

Prescription drugs go through a lengthy FDA approval process, requiring clinical trials and formal evaluation. Dietary supplements are not evaluated in this way. Instead, the FDA monitors supplements for safety once they are available to consumers and can take action if a product is found to be unsafe or mislabeled.

Have More Questions?

If you want to know more about Calocurb’s safety standards, ingredient sourcing, or manufacturing practices, you can contact Calocurb support for additional details.