Quality & Safety
Calocurb is distributed in the US under the Dietary Supplement Health and Education Act (DSHEA) of 1994, regulated by the U.S. Food and Drug Administration.
In the US the use of hops extract, or hops oleoresin, is approved by the U.S. FDA as an essential oil, oleoresin (solvent-free), and natural extract (including its distillate) which are generally recognized as safe (GRAS).
Amarasate®, of New Zealand bitter hops and the active ingredient in Calocurb is a naturally extracted used food-grade supercritical carbon dioxide (CO2) and conducted at New Zealand Hops, Inc (NZIPFR) facilities under current Good Manufacturing Practice (cGMP) guidelines. During this process, the levels of resins, tannins, polyphenols (8-PN), fats and waxes typically found in hops are reduced to negligible levels in the Amarasate® extract.
The finished hops extract material is a thick, viscous, honey-like paste with an oily consistency, coloured golden to tan to greenish/brown, and exhibiting a typical hops aroma. Audited stability testing is conducted on the bulk hops extract to ensure α-acid concentration is within standard level and this is tested periodically.
Amarasate® is packaged in DR Licaps capsules at FDA, TGA, NFS and GMP-approved facilities at a Lonza company in Greenwood, SC, USA. Quality auditing and stability testing is diligently conducted every six months on new and existing batches including the bulk capsules and the finished packaged bottle.