We know its been a long time since we’ve made a public post, but we felt that this is something that we should bring to the Public’s attention. Its the same thing we have been preaching for years… FDA cGMP compliance, COAs, proper labeling and packaging, etc., well, the FDA has finally taken notice and is beginning to thin the heard on Kava vendors who are unwilling to follow the rules.
Following a media inquiry regarding the regulatory status of Kava and Kava serving establishments in the US back in late July 2016, the FDA sent letters to both State Departments of Health who are tasked with inspecting restaurants, and local FDA field offices who are tasked with inspecting food and dietary supplement facilities, instructing them to investigate Kava bars and Kava vendors for compliance. The bottom line BOTH AKA vendors made it, three non AKA members did not!
We’re happy to announce that two of our members were inspected, both of whom either buy their kava from AKA “Approved Sources” and were able to present FDA with full documentation from FDA cGMP facilities showing full traceability from farm to bowl (or bag) which met their cGMP requirements. Unfortunately, four Kava vendors who were not AKA members contacted us after failing their FDA inspections.
Those who failed their inspections were unable to meet FDA cGMP compliance which includes full import traceability, quality assurance measures, and utilizing an FDA cGMP registered facility to package their materials. Three serving establishments closed their doors or were unable to open, and one vendor has an FDA warning letter citing a multitude of serious violations of the Food Drug and Cosmetic Act.
We are currently working with two of the serving establishments and their States Department of Health to get those establishments into compliance and back up and running. We expect a full resolution within the next month which will hopefully set precedents moving forward with other states and finally the FDA as a whole.
The easiest way to avoid FDA entanglements is to become a member of the AKA and utilize an AKA approved vendor, or an AKA approved manufacturer who will co-pack your materials in an FDA cGMP facility and issue you a COA on your products.