Austin Organic Village has gone GMP compliant and become a GMP certified vendor. We are now one of 26 American Kratom Association Qualified Vendors. AOV has taken the steps to be in compliance with standards being set for vendors. Being certified helps vendors and consumers stay protected during the continued fight to keep kratom legal and allows us to continue to grow and serve more consumers.
What Do GMP and cGMP Mean?
GMP stands for Good Manufacturing Practice and cGMP stands for current Good Manufacturing Practice. They essentially mean the same thing except that cGMP states that it is the most current set of standards in the ever evolving cycle of regulations placed on the sale of products in the United States while GMP is a broader term that stands for a set of standards put out by the FDA (Food and Drug Administration) in order to ensure the quality and safety of products being sold for consumption. GMP regulations are extensive, including production, packaging, equipment, employee hygiene, and training of all employees.
In order to become GMP certified, a company must be assessed by a third party assessment entity. This means that they have to be tested, observed, and accomplish a specific set of requirements. Some companies, like Austin Organic Village, choose to use a third party GMP packaging facility and send their products to be packaged there while every employee learns how to be GMP compliant in all other written aspects of business. Employees are tested on Standard Operating Procedures (SOP’s) regularly. Employees are not allowed to make medical claims or give medical advice. This doesn’t stop consumers from sharing tips from person to person. However, employees have to be very careful with the claims and statements they make to customers.
In order to maintain GMP certification and stay compliant, the company must review practices and make changes regularly as the standards change. They must also be prepared for a yearly external audit, yearly testing, and inspections on demand.
Why Is This Important?
As the kratom community continues the fight to keep kratom legal and continues to lobby in order to pass the KCPA (Kratom Consumer Protection Act) in more states, having vendors who are in compliance with the FDA’s GMP standards allows the industry to show that kratom is a legitimate product whose vendors are willing to follow government guidelines.
Thorough testing products for biological contaminants like bacteria, mold, and heavy metals helps to protect consumers. Using clean rooms, and sterile equipment for packaging are just a few things that help make sure products remain safe and uncontaminated. Both vendors and consumers enjoy greater protection through GMP regulations. The sale and safety of kratom is more easily tracked in the event of an issue. Consumers are less likely to receive tainted products and recalls are less likely.
The AKA (American Kratom Association) is working hard to lobby banned states and bring other states in line with the KCPA. In order to do that, everybody in the community needs to do their part. That includes vendors, because success starts at the top.
Below is a map from the AKA showing the progress made and where the fight continues.
Not shown on the map are the lobbyists working in banned states to overturn kratom bans and make the KCPA a reality in those places as well.
How Can You Help?
1- Only use GMP certified vendors on the AKA qualified vendor list. https://www.americankratom.org/vendor/gmp-participants.html
2- Hold vendors accountable! If vendors are making medical claims, even as benign as claims that products give energy, please call them on it. If they are making claims about COVID-19, or kratom affecting immunity, please send them this link: https://www.americankratom.org/advocacy/update.html
3- Donate to the American Kratom Association to help continue pushing back! Even donating as little as $5 helps.
4- Keep an eye out for any legislation being pushed through the government at the local level. Some states have been sneaky about trying to pass kratom legislation. Make sure to always know what’s on your local government agenda. If you find something troubling that has to do with kratom, please contact the AKA.
5- Be a responsible consumer. Make sure that you are making responsible decisions with kratom consumption. Negative stories in the media will only hurt the cause and make it more likely that we will ultimately lose.
6- Make sure to report any severe issues you have with the product received to the vendor you purchased it from. The vendor, if GMP compliant, should have a process in place for handling these issues properly to ensure a safe consumer experience.
As kratom consumers, protecting this plant is the number one priority. Keeping kratom legal is essential for millions of people in this country. Being a responsible vendor means becoming GMP certified. Being a responsible consumer means stepping up and pointing out when issues arise that could hurt the legality of kratom. If everybody does their part, the community as a whole will win in the end.
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**These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease or condition.**