Etha™ Natural Botanicals is an approved AKA GMP Vendor!
The American Kratom Association (AKA) is committed to restoring full consumer access to kratom and to preserve and protect the freedom of consumers in the United States to make their own choices on their well-being and maintaining a healthy lifestyle. One of the ways it ensures consumers have access to safe and effective kratom, is through their Good Manufacturing (GMP) Standards Program. The AKA GMP Standards program is a way for the AKA to verify if a vendor is abiding by a higher level of manufacturing committed to the safety of their employees and customers. As a kratom consumer, you should only purchase from vendors that meet this basic manufacturing standard. Etha™ is one of only a handful of vendors who have met this standard.
To learn more about cGMP, why it is important, and how Etha™ goes beyond basic GMP standards to be the very best kratom manufacturing, please read below:
Current Good Manufacturing Practices, or most commonly referred to as cGMP, has been a large topic of discussion in the kratom community. The awareness that has been brought to kratom by the FDA has lead such organizations as the American Kratom Association (AKA), to deploy baseline cGMP recommendations for the manufacture and distribution of kratom. It is important for consumers to understand what cGMP is and even more important for them to understand why it is important.
What is cGMP for kratom companies?
cGMP, as it relates to the kratom industry, is the proper monitoring and control of all manufacturing processes and facilities. A company has to ensure that kratom is manufactured and sold in a safe, high quality way. Robust operating procedures of how to handle kratom, such as receiving, testing, processing, validating, and packaging are well documented and followed by employees. Systems are established to detect and investigate product quality deviations and issues all while maintaining reliable testing laboratories. Adequate labeling is provided with the product to inform customers of the contents of each package as well as any risks associate with a given product. These systems allow for controls to prevent instances of contamination, errors, and product being sold that doesn’t meet quality standards.
Why do we need it?
As consumers, we all want to know that the product we are purchasing is not only safe, but that it is exactly what it claims to be. It is not sufficient for companies to simply test their products and put it out into the marketplace. In most instances, testing is done on a sample batch rather than testing a batch in its entirety to help ensure that the remainder of the batch can be used for production rather than all consumed during test. It is at each company’s discretion to determine what sample size is sent for testing and how that sample is selected. This is precisely why it is important for companies to have procedures and manufacturing practices in place to ensure that quality is built into the manufacturing process at each step, validating that consumers are getting pure and compliant products from start to finish. Facilities that are in good condition, equipment that is properly maintained, calibrated and sanitized, employees who are qualified and fully trained, and processes that are reliable and reproducible, are only a few examples of how CGMP requirements help to assure the safety and efficacy of the products being produced. Companies that are compliant and have implemented current Good Manufacturing Practices are providing consumers with trust and confidence that the product they are purchasing has gone through quality checks and is safe to use.
At Etha™, we take pride in being one of only a handful of AKA GMP approved vendors. In fact, we have exceeded the baseline standards that have been set forth. With the help of Pakala Consulting, Etha™ has been able to develop and implement necessary procedures and protocols to ensure that we are delivering 100% safe and pure kratom. We source and supply products directly from the forest and then process them in a controlled environment that is routinely checked for sanitation and contaminants. Our facility requires employees to wear proper gear such as lab coats, hair nets, gloves and protective eye wear. Our controls and procedures not only set forth the necessary steps for production, but they also address issues such as quarantine, rejected lots, vendor qualification, test validation, material traceability in the form of labeling and record retention of production logs/forms, customer complaints and adverse effects, and ultra high-heat pasteurization. We test all of our products in our own controlled lab as well as independent, third-party testing facilities. All test results are published for our customers to view and all product is labeled with proper information to inform customers of the contents as well as leading customers back to the test results for their specific purchased product. We believe that our transparency to our customers is one of the many reasons that Etha™ is set apart. Our quality procedures and controls have been put in place to ensure that we are a trusted and reliable source for all of your botanical needs.
cGMP Consulting Services - www.pakalaconsulting.com
American Kratom Association GMP Program -
FDA cGMP Guidance - https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm