cGMP Manufacturing - Why It Matters to Kratom Consumers - Laughing Lion Herbs

cGMP Manufacturing - Why It Matters to Kratom Consumers - Laughing Lion Herbs

Posted by Laughing Lion Herbs on 29th Oct 2020

If you’ve been shopping for the best kratom online, you might have noticed the acronym cGMP or GMP. Depending on which is used, it stands for either Current Good Manufacturing Practices or just Good Manufacturing Practices. This designation is important to people who want to buy kratom online and rest assured that they’re receiving a product of the finest quality. The most common guidelines for cGMP kratom have been established by the United States Food and Drug Administration (FDA).

What Are the FDA’s CGMPs?

The FDA publishes and enforces regulations for Current Good Manufacturing Practice based on their understanding of what it takes to keep a product safe. Following these regulations is intended to protect the strength, quality, and purity of drug products. Additionally, following the cGMP regulations from the FDA helps consumers verify the identity of a given product. The following controls are designed to help pharmaceutical companies prevent contamination, deviations, failures, and other types of errors:

  • A company must establish strong quality management systems.
  • A company must obtain raw materials that are of appropriate quality.
  • A company must detect and investigate deviations in the quality of their products.
  • A company must maintain reliable testing labs.
  • A company must establish robust operating procedures.

The Food and Drug Administration makes its requirements flexible enough that each manufacturer can individually decide how to apply the appropriate controls. The FDA is also updating its regulations to account for advances in technology and best practices. That’s why the organization makes a point of emphasizing that their good manufacturing products are “current.”

Why Do CGMP Regulations Matter for Kratom?

Sometimes it’s hard to tell if a product is safe or if it will work. Many people wouldn’t be able to tell pure kratom apart from tainted kratom simply by touching it, smelling it, or looking at it. That’s why the cGMP requirements include testing. Additionally, the requirements take the inadequacy of some testing into account. This is because so many types of testing only test a small batch.

Since testing isn’t enough on its own, the cGMP regulations include requirements that products be manufactured under conditions that increase the quality. Facilities must be clean and in good condition. The equipment used must be calibrated correctly and maintained consistently. Additionally, reliable processes must be carried out by qualified employees.

How Does the FDA Enforce cGMP Requirements?

If a company does not comply with the regulations, the Food and Drug Administration can legally categorize their products as adulterated. The FDA’s standards for adulteration don’t require there to be any problem with the product itself. Instead, products declared adulterated by the FDA simply were not manufactured under conditions that qualify with the Current Good Manufacturing Practice regulations.

When problems are identified, the FDA can request a recall. If a pharmaceutical company declines to issue a recall on one of their adulterated drugs, the FDA normally proceeds to warn the public about the dangers of this drug. In the most severe case, the Food and Drug Administration has the legal authority to seize a drug. Assessments of cGMP compliance are made by conducting inspections and reviewing product reports. About a year ago, the FDA did actually do a mandatory recall on a kratom company when it was found they had Salmonella in their product and they refused to cooperate with the voluntary recall.

Other Types of cGMP Kratom

The FDA itself has stated that their cGMPs are minimum requirements, so many organizations choose to go above and beyond as they seek to ensure quality and minimize risk. Additional standards for cGMP kratom have been established by the American Kratom Association as part of their effort to keep natural kratom safe and available. One of the biggest issues with the kratom industry is that it can be so hard to verify whether or not a vendor and a product offer appropriate levels of quality.

The industry isn’t regulated very efficiently yet, and some manufacturers take advantage of that by selling impure or unsafe products and calling it kratom. To motivate kratom companies to be better and give consumers a way to vet their products, the American Kratom Association (AKA) created their GMP Standards Program. This program is intended to raise the quality of kratom products.

What Is the American Kratom Association?

Founded in 2014, the American Kratom Association is on a mission to restore full consumer access to kratom by protecting the rights of Americans to make their own choices as they strive for well-being. The AKA is a registered non-profit organization. They are focused on maintaining compliance with both state and federal regulations. This organization advocates on behalf of kratom consumers, and states that their five primary goals are as follows:

  1. Support consumers by advocating on their behalf to political and private entities that wouldn’t otherwise prioritize the needs of the kratom community.
  2. Educate all Americans about the benefits of natural kratom leaves. The AKA states that they are focused on potential consumers, regulators, and everyone in between.
  3. Amplify the voices of the kratom community. As an organization, they help thousands of individuals get their voices heard.
  4. Spread global awareness of kratom while demonstrating responsible practices and applicable knowledge for other countries to consider when making their own kratom legislation.
  5. Protect the natural resource that is kratom by supporting sustainable harvesting practices and reforestation.

What Are the Standards for AKA cGMP?

The AKA’s establishment of their Good Manufacturing Practice Standards was a big step for the kratom community. Consumers can now purchase cGMP kratom with confidence that their product has been verified by one of the world’s leading authorities on kratom. The program has standards related to manufacturing, labeling, and verification. The standards identified by the AKA are more demanding than the requirements from the United States Food and Drug Administration, setting a higher bar.

To participate in the American Kratom Association GMP program, a company must have its facilities audited by an independent third party. Additionally, a company is required to test every production lot they produce. These tests are to confirm that the products are free of microorganisms that may be concerning from a health perspective. Beyond ensuring that the product is not contaminated, these tests must also identify the levels of mitragynine and 7-hydroxymitragynine. The American Kratom Association GMP program goes on to set additional standards. You may find a more complete description of the program here.

Buy cGMP Kratom Online at Laughing Lion Herbs

When you’re ready to buy high-quality kratom online, you can find it here at Laughing Lion Herbs. We implemented cGMP policies and procedures to ensure that our operation meets the highest standards for cleanliness and safety:

  • We never touch the products with our bare hands, using non-latex gloves.
  • All employees wear appropriate clothing, coverings, face masks, and hairnets.
  • Our equipment is made of high-end stainless steel and is GMP compliant.

In addition to following cGMP standards, our team at Laughing Lion Herbs goes above and beyond to ensure quality and purity. Instead of just taking random sample tests, we homogenize every single batch. In other words, we blend it together to create uniformity and ensure that every bag from the same batch is as close to identical as possible. While 100% consistency isn’t possible because of the nature of the plant material, our mixer provides the best and most predictable blends possible.

Our goal is for every product to leave our facility just as pure and clean as it was when it arrived. We also work hard to maintain productive relationships with the best kratom harvesters and vendors in the world. Working with the best in the business has allowed us to build our reputation for reliability and consistency. Shop our selection of kratom today, and you’ll see exactly what we mean.