Kratom Compliance

Kratom is gaining popularity in the United States and other Western countries due to its uses for medicinal values. An estimated 1.7 million Americans aged 12 and older used kratom in 2021, according to the Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health. This herbal supplement is often used as an alternative to prescription opioids. One may see the allure kratom offers, especially when trying to avoid the detrimental opioid addiction epidemic. We are seeing more Kratom products available to consumers, and this month we sought to shed light on Kratom and its compliance in the United States.

What is Kratom?

Kratom is often sold in the forms of herbal tea, tinctures, and various infused edibles. You may have seen Kratom for sale at coffee shops, gas stations, head shops, or online. Kratom travels extensive distances from its originating homeland to the US or other Western countries. Kratom is sourced from a specific tropical tree that is native to Southeast Asia and can be found in Thailand, Malaysia, Indonesia, and Papua New Guinea.

Its primary active compounds interact with the opioid receptors in the brain. Kratom leaves have been used for centuries for their stimulant and opioid-like effects.

Regulatory Issues with Kratom

Kratom obviously has benefits for its users, but it’s important to note its regulatory issues.

• Lack of Safety Data: The safety of kratom is still being studied, and there is a lack of long-term research on its effects.
• Dependance: Because Kratom is an alternative to opioids, its user may experience dependance leading to addiction and withdrawal symptoms. Dosing plays a major role with kratom use. It is suggested that users discuss kratom dosing with their physician prior to use. Because of Kratom’s potential harmful effects and addictive properties, the Drug Enforcement Agency (DEA) has considered labeling kratom a controlled substance.
• Lack of Education Leads to Improper Use: Without education, consumers will unknowingly misuse any product. Spreading kratom education is needed, especially since kratom is sweeping in popularity. The American Kratom Association (AKA) is spearheading education efforts amongst regulators and consumers.
• Lack of Regulations: Kratom is not regulated by the FDA which means that the quality, purity and safety of kratom products can vary widely. Some states are starting to take a stance on creating regulatory frameworks to ensure products are safe for consumers. Although some states are taking the lead in creating regulatory frameworks, kratom is still illegal in other states.

Kratom Regulations

Kratom is not federally regulated. According to the FDA, “kratom is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food.” Since the FDA took a hard stance against legalizing and regulating kratom, it is up to the states to determine whether kratom can be sold and regulated. Although kratom is not legal in all states and certain cities and counties, it is becoming easily accessible for purchase.

Kratom’s supporters created a movement, called the Kratom Consumer Protection Act (KCPA) that protects the legality of kratom in particular states. States like Nevada, Utah, Arizona, and Georgia has passed KCPA bills. These bills are unique to each state and their allowances may vary from state to state. Other states, such as Oregon and Colorado are taking steps toward a more legal and regulated space for kratom. Sprout Health Group has a detailed state-by-state breakdown.

Some states have taken a strict stance against kratom and have decided to ban the product. Banning includes making it illegal to sell, prosses, grow or use kratom. These states include Wisconsin, Indiana, Arkansas, Alabama, Vermont, and Rhode Island. Checking with your state’s legislative and legal resources or contacting local authorities to determine the current legal status of kratom in your area is highly suggested as regulations change frequently.

American Kratom Association

The American Kratom Association (AKA) is a non-profit corporation that is committed to restoring consumer access to safe kratom products. According to AKA’s website, “The American Kratom Association is dedicated to protecting the rights of all Americans to legally consume safe kratom to better manage their overall health and well-being.” The association’s top 5 main goals include: support consumers, educate, speaking the truth on kratom, global awareness, and protect natural resources.

Since the industry is lacking regulatory guidance, the AKA created their own GMP standards! This allows kratom companies to have an opportunity to abide by a regulatory framework.

“The ultimate goal of AKA’s GMP Standards Program is to provide consumers with information to help them make an informed decision regarding their selection of kratom-containing products. The GMP Standards Program includes requirements that participants must satisfy to demonstrate that they have taken steps necessary to ensure the safety, identity, wholesomeness, and quality of the kratom-containing products they manufacture or distribute and that the label and labeling of such products ensures consumers have all the meaningful information required to make an informed purchasing decision.”

– American Kratom Association

Under the GMP Standards Program, kratom companies undergo a GMP audit from a third-party company. The independent third-party auditors are vetted and approved by AKA. Once approved, the kratom company is placed on AKA’s website as a trusted vendor. To ensure ongoing compliance, each kratom company must complete and pass an annual third-party re-certification audit.

Allay Consulting is a proud independent approved third-party GMP audit company for AKA! We are happy to support the kratom industry to ensure quality and safety products for consumers. Contact Allay Consulting for your kratom GMP audit needs.