FDA Heavy Metals in Kratom Testing Report – What To Know

 

Despite the growing success of kratom in the US, the plant remains federally unregulated. Kratom vendors operating in the U.S. who have not implemented the KCPA (Kratom Consumer Protection Act) are not required to comply with any product regulatory controls or any specific quality control requirements.

That being said, kratom does come within the mandate of the U.S. Food and Drug Administration (FDA)—an agency that has expressed concern over the heavy metal and bacterial toxicity of some kratom. Although the FDA has focused extensively on an FDA ban on kratom, and several bacteria-contaminated kratom products have been recalled in the past, heavy metal toxicity also presents a real risk to consumer safety.

Ingestion of bacteria such as salmonella can cause severe digestive problems as pathogens penetrate the digestive system. Unlike salmonella and other bacteria, however, heavy metals grow gradually in the body over time, where they can linger for weeks, if not years, in bones, hair, and tissues. Consequently, an excess concentration of heavy metals can undermine human health rapidly even before signs are visible.

Last year the FDA conducted a series of kratom studies to assess the threat of kratom heavy metal toxicity. While polarizing, their findings — which have been published online — have significant consequences for the kratom industry and its consumer safety.

The FDA Kratom Test Report

The US FDA released its review of thirty different kratom products from a number of US-based kratom suppliers on April 3rd, 2019. Many of these products, according to the FDA, contained “significant levels of lead and nickel at concentrations exceeding safe exposure” with the average product having 5425ng (nanograms) of nickel and 613ng of lead per gram.

Considering the kratom heavy metal toxicity of these drugs, the FDA reported that “heavy kratom users may be exposed to levels of lead and nickel many times greater than safe daily exposure.” Because both lead and nickel are toxic to humans and ingestion does not provide any biological purpose, the FDA also indicated that the negative effects of exposure may include “nervous system or kidney damage, anaemia, high blood pressure or increased cancer risks.

The FDA is no newcomer to the ill effects of heavy metals present in kratom; it checks thousands of products from food and health supplements and cosmetics every year.

Currently, the FDA classifies lead as a Class 1 impurity, indicating it has a high level of toxicity and “has limited or no use in the manufacturing of pharmaceuticals.” If ingested in higher than normal concentrations, lead can cause neurological, hormonal, cardiovascular and immune damage. For infants, who are particularly sensitive to intake and processing, the metal can also induce developmental delays and cognitive deficits.

Nickel, the second kratom heavy metal contained in the checked samples, is also listed by the FDA as a Class 2A impurity, meaning it is significant, but not as lead. Nickel is known to be toxic to humans at large doses, and overexposure has been associated with increased risk of lung cancer. The precise hazard of nickel is however less well-established than that of lead.

Why can Heavy Metals Be Found In Kratom?

While at first glance the FDA’s kratom test may be disturbing, there is more to the picture than what is immediately evident.

For instance, in hundreds of plants including kratom, nickel and lead-the kratom heavy metals listed by the FDA-are found naturally. Lead accumulates over time in soil where it is able to remain present for generations. Plants can then absorb lead through the soil and transfer it via bioaccumulation through the food chain. On the other hand, nickel is commonly found in food and water, and is important for many plants, unlike lead.

We are regularly exposed to lead and nickel in differing concentrations throughout our lives. While some use of lead and nickel is natural, all heavy metals are threats to the ecosystem and hazards at higher than normal concentrations. Protecting yourself from these kratom heavy metals thus has more to do with limiting exposure rather than abstinence entirely.

The FDA recognizes the need to protect consumers from heavy metals, and has set reasonable standards for their use in water, cosmetics, and many other products. The FDA describes the permissible daily exposure for lead as 5mcg (micrograms) and 220mcg for nickel in their recommendations for pharmaceutical products. Nevertheless, many of the toxicity levels of the kratom products examined fell well below certain guidelines, with certain products containing as little as 0.5mcg lead and 1.57mcg nickel.

Another possibility for the presence of lead and nickel in kratom products has to do with the conditions they are manufactured in. While kratom is not a pharmaceutical,  kratom products are often manufactured and processed in pharmaceutical-like conditions where impurities like lead and nickel can contaminate the manufacturing equipment. As a result, soil-borne amounts of kratom heavy metals such as lead and nickel may increase as these goods move through polluted production equipment and closing systems for containers.

Heavy Metals In Other Products and General Exposure

While the FDA kratom report has drawn attention to high levels of nickel and lead in different kratom products, the same heavy metals are found in both lower and higher quantities in thousands of products used by Americans every day.

One study found that vegetables and fruits were the highest sources of dietary lead among all food groups eaten by the American participants being studied. It was calculated that the participants ingested up to 20mcg of lead from fruit and ~25mcg from vegetables a day. Although the study was published in 1975, the authors noted that “the levels in foods of these elements do not differ significantly from year to year.”

Event for products targeted at the most susceptible consumer, children, the same heavy metals have been identified repeatedly as well. Infants and children are especially vulnerable to the detrimental effects of lead and other heavy metals because of their smaller, growing bodies which can accumulate heavy metal at higher rates than adults.

A 2018 study found detectable amounts of at least one heavy metal including cadmium, inorganic arsenic, and lead in a variety of brands such as Earth’s Best and Gerber for baby foods. For fifteen of the foods tested the heavy metal content was high enough to pose a health risk to children who consumed as little as one portion daily. The consequences of excessive heavy metal intake for infants and children include irreversibly compromised cognitive function, behavioral problems and lifelong health conditions such as asthma, autism and ADHD.

The FDA finding of kratom heavy metals aren’t exclusive to kratom or kratom products. Consumption of heavy metals is a common health concern that affects a huge number of consumer goods.

What Does This Mean For The Future?

The identification of lead and nickel in the FDA’s report on kratom testing has troubled many users of kratom. But, whether deliberately or not, the test results of the FDA have underlined the need to increase quality assurance expectations for kratom products

Fortunately, the American kratom industry has taken several steps towards enhancing product quality and reducing customer risk since the FDA initially published its test results in April 2019.

More American kratom vendors have been vigorously checking their products for kratom heavy metals since the start of 2019, and making their lab results available in many cases. Some vendors also test their kratom in lots and digitally store their test data to make sure every gram and item is tested and logged before shipping out.

Customers have also taken a serious interest in the transparency of kratom products The findings of the FDA’s kratom report have highlighted the potential health risks of untested kratom to many consumers who had previously been unaware of the prevalence of toxicity of the substance. Today Americans are more likely to buy kratom from reputable kratom vendors who routinely perform laboratory testing and import their goods from reliable sources.

American law has also shaped around the risks of kratom heavy metals and the push for greater transparency. The American Kratom Association, a non-profit kratom advocacy organization, launched the Kratom Consumer Protection Act in early 2019, a law designed to improve transparency for kratom vendors through more strict product quality and standards for labeling. KCPA versions have been adopted in a number of states, with 21 more targeted for legislation in 2020.

While there has been some confusion caused by the FDA’s kratom test report, their kratom heavy metal test results have also provided support for positive change within the American kratom industry. With a new focus on distributor openness and product safety, it seems America’s kratom customers are in better hands than ever before.

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The Kratom Consumer Protection Act

 

At Kratom Virtue we’re fully committed to finding and creating ways to help people locate safe and high-quality Kratom. There are many irresponsible Kratom merchants out there who adulterate their products or disregard proper handling and packaging processes. These risks are very evident and only work to create danger within the community and promote an appearance of irresponsibility within the industry. Therefore the American Kratom Association and the majority of reputable vendors are committed to doing our part to protect the Kratom consumer community from fly-by-night vendors and potential health risks.

This is the purpose the Kratom Consumer Protection Act serves – it is being promoted by the AKA for adoption in 21 additional states in the year 2020 to guarantee access, safety and quality to Kratom products. When the Act is approved and adopted in these states, it guarantees the Kratom consumers safety and access to quality product.

Kratom Consumer Protection Act

This Act is a part of a larger legislation that will allow customers to buy Kratom legally, while also protecting the Kratom community by banning adulterated and dangerous Kratom products that are available for sale today in an unregulated market. Currently Kratom is at serious risk because of the sale of unsafe and unregulated Kratom products in the market. The sale of these products could lead to many adverse effects that can even be life-threatening. The potential to expose ones self to potential health risk is very real in the Kratom industry today because of the lack of regulations or enforcement for processing Kratom tea leaves and Kratom powders. Because of this, the Kratom Consumer Protection Act is incredibly important because it requires the ban of all unsafe Kratom products on the market.

The key aspect of this act is that AKA has provided certain terms for the Act to be followed for the sale of quality, safe Kratom products. But this might change between different states and some might introduce new terms or amend the existing terms based on certain criteria. That said, there are few key aspects that will remain static and will include the following information on Kratom:

  • Kratom is defined accurately
  • Manufacturers and Kratom merchants must label products accurately according to specific requirements.
  • Bans the sale of certain unsafe Kratom products completely
  • Introduces certain penalties in case of any violations
  • Demands compulsory registration for the production of Kratom
  • Demands Agricultural standards to be met
  • Provides protocols to ensure that the Kratom is provided to market satisfies all requirements.
  • Protects customers purchasing Kratom for their well being. The permission for Kratom sale is only provided if the vendors share a sense of compassion and commitment towards the community.

States where the Act has been implemented

The Kratom Consumer Protection Act is being observed by the following states since the Federal Government has given the rights to the State for the regulation of sale and production of products like Kratom. Therefore, the Kratom Consumer Protection Act is planned to be lobbied in specific tactical states over the next few years with the intention of applying the same set of regulatory safety rules nationally. There are certain States that have adopted this Act already, but the Act might not be the same as proposed with minor changes applied by the State accordingly without changing the bedrock of it.

In Utah, it was passed on March 26, 2019. This is the first state where the Act was approved and adopted.

The legislation was passed in April on the 27th in Georgia. Georgia amended the existing clause and the State was quick enough to accept it and change the laws accordingly to protect consumer safety.

Arizona adopted this Act on May 1, 2019. Arizona was a surprise and passed the entirety of the act very quickly.

Oregon is targeted for 2020 and lobbyists have been retained. The Act should be adopted anytime. It is going to be voted on very soon.

Why is it important to advocate for the Kratom Consumer Protection Act?
The Act in itself can be intimidating and will alter the Kratom market through the removal of irresponsible merchants because of the strict additional regulations and enforcement. Many vendors might not like the idea of being governed because it will affect their income and operating costs. So why is it important to Support the Act? Because the Act primarily focuses on the safety of customers. Without regulations, irresponsible Kratom merchants cut corners on processing, quality control and safety testing to turn better profits. In addition to that, the lack of regulation might adversely affect the health of the customers who become victims of it.

Kratom has also been garnering some negative attention due to ‘adverse effects’ of Kratom…however, not all are aware that said side effects were caused by adulterated Kratom products. Some merchants willingly and knowingly put their customers at risk and the industry and product receives a bad reputation because of it. By following Good Manufacturing Process rules, Kratom can develop a positive reputation when it is proven that the plant is not harmful on its own.

For Kratom to remain legal altogether, it is important that these rules are adopted and embraced. With regulations from the Food and Agriculture department, the community can be grown into something stronger, making the customers and merchants confident about what they buy and sell. The industry will also get healthier so it is important that every Kratom merchant adopt the Act.

What is in store for the Future?
The efforts of the AKA in pushing this Act in these 21 states for 2020 must be supported by all vendors and consumers for the protection of the Kratom community as a whole but also for Kratom to remain legal and accessible in the years to come.

Kratom’s Current Legal Status

 

When people discover Kratom they are most often first curious about the Kratom benefits, then about Kratom legality or if they can buy kratom in their state.

The answer is generally yes, Kratom is legal, and there are no laws prohibiting selling Kratom or possession of it.

There are some exceptions to this rule though, as there are some folks who happen to live in one of the few states or cities where Kratom is restricted, or even illegal – as much as we would like to offer services to them we cannot as a law abiding Kratom merchant.

Where does that leave you? Is Kratom legal in your state? Read more to find out!

Kratom’s Current Legal Status in America: Is It Legal in My City/State?

As of 2020, Kratom’s Legal Status is very mixed. Currently six states have bans on Kratom by listing it as a controlled substance. It is illegal to sell or possess Kratom in these states. In addition to these states there are also some counties and even some municipalities that have restrictions on Kratom. There is usually pending legislation both for and against the legalization of Kratom so we recommend checking AKA’s resources to get the very latest status on Kratom legality in your location.

States where Kratom is currently illegal:

  • Alabama
  • Arkansas
  • Indiana
  • Rhode Island
  • Vermont
  • Wisconsin

Counties and cities where Kratom is currently illegal:

  • Denver, Colorado (restricted as “not for human consumption”)
  • Jerseyville, Illinois
  • San Diego, California
  • Sarasota County, Florida
  • Union County, Mississippi

States with legalized regulation under the Kratom Consumer Protection Act (KCPA):

  • Arizona
  • Georgia
  • Nevada
  • Utah

States with Age Restrictions on Kratom:

  • New Hampshire: 18 years
  • Tennessee: 21 years
  • States with legalized restriction under the KCPA

The American Kratom Association has set a goal for 2020 of  securing passage of the KCPA in 21 states. Accomplishing that goal would bring 25 total states under consumer protection to make Kratom legal. Kratom Virtue fully supports these efforts and is actively working to keep Kratom legal.

Kratom’s Current Legal Status in the World: Is It Legal in My Country?

Because of the constantly shifting legal status of Kratom worldwide it is always best to check directly with the local government if you plan to ship Kratom or travel with Kratom. Kratom is banned or restricted in a number of countries, in some cases permanently and in others temporarily, often for politically motivated reasons. Due to the uncertain legality internationally, we’re currently unable to ship Kratom outside the continental U.S.

Countries where Kratom is currently illegal (or heavily regulated):

  • Austria
  • Australia
  • Denmark
  • Finland
  • Germany
  • Malaysia
  • Myanmar
  • New Zealand
  • Romania
  • Russia
  • South Korea
  • United Kingdom

What You Can Do

There are both positive and negative outlooks for the legality of Kratom and protection of Kratom consumers in 2020. Some states have new bills supporting the ban of Kratom while (many) others are considering adopting and enacting the KCPA. Generally when a bill is proposed to ban Kratom the American Kratom Association and the testimonies of Kratom consumers are able to strike it – but not always.

Visit the AKA’s website to learn more about how you can get involved with advocacy efforts for our favorite botanical!