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 Product Labels: What to Know

 

You may have noticed that the data on Kratom Product labels can differ significantly from vendor to vendor. Have you ever taken the time to examine the labels on the Kratom products you’ve purchased? Do you know what data should be included? Does it include data you don’t understand other than the brand name?

If you’ve ever taken the time to inspect your Kratom labels, chances are you’ve noticed the disparity of data included between different products. Because Kratom is unregulated, there are no standards or enforcement on what must be included. At Virtue, we include as much source and handling data as we can on every Kratom product to keep our customers as informed as possible.

Let’s investigate the universe of Kratom labels and consider where we want to see them later on.

The Brand

The first and most evident thing we see on Kratom labels is to educate you who produced it. Merchants are anxious to put their names and logos on everything that they produce because of the brand recognition and organic advertising it generates will acquire them more business.

Customers who’ve purchased from them before are bound to remember their name and logo when they see it on another product, and that acknowledgment can lead them to purchase once more. That is the reason companies invest such time and energy into picking the correct symbolism, palettes, and words for their logos and packaging.

Brand is unimaginably significant in all industries, including the Kratom business.

General Label Expectations

Right now, not all states explicitly require certain data to be displayed on Kratom product labels. This makes it even more important for Kratom companies to include as much relevant product information as possible so as to not convey the appearance of irresponsibility in the industry, and to remain as transparent as possible with our customers.

Usage

Perhaps the most significant factor that should be incorporated is the guidance on using the product. All relevant data and recommendations from the producer to the purchaser should be incorporated clearly.

Warnings

Another very important aspect of a product label are any warnings associated to using the product. Any warnings, admonitions, or other precautionary  data that would better inform the consumer is a mindful company’s responsibility to caution the purchaser about.

Numerous items have alerts that are regulated and required to be displayed on each item, for example, liquor and tobacco items. For unregulated items, for example, Kratom, no such prerequisites or enforcement are in place.

Product Specifics

Other significant data to display on the label is any particular information about what constitutes the final product. Ingredients, dietary instruction, serving size, etc, are some of the data that you may discover on a product label.

As Kratom isn’t under any FDA guidelines, Kratom product labels should exclude dietary instructions.

The Current Kratom Label Situation

On the chance you’re aware of Kratom’s current legal status, you understand that the status is consistently in danger and always in transition. While some states have legalized Kratom and made preparations to shield customers from unregulated risks, others have banned it altogether or heavily regulated it as a controlled substance.

Accordingly, there are no official guidelines that Kratom merchants must abide by when they produce their packaging. There are a few things that sellers are not permitted to state because of FDA rules, yet that doesn’t mean they need to express different things.

Kratom suppliers can as of now put anything they desire on packaging – and we believe that requirements need to change, and be enforced. Some merchants may opt to incorporate more than others, and Kratom suppliers should likewise be cautious about the language they incorporate to avoid potential legal dangers.

At Virtue, we include the following to help consumers understand the product’s source and safety:

  • Lot # to cross reference with lab results
  • Country/Region of origin
  • Strain type
  • QR code for additional information

In addition to these, there are a number of claims that are explicitly prohibited from labelling according to AKA guidelines:

  • Labels or advertising of any kratom product should not bear any disease claims (i.e., claims regarding the treatment, cure, prevention, or mitigation of disease) or unauthorized health claims.
  • Labeling, or advertising of any kratom product should not bear any structure/function claims.
  • The labels, labeling, or advertising of any kratom product should not reference any research or clinical data.
  • No kratom products may be sold to individuals under the age of 18.
  • All labels, labeling, or advertising should include the following statement: “This product is not intended to diagnose, treat, cure, or prevent any disease or condition.”

 

 

 

 

Risks of Cheap Kratom

Many people are looking to purchase cheap Kratom, and there’s nothing wrong with that – who doesn’t like saving money on things? However have you ever purchased something cheap, believing you made a wise decision, only for the product to fail you in some way ultimately? Many people desire instant gratification but neglect potential negative consequences, and that can be detrimental with products such as Kratom.

There’s a big difference between buying cheap Kratom and getting a good deal, and some very real dangers to watch out for if you’re focusing on finding the lowest price.

More and more Kratom merchants are appearing online as Kratom becomes more popular and consumers want to leverage the buying power of the internet. You may notice while shopping for Kratom the apparent range and disparity of pricing between vendors. Some vendors seem to be selling at outrageous prices and leaning heavily on marketing and volume to operate, while others are selling at basement-bargain price points and seeming to skimp on processing and packaging. The reason these discounted merchants are offering Kratom at such low prices compared to established, reputable merchants like us is that those merchants are ignoring quality control, product purity, and disregarding the safety of their customers. Cheap Kratom has the potential to expose you to some serious risks.

How are discount Kratom vendors selling so cheap?

Kratom prices vary from merchant to merchant for a variety of reasons. However when a new vendor suddenly offers Kratom powder at prices much lower than most other sites on the market, it should be an immediate red flag to the consumer.

As mentioned earlier, these merchants are likely ignoring important quality control steps when it comes to ensuring purity and safety. It’s always possible for you to enjoy Kratom from these discounted merchants without problem, but you may be exposing yourself to potentially serious health risks.

While it’s near impossible to know for sure, it’s likely that these discount Kratom vendors are ignoring crucial aspects of the sourcing and handling chain:

  • Wholesale supplier monitoring and quality control
  • Critical facility sanitation control
  • Proper mixing and storage of different batches
  • Regular lab testing for contaminants, pathogens and heavy metals

These are critical steps of the Kratom source and supply process, but can be expensive and effort intensive. Many discount Kratom vendors choose to disregard them altogether, or place blind trust in the wholesale distributor who supplies them to perform some of the steps before they receive their shipments; this behavior damages the reputability of Kratom merchants in general and can allow poor quality product onto the market but most importantly totally disregards the health safety of the customer.

Below we’ll explore these potential risks in more detail to fully inform you of the potential dangers of working with discount Kratom vendors.

E.Coli and other Pathogens in Kratom

The primary reason testing Kratom is so important is that there is the same possibility that exists for many natural, dried products for e. Coli, molds, or other pathogens to build up if it is not handled properly throughout manufacturing, packaging and shipping.

Similar to other dried natural products, Kratom powder and Kratom teas are potentially subject to the risk of being contaminated by pathogens. One honest mistake by the wholesale supplier (or a dishonest oversight), and a contamination can occur.

Kratom suppliers protect their customers through properly mixing lots and testing their products regularly!

At Kratom Virtue we ensure proper testing of our products for all of the following:

  • Quality
  • Identification
  • Salmonella [AOAC-RI 050701]
  • Heavy metals content ([AOAC 2013.06] Arsenic, Cadmium, Lead, Mercury, Nickel)
  • Microbial safety (Aerobic Plate Count [AOAC 990.12]
  • Yeast and Mold [AOAC 997.02]
  • Coliforms and E. Coli [AOAC 991.4]

We regularly mix and run our lots through all of these tests to ensure that we are providing only quality, safe products to you.

Adulterated or Contaminated Kratom

Reputable Kratom suppliers only sell products that are 100% pure, organic Kratom. The Kratom is free of other dried products mixed in to bulk it up; there are no chemicals used in the harvesting or drying process to replicate or alter the naturally occurring alkaloids of the Kratom.

That said, some dishonest Kratom suppliers are out there. Contrary to adhering to Good Manufacturing Practices, they use potentially dangerous synthetics in their Kratom products, their processing or packaging equipment is not kept in a clean environment, or (most importantly) they do not routinely test for contaminants and heavy metals.

If a Kratom merchant sells a product made with little or no quality assurance, they’re going to be able to save some on costs. But the risks are grossly irresponsible.

When searching for a Kratom supplier, make certain they have a healthy relationship with their wholesale suppliers and are monitoring the manufacturing processes in place in their upstream supply chain. Double check that they are performing proper mixing and testing of their lots, and that lot numbers are included on each product advertised so they can be cross referenced back to the correct testing results.

GMP Compliance

GMP stands for Good Manufacturing Practice. GMP is promulgated by FDA regulations, and compliance is required to market dietary supplements. These regulations provide a quality control framework for manufacturers and merchants to follow. While these regulations do not explicitly tell businesses how to operate (all businesses have unique ways of doing things) they do provide clear guidelines to follow.

By implementing GMP processes, Kratom suppliers ensure the quality and safety of their products. This is especially important because Kratom that is imported to the United States is delivered in a raw form that does not meet modern food safety standards.
You want a reliable, safe source of Kratom; we want to be that for you. To ensure that we do just that, we comply with all of the best practices for importing, testing, storing, and selling our Kratom products.

Suppliers should be willing and eager to inform you of their processes

While we hope every Kratom merchant out there will embrace processing and handling measures to ensure the quality of their products and the safety of their customers, as a customer, it’s your right to be informed of the quality of the product you’ve purchased and it’s up to the supplier to tell you.

If you have additional questions about our testing practices, lot testing, or supply chain, feel free to reach out to us. Kratom suppliers that put the investment into selling quality, safe products will be happy to discuss the details of their work towards ensuring a quality product and your safety, so make certain you receive all the information you are looking for before purchasing cheap Kratom from a discount merchant.

Cheap Kratom powder might sound appealing on the surface, but there can be risks you expose yourself to when only focusing on a low price. Make sure you are purchasing a safe, quality product!