Heavy Metals and Plastic Residue Found in Many CBD Products

By Pat Anson, PNN Editor

Yet another study has found evidence that cannabidiol (CBD) products are frequently mislabeled, with over half of the edibles and topicals tested containing significantly more or less CBD than their labels indicated. Researchers at the University of Miami School of Medicine also found that many CBD products are contaminated with low-levels of heavy metals and plastic chemicals.

“Because the cannabis plant is recognized as a bioaccumulator, which is highly effective at absorbing and retaining contaminants (e.g., heavy metals) in soil, it is important to characterize the degree of contamination in CBD products and their label accuracy to better estimate potential health benefits and risks associated with consumption,” researchers explained in the journal The Science of the Total Environment. 

Investigators analyzed 516 CBD products that were purchased online or at retail stores and had them tested at Ellipse Analytics in Denver. About a quarter of the CBD products were edibles.

Less than half of all the products tested had CBD concentrations within 10% of their label claims. Forty percent of the products contained significantly less CBD than claimed by the manufacturer, while 18% contained significantly more CBD.

Of the edible products analyzed, 42% tested positive for the presence of lead, 37% tested positive for mercury, 28% tested positive for arsenic, and 8% tested positive for cadmium. Most contained only trace amounts of heavy metals, but four edibles had lead levels that exceeded California’s recommended limit for daily lead consumption.

THE SCIENCE OF THE TOTAL ENVIRONMENT

Many of the edibles also contained low levels of plastic chemicals – known as phthalates – that are designed to make plastics more flexible. Phthalates leach off plastic and have become pervasive in the air, soil and water. Some phthalates have affected the reproductive systems of animals, although their impact on human health is not clear.

The percentage of CBD edibles with detectable phthalate concentrations ranged from 13% to 80% across four phthalates, with DEHP being the most prevalent. DEHP has been linked to cancer, birth defects and other reproductive harm. Federal law prohibits the manufacture and sale of children’s toys and child care products containing DEHP at levels greater than 0.1%. 

“Low-level contamination of edible CBD products with heavy metals and phthalates is pervasive. There is substantial discrepancy between the product label claims for CBD potency and the amount measured in both edible and topical products, underscoring the need for tight regulations for CBD product label integrity to protect consumers,” researchers concluded.

“Given that the consumer demographic purchasing CBD products includes those afflicted with pain, insomnia, anxiety, and other health conditions, these findings could give consumers and medical practitioners hesitation about the benefits and potential harm of CBD use.”

The study was funded by Jazz Pharmaceuticals and the Clean Label Project, a non-profit that seeks to improve food and consumer product labeling.

Previous studies have also found that many CBD products are mislabeled. A recent study at the University of Kentucky College of Medicine found that only half of the CBD oil products had concentrations of cannabidiols that were within 10% of their label claims. Researchers also found that most CBD oils contained trace amounts of THC (tetrahydrocannabinol), the psychoactive substance in cannabis, including some oils that were labeled "THC Free."

FDA Finds Unsafe Levels of Heavy Metals in Kratom

By Pat Anson, PNN Editor

The American Kratom Association’s new certified vendor program has gotten off to an inauspicious start. Kraken Kratom, the first vendor to qualify under the AKA’s Good Manufacturing Standards (GMP) program, has been flagged by the Food and Drug Administration for having dangerous levels of heavy metals in some of its products.

The FDA this week released the final test results on 30 kratom products found to contain levels of lead and nickel considered unsafe for daily human consumption. Five of the 30 samples that tested positive came from Kraken Kratom or one of its affiliated vendors.

“The analysis found significant levels of lead and nickel at concentrations that exceed safe exposure for oral daily drug intake,” the FDA said in a statement. “Based on these test results, the typical long-term kratom user could potentially develop heavy metal poisoning, which could include nervous system or kidney damage, anemia, high blood pressure, and/or increased risk of certain cancers.”

Ironically, last month Kraken Kraken became the first company to receive the AKA’s seal of approval as a certified GMP vendor. To qualify, participants must undergo a third-party audit and inspection of their manufacturing and packaging facilities.   

The company said in a statement posted online that it was never contacted by the FDA about the heavy metal findings or told to take its kratom products off the market.

“Kraken has no information regarding the samples the FDA used in their tests, including when or how the FDA acquired our products or when they tested the samples they obtained,” the statement said.

This isn’t the first time Kraken Kratom has come under FDA scrutiny. Its parent company, PDX Aromatics of Portland, Oregon, recalled thousands of kratom packages last year after samples tested positive for Salmonella bacteria. The company believes the samples that tested positive for heavy metals may have come from an FDA inspection in March, 2018.

“If these samples are from that investigation, their product lots were pulled from the market over 12 months ago as part of the extensive recall we did in cooperation with the FDA. Further, it would indicate that the FDA was rehashing old information, not in an attempt to protect the public, but as a way to target and further stigmatize kratom,” the company said.

In recent years, millions of Americans have discovered kratom, an herb grown and used in southeast Asia for centuries as a natural stimulant and pain reliever. Kratom is widely available online and in smoke shops, but the quality of what’s being sold and what country it came from are often unknown. Like other dietary supplements, kratom products are essentially unregulated and there are little or no quality controls.

That’s one of the reasons the AKA launched its GMP certification program. The organization said it wanted to protect kratom consumers from “unscrupulous vendors using sloppy manufacturing procedures” and those who adulterate kratom to boost its potency by adding substances like fentanyl or morphine.

But under the AKA’s certification program, no kratom products are actually tested for Salmonella bacteria, heavy metals, fentanyl or any other foreign substances.

“No, absolutely not. That is not our function,” AKA President Dave Herman told PNN. “The audit does not inspect the products. The audit inspects the procedures in place to manage the facility.”

Herman says third party auditors hired by the vendor and approved by the AKA only inspect manufacturing procedures — not the kratom itself. He declined to comment on the FDA’s discovery of heavy metals in Kraken Kratom products.

“I have no way of knowing when samples were taken or under what conditions they were taken,” he said. “Was it prior to an inspection? After an inspection? And without that knowledge I’m not sure I can say anything intelligent,” Herman said.

A handful of states have banned kratom and there is speculation the Drug Enforcement Administration will try again to schedule it as a controlled substance, something the agency backed away from in 2016 after a public outcry. FDA commissioner Scott Gottlieb, MD – who leaves office today -- has also mounted an extended public relations campaign against kratom.

"Over the last year, the FDA has issued numerous warnings about the serious risks associated with the use of kratom, including novel risks due to the variability in how kratom products are formulated, sold and used both recreationally and by those who are seeking to self-medicate for pain or to treat opioid withdrawal symptoms,” Gottlieb said in a statement.

“Data suggest that certain substances in kratom have opioid properties and that one or more have the potential for abuse. The findings of identifying heavy metals in kratom only strengthen our public health warnings around this substance and concern for the health and safety of Americans using it."