DENVER -- The Food & Drug Administration is warning about heavy metal contamination in 30 kratom products tested.
An FDA news release states their analysis "found significant levels of lead and nickel at concentrations that exceed safe exposure for oral daily drug intake."
"If they did find heavy metals in the product, good for them," said Rick Clifford, owner of Kratom by Mile High Botanicals LLC. "They're actually doing their job."
Clifford said he believes that the FDA cries wolf too often as it comes out with different claims every year.
"For instance, two years ago the FDA claimed 44 deaths (caused by kratom)," he said. "The American Kratom Association was able to obtain the toxicology reports... They discovered that the people who died had other drugs in their systems, that no one had died from kratom alone."
Clifford said he believes the FDA is making exaggerated claims because of its ties to big Pharma. He said big Pharma doesn't want the kratom industry to prosper at its expense.
The kratom shop owner told Denver7 that he was born with a defective heart valve and had surgery as an adult.
He said he was prescribed powerful painkillers and became addicted.
"After 12 years, I wanted to get off, but didn't want to suffer," he said.
He decided to give kratom a try.
"I went through 30 days of taking kratom, instead of opioids, and after 30 days I said, 'OK, I want to see what happens if I stop,'" he said. "That was it. I was done."
Clifford said he had no more pain, and no more addiction.
"It was so life-changing for me that I really wanted to get the message out," he said. "That's why I started the business."
In 2017 Denver placed restrictions on the sale of kratom.
"It must be labeled 'not for human consumption,'" he said. "We put a warning label on every bag."
Now, other cities are considering restrictions.
In mid-December, Castle Rock temporarily suspended the establishment of new kratom-related businesses to give town staff 180 days to further survey and collaborate with both the kratom industry and regulatory agencies to identify, and potentially regulate kratom sales within the town.
Because of the potential risk to public safety, the ordinance was adopted on an emergency first and final reading.
Kratom comes from a tropical tree that is native to Southeast Asia, primarily Malaysia and Thailand.
According to the Colorado Department of Public Health & Environment, leaves from the tree have been used in those countries for centuries as traditional medicine to relieve pain, increase energy and ease opioid withdrawal.
The leaves are traditionally brewed as tea or chewed.
According to the health department's fact sheet, kratom products are not regulated or required to be tested, so there may be a risk of contamination by toxic substances or other drugs.
The fact sheet says kratom has the potential to interact with other drugs, which could result in toxic effects. Using kratom, especially in combination with opioids or other psychoactive drugs that affect the brain, has resulted in death.
Even when not mixed with other prescription or illicent drugs, kratom might, on rare occasions, result in death.
Clifford told Denver7 that his industry has been asking the FDA, for years, to implement manufacturing guidelines.
"We don't want anyone to get sick from Salmonella or E-coli," he said.
While it is legal to possess kratom in Colorado, the FDA has not approved it for use as a drug, food ingredient or dietary supplement.
