The FDA is receiving pushback over a warning it published yesterday about a drug that's being used as an alternative to opioids.
Advocates argue kratom, the supplement at the center of the FDA warning, helps opioid users beat addiction.
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The FDA said kratom is linked to at least 36 deaths. In a public advisory it published yesterday, the FDA said it’s determined to block imports of the product, which is derived from a tree leaf found in Asian countries.
“The increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning,” the advisory reads. “There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder.”
Kratom is banned in Arkansas and Tennessee, but it’s legal in Mississippi. Bethany Cook moved from Arkansas to Southaven, Miss. to access the supplement legally.
“It’s just a leaf they take and grind into a powder,” Cook said, as she showed FOX13’s Kristin Leigh how she uses the plant product.
“The heroin epidemic is crazy,” Cook said. “I’ve seen it firsthand. Kratom can help people get off of it. I see it every day.”
Cook said she learned about kratom in a Facebook group for people with chronic pain. She suffers from fibromyalgia and other illnesses that cause severe pain and anxiety.
Before she discovered kratom, Cook said she was taking a dangerous mix of drugs, including some that were prescribed by doctors.
"I was scared I was going to hurt somebody," Cook told FOX13. "I was fixin' to commit myself to Lakeside because I couldn't control what was going on in my head and it was scaring me, because it wasn't me."
When she tried kratom, the change was almost instant, she added.
“It was like a lightswitch, and it put me back to a me that I had not seen in a long time,” Cook said. “Within 20 minutes I was singing, cleaning, dancing around the house like nothing was ever wrong with me.”
The FDA said there are “significant safety issues” associated with Kratom, and it needs time to study the product’s side effects.
“Kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with,” the advisory said.
“The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider,” the statement continued.
Captain Chuck Mays is assigned to the narcotics unit at the Shelby County Sheriff’s Office. Like the FDA, Mays warned people to stay away from kratom, which is illegal in Tennessee.
“Due to the unregulated manufacture of it, it’s extremely dangerous,” Mays said. “It's just something that someone in a foreign country made, put in a bag, and shipped here. Obviously there's risks involved with that.”
The FDA said in its advisory that law enforcement has seen cases where kratom was laced with opiates like hydrocodone. While some use it to relieve pain, others use it for recreation.
“Anything that comes through the black market so-to-speak is dangerous,” Mays said. “You don't know what you're dealing with. Each time you get something new it's a completely different product, or has the potential to be.”
Cook said she supports the supplement being regulated. She believes kratom products that are laced with chemicals or other drugs give the pure kratom plant she uses a bad reputation.
“We want it regulated,” Cook said. “Keep it out from anybody under 18, and make sure there’s no synthetics in there. Make sure it’s plain leaf. Have it tested.”
Cook purchases her kratom from a vendor in Northern Mississippi, which imports the drug from overseas. She said the vendor tests it for dangerous chemicals.
“There's people that you can get it and it's tested to make sure there's nothing in there,” Cook said, emphasizing repeatedly the power kratom has to change lives.
“When you're in pain you have to have something to be able to function,” Cook said. “Going back to the pain pills - I was going back down the same road. I hated it. It helped me get away from all that.”
In 2016, the Drug Enforcement Administration announced its intention to classify the plant as a Schedule I substance, but reversed its decision after receiving backlash from kratom vendors and advocates.
Cook believes the FDA will get the same type of backlash, if its plan to stop imports of the plant product prevents users from buying it.
Until kratom can be studied further, the FDA and local law enforcement warn people not to touch the substance.
“It’s not worth it,” Mays said. “Most of it comes from overseas where it’s manufactured and there’s just going to be no way to tell what you got.”
Cox Media Group