The Food and Drug Administration issues warning letters on Tuesday to two private companies to illegally sell unauthorized, abused drugs containing kratom, claiming that their products can cure opioid dependence and withdrawal symptoms.
Cali Botanicals, based in Folsom, California, and Kratom NC, Wilmington, North Carolina, also argue that their products can treat pain and cancer as well as mental health conditions such as depression and anxiety.
"We have issued many warnings about the serious risks associated with the use of kratom, including warnings of contamination of chromate products with high levels of salmonella that put people into use of chromate products in danger and resulted in many diseases and reminds that" the working FDA commissioner, Dr. Down Sharpless, said in a statement. "Despite our warnings, companies continue to sell this dangerous product and make fraudulent medical claims not supported by science or reliable scientific evidence."
The federal agency says companies use websites and social media to illegally market kratom products that make unjustified claims about their ability to cure, treat, or prevent disease.
Proponents say the kratom helps relieve the pain and reduce the symptoms of opioid withdrawal, but the FDA has not approved it for any medical use. In 201
A report released in April linked the kratom to 91 overdose deaths in 27 states, but in the majority of these cases kratom was taken along with other drugs including heroin and fentanyl.
Kratom comes from a plant native to Southeast Asia. It is sold in capsules and powders, and sellers market it as a safe "plant-based" product, but as former FDA commissioner Dr. Scott Gottleib has pointed out, heroin also comes from plants.
The FDA has clamped down on the supplement and has previously issued warnings to companies that market it to combat opioid use. The agency has also warned of traces of heavy metals as lead in certain chromate products.
"When we work to fight the opioid crisis, we cannot allow unscrupulous providers to take advantage of consumers by selling products with untreated claims that they can treat opioid addiction or alleviate other medical conditions," says Sharpless.
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