The FDA is cracking down on the sale of Kratom and demanding companies stop marketing the supplement to treat opioid addiction. A warning letter sent to a North Carolina company, Kratom NC, requested the company remove any claims that market kratom as an alternative to opioids.
In the letter sent on June 25, 2019, the FDA told Kratom NC that their website was out of compliance with federal laws. According to the FDA, the company marketed kratom as an alternative to opioids, anti-depressants, and sleep aids.
One statement on the website that the FDA found said:
“Kratom is used for energy, to increase attention/focus, to relax, and also to treat pain and addiction. Here is just some of what our customers have used kratom to treat . . . Chronic Pain, Migraines, Opiate Addiction, ADHD/ADD, Anxiety, Depression, Arthritis, Insomnia and much more!”
Other claims included:
Red Vein Kratom . . . is generally used for it’s [sic] sedation and pain killing effects. It’s better for treating pain & for relaxation.”
“Green Vein Kratom . . . used more for focus/energy . . ..”
“Greens . . . are great for ADHD and depression . . .”
Despite the statements made by the company, the FDA stated there is no known evidence supporting that kratom works to treat any illnesses or diseases. Instead, the product is not regulated nor considered medically useful by the government. As a result, companies that market the herbal supplement as an alternative to known pharmaceuticals are misleading customers.
Most importantly, the FDA states that customers may forego treatment by a doctor in place of the products sold by Kratom NC. Without doctor supervision, the FDA called the sale of the supplement to treat illness a “public health threat.”
“Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction and withdrawal. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health”
The letter also addressed issues with the branding and labeling of the products. According to the FDA, the website and packaging contained no dosing instructions. Products sold to treat an illness most include proper dosing instructions to avoid overdose to consumers.
The FDA ended their letter by telling the company that they must comply with the FDA within 15 days, or they risk losing their business. By publication this morning, Kratom NC appeared to scrub their website of any medicinal claims of the plant.For the past several years, the FDA has been working diligently to stop the sale of kratom. Kratom is classified as an opioid by the FDA due to how the plant affects the brain. The plant is native to parts of Asia and the Pacific Islands. In many of the countries of origin, the plant is a banned substance.
Users of kratom say the product enables them to stop their use of opioids like heroin, oxycontin, fentanyl, and oxycodone. However, the FDA says that users replace one addiction for another because the supplement is addictive as well.
Organizations that aim to stop the ban of the plant in the United States, like the American Kratom Association, often downplay the risks of the plant. The APA insists that the plant is not addictive nor can it cause overdoses.
However, the Centers for Disease Control released data in March that connected the supplement to 91 deaths in the United States. Additionally, the CDC reported that over 1800 people reported adverse effects from kratom to Poison Control.
For now, the letter from the FDA is clear that the government is cracking down on the marketing of kratom to consumers. Vendors of the plant are not permitted by law to sell the supplement as a drug or an alternative to any pharmaceutical drugs.
How the kratom industry will respond to the latest threat by the FDA remains to be seen.
*Katie Joy is a columnist and hosts Without A Crystal Ball on Patheos Non-Religious Channel. She writes articles on parenting, disability advocacy, debunking pseudoscience, atheism, and crimes against women and children.
She co-hosts the YouTube show, “The Smoking Nun,” with Kyle Curtis on The Non-Sequitur Channel. The show airs weekly and tackles pseudoscience, current events, and crime stories.
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