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FDA issues warning letters to three manufacturers of kratom products

05-28-18 Category: Addiction

FDA issues warning letters to three manufacturers of kratom products

In an effort to combat the opioid epidemic in the United States, the Food and Drug Administration (FDA) recently issued warning letters to three companies for marketing and distributing more than 65 kratom products with deceptive medical claims of treating opioid addiction and withdrawal. The agency has sought response from the three companies – Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California and Revibe, Inc., of Kansas City, Missouri – within 15 working days, directing them to inform the FDA about the specific actions taken to address the highlighted concerns.

Some of the products listed include ‘Maeng Da White Vein Capsules,’ ‘Red Thai Kratom Powder’ and ‘Green Indo.’ As per the warning letter, failure to correct the violations could result in seizure or injunction. In the interim, the FDA has also warned consumers not to use kratom or any products containing the substance.

A tree-like plant native to Southeast Asia, kratom (Mitragyna speciosa) is being used since centuries to increase energy, alertness and limit fatigue. The drug is also used for treating pain, preventing opioid withdrawal and for mild stimulation. Regular kratom use can expose its users to risks of abuse, dependence,  addiction and kratom withdrawal symptoms, similar to that of narcotic withdrawal.

Not a medical cure but a dangerous drug

According to FDA Commissioner Scott Gottlieb, despite FDA warning that “no kratom product is safe,” the agency discovered that these products were being sold under false medical claims of treating pain, opioid addiction and opioid withdrawal. Gottlieb said that far from treating opioid addiction, “kratom is an opioid analogue that may actually contribute to the opioid epidemic” and be a risk to public health. He added that if kratom’s active ingredients had any such pain-relieving or addiction-treating properties, “the FDA is open to reviewing that data” under its new drug approval process.

While the DEA considered banning the drug in 2016, the move was retracted due to vast public outcry. However, in 2017, the agency declared kratom as an illegal and a dangerous drug. At present, kratom is not a controlled substance in the U.S. and placed under “Drugs of Concern.”

Some of the steps taken by the FDA to fight the opioid menace include improving access to safe and effective opioid addiction treatment options, including medication-assisted treatment (MAT) as well as reducing the stigma associated with addiction.

Taking the first step toward addiction treatment

No matter to what substance a person is addicted to, detox treatment constitutes one of the most important aspects of addiction recovery process. It helps the body get rid of the toxic substances, prevents further damage to the organs, reduces cravings and facilitates smooth transition to other phases of the treatment. Detox should be followed by behavioral therapies or counseling sessions to address any underlying psychological issues, if any, that may have contributed to addiction.

Sovereign Health is one of the leading treatment centers in the U.S. offering patients medically assisted as well as nutritionally assisted detox programs to help them overcome substance addiction, manage withdrawal symptoms and attain sobriety. Post a successful detox, the patients undergo various other recovery plans and learn essential life skills for life outside rehab. For more information on our programs or to locate our nearest detox treatment center, call us at our 24/7 helpline number or chat live online with a member of our team.

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