FDA issues new warning on Kratom – May 22, 2018.

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U.S. Food & Drug Administration Logo, credit: FDA.gov

On May 22, 2018, the U.S. Food and Drug Administration (FDA) issued a new warning (full text here) for three marketers and distributors of kratom products:

1. Front Range Kratom of Aurora, Colorado;
2. Kratom Spot of Irvine, California and
3. Revibe, Inc., of Kansas City, Missouri.

The FDA claims the above distributors and others like them are illegally selling unapproved kratom-containing drug products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal.

The FDA cited the companies claims that kratom also treats pain, lowers blood pressure, treats cancer and reduces the damage caused by strokes.

As you are aware, all medical claims from a food or drug product must be approved by the FDA. The FDA position is that kratom as an “opioid analogue” that may contribute to the opioid epidemic instead of treating the addiction.

The FDA warning reiterated FDA”s position that Mitragyna speciosa (kratom) use expose users to a risk of addiction, abuse and dependence by affecting the same opioid brain receptors as morphine. At the moment there are no FDA-approved uses for kratom.

Benefits of kratom?
Commonly argued benefits of kratom include: helping end drug addiction, ability to lower blood pressure, relieve pain, boost metabolism, increase sexual energy, improve the immune system, prevent diabetes, ease anxiety, eliminate stress, and induce healthy sleep. It is believed that kratom also reduces the opiate withdraw effects allowing those addicted to other opioids an opportunity to quit. The list of kratom benefits also include relieving headaches, vascular pain, arthritic pain and muscle pain?

FDA-Approval soon?
A check on the FDA site shows no indicating kratom/mitragyna speciosa will be approved anytime soon or even in the near future. Some argue FDA-approval doesn’t legitimize a drug as evidenced by the multitude of mass tort pharmaceutical lawsuits over dangerous drugs (trasylol, accutane, actos, depakote, hydroxycut, etc).

How does this FDA release impact imports of kratom?
U.S. Customs and Border Protection (CBP) enforces the laws of all the US government agencies (FDA, Consumer Product Safety Commission, Department of Commerce, Department of Defense, etc). This new FDA warning and others before it mean that imports of kratom may be subject to detainment and seizure if the imports of kratom contain non FDA-approved statements concerning the benefits of kratom. Officially, kratom is still being imported into the US with sporadic reports of seized kratom shipments.

More questions?
If you have any questions about the importation of kratom or a seizure related to kratom, contact experienced trade and customs attorney David Hsu by text/phone at 832-896-6288 or by email at: dhsu@givensjohnston.com.

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