FDA WARNING_LETTER - Kratom Spot

The FDA issued a Warning Letter to Kratom Spot after reviewing their website (www.kratomspot.com) and social media (Facebook, Twitter) in April 2018. The FDA determined that Kratom Spot sells various kratom products, including powders and capsules, with unapproved drug claims.

The primary violation is that these kratom products are marketed as unapproved new drugs, in violation of sections 505(a) and 301(d) of the FD&C Act. The FDA cited claims on Kratom Spot's website and social media promoting kratom for the diagnosis, cure, mitigation, treatment, or prevention of disease, specifically for opioid addiction and withdrawal symptoms, pain relief, and mood elevation. Examples include claims like "Kratom offers people who suffer from chronic pain an option to synthetic drugs" and "Kratom can successfully eliminate opiate withdrawal symptoms."

Furthermore, the products are deemed misbranded drugs under section 502 of the FD&C Act. As these products are intended for conditions requiring professional supervision (e.g., opioid addiction), adequate directions for layperson use cannot be provided, violating section 502(f)(1).

The FDA emphasizes that these unproven treatments could cause patients to delay or forego FDA-approved treatments for opioid addiction, posing a significant public health threat, especially in the context of the declared opioid crisis.

Kratom Spot must take prompt