Kratom Company Issued Warning Letter for Opioid Support Claims

FDA recently issued its first kratom warning letter of the year to a company making opioid withdrawal and support claims.

🔷So far this year FDA has been quiet on kratom enforcement compared with the four kratom-related warning letters they issued last. All these letters have the same theme, with the companies making opioid withdrawal and support claims. Products marketed for opioid and substance withdrawal remain a high risk as those suffering from addiction are considered a “vulnerable population” and are top of mind for the FDA/FTC. Other vulnerable populations are the elderly, children, and those with mental illness.

🔷This warning letter also makes a comparison to drugs. As we know, comparing an herb or supplement to a drug is a great way to attract FDA attention, as I wrote about here.

👉From warning letter. “Although kratom is not an opiate, it produces effects similar to opiate drugs. For this reason, kratom is often sought after for its analgesic effects. It is also used by those addicted to opioids to help with their withdrawal symptoms.”

🔷FDA has a very unfavorable position on kratom and considers it a New Dietary Ingredient (NDI) according to this import alert, but I am unaware of any successful kratom NDI submission at this time. FDA also sent out this kratom alert where several US Marshall kratom seizures are highlighted, including $3 million worth of kratom in February. There have also been numerous kratom-related recalls because of salmonella contamination.

🔷The family of a deceased person who apparently died from kratom use was just issued summary judgment in their case, which opens up not only the manufacturer but possibly the distributor to penalties. It seems like kratom is for sale everywhere, and I wonder if this case will give these smoke shops and gas stations pause before selling kratom. At the very least, I hope it will encourage distributors to do quality, labeling, and safety checks on the kratom products it sells.

👉Read the full warning letter. 

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.