The warning letters allege that the companies have been making disease treatment claims on the products, which were sold primarily in capsule form. Among the disease treatment claims were pain relief, blood pressure, and depression indications.
Focus on opioid claims
One unifying factor, however, were the claims being made by the four companies to help consumers addicted to opioids or other drugs wean themselves off those substances and to help manage the severe symptoms of opioid withdrawal.
That prompted the inclusion of a section in the warning letters pertaining to violations of the FTC Act, 15 U.S.C. §§ 41–57, which makes it illegal to advertise that a product can prevent, treat, or cure human disease without human clinical studies backing up the claim. In particular, the Agency said that includes claims to help consumers addicted to alcohol, nicotine, or other substances.
Examples of the opioid addiction claims mentioned in the letters include:
- “In the US, the major reasons for Kratom use are to self-treat acute and chronic pain, manage opioid and/or heroin addiction, and to manage emotional or mental health concerns.”
- "[T]his strain is best for the removal of any opioid effects . . . This strain lessens the effects of other opiates and, most of the time, removes the habit of other opiates too."
- "Kratom can treat opioid addiction without causing any adverse effects."
Potential per-violation fines
These sections of the warning letters demand the companies immediately stop making the claims. FDA said that the FTC Act would allow remedies including a permanent injunction. In addition the warning letters state another federal law, the Opioid Addiction Recovery Fraud Prevention Act of 2018, that includes civil fines of up to $46,517 per violation.
The letters are formulated as being part of the Department of Health and Human Services’ declaration of a national opioid addiction health emergency. As such, they do not bear on the legal status of kratom as a dietary ingredient and focus solely on the claims being made on the products
Kratom’s legal status
Interestingly, the letters have nothing to say about the legal status of kratom. At the moment, kratom exists in a legal limbo similar in some ways to CBD products. It’s on the market, and apparently in significant quantities, but is technically not a legal dietary ingredient, though some states, like Arizona and Utah, regulate its use.
Recently, FDA rejected a sixth NDI Notification on kratom. It was the third filing by American Botanicals Corporation on something the company was calling a ‘kratom extract,’ and the third time FDA responded that the ingredient was not sufficiently well characterized and lacked sufficient safety information.
At the time of this most recent kratom NDI rejection in February, attorney Marc Ullman, of counsel with the firm Rivkin Radler, said that even companies willing to take the time to put together a carefully constructed NDI Notification for kratom have shied away because FDA seems unlikely to approve any filing, no matter how carefully done.
“FDA is hostile to the ingredient, and that means you have an extremely high bar,” he said.