Herbsens Botanicals – FDA Warning Letter, Jun 30, 2022

On June 30, 2022, the FDA and FTC issued a Warning Letter to Herbsens Botanicals regarding their kratom capsule and powder products, including "Kratom Red Maeng da," "Kratom Green Malay," and "Kratom Train wreck," sold on their website, https://herbsenskratom.com/.

The FDA determined that the claims on the website establish these kratom products as unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act. The products are marketed for treating opioid addiction and withdrawal symptoms, pain, sleep, and other conditions, making them "drugs" under section 201(g)(1) of the FD&C Act. Since they are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) and lack FDA approval.

The FTC also found that the company's advertising claims regarding treating or curing human diseases, including addiction, lack competent and reliable scientific evidence, violating the FTC Act. The letter highlights that no well-controlled human clinical studies currently support addiction treatment claims for kratom.

Herbsens Botanicals must notify the FDA within fifteen working days of the specific steps taken to correct these violations and prevent recurrence. Failure to comply may result in legal action, including seizure and injunction. Additionally, the company must notify the FTC