FDA WARNING_LETTER - The Golden Road Kratom - May 01, 2020

On May 15, 2020, the FDA issued a Warning Letter to The Golden Road Kratom after reviewing their website, www.thegoldenroadkratom.com, on May 1, 2020. The FDA observed the company offering kratom products for sale in the U.S. with claims indicating they were intended to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products were deemed unapproved new drugs, violating section 505(a) of the FD&C Act, and misbranded drugs under section 502. Their introduction into interstate commerce violated sections 301(a) and (d). The FDA emphasized the urgency of protecting consumers from unapproved products making COVID-19 claims, given the public health emergency declarations.

While the specific claims cited on the website appeared to have been removed by the letter's date, the FDA stressed that such violations must not recur. The company is responsible for ensuring product compliance with the FD&C Act and FDA regulations.

The FDA required the company to email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing steps taken to prevent future violations. The firm will be added to a public FDA list of companies receiving warning letters for COVID-19-related product violations, with a notation that the listed products are no longer sold for COVID-1