Ricketts’ Letter Calls on FDA to Address Kratom Scheduling Loophole

WASHINGTON, D.C. - Today, U.S. Senator Pete Ricketts (R-NE) and Senator Richard Blumenthal (D-CT) led a letter to the Food and Drug Administration (FDA) Commissioner Makary recommending scheduling action of the whole Kratom leaf and 7-OH under the Controlled Substances Act (CSA). 7-OH is a Kratom-derived opioid that can be more potent than morphine. Kratom-derived concentrates are found online and in gas stations as tablets, gummies, and drink mixes. This makes them easily accessible and attractive to young Americans. Senators Marsha Blackburn (R-TN), John Boozman (R-AR), Katie Britt (R-AL), Ted Budd (R-NC), Mike Crapo (R-ID), Steve Daines (R-MT), James Justice (R-WV), Alex Padilla (D-CA), and Jeanne Shaheen (D-NH) also signed this letter.

In the letter, Senator Ricketts detailed the detrimental effects 7-OH has on Americans, especially teenagers and children. The product increasingly causes addiction, seizures and, in some instances, deaths. Kratom is currently banned in six states and Washington, D.C., and at least 18 states have some form of regulation.

The letter reads:

"Young people across the country have reported growing addicted to kratom supplements, consuming up to a dozen products a day and going through severe withdrawal symptoms after ceasing use. Some cities, counties and states have responded by banning kratom or raising the minimum purchase age to 18 or 21. But in many areas, enforcement remains inconsistent, and some addiction specialists say clearer federal guidance is needed.

"Singling out 7-OH to schedule would leave these addictive products on the shelf and tacitly declare them safe for consumption. There will be no standardized control over product quality, concentration, or labeling, allowing inconsistent and potentially dangerous products to stay on the market."

Read the full letter here and below:

Commissioner Makary:

We appreciate the Food and Drug Administration's (FDA) targeting 7-hydroxymitragynine (7- OH), a concentrated byproduct of the kratom plant. As you know, 7-OH is an opioid that can be more potent than morphine. We are particularly concerned with the products that appeal to teenagers and children. Kratom-derived concentrates in forms like tablets, gummies, and drink mixes are available online and in gas stations. This makes them easily accessible and attractive to young Americans.

Recommending scheduling action of 7-OH under the Controlled Substances Act (CSA) is an important first step. However, we encourage you to consider scheduling the whole kratom leaf, given that some of the most accessible and addictive products contain whole kratom leaf, not 7- OH.

So-called "herbal supplements" are sold at many gas stations and retailers across the country. Their ingredients include kava extract, which the company says promotes relaxation and lifts mood. They also include kratom leaf, which is said to enhance energy and focus. The supplement only contains trace amounts of 7-OH, so it would not be regulated under the CSA if 7-OH is scheduled

To be clear, the kratom leaf acts on mu-opioid receptors, similar to opioids. Frequent use leads to tolerance, dependence and withdrawal symptoms that resemble those from morphine or heroin. Reported side effects of kratom include nausea, vomiting, constipation, tremors, seizures, hallucinations, elevated blood pressure and liver damage.

Young people across the country have reported growing addicted to kratom supplements, consuming up to a dozen products a day and going through severe withdrawal symptoms after ceasing use.

Some cities, counties and states have responded by banning kratom or raising the minimum purchase age to 18 or 21. But in many areas, enforcement remains inconsistent, and some addiction specialists say clearer federal guidance is needed.

Singling out 7-OH to schedule would leave these addictive products on the shelf and tacitly declare them safe for consumption. There will be no standardized control over product quality, concentration, or labeling, allowing inconsistent and potentially dangerous products to stay on the market.We remain committed to protecting America's youth from dangerous and addictive substances and look forward to working with you to address the full scope of the rising danger of the kratom plant through the CSA.