Deerfield-News.com-Deerfield Beach, FL-No prescription needed, sold in gas stations and convenience stores, the internet, and “Kratom Shops”. There is no shortage of “KRATOM” in Deerfield Beach and surrounding areas. Over the last few years, more and more gas stations, convenience stores, the internet, and “Kratom Shops” have flooded the market with Kratom.
What is it, and why is it not regulated by the FDA or another federal or state agency? While currently not against any Federal law, states may regulate the sale and possession of Kratom according to the DEA.
A quick Google search for Kratom will show a comparison to morphine.YouTube videos also compare its effects to those of morphine or other controlled opioids. Also found on the internet, the search results are endless for companies that sell KRATOM.
Below is the most recent information posted to DEA.gov and FDA.gov about KRATOM.
SOURCE DEA.GOV-
Kratom
What is their effect on the body?
At low doses: increased alertness, physical energy, and talkativeness. At high doses: sedation Addictive: causes hallucinations, delusion, and confusion, nausea, itching, sweating, dry mouth, constipation, increased urination, and loss of appetite. Long-term use can cause anorexia, weight loss, and insomnia.
What is its legal status?
Kratom is not controlled under the Controlled Substances Act; however,
there may be some state regulations or prohibitions against the possession and use of kratom. FDA has not
approved kratom for any medical use. In addition, DEA has listed kratom as a Drug and Chemical of Concern.
SOURCE FDA.gov-
FDA and Kratom
Kratom is a tropical tree (Mitragyna speciosa) that is native to Southeast Asia. Products prepared from kratom leaves are available in the U.S. through sales on the Internet and at brick-and-mortar stores. Kratom is often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal. An estimated 1.7 million Americans aged 12 and older used kratom in 2021, according to the Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health.
There are no drug products containing kratom or its two main chemical components that are legally on the market in the U.S. FDA has not approved any prescription or over-the-counter drug products containing kratom or its two main chemical components, mitragynine and 7-hydroxymitragynine (7-OH-mitragynine). If a new drug application (NDA) is submitted for kratom (or one of its components) to treat a specific medical condition, FDA will review the scientific data to determine if a drug product containing kratom (or its components) is safe and effective to treat that specific medical condition. Consistent with FDA’s practice with unapproved substances, until the agency scientists can evaluate the safety and effectiveness of kratom (or its components) in the treatment of any medical conditions, FDA will continue to warn the public against the use of kratom for medical treatment. The agency will also continue to monitor emerging data trends to better understand the substance and its components.
Kratom is not appropriate for use as a dietary supplement. FDA has concluded from available information, including scientific data, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury and, therefore, dietary supplements that are or contain kratom are adulterated under section 402(f)(1)(B) of the FD&C Act. Further, FDA has determined that kratom, when added to food, is an unsafe food additive within the meaning of section 409; food containing an unsafe food additive, such as kratom, is adulterated under section 402(a)(2)(C)(i). Based on these determinations by FDA, kratom is not lawfully marketed as a dietary supplement and cannot be lawfully added to conventional foods.
Therefore, kratom is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food. For more information on this topic or FDA’s seizure alerts, see Seizures and Injunctions.
