FDA Investigates Synthetic Compound in Kratom Supplements, Links Deaths to Use with Alcohol

The Food and Drug Administration is investigating potential dangers associated with a synthetic compound found in some kratom-containing dietary supplements, with Los Angeles County health officials linking three local deaths to the consumption of products containing the compound in combination with alcohol.

Concerns are growing over the accessibility and addictive potential of kratom products, particularly one brand called Feel Free. Chris Oflyng, 28, shared on social media his struggle with addiction to the supplement, stating, “I’ve been addicted to these for a while…Falling into even taking one, two, three bottles at a time,” despite a label recommending no more than two servings daily. Influencer McKenzie Wisdom also posted about a previous addiction to Feel Free, saying she ultimately sought treatment in rehab.

Experts warn that kratom, derived from a tropical tree in Southeast Asia, carries serious health risks despite being used by some to self-treat chronic pain, depression, and anxiety. Dr. Terry Simpson, a culinary medicine specialist at Dignity Health St. John’s Regional Medical Center, explained, “Kratom has never been regulated. It’s a mild opiate, but it is highly addictive, and it can cause people to do all the things opioids do.” The FDA has recommended 7-hydroxymitragynine (7-OH), a psychoactive component of kratom, be placed under the Controlled Substances Act, though the agency clarified its focus remains on synthetic kratom products. The National Institute on Drug Abuse provides further information on kratom’s effects and potential for abuse.

Botanic Tonics, the maker of Feel Free, maintains its product contains only natural whole leaf kratom with limited 7-OH content (1%). However, cardiologist Dr. Jennifer Miao argues the body metabolizes synthetic and natural forms similarly, adding, “We just don’t know what it does long term, and we don’t have a good safety profile for this substance.” The company previously settled a class action lawsuit related to misleading marketing and now labels Feel Free for adults 21 and older, acknowledging its potential for habit formation. The U.S. Drug Enforcement Administration lists kratom as a “drug of concern,” and the FDA and medical studies have linked kratom products to severe liver damage, heart problems, and even death, especially when combined with other substances. Headlinez News will continue to follow developments in drug safety.

Officials say the FDA investigation is ongoing, and consumers should exercise extreme caution when considering kratom products.