The US Food and Drug Administration (FDA) has issued seven warning letters to companies accused of illegally selling products containing 7-hydroxymitragynine (7-OH), a substance also referred to as synthetic Kratom.

Growing concern over potent opioid alternatives

These companies, based in California, Florida and Texas, are accused of marketing synthetic 7-OH products through online platforms, gas stations, smoke shops and convenience stores. The FDA expressed increasing concern over “novel, potent opioid products” entering the market and potentially putting public health at risk.

The warning letters focus on products that either contain added 7-OH or have elevated levels of the compound. According to the FDA:

• Some products are classified as adulterated foods or supplements because 7-OH doesn’t meet safety standards;
• Others are considered unapproved drugs due to unsubstantiated claims such as pain relief or anxiety management.

Not your normal cup of coffee

Dr. Daniel Fabricant, PhD, president and CEO of the Natural Products Association, supported the FDA’s move. He said: “These 7-OH products are not legitimate ‘dietary supplements’ and NPA encourages FDA in collaboration with the U.S. Department of Justice to take any necessary steps to swiftly remove them from U.S. commerce.”

Robert Durkin, partner at law firm Amin Wasserman Gurnani and co-chair of its regulatory group, questioned the delay in action: “Even in the 7-OH warning letters, FDA mention Kratom. Fact is, 7-OH is not Kratom... Saying 7-OH is Kratom is like saying if someone took coffee beans, brewed a pot of coffee, extracted the caffeine, converted it into something else and then called it coffee.”

Products and companies targeted

The FDA flagged concentrated forms of 7-OH, including:

• Tablets
• Gummies
• Drink mixes
• Liquid shots

One letter was addressed to the CEO of Kansas City-based Shaman Botanicals, citing illegal marketing of 7-OK branded products. The letter stated: “Your product labeling... declares 7-hydroxymitragynine (7-OH) as an ingredient... introducing or delivering these products... violates the Federal Food, Drug and Cosmetic Act.”

Other companies receiving warnings include:

• My Smoke Wholesale
• Relax Relief Rejuvenate Trading, LLC (dba RRR Trading or EDP Kratom)
• Thang Botanicals, Inc. (dba multiple 7-OH-related names)
• Royal Diamond Imports, Inc. (dba Roxytabs.com)
• 7Tabz Retail, LLC

The FDA also previously warned Hydroxie, LLC for marketing its 7-OH drink mix as a dietary supplement. The agency found:

• The drink mix is an unsafe food additive;
• The company’s website promoted disease-related claims, classifying the products as unapproved drugs.

Examples of user testimonials included relief from fibromyalgia, multiple sclerosis, and chronic pain.

A call for regulation over prohibition

Jeff Smith, national policy director for the nonprofit HART, argued that the focus should be on responsible regulation: “We are not asking the FDA to take our word for it. We are asking the agency to consider the data.”

According to HART:

• Roughly 1 million Americans use 7-OH monthly.
• FDA’s adverse event database shows no confirmed deaths from 7-OH alone and just three serious incidents.
• Over 200 deaths have been associated with Kratom products over the same period.

Smith added: “Emerging data strongly suggests that 7-OH, when produced and used responsibly, has a significantly lower risk profile than many Kratom products that are not being targeted by the FDA.”

Synthetic versus natural Kratom

While 7-OH is found in trace amounts in natural Kratom leaves from Southeast Asia, synthetic forms are much more potent. According to Paula Brown, director at BCIT’s Natural Health and Food Products Research Group:

• Synthetic 7-OH can be up to 30 times stronger than morphine at opioid receptors;
• This significantly increases the risk of addiction and overdose.

Industry leaders urge action

Matthew Lowe, executive director of the Kratom Coalition, applauded the crackdown: “There’s been a slew of consumer issues... people being tricked into thinking it’s natural Kratom, developing intense addictions... it’s always been our contention that these products have been unapproved drugs.”

Dr Sibyl Swift, PhD, chief science officer at Johnson Foods, echoed the sentiment: “These products are derived from synthetic processes with no benefit and a tremendous potential to harm consumers. FDA’s actions are a welcome step toward protecting consumers.”

Next steps

The companies named in the warning letters have 15 days to respond and address the alleged violations. As the FDA intensifies its oversight, debate continues over how best to regulate synthetic substances masquerading as natural supplements.