After the Food and Drug Administration announced a crackdown on kratom-based products, at least one company says its items are safe and should remain legal.
Botanic Tonics, which makes Feel Free shots that can be added to smoothies, juices, and other drinks, says its products are not impacted by the FDA's announcement. The FDA stated it is focusing on synthetic 7-OH, not natural kratom leaf products.
Botanic Tonics claims its products contain natural leaf kratom and would not be affected by a nationwide ban. The company states its products "provide mood lift, chilled energy, and enhanced focus."
Company leaders say they welcome efforts to regulate synthetic 7-OH products.
RELATED STORY | US health officials crack down on kratom-related products
"Our products contain trace amounts of 7-OH that occur naturally during the traditional drying process — levels that are dramatically different from the concentrated synthetic products now under FDA scrutiny," said Cameron Korehbandi, CEO of Botanic Tonics. "The difference between natural leaf kratom and synthetic 7-OH concentrates represents a night-and-day distinction in terms of safety and consumer protection."
The FDA stated in July that "7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors."
Federal regulators say these products are being sold more often in convenience stores and markets.
"Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again," said FDA Commissioner Marty Makary. "7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic."
What is 7-OH?
According to the FDA, 7-OH is present in some products in amounts far exceeding its natural levels in the kratom plant.
The FDA states that "kratom has been used to treat headaches, diarrhea, insomnia, anxiety, opioid use withdrawal, and more, while in recreational use cases, it has been associated with feelings of euphoria." However, the FDA has not approved any medicines that use kratom leaves.
Additionally, the Mayo Clinic has issued warnings on kratom-based products. The Mayo Clinic noted that "kratom sellers add more of the active ingredient than kratom naturally has."
"Depending on the amount of active ingredient in the product and the health of the user, taking kratom can be harmful. There are too few studies to be able to rate the claims about the benefits of kratom," the Mayo Clinic said.
