A newly-established research organization is drawing attention to the growing public health concerns associated with 7-hydroxymitragynine (7-OH), sometimes referred to as synthetic Kratom.

The Scientific Association for Botanical Education and Research (SABER) is a non-profit organization made up of scientists from institutions across the United States and Canada who focus on research related to Kratom, the common name for a tree species native to Southeast Asia.

While 7-OH occurs naturally at low levels in Kratom leaves, chemical manipulation of the plant’s alkaloids can substantially increase its concentration. Over the past year, there has been a noticeable rise in the sale of synthetic products containing high levels of 7-OH, available through convenience stores and online retailers.

“Synthetic 7-OH is up to 30 times more potent than morphine at opioid receptors, significantly increasing the risk of dependence and overdose,” said Dr Paula Brown, director of the BC Institute of Technology’s Natural Health and Food Products Research Group (NRG) and a member of SABER’s steering committee.

“Synthetic 7-OH is not Kratom - it is a highly potent, unregulated chemical,” she added. “Consumers deserve transparency, yet these products are often mislabeled and deceptively marketed as natural extracts. Without proper quality and safety testing, they pose a significant risk to public health.”

Last year, the FDA concluded a pilot study examining Kratom, in which participants received doses ranging from 1g to 12g. Researchers monitored participants’ blood pressure, pulse, respiratory rate and body temperature to assess adverse effects.

“The FDA study that used our Kratom found it was generally well-tolerated, even at doses higher than what we would typically recommend,” said Ken Loricchio, co-founder of a leading American Kratom supplier. “While we understand the FDA’s concerns, the study underscores Kratom’s potential for responsible use when sourced and used properly. Like many foods and supplements, Kratom can carry risks if misused.”

Loricchio emphasized the need for continued education of lawmakers about Kratom and the importance of clear product labeling.

“Many lawmakers are still basing decisions on outdated information from 2012, which wrongly compared Kratom to bath salts,” he said. “We’ve seen a trend toward more sensible regulation as advocacy groups educate policymakers. For example, there have been no new state bans in recent years, and we expect that existing bans could eventually be reversed in favor of regulated markets.”

Some stakeholders advocate for kratom to be regulated as a dietary supplement; others, like the American Kratom Association, campaign for regulation to protect Kratom, its consumers and suppliers. However, the FDA maintains a different view. The agency warns that 7-OH products can cause sedation, nausea and vomiting, constipation, physical dependency and withdrawal, as well as respiratory depression that can be fatal.

In a statement, the FDA said, “Kratom is not appropriate for use as a dietary supplement. FDA has concluded that from available information, including scientific data, 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. Therefore, dietary supplements that are or contain Kratom are adulterated under section 402(f)(1)(b) of the FD&C Act.”

Loricchio noted that the presence of synthetic Kratom products began increasing noticeably in the marketplace last year.

Researchers have pointed out that “7-OH product marketing fails to distinguish itself from Kratom. Kratom-naive consumers purchasing 7-hydroxymitragynine products may mistakenly believe they are relatively safe, natural products similar to traditional Kratom, which has been used in the United States for at least two decades.”

SABER aims to counter this misinformation.

“Our mission is to protect legitimate nootropic products from being associated with harmful substances - we view any adulterated product as a public health threat,” said Thomas Brendley, a scientist, regulatory consultant and member of SABER’s steering committee.

“The academic and scientific leaders of SABER are among the foremost experts on botanical products worldwide,” said Matthew Lowe, executive director of the Global Kratom Coalition, an organization not affiliated with SABER. “Specific to Kratom, it is essential that regulation at both the state and national level in the USA is grounded in science. High-concentration isolate products have recently become available, are mislabeled as Kratom, and are being falsely marketed as dietary supplements.”