A new New York State Department of Health regulation, which does not approve kava as a food additive, is forcing kava bars across the state — including Sacred Root Kava Lounge & Tea Bar in Ithaca — to stop the sale of traditional kava drinks.
Kava, a shrub native to the South Pacific, has been used by Pacific Islanders to promote physical relaxation for medicinal and ceremonial purposes. In the U.S., kava is sold in both supplements and as a traditional drink, such as in tea bars.
In an email to The Sun, Prof. Giulia Friso, plant biology, who teaches “Medicinal Ethnobotany,” explained the properties of kava and its effects on the human body.
“Kavalactones are the primary bioactive compounds in kava and are responsible for most of its effects on the human body,” Friso wrote in an email to the Sun.
Friso further explained the various ways kavalactones affect the brain and body. Kavalactones increase the activity of gamma-aminobutyric acid, a calming brain chemical, leading to feelings of relaxation. They also boost levels of mood-related chemicals like dopamine and norepinephrine by possibly preventing their breakdown, which may improve mood and lower anxiety. Kavalactones can also block certain signals linked to pain such as sodium and calcium channels, potentially offering mild pain relief.
However, Friso said that users should exercise caution when consuming kava.
“While kava may be effective in reducing anxiety and promoting relaxation, it should be used cautiously, especially in high doses or with alcohol, as it may have hepatotoxic effects if misused,” Friso wrote.
Hepatotoxic effects are a “medical term for liver damage caused by a medicine, chemical, or supplement (herbal or dietary),” according to the National Institutes of Health.
Friso noted that the way kava is processed or consumed can significantly impact its safety.
“Traditional kava preparation is generally safer because it uses just the root, and people know how to prepare it properly,” Friso wrote in an email to the Sun. “Kava extracts, especially in the Western world, can be riskier as they may contain additives, use the wrong parts of the plant, or contain chemicals from pesticides or contaminated soil, like heavy metals. Extracts are also more concentrated, which increases the risk of side effects like liver issues if taken in excess.”
However, the new NYSDOH regulation largely targets traditional forms of kava. The regulation follows a 2020 review by the U.S. Food and Drug Administration, which raised concerns about the safety of kava as a food additive. As a result, food establishments are prohibited from selling kava drinks, as traditional kava preparations are considered an unapproved food additive.
The FDA report cited the potential health risks of kava including liver damage such as hepatitis, an inflammation of the liver and cirrhosis, a chronic liver disease that occurs when scar tissue replaces healthy liver tissue. Based on these concerns, the FDA concluded that kava is not generally recognized as safe for human consumption, meaning that kava was deemed not “adequately shown to be safe under the conditions of its intended use.”
Paul Galgoczy, founder and co-owner of Sacred Root Kava Lounge & Tea Bar, noted that many in the Ithaca community are frustrated by the state’s decision, arguing that it unfairly targets kava while more harmful substances remain legally accessible.
“In online [and] in conversations about it, the reaction seems so consistent, which people are saying, ‘This is absolutely absurd. Alcohol is legal and so many more obviously known to be harmful [substances] are allowed to be used, while something like this, which in its natural form, has so much positive impact on the people that use it, is being restricted,’” Galgoczy said.
New York Assemblywoman Anna Kelles (D-125th District), a former Cornell professor in nutritional science, said that she is aware of the challenges that Sacred Root and other kava bars across the state are facing and attributed the state’s regulations on kava to a deeper, systematic issue within the FDA.
“The FDA does not have the money or the personnel to be an entity that scientifically evaluates a food additive before it goes to market or evaluates it regularly over time,” Kelles said.
Due to limited resources, the FDA allows food industries to self-regulate, letting them decide which substances are generally recognized as safe and approved as food additives — often based on data that the FDA does not review, according to a study published in American Journal of Public Health.
“[The FDA] depends 100 percent on the food additive chemical companies themselves to do all the research,” Kelles said. “We don't know what's in our food. There is no transparency whatsoever.”
Kelles said that the FDA’s reliance on research from the food industry has left traditional kava under-researched, as companies lack the profit incentive to invest in extensive studies on its safety as a food additive.
“[The regulation is] only on food additives and not supplements [and] the supplements are where they're making all their money,” Kelles said. “So why would they put all of their money to do a pre-market analysis for something that is a food additive, that maybe not that many people would buy, except for buying kava tea?”
Although efforts to strengthen FDA regulations advanced in June 2023 with Rep. Jan Schakowsky’s (D-IL) introduction of the Food Chemical Reassessment Act — which requires routine safety reviews of additives — Kelles explained that recent mass firings of federal employees under the Trump administration has exacerbated existing weaknesses within the agency and jeopardized reform efforts.
FDA Deputy Commissioner for Human Foods Jim Jones’ resigned on Feb. 17, citing that the “indiscriminate” layoffs of 89 employees in the Human Foods Program made his efforts to reform the agency “fruitless.”
With the under-resourced FDA and lack of outside research, Kelles argued that the safety assessment of kava is outdated and incomplete.
“The FDA did a perusal of the existing research, [since] they do not have the ability to do a comprehensive analysis, [and] determined [that] it wasn’t eligible to be approved for GRAS — and no one attempted to put it through the pre-market review,” Kelles said. “It isn't that [kava is] proven unsafe, but rather, a [comprehensive] analysis hasn't been done and therefore it's defaulted to simply not being approved by this generally recognized as safe process.”
Friso echoed Kelles’ sentiment on the need for more research on kava.
“Scientific evidence on kava’s safety is still evolving, and many studies suggest that when kava is properly prepared and consumed in moderation, it can be safe,” Friso wrote in an email to The Sun. “Given the complexity of kava’s effects and the variability in how it's consumed, further research is needed to better understand the risks and benefits and to ensure that regulations are based on comprehensive, evidence-driven findings.”
Kelles said she is currently working to fill the regulatory gap of the FDA at a state level, especially given the recent layoffs in the FDA.
“States need to evaluate how we are relying on federal departments and agencies’s guidelines, recommendations and approval processes,” Kelles said. “I'm just in the beginning of evaluating this process … to see if we can create something that is more nuanced so that we aren't hurting businesses unduly.”
Taehee Oh can be reached at to242@cornell.edu.
