Garcinia gummi-gutta (L.) N. Robson—more commonly known as Garcinia cambogia and native to South and Southeast Asia—has been increasingly linked to adverse events and case reports of liver injury. Used for centuries as a culinary ingredient to provide acidity and in traditional medicine to address stomach complaints, it was not until researchers in the 1960s identified hydroxycitric acid—the compound thought to affect fat metabolism—that Garcinia was associated with weight loss.
By the diet culture boom of the 1990s and 2000s, a recently formalized U.S. dietary supplement industry began harnessing this discovery, incorporating Garcinia extracts into products marketed for weight management and fat burning. The spike and market saturation, however, occurred after the 2012 airing of a Dr. Oz Show episode titled “The Newest, Fastest Fat Busters” which presented Garcinia cambogia as a revolutionary weight loss solution.
A claim displayed on screen read: “No Exercise. No Diet. No Effort”.
Mounting regulatory actions
In February 2025, French food safety regulator ANSES issued the strongest public health warning against Garcinia cambogia to date following a case of fatal fulminant hepatitis and several other cases of serious side effects reported to its nutrivigilance system. The agency advised consumers not to consume food supplements containing the extract due to reports of severe adverse effects including acute hepatitis, cardiac, digestive, psychiatric and muscle problems.
A 69-page scientific opinion accompanying the advisory detailed 38 adverse events linked to Garcinia between 2009 and early 2024. Of these, the agency found that 18 had sufficient data for analysis, with the level of causality ranging from “possible” to “very plausible” for many cases. Several serious events (e.g., pancreatitis, significant liver injury, cardiovascular disturbances) were reported in otherwise healthy individuals.
While the ingredient has been banned in medicinal preparations in France due to lack of proven therapeutic benefits and safety concerns since 2012, a ministerial order dated April 15, 2025 suspended the importation, marketing and sale of food supplements containing Garcinia cambogia for one year from date of issue. This measure requires withdrawal of some 340 products on the French market and mandates consumer recalls.
The ban also signals potential regulatory shifts across Europe, particularly as the European Food Safety Authority (EFSA) is conducting an ongoing safety risk assessment of hydroxycitric acid (HCA) derived from Garcinia cambogia.
“This assessment could lead to restrictions or even a ban on this substance and plant preparations containing it, including Garcinia cambogia Desr.,” ANSES stated in its press announcement. “Beyond the specific case of Garcinia cambogia Desr., ANSES emphasizes the need to harmonize, at the European level, lists of plants, parts of plants, uses and authorized doses in food supplements, as well as restrictions and warnings governing their use.”
The United Kingdom’s Committee on Toxicity is also actively reviewing Garcinia safety, calling for more data at its October 2025 meeting to form final conclusions on safety and manufacturing processes.
Several Asian-Pacific countries have published advisories on Garcinia-containing products, citing liver toxicity, urticaria, abdominal pain and menstrual cycle disruption as adverse events.
South Korea introduced new precautionary statements and usage warnings on Jan. 7, 2025, requiring manufacturers to include label messaging advising against combining Garcinia with functional foods that reduce body fat. It has also amended Ministry of Food and Drug Safety standards to prohibit Garcinia extract from being mixed with other body‑fat‑reducing functional ingredients during manufacturing to reduce overlapping effects and potential adverse events. Following two cases of acute hepatitis reported in August, South Korea announced that Garcinia supplements must now carry an additional label warning stating that “in rare cases, it may cause harm to the liver, and alcohol consumption should be avoided during intake” due to the significant interaction. The recommended daily intake was also reduced from a maximum of 2,800 mg/day to 1,500 mg/day.
As of March 1, Australia will require that complementary medicines containing Garcinia cambogia and other HCA‑containing ingredients include warnings about liver harm risks on their labels as part of increased safety oversight. The country has cancelled multiple listed products formulated with Garcinia from the Australian Register of Therapeutic Goods over the years and issued a safety advisory in August 2024 after reviewing the evidence of rare but potentially serious liver injury events.
“Garcinia gummi-gutta and Garcinia quaesita are permitted for use in listed (complementary) medicines in Australia,” said Avinash Clarke, assistant secretary of complementary and OTC medicines at the Therapeutic Goods Administration (TGA). “The requirements for inclusion of these ingredients are outlined in a Permissible Ingredients Determination. These include mandatory label warning statements related to very rare cases of liver harm and that medicines containing these ingredients must not be directed for use in children, or in pregnant or lactating women.”
In other jurisdictions, such as Singapore, regulatory agencies have issued public warnings about Garcinia products found to contain undeclared, banned or harmful substances such as sennusides and sibutramine, leading to enforcement actions and potential penalties.
While there is no outright ban in the United States, public health notification have flagged safety concerns like liver toxicity and contamination with undeclared drugs. In headline-making news in 2009, the Food and Drug Administration (FDA) requested the recall of 14 Hydroxycut-branded weight loss products after numerous reports of liver injury were linked to its Garcinia content, although the combination formula also included high-dose EGCG. At the time, the brand was among the most popular weight-loss supplements, with over nine million units sold in 2008. Iovate, the Canadian manufacturer of Hydroxycut, reformulated the range shortly thereafter with ingredients including caffeine, Lady’s mantle, wild olive and green coffee bean extract.
More recently, Garcinia cambogia has been included in the list of ingredients targeted by restrictive state bills or laws that affect the sale of weight‑loss and muscle-building supplements to minors. New York State is the only state so far to have enacted the ban, which took effect in April 2024.
What the science says
The first significant, randomized clinical trial on Garcinia cambogia (HCA) for weight loss in humans was published in JAMA in 1998. Completed in 84 adults over a 12-week period, it reported that 1,500 mg of HCA per day “failed to produce significant weight loss and fat mass loss beyond that observed with placebo,” despite initial excitement from animal studies in the 1970s.
While extracts have shown potential mechanisms for weight loss, the U.S. National Center for Complementary and Integrative Health determined that more research is needed to confirm any effects. The center, however, does highlight liver damage, headaches, nausea and diarrhea as potential side effects of Garcinia cambogia extracts consumed in isolation or in multi-ingredient products. It also cautions against herb-drug interactions.
Noting the rise in adverse event reporting, the United States Pharmacopeia (USP) recently updated its review of preclinical and clinical evidence on Garcinia toxicity, determining that it was consistent with drug-induced liver injury. This latest review, published in the journal Pharmaceutical Biology, identified more than 200 adverse events of liver injury resulting from Garcinia consumption. including a total of 34 case reports of Garcinia hepatotoxicity, one death and nine liver transplants. Of these, 17 received RUCAM scores indicating causality ranging from possible to highly probable for Garcinia dietary supplements. In one case, the researchers reported that causality was further confirmed through rechallenge.
“USP initially evaluated safety of Garcinia cambogia in January 2009 and updated the review in 2017,” said Kit Goldman, senior director of dietary supplements and herbal medicines at USP. “However, after 2017, numerous cases of liver injury correlated with use of Garcinia cambogia products were reported, and the Dietary Supplement Admission Evaluation and Labeling Expert Committee reviewed the additional information and determined that while the adverse events were rare, due to their severity, a cautionary label was recommended on the ingredient.”
The new cautionary label, added to the monograph in 2024, reads: “Do not use if you have a liver problem; discontinue use and consult a healthcare practitioner if you develop symptoms such as abdominal pain, dark urine, or jaundice (yellowing of the skin or eyes).”
USP, which has established detailed quality standards for supplements since the 1990s, publishes summaries of all the completed admission evaluations for dietary ingredients in the Dietary Supplement Compendium, which may be used as reference for product development.
Commenting on the review, Rick Kingston, co-founder of SafetyCall International, which specializes in managing adverse event reporting for healthcare and consumer products, called the findings a good summary of the available hepatic adverse events found in anecdotal case reports and other databases including FDA’s Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS).
He also highlighted several potential confounders that could distort the conclusions, including the lack of corroborating information such as specific products, dosage and comorbidities; the absence of a definition for the diagnosis of liver damage—particularly the liver function test (LFT) thresholds required to support diagnosis; and failure to consider the ratio of reports to actual use.
“The challenge in characterizing the level of risk consumers might be assuming when using these products would depend on knowing not only the numerator but also the denominator and relative incidence rates compared to sales or consumption,” he said. “Despite the likely safety signal, one or two reports per year may not be that significant if millions or billions of servings are concomitantly consumed annually.”
He also noted that if the relative normalized incidence rates are extremely low, “idiosyncratic reactions or autoimmune issues associated with HLA allele mutations are likely a significant contributing factor as alluded to by the authors” and that elevated LFTs can occur in 15% to 20% of the general population independent of product use.
“Sorting out or ruling out that background noise would help identify unique populations that might be affected,” he said, calling for prospective studies to monitor these types of cases and collect key data necessary to address causation.
‘Not a free pass for Garcinia, but science-based differentiation’
Industry leaders such as Sabinsa argue that regulatory actions often fail to distinguish between high-quality, clinically tested extracts and commodity products. They call for the adoption of science-based standards that reward quality and evidence, rather than blanket bans that, in this case, treat Garcinia cambogia, as an undifferentiated category.
According to Shaheen Majeed, global CEO and managing director of Sabinsa, while category-wide restrictions may protect consumers from problematic products, they overlook the substantial clinical evidence supporting properly manufactured ingredients like Sabinsa’s Citrin line. He highlighted that Citrin has 30 years of safe use backed by extensive human clinical trials, even among users with pre-existing conditions taking multiple prescription medications, including antihypertensives, statins and antidepressants, with comprehensive monitoring showing no drug interactions or liver enzyme elevations.
Citrin-branded extracts, first launched in 1994 and today sold in more than 50 countries, are standardized to stable salt forms (rather than the unstable free acid) containing 50% to 60% free hydroxycitric acid (HCA) and less than 1% to 2% lactone since lactone content may influence toxicity profiles. Every batch undergoes comprehensive HPLC, heavy metals, microbial and pesticide testing.
Regarding efficacy, Majeed acknowledged that results vary across studies—“reflecting the complex, multifactorial nature of weight management”—but that Sabinsa’s clinical trials have demonstrated statistically significant reductions in body weight and favorable lipid profile changes, with optimal results typically seen at 2,800 mg HCA daily as part of a comprehensive weight management program.
“Our standardization approach differs fundamentally from commodity suppliers: We use pharmaceutical-grade extraction processes, maintain complete traceability from fruit sourcing through final product and can provide full analytical profiles including identification of all plant constituents, not just HCA content,” he said. “This level of characterization is essential for safety assessment but unfortunately not outlined by current regulations, creating a market where high-quality and low-quality products appear equivalent to consumers.”
Majeed added that although the risk of hepatotoxicity appears to be rare and idiosyncratic, it is sufficiently documented to justify precautions for individuals with pre-existing liver conditions, as well as guidance on recognizing relevant symptoms. The USP language, he noted, is similar to warnings used for many pharmaceuticals and other dietary supplements, such as high-dose green tea extracts, and that it appropriately balances consumer protection with continued access.
In response to what he describes as “the most significant scrutiny of Garcinia cambogia in three decades”, surpassing previous market disruptions including the 1998 JAMA study and the Hydroxycut hepatoxicity cases, Majeed emphasized that “this situation powerfully illustrates why quality standards matter in the dietary supplement industry.”
“Let me be clear about what we’re asking from regulators: not a free pass for Garcinia, but science-based differentiation,” he said. “If a supplier has 30 years of safe marketing, 100+ subjects in clinical trials with no hepatotoxicity, comprehensive toxicology studies, GRAS affirmation and pharmaceutical-grade manufacturing, that should be evaluated differently than an unknown product with no safety data.”
He called for a regulatory framework to create incentives for companies to invest in clinical research and quality systems and suggested that enhanced labeling combined with quality standards that differentiate between evidence levels may better serve public health than categorical prohibitions that eliminate access for the vast majority of users who experience no adverse effects.
