Liver Injury from Supplements
Almost everything you swallow passes through the liver, and the liver does not care whether the label says "prescription" or "herbal". In the US Drug-Induced Liver Injury Network, the share of serious liver injuries caused by herbal and dietary supplements rose from about 7% to about 20% in a decade, and the injuries from non-bodybuilding supplements were more likely to end in a transplant or a death than injuries from medicines. This page explains why that is, which ingredients carry the strongest records, what the public regulatory record actually says about the best-known brand names, how liver injury shows up, and exactly what to do if you suspect it.
Table of Contents
- 1. The Scale of the Problem
- 2. Why Supplement Injury Is Often Worse
- 3. Two Patterns: Bodybuilding Products and Everything Else
- 4. Green Tea Extract and EGCG
- 5. OxyELITE Pro and the 2013 Hawaii Outbreak
- 6. Hydroxycut and the 2009 Recall
- 7. Kava
- 8. Pyrrolizidine Alkaloids, Older Records and Newer Names
- 9. "It's Natural, So It's Safe"
- 10. How Liver Injury Shows Up
- 11. Who Is at Higher Risk
- 12. What to Do
- 13. The Honest Bottom Line
- Research Papers
- Connections
- Featured Videos
1. The Scale of the Problem
The best data in the United States come from the Drug-Induced Liver Injury Network (DILIN), a group of referral centres funded by the National Institutes of Health that has enrolled patients with serious liver injury since 2004. Between 2004 and 2013, 130 of the 839 patients enrolled (15.5%) had liver injury attributed to a herbal or dietary supplement rather than a medicine, and the supplement share of cases rose from 7% at the start of the period to 20% at the end (Navarro 2014). By the time the network's investigators wrote their 2017 review, supplements accounted for about one in five cases of hepatotoxicity in US research data, with anabolic steroids, green tea extract and multi-ingredient nutritional products the main culprits (Navarro 2017).
Those are referral-centre numbers: injuries serious enough to reach a liver specialist. Nobody knows the national total, because there is no registry and reporting is voluntary. What is known is how many people are exposed. In the nationally representative NHANES survey of 2017–2020, an estimated 15.6 million US adults had taken at least one of six botanicals with a documented liver record in the previous 30 days: turmeric or curcumin, green tea extract, ashwagandha, Garcinia cambogia, red yeast rice and black cohosh. That is about as many people as take simvastatin or a non-steroidal anti-inflammatory drug. Users were older, better educated and more likely to have arthritis than non-users, and most said they took turmeric or green tea "to improve or maintain health" (Likhitsup 2024).
Two things should be said plainly. Most people who take these products are not harmed; the injury is unpredictable and, for most ingredients, uncommon. And a second kind of supplement harm, the heart-rate and blood-pressure effects of stimulant weight-loss and energy products, is a separate story told on its own page: Stimulants in Weight-Loss and Energy Products.
2. Why Supplement Injury Is Often Worse
The DILIN comparison is stark. Among the non-bodybuilding supplement cases, 13% ended in death or liver transplantation, against 3% of the injuries caused by medicines (Navarro 2014). Hepatologists' explanation comes down to a few practical facts, the first of them documented by the network itself (Navarro 2017) and the last by product analysis (Stolz 2019):
- Most cases involve multi-ingredient products, and the component responsible is usually unknown or can only be suspected. A medicine is one named molecule at a known dose; a "fat burner" is a proprietary blend.
- Nobody is watching. A doctor who prescribes a drug known to stress the liver checks liver enzymes. A supplement arrives with no one assigned to notice.
- People do not think of a supplement as a drug, so early symptoms are not connected to it, the product is not mentioned to the doctor, and it is often still being taken when the patient reaches hospital.
- Doses and contents vary. Extract strength differs between brands and batches, and some products contain ingredients that are not on the label at all.
An analogy: a prescription is a key with a name on it. A multi-ingredient supplement is a bag of unlabelled keys, and when one of them turns out to be the wrong key, nobody can tell which.
3. Two Patterns: Bodybuilding Products and Everything Else
Liver injury comes in two broad shapes, and it helps to know both because they look and behave differently.
Hepatocellular injury is hepatitis-like: the liver cells themselves are damaged, the enzymes ALT and AST rise steeply, and the person feels unwell, nauseated and exhausted. Cholestatic injury is a bile-flow problem: bile backs up, the enzyme ALP and bilirubin rise, the skin turns yellow, and the itching can be relentless. Mixed pictures exist, and cholestatic injury tends to be slower to clear.
Bodybuilding products produce the cholestatic pattern. In DILIN's first decade these cases were young men who developed prolonged jaundice, a median of 91 days, but none of them died or needed a transplant (Navarro 2014). A later DILIN series of 44 men (mean age 33) found a median of 73 days from starting the product to the injury; every one of them was jaundiced, 84% itched, 71% were admitted to hospital, and again none died or needed a transplant. Chemical analysis of the products found anabolic steroids, controlled substances, that were not listed on the label (Stolz 2019). Recovery is the rule, but it is slow and miserable, and it is often caused by a drug the buyer never knew he was taking. That labelling problem has its own page: Hidden Prescription Drugs in "Natural" Supplements.
Everything else, the weight-loss blends, green tea extract, turmeric and the rest, produces the hepatocellular pattern, more often in middle-aged women, and this is the group with the 13% death-or-transplant rate (Navarro 2014). The rest of this page is mostly about that group.
4. Green Tea Extract and EGCG
A cup of brewed green tea is not the concern. The concern is the concentrated extract, standardised to the catechin EGCG, that goes into weight-loss and "metabolism" capsules. The European Food Safety Authority reviewed the evidence in 2018 and separated the two clearly: catechins from traditionally prepared green tea infusions are in general considered safe (rare idiosyncratic cases of liver injury have been reported even with tea), whereas for food supplements there is evidence from clinical trials that EGCG doses of 800 mg per day or more produce a statistically significant rise in serum transaminases, the earliest laboratory sign of liver damage; the panel could not identify a safe supplement dose (EFSA 2018).
The United States Pharmacopeia's expert panel, which included DILIN hepatologists and an FDA liaison, reached similar conclusions in 2020. Published cases of liver injury involved EGCG intakes from 140 mg to about 1,000 mg per day, with substantial person-to-person variability that may be genetic. The injury pattern is hepatocellular. One mechanism matters for anyone who takes the capsules: repeated bolus doses on an empty stomach significantly increase the absorption of EGCG, possibly by saturating the liver's first-pass clearance, so the same capsule taken fasting delivers more to the liver than the same capsule taken with food. USP therefore added a cautionary label to its green tea extract monograph: "Do not take on an empty stomach. Take with food. Do not use if you have a liver problem and discontinue use and consult a healthcare practitioner if you develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice" (Oketch-Rabah 2020).
Practical reading of a label: find the milligrams of EGCG (or "catechins") per serving and multiply by the servings per day. A "fat burner" that stacks green tea extract with several other liver-active ingredients is the combination hepatologists are most wary of. The herb itself is profiled at Green Tea, and the NIH LiverTox monograph is here.
5. OxyELITE Pro and the 2013 Hawaii Outbreak
On 9 September 2013 the Hawaii Department of Health was notified of a cluster of acute hepatitis and fulminant liver failure in people taking the weight-loss and muscle-building product OxyELITE Pro. Liver specialists at The Queen's Medical Center in Honolulu described the cluster of severe hepatitis cases (Roytman 2014). The state investigation, run with the CDC and FDA, reviewed 76 reports; 44 met the case definition, and 36 of those (82%) had taken OxyELITE Pro in the two months before falling ill. Among the exposed patients two needed a liver transplant and a third died. No one reported taking more than the label directed. The consumed products matched their labelled ingredients, and the mechanism of injury was never identified (Johnston 2016). Nationally, FDA's count was 97 people with acute non-viral hepatitis, 72 of whom reported using an OxyELITE Pro product; at least 47 were hospitalised, at least 3 received a liver transplant, and one died (FDA 2014 report to Congress).
The product implicated was a reformulation. In early 2013 the manufacturer replaced the stimulant DMAA with aegeline, an alkaloid from the bael tree, without submitting the "new dietary ingredient" notification the law requires for an ingredient not sold in the US before October 1994. FDA's laboratory found no drugs, toxic metals, pyrrolizidine alkaloids, usnic acid or aristolochic acid in the product (Klontz 2015). On 11 October 2013 FDA issued a warning letter stating that OxyELITE Pro and VERSA-1 were adulterated because they contained aegeline without the required notification; on 6 November it wrote to the company about the Hawaii link; the company recalled the products on 9 November and expanded the recall on 19 November (FDA 2014 report to Congress). The earlier DMAA formulation belongs to the stimulant story on the weight-loss stimulants page.
The Department of Justice record, stated as the record states it: on 17 November 2015 an 11-count indictment was unsealed against USPlabs LLC, S.K. Laboratories Inc. and several officers. The indictment alleged that ingredients were imported from China under false certificates of analysis, that retailers were told the products contained natural plant extracts when they contained a synthetic stimulant, that products were sold without determining whether they were safe, and that after telling FDA in October 2013 it would stop distributing OxyELITE Pro the company tried to sell as much as it could. In February and March 2019 the two companies and five individuals pleaded guilty to felony misbranding charges (conspiracy to introduce misbranded food into interstate commerce, or introducing misbranded food with intent to defraud or mislead) and agreed to fines and forfeitures of about $60 million; the misbranding charges related in part to OxyELITE Pro. In October 2020 the former chief executive was sentenced to 60 months in prison and the former president to 24 months, with USPlabs ordered to forfeit $4.7 million and S.K. Laboratories $6 million. The guilty pleas were to misbranding; no plea concerned the liver injuries themselves.
The lesson is the uncomfortable one. Here was a product with no hidden drug, no contaminant, and ingredients that matched the label, and it still put people on the transplant list. A clean label is not the same thing as a safe product.
6. Hydroxycut and the 2009 Recall
On 1 May 2009 FDA warned consumers to immediately stop using Hydroxycut products made by Iovate Health Sciences of Oakville, Ontario. The agency had received 23 reports of serious health problems "ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant", and one death due to liver failure. Iovate agreed to recall 14 listed products. Two sentences from the notice matter most: "Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle", and "The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products" (FDA 2009).
A DILIN case series filled in the clinical picture: eight patients treated at different centres, all hospitalised, three of whom needed a liver transplant, plus nine further cases with adequate records from the FDA MedWatch database, one of them a fatal acute liver failure. The pattern was mostly hepatocellular, and the usual symptoms were jaundice, fatigue, nausea, vomiting and abdominal pain (Fong 2010). Products are still sold under the Hydroxycut name; the 2009 action concerns the 14 products listed in the recall, and the ingredient responsible was never identified.
7. Kava
Kava (Piper methysticum) is a Pacific-island root taken for anxiety and sleep. On 25 March 2002 FDA issued a consumer advisory stating that kava-containing products had been associated with liver-related injuries, including hepatitis, cirrhosis and liver failure, in more than 25 adverse-event reports from other countries, four of which required a liver transplant, and that in the US a previously healthy young woman had needed a transplant, alongside several other reports of liver injury. The advisory told people with liver disease, or taking medicines that affect the liver, to consult a physician before using kava, and told anyone with jaundice, brown urine, nausea, vomiting or abdominal pain to seek medical attention (FDA 2002). Kava is still legally sold in the US. The full profile, including the traditional-preparation and extract questions, is at Kava; the LiverTox monograph is here.
8. Pyrrolizidine Alkaloids, Older Records and Newer Names
Comfrey (Symphytum) contains pyrrolizidine alkaloids, which the liver's cytochrome P450 enzymes convert into highly toxic pyrrole metabolites that damage the small veins inside the liver. The result is sinusoidal obstruction syndrome, once called hepatic veno-occlusive disease: pain under the right ribs, nausea and weight gain from fluid retention, then jaundice; it can move rapidly to acute liver failure, though more often it creeps in with fluid in the abdomen and weakness (LiverTox: Comfrey). In a letter of 6 July 2001, FDA described pyrrolizidine alkaloids as "firmly established" liver toxins in animals, noted that outbreaks of hepatic veno-occlusive disease had been reported in other countries and that the toxicity of these substances in humans "is generally accepted", and strongly recommended that firms remove comfrey and any other pyrrolizidine-alkaloid product from the market and tell customers to stop using it (FDA 2001). Oral comfrey is now restricted or banned in most countries. Swallowing comfrey, as a tea, capsule or "internal" tonic, is the problem; the herb's profile and the separate question of skin ointments are at Comfrey.
Chaparral (creosote bush, Larrea tridentata), once sold for everything from skin rashes to cancer, has been linked to several cases of clinically apparent liver injury, some progressing to acute liver failure and emergency transplantation (LiverTox: Chaparral). Germander (Teucrium), marketed in Europe in the late 1980s as 600 mg weight-loss capsules, produced multiple reports of severe and sometimes fatal liver injury from both capsules and tea, which led to bans in many countries (LiverTox: Germander). Neither should ever be taken by mouth.
The newer names are more surprising because they are household ones. DILIN found ten cases of turmeric-associated liver injury, all enrolled since 2011 and six since 2017; eight were women, the injury was hepatocellular in nine of the ten, five were hospitalised and one died of acute liver failure. Three of the seven products tested also contained piperine (black pepper extract), which is added to boost curcumin absorption. Seven of the ten patients carried the gene variant HLA-B*35:01, an allele frequency of 0.45 against 0.056 to 0.069 in population controls, which points to an immune reaction in genetically susceptible people (Halegoua-DeMarzio 2023). The other names on the NHANES exposure list, ashwagandha, black cohosh, Garcinia cambogia and red yeast rice, are there for the same reason: each has a published record of liver injury (Likhitsup 2024). This site's own detailed example of an HLA-B*35:01-linked herb is He Shou Wu: Liver Health and Hepatotoxicity Warning; see also Turmeric and Ashwagandha.
9. "It's Natural, So It's Safe"
For the liver, this argument is exactly backwards. The liver's job is to chemically dismantle foreign molecules, and plant molecules are foreign. Some of them, pyrrolizidine alkaloids among them, become toxic only after the liver processes them. Extraction concentrates: a capsule of green tea extract can deliver in one swallow what would take many cups of tea, and it arrives without the food that slows absorption. Some injuries are not about dose at all but about the immune system, which is why a gene variant such as HLA-B*35:01 turns up in turmeric cases: the product is the same for everyone, the reaction is not. And a supplement sold in the US does not have to be tested for safety before it is sold. Under the 1994 law that governs supplements, the manufacturer is responsible for safety, FDA acts after reports come in, and an ingredient not marketed before October 1994 requires only a notification, the step the OxyELITE Pro reformulation skipped. What is in the bottle is a separate question again, covered at Contamination: Heavy Metals, Bacteria and Substitution.
"Natural" describes where a molecule came from. It says nothing about what the liver will do with it.
10. How Liver Injury Shows Up
Timing. Supplement liver injury usually appears weeks to months after starting the product, not days: a median of 73 days for bodybuilding products (Stolz 2019), one to four months for turmeric (Halegoua-DeMarzio 2023). The first phase is silent. Liver enzymes are rising for days or weeks before anything is felt, which is why a blood test finds injury that symptoms have not yet announced.
Symptoms, roughly in the order they tend to appear:
- Unusual fatigue, loss of appetite, nausea, sometimes vomiting
- An ache or fullness under the right ribs
- Dark, tea-coloured urine, and pale or clay-coloured stool
- Yellowing of the whites of the eyes, then the skin (jaundice)
- Itching, which can be intense in the cholestatic pattern
The blood tests. A liver panel reads the two patterns directly. ALT and AST leak from damaged liver cells and dominate the hepatocellular pattern; ALP and GGT rise when bile flow is blocked and dominate the cholestatic pattern; bilirubin is what makes you yellow, and its rise on top of high ALT is the combination hepatologists worry about most; INR (a clotting test) measures whether the liver is still doing its job. The doctor will also run a hepatitis panel to rule out viral causes. How to read all of these is explained at Liver Function Tests, and the full menu of tests is at Lab Tests.
11. Who Is at Higher Risk
- Anyone with existing liver disease. In DILIN's first 899 confirmed cases, patients with pre-existing liver disease died at three times the rate of those without it, 16% versus 5.2% (Chalasani 2015). Fatty liver is frequently undiagnosed, so "I don't have liver disease" is often a guess.
- Heavy drinkers. Alcohol is itself a liver toxin (Alcohol), and a liver already coping with it has less reserve for a second insult.
- Regular acetaminophen users. Acetaminophen is hard on the liver at high doses and hides in many cold, flu and pain products. Read Acetaminophen and Acetaminophen Overdose, and know that its antidote, N-acetylcysteine, exists for acetaminophen specifically.
- People taking several products at once. The majority of supplement liver injuries involve multi-ingredient products, and stacking bottles recreates that problem at home (Navarro 2017). It also makes the culprit impossible to identify afterwards.
- Green tea extract on an empty stomach. Fasting bolus doses raise EGCG exposure (Oketch-Rabah 2020).
- Genetics you cannot see. HLA-B*35:01 carriers are over-represented in turmeric injury (Halegoua-DeMarzio 2023); it is not a routine test.
- Demographics of the two patterns. Young men for bodybuilding products; middle-aged women for the rest (Navarro 2014).
12. What to Do
- Stop every supplement, not just the one you suspect. The culprit in a multi-product regimen is usually unknown (Navarro 2017). Do not "finish the bottle" and do not taper. Stopping is the treatment.
- Get a liver panel this week: ALT, AST, ALP, GGT, bilirubin and INR, plus a hepatitis panel. If you have symptoms from section 10, make it today.
- Bring every bottle, with lot numbers. Product analysis is how the unlabelled steroids were found (Stolz 2019) and how the Hawaii investigators traced lots (Johnston 2016).
- Never restart to "see if it was really the supplement". A second exposure to a product that has already injured the liver is more dangerous than the first, and hepatologists do not deliberately re-challenge.
- Know the emergency signs. Confusion or unusual drowsiness, bleeding or easy bruising, vomiting blood, a swelling abdomen, or deepening jaundice mean acute liver failure may be developing; go to an emergency department. Acute liver failure moves in hours to days and is managed at a transplant centre. For a large one-time ingestion, a child who has swallowed pills, or any acetaminophen question, call Poison Control at 1-800-222-1222.
- Report it to FDA MedWatch at fda.gov/safety/medwatch ("Report a Problem"); your doctor can file too. This is not paperwork for its own sake. The 2009 Hydroxycut action rested on 23 reports, and FDA's national response to OxyELITE Pro was built from MedWatch reports (Klontz 2015).
- Expect recovery to take time, and follow it with blood tests. Most injuries resolve once the product is stopped, but cholestatic cases can take months, and 17% of DILIN's confirmed cases had chronic liver injury at follow-up (Chalasani 2015). Repeat the panel until it is normal. There is no "liver cleanse" that speeds this up.
- Before taking anything again, look the ingredient up in the NIH's free LiverTox database, and use the checklist at How to Verify a Supplement Before You Take It.
13. The Honest Bottom Line
Most people who take supplements will never have a liver problem from them. But when the injury comes, it is unpredictable, it is more likely to be severe than a drug injury, and it is usually in exchange for a modest or unproven benefit. The rules that would have prevented most of the cases on this page are short:
- No concentrated green tea extract on an empty stomach, and none at all inside a multi-ingredient "fat burner".
- No bodybuilding "prohormone" or "natural anabolic" products; the steroid is often real and unlabelled.
- No comfrey, chaparral or germander by mouth, ever.
- Kava, turmeric extracts and ashwagandha with eyes open: one product, a normal dose, and a stop at the first symptom.
- One product at a time, and tell your doctor and pharmacist about every one of them.
- If you have liver disease, drink heavily or take acetaminophen daily, your margin is thinner than everyone else's.
- Learn the symptoms in section 10; the difference between a full recovery and a transplant is often how long the product was continued after they began.
- Report what happens to you. The next outbreak is found by the reports of the last one.
Research Papers
- Navarro VJ, Barnhart H, Bonkovsky HL, et al. Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Hepatology. 2014;60(4):1399-1408. doi:10.1002/hep.27317 — 130 of 839 DILIN cases (15.5%) caused by supplements, rising from 7% to 20% over 2004–2013; bodybuilding cases had prolonged jaundice but no deaths; non-bodybuilding cases died or needed transplant at 13% versus 3% for medications.
- Navarro VJ, Khan I, Björnsson E, Seeff LB, Serrano J, Hoofnagle JH. Liver injury from herbal and dietary supplements. Hepatology. 2017;65(1):363-373. doi:10.1002/hep.28813 — AASLD/NIH symposium review: supplements now about 20% of US hepatotoxicity cases; anabolic steroids, green tea extract and multi-ingredient products the main agents; the responsible component is usually unknown.
- Chalasani N, Bonkovsky HL, Fontana R, et al. Features and outcomes of 899 patients with drug-induced liver injury: the DILIN prospective study. Gastroenterology. 2015;148(7):1340-1352.e7. doi:10.1053/j.gastro.2015.03.006 — 10% of confirmed cases died or were transplanted and 17% had chronic injury; mortality 16% with pre-existing liver disease versus 5.2% without.
- Stolz A, Navarro V, Hayashi PH, et al. Severe and protracted cholestasis in 44 young men taking bodybuilding supplements: assessment of genetic, clinical and chemical risk factors. Aliment Pharmacol Ther. 2019;49(9):1195-1204. doi:10.1111/apt.15211 — median latency 73 days, 100% jaundiced, 71% hospitalised, no deaths or transplants; unlabelled anabolic steroids found in some products.
- Oketch-Rabah HA, Roe AL, Rider CV, et al. United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts. Toxicol Rep. 2020;7:386-402. doi:10.1016/j.toxrep.2020.02.008 — case reports at EGCG 140 to about 1,000 mg/day; fasting bolus doses raise EGCG bioavailability; hepatocellular pattern; USP's cautionary label requirement.
- EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). Scientific opinion on the safety of green tea catechins. EFSA J. 2018;16(4):e05239. doi:10.2903/j.efsa.2018.5239 — catechins from green tea infusions generally safe; supplement doses of EGCG at or above 800 mg/day associated with rises in liver transaminases; no safe supplement dose could be set.
- Roytman MM, Pörzgen P, Lee CL, et al. Outbreak of severe hepatitis linked to weight-loss supplement OxyELITE Pro. Am J Gastroenterol. 2014;109(8):1296-1298. doi:10.1038/ajg.2014.159 — the Honolulu liver centre's report of the 2013 cluster of severe hepatitis in users of the product.
- Johnston DI, Chang A, Viray M, et al. Hepatotoxicity associated with the dietary supplement OxyELITE Pro — Hawaii, 2013. Drug Test Anal. 2016;8(3-4):319-327. doi:10.1002/dta.1894 — 44 cases met the definition, 36 (82%) had taken the product; two transplants and one death among the exposed; no excess dosing; products matched their labels; mechanism unidentified.
- Klontz KC, DeBeck HJ, LeBlanc P, et al. The role of adverse event reporting in the FDA response to a multistate outbreak of liver disease associated with a dietary supplement. Public Health Rep. 2015;130(5):526-532. doi:10.1177/003335491513000515 — 114 MedWatch reports, 55 describing liver disease, 33 hospitalised, three transplanted; the 2013 reformulation replaced DMAA with aegeline without a new-dietary-ingredient notice; FDA laboratory found no drugs, metals or known plant toxins.
- Fong TL, Klontz KC, Canas-Coto A, et al. Hepatotoxicity due to Hydroxycut: a case series. Am J Gastroenterol. 2010;105(7):1561-1566. doi:10.1038/ajg.2010.5 — eight hospitalised patients, three transplanted, plus nine MedWatch cases including one fatal acute liver failure; hepatocellular pattern.
- Likhitsup A, Chen VL, Fontana RJ. Estimated exposure to 6 potentially hepatotoxic botanicals in US adults. JAMA Netw Open. 2024;7(8):e2425822. doi:10.1001/jamanetworkopen.2024.25822 — an estimated 15.6 million US adults used turmeric, green tea extract, ashwagandha, Garcinia cambogia, red yeast rice or black cohosh in the past 30 days, comparable to simvastatin or NSAID users.
- Halegoua-DeMarzio D, Navarro V, Ahmad J, et al. Liver injury associated with turmeric — a growing problem: ten cases from the Drug-Induced Liver Injury Network [DILIN]. Am J Med. 2023;136(2):200-206. doi:10.1016/j.amjmed.2022.09.026 — ten cases, all since 2011; hepatocellular; five hospitalised, one death; piperine in three of seven products; HLA-B*35:01 in seven of ten patients.
Regulatory Records
- U.S. Food and Drug Administration. FDA Warns Consumers to Stop Using Hydroxycut Products. Press release, 1 May 2009. FDA web archive — 23 reports of serious health problems involving the liver, one death, transplant cases; Iovate's recall of 14 products; ingredient not identified.
- U.S. Food and Drug Administration. Annual Report to Congress on the Use of Mandatory Recall Authority — 2014. fda.gov — the 11 October 2013 warning letter on aegeline, the 6 November letter on the Hawaii cluster, the 9 and 19 November recalls; 97 cases, 72 with OxyELITE Pro exposure, at least 47 hospitalised, at least 3 transplants, 1 death.
- U.S. Department of Justice. Justice Department and Federal Partners Announce Enforcement Actions of Dietary Supplement Cases. Press release, 17 November 2015. justice.gov — the 11-count indictment of USPlabs, S.K. Laboratories and their officers, and what it alleged.
- U.S. Department of Justice. Five Individuals and Two Companies Plead Guilty to Felony Charges in Multimillion Dollar Scheme to Fraudulently Sell Popular Dietary Supplements. Press release, 13 March 2019. justice.gov — guilty pleas to misbranding and conspiracy counts; fines and forfeitures of about $60 million agreed.
- U.S. Department of Justice. Two Individuals and Two Companies Sentenced in Scheme to Fraudulently Sell Popular Dietary Supplements. Press release, 15 October 2020. justice.gov — 60- and 24-month prison sentences; $4.7 million and $6 million forfeitures.
- U.S. Food and Drug Administration. Consumer Advisory: Kava-Containing Dietary Supplements May be Associated With Severe Liver Injury. 25 March 2002. FDA web archive — more than 25 foreign reports of hepatitis, cirrhosis and liver failure, four transplants; a US transplant case.
- U.S. Food and Drug Administration. FDA Advises Dietary Supplement Manufacturers to Remove Comfrey Products From the Market. Letter, 6 July 2001. FDA web archive — pyrrolizidine alkaloids, veno-occlusive disease, and the request to withdraw products.
- European Food Safety Authority. Green tea catechins: EFSA assesses safety. Press release, 18 April 2018. efsa.europa.eu — the plain-language summary of the opinion cited above.
- U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. fda.gov — where to report a suspected supplement injury.
Connections
- All Toxins
- Dangerous Supplements (hub)
- Green Tea
- Kava
- Comfrey
- Turmeric
- He Shou Wu: Hepatotoxicity Warning
- Liver Function Tests
- GGT
- Hepatitis Panel
- Acetaminophen
- Acetaminophen Overdose
- NAC: Acetaminophen Antidote
- Alcohol