Noni juice has been promoted as a cure for a number of human diseases. However, there is no evidence to support these claims.
Sold in capsule form, pulp powder was the first M. citrifolia product brought to the commercial market in Hawaii by Herbert Moniz of Herb's Herbs in 1992 after patenting a unique M. citrifolia dehydrating method.(US 5288491 ) The noni fruit is endemic in the Hawaiian islands.
Regulatory warnings and safety testing
In August 2004, the US Food and Drug Administration issued a Warning Letter to Flora, Inc. for violating section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. Flora made twelve unfounded health claims about the purported benefits of noni juice as a medical product, in effect causing the juice to be evaluated as a drug. Under the Act, this necessitates all safety and clinical trial evidence for the juice providing such effects in humans.
The FDA letter also cited 1) absent scientific evidence for health benefits of noni phytochemicals, scopoletin, and damnacanthal, neither of which has been confirmed with biological activity in humans, and 2) lack of scientific foundation for health claims made by two proponents of noni juice, Dr. Isabella Abbot and Dr. Ralph Heinicke.
In the European Union, after safety testing on one particular brand of noni juice (Tahitian Noni), approval was granted in 2002 as a novel food by the European Commission for Health and Consumer Protection Directorate-General. In their report, the European Commission's Scientific Committee made no endorsement of health claims.
In 2005, two scientific publications described incidents of acute hepatitis caused by ingesting M. citrifolia. One study suggested the toxin to be anthraquinones, found in roots, leaves and fruit of the M. citrifolia, while the other named juice as the delivery method.
This was, however, followed by a publication showing that noni juice 1) is not toxic to the liver even when consumed in high doses, and 2) contains low quantities of anthraquinones, which nevertheless are potentially toxic to the liver and other organs.
The case reports of hepatitis were reviewed by the European Food Safety Authority (EFSA), wherein it was concluded that no causal link could be established. The potential for toxicity caused by noni juices remains under surveillance by EFSA, individual food safety authorities in France, Finland and Ireland, and medical investigators in Germany. A review of toxicity tests and the safety issues surrounding noni juice has been published.
The Physicians Desk Reference ("PDR") for Non-Prescription Drugs and Dietary Supplements lists only one particular commercial brand of noni juice, with no side-effects mentioned. Consumers of noni juice are advised to carefully check labels for warnings, which may say "Not safe for pregnant women" or "Keep out of reach of children."
The genus Morinda (of which M. citrifolia is a species) has attracted limited medical research, with 145 papers published since 1994 and 55 since 2006 (search "noni" and "morinda"; PubMed search, January 2008).
Noni plants and juice have been promoted by practitioners of alternative medicine as a cure for a number of human maladies including HIV, heart disease and cancer. However, according to the American Cancer Society "there is no reliable clinical evidence that noni juice is effective in preventing or treating cancer or any other disease in humans".
- "Noni Plant". American Cancer Society. 1 November 2008. Retrieved 20 September 2013.
- Breen, Charles M. (August 26, 2004). "Warning letter from the FDA to Flora, Inc." (PDF).
- "Noni Tahitian Plus". Fda.gov. 2009-04-30. Retrieved 2011-07-09.
- "Cyber Warning Letter". Fda.gov. 2009-04-30. Retrieved 2011-07-09.
- European Commission Health and Consumer Protection Directorate-General (December 11, 2002). "Opinion of the Scientific Committee on Food on Tahitian Noni juice" (PDF).
- Pawlus, A.D.; Pawlus AD, Su BN, Keller WJ, Kinghorn AD. (December 2005). "An anthraquinone with potent quinone reductase-inducing activity and other constituents of the fruits of Morinda citrifolia (noni).". J. Nat. Prod. 68 (12): 1720–2. doi:10.1021/np050383k. PMID 16378361.
- Millonig, Gunda; Millonig G, Stadlmann S, Vogel W (April 2005). "Herbal hepatotoxicity: acute hepatitis caused by a Noni preparation (Morinda citrifolia)". European Journal of Gastroenterology & Hepatology 17 (4): 445–7. doi:10.1097/00042737-200504000-00009.
- Stadlbauer, V; Stadlbauer V, Fickert P, Lackner C, Schmerlaib J, Krisper P, Trauner M, Stauber RE (August 2005). "Hepatotoxicity of noni juice: Report of two cases". World Journal of Gastroenterology 11 (30): 4758–60. ISSN 1007-9327. PMID 16094725.
- "World J Gastroenterol". Wjgnet.com. Retrieved 2011-07-09.
- West, BJ; West B, Jensen C J, Westendorf J (June 2006). "Noni juice is not hepatotoxic". World Journal of Gastroenterology 12 (22): 3616–3619. ISSN 1007-9327. PMID 16773722.
- Dodd, D. E.; Layko, D. K.; Cantwell, K. E.; Willson, G. A.; Thomas, R. S. (2013). "Subchronic Toxicity Evaluation of Anthraquinone in Fischer 344 Rats". International Journal of Toxicology 32 (5): 358–367. doi:10.1177/1091581813501701. PMID 23966314.
- EFSA ::. EFSA re-assesses safety of noni juice[dead link]
- "France warns consumers off noni juice". Nutraingredients.com. Retrieved 2011-07-09.
- "Press release: National Food Agency warns about illegal noni products - Finnish Food Safety Authority Evira". Evira.fi. Retrieved 2011-07-09.
- FSAI - Food Safety Authority Warns of Unsubstantiated Claims on Noni Juice
- YÜCe, B.; Yuce B, Gulberg V, Diebold J, Gerbes AL. (February 2006). "Hepatitis induced by Noni juice from Morinda citrifolia: a rare cause of hepatotoxicity or the tip of the iceberg?". Digestion 73 (2–3): 167–70. doi:10.1159/000094524. PMID 16837801.
- West BJ, Jensen CJ, Westendorf J, and White LD. A Safety Review of Noni Fruit Juice. Journal of Food Science 2006 October; 71(8):R100-R106. <http://www.blackwell-synergy.com/doi/full/10.1111/j.1750-3841.2006.00164.x>
- Thomson Healthcare (Micromedex) (November 25, 2006). "Tahitian Noni Juice".
- ConsumerLab.com (September 2005). ConsumerLab.com Athletic Banned Substance Screening Program. Retrieved 2007-01-12.
- USA (2011-03-18). "PubMed Home". Ncbi.nlm.nih.gov. Retrieved 2011-07-09.