Noni juice

History

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.
In 1996, Morinda Inc. (now Tahitian Noni International headquartered in Provo, Utah) acquired M. citrifolia from French Polynesia to manufacture juice, capsule and personal-care products for the Western market.^{[citation needed]}
There are now approximately 300 companies marketing noni juice in a global market estimated at more than $2 billion annually.^{[citation needed]} Today, raw materials for noni juices on the world market come mainly from Polynesia, but most manufacturers are in the United States.^{[citation needed]}

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.^[1]
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.^[1]
Two other FDA letters have been issued for the same types of violations.^[2][3]
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.^[4] In their report, the European Commission's Scientific Committee made no endorsement of health claims.
No M. citrifolia products have achieved sufficient scientific foundation for being licensed as medicines or therapies. Companies today must still apply to the European Commission for Health and Consumer Protection Directorate-General to have their own brand of noni juice included as a novel food under the initial approval.

Research

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,^[5][6] while the other named juice as the delivery method.^[7]
This was, however, followed by a publication^[8] 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 are potentially toxic to liver tissue.^[9]
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.^[10] The potential for toxicity caused by noni juices remains under surveillance by EFSA, individual food safety authorities in France,^[11] Finland^[12] and Ireland,^[13] and medical investigators in Germany.^[14] A review of toxicity tests and the safety issues surrounding noni juice has been published.^[15]
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.^[16] 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."
Some commercial brands of noni juice may be high in potassium^{[citation needed]}. While potassium is a valuable nutrient in a normal diet, persons with advanced kidney disease cannot excrete it properly and should avoid noni juice, which has been known to cause hyperkalemia.^[17] Of related significance is a report showing high variability in mineral contents between various brands of noni juice.^[18]
Two brands of noni juice are listed on ConsumerLab.com's "Athletic Banned Substance Screening Program" as having been screened for substances on the World Anti-Doping Code Prohibited List.^[19]

Preliminary medical research

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^[20] (search "noni" and "morinda"; PubMed search, January 2008). Despite the large market for juice products and research developments, the nutrient and phytochemical profiles of M. citrifolia have not been extensively studied and remain poorly related to potential health benefits.
The numerous health claims made in noni juice marketing^{[citation needed]} are not supported by significant scientific agreement^[13][21] and only one human cancer study completed under NIH peer-review in 2006 has been conducted, the results of which remain unpublished and unconfirmed^[22] as of February 2012.
In a university-based pilot study funded by the noni juice manufacturer, Tahitian Noni International, Inc., it was reported that noni juice consumption may lower blood cholesterol levels^[23] but the results of this study completed in 2006 were never published and met skepticism by experts.^[24][25]
Laboratory studies of M. citrifolia's effect on tumors in mice^[26] include evidence for reduced growth of capillaries in tumor explants.^[27] One study showed noni juice to lower the number of DNA adducts in rats induced with a carcinogen^[28] and also showed antioxidant properties of noni juice compared with those of vitamin C, grape seed powder, and pycnogenol. Reductions in DNA adducts and lowering of free radicals by noni juice were shown in blood samples from heavy smokers.^[29][30] Further studies of whether such effects occur in other animal models or in cancer patients have not been published.
Preliminary experiments showed that noni juice may affect physical endurance of mice^[31] and athletes.^[32]