Noni juice is derived from the fruit of the Morinda citrifolia tree indigenous to Southeast Asia

Southeast Asia

Southeast Asia, South-East Asia, South East Asia or Southeastern Asia is a subregion of Asia, consisting of the countries that are geographically south of China, east of India, west of New Guinea and north of Australia. The region lies on the intersection of geological plates, with heavy seismic...

 and Australasia

Australasia

Australasia is a region of Oceania comprising Australia, New Zealand, the island of New Guinea, and neighbouring islands in the Pacific Ocean. The term was coined by Charles de Brosses in Histoire des navigations aux terres australes...

.

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.

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.

There are now approximately 300 companies marketing noni juice in a global market estimated at more than $2 billion annually. Today, raw materials for noni juices on the world market come mainly from Polynesia

Polynesia

Polynesia is a subregion of Oceania, made up of over 1,000 islands scattered over the central and southern Pacific Ocean. The indigenous people who inhabit the islands of Polynesia are termed Polynesians and they share many similar traits including language, culture and beliefs...

, but most manufacturers are in the United States

United States

The United States of America is a federal constitutional republic comprising fifty states and a federal district...

.

Regulatory warnings and safety testing

In August 2004, the US Food and Drug Administration

Food and Drug Administration

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 issued a Warning Letter

FDA Warning Letter

The United States Food and Drug Adminstration defines a Warning Letter as "...a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations...

 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.

Two other FDA letters have been issued for the same types of violations.

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

Novel food

Novel food is defined as a type of food that does not have a significant history of consumption or is produced by a method that has not previously been used for food.-European Union:...

 by the European Commission for Health and Consumer Protection Directorate-General

Directorate-General for Health and Consumer Protection (European Commission)

The Directorate-General for Health and Consumers , formerly Directorate-General for Health and Consumer Protection and often abbreviated as "SANCO" or "DG-SANCO" for the French words Santé & Consommateurs , is a Directorate-General of the European Commission...

. 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.

Health and research problems

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 are potentially toxic to liver tissue.

The case reports of hepatitis were reviewed by the European Food Safety Authority

European Food Safety Authority

The European Food Safety Authority is an agency of the European Union that provides independent scientific advice and communication on existing and emerging risks associated with the food chain, created by European Regulation 178/2002....

 (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."

Some commercial brands of noni juice may be high in potassium

Potassium

Potassium is the chemical element with the symbol K and atomic number 19. Elemental potassium is a soft silvery-white alkali metal that oxidizes rapidly in air and is very reactive with water, generating sufficient heat to ignite the hydrogen emitted in the reaction.Potassium and sodium are...

. While potassium is a valuable nutrient in a normal diet, persons with advanced kidney disease

Chronic renal failure

Chronic kidney disease , also known as chronic renal disease, is a progressive loss in renal function over a period of months or years. The symptoms of worsening kidney function are unspecific, and might include feeling generally unwell and experiencing a reduced appetite...

 cannot excrete it properly and should avoid noni juice, which has been known to cause hyperkalemia

Hyperkalemia

Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated...

. Of related significance is a report showing high variability in mineral contents between various brands of noni juice.

Athletes intending to use noni juice to supplement their diet should be aware that 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

World Anti-Doping Agency

The World Anti-Doping Agency , , is an independent foundation created through a collective initiative led by the International Olympic Committee . It was set up on November 10, 1999 in Lausanne, Switzerland, as a result of what was called the "Declaration of Lausanne", to promote, coordinate and...

.

Preliminary medical research

The genus

Genus

In biology, a genus is a low-level taxonomic rank used in the biological classification of living and fossil organisms, which is an example of definition by genus and differentia...

 Morinda

Morinda

Morinda is a genus of flowering plants in the madder family, Rubiaceae. The generic name is derived from the Latin words morus, meaning "mulberry," and indica, meaning "of India," referring to the shape of the fruits. -Description:...

 (of which M. citrifolia is a species

Species

In biology, a species is one of the basic units of biological classification and a taxonomic rank. A species is often defined as a group of organisms capable of interbreeding and producing fertile offspring. While in many cases this definition is adequate, more precise or differing measures are...

) has attracted limited medical research, with 145 papers published since 1994 and 55 since 2006 (search "noni" and "morinda"; PubMed search, January 2008). Despite the large market for juice products and research developments, the nutrient and phytochemical

Phytochemical

Phytochemicals are biologically active chemical compounds that occur naturally in plants . Phytochemicals are the molecules responsible for the color and organoleptic properties . For example, the deep purple color of blueberries and the smell of garlic...

 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 are not supported by significant scientific agreement and only one human cancer study completed under NIH peer-review in 2006 has been conducted, the results of which remain unpublished and unconfirmed as of November 2009.

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

Cholesterol

Cholesterol is a complex isoprenoid. Specifically, it is a waxy steroid of fat that is produced in the liver or intestines. It is used to produce hormones and cell membranes and is transported in the blood plasma of all mammals. It is an essential structural component of mammalian cell membranes...

 levels but the results of this study completed in 2006 were never published and met skepticism by experts.

Laboratory studies of M. citrifolias effect on tumors in mice include evidence for reduced growth of capillaries in tumor explants. One study showed noni juice to lower the number of DNA adducts in rats induced with a carcinogen

Carcinogen

A carcinogen is any substance, radionuclide, or radiation that is an agent directly involved in causing cancer. This may be due to the ability to damage the genome or to the disruption of cellular metabolic processes...

  and also showed antioxidant

Antioxidant

An antioxidant is a molecule capable of inhibiting the oxidation of other molecules. Oxidation is a chemical reaction that transfers electrons or hydrogen from a substance to an oxidizing agent. Oxidation reactions can produce free radicals. In turn, these radicals can start chain reactions. When...

 properties of noni juice compared with those of vitamin C

Vitamin C

Vitamin C or L-ascorbic acid or L-ascorbate is an essential nutrient for humans and certain other animal species. In living organisms ascorbate acts as an antioxidant by protecting the body against oxidative stress...

, grape seed powder

Grape seed extract

Grape seed extracts are industrial derivatives from whole grape seeds that have a great concentration of vitamin E, flavonoids, linoleic acid, and OPCs...

, and pycnogenol. Reductions in DNA adducts and lowering of free radicals by noni juice were shown in blood samples from heavy smokers. 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 and athletes.