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 )

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 the 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 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.

Research

In 2005, two scientific publications as clinical case reports described incidents of acute hepatitis caused by ingesting noni juice. Research has pointed to anthraquinones found in noni roots, leaves and fruit as potentially toxic to the liver and other organs. These case reports were reviewed in 2006 by the European Food Safety Authority (EFSA), concluding that no causal link could be established. One government report, however, advises against consumption of noni products if one has a history of liver disorders.

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. One review of toxicity tests and safety issues surrounding noni juice was published, finding that there were no adverse effects from consumption of the juice, but another review indicates that safety concerns about consuming noni products have not been adequately addressed in scientific studies.

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."

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, noni products may contain high amounts of potassium, leading to one advisory that people on potassium-restricted diets because of kidney problems should avoid using noni. Also, 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".