Sold in capsule form, pulp powder was the first Noni supplement brought to the commercial marketplace in Hawaii by Herbert Moniz of Herb’s Herbs in 1992 after patenting an exclusive Noni dehydrating method. (US patent 5288491) In 1995, David Marcus, of Hawaiian Herbal Blessings Inc., began advertising the first conventionally fermented Noni juice from Maui, Hawaii.
In 1996, Morinda Inc. (now Tahitian Noni International headquartered in Provo, Utah) acquired Noni from French Polynesia to make juice, capsule and personal care products for the western marketplace. [Citation needed]
There are now around 300 companies advertising the Noni juice in a worldwide market estimated at more than $2 billion per annum. Today, raw materials for Noni juices on the globe market mainly come from Polynesia but most manufacturers are in the United States
Regulatory warnings and safety testing
In August 2004, the US FDA 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 groundless health claims about the purported health benefits of Noni juice as a therapeutic product, in effect causing the Noni juice to be appraised as a drug. Under the Act, this requires all safety and clinical trial proof for the Noni juice providing such effects in humans.
The FDA letter also mentioned 1) absent scientific data for health benefits of Noni photochemical, scopoletin and damnacanthal, neither of which has been confirmed with biological activity in humans, and 2) be short of scientific groundwork for health claims made by two promoters of the Noni juice, Dr. Isabella Abbot and Dr. Ralph Heinicke.
Two other FDA letters have been issued for the similar types of health claim contraventions.
In the European Union, after safety testing on one particular product of the Noni juice (Tahitian Noni), consent was granted in 2002 as a new food by the European Commission for Health and Consumer Protection Directorate-General. In their statement, the European Commission’s Scientific Committee made no approval of health claims.
No Noni juice supplements have achieved adequate scientific foundation for being licensed as medicines or therapies. Companies these days must still apply to the European Commission for Health and Consumer Protection Directorate-General to have their individual brand of Noni juice included as a novel food under the early approval.
Health and research problems
In 2005, two scientific publications expressed incidents of severe hepatitis caused by ingesting the Noni juice. One study suggested the toxin to be anthraquinones, found in roots, leaves and fruit of the Noni fruit, while the other named juice as the delivery method.
This was, however, followed by a publication showing that Noni juice 1) was not poisonous to the liver even when consumed in high doses, and 2) contained low amounts of anthraquinones which are potentially toxic to liver tissue.
The case reports of hepatitis were evaluated by the European Food Safety Authority (EFSA), in which it was concluded that no fundamental link could be established. The potential for toxicity caused by the Noni juices remains under observation by EFSA, individual food safety authorities in France, Finland and Ireland, and medical investigators in Germany. An analysis 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 viable brand of Noni juice, with no side-effects mentioned. Consumers of the Noni juice are advised to vigilantly check labels for warnings which may say, “Not safe for pregnant women” or “Keep out of reach of children.”
Some commercial brands of the Noni juice may be high in potassium [citation needed]. While potassium is a valuable nutrient in a normal diet, persons with advanced kidney infection cannot emit it properly and should keep away from Noni juice which has been known to cause hyperkalemia. Of related importance is a report showing high inconsistency 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 the Noni juice are listed on ConsumerLab.com’s “Athletic Banned Substance Screening Program” as having been monitored for substances on the World Anti-Doping Code Prohibited List.
Preliminary medical research
Noni has gradually more stimulated the interest of medical science, with 145 papers published since 1994 and 55 just since 2006 (search “Noni” and “Morinda”; PubMed search, January 2008). Despite the large marketplace for Noni juice products and research developments, the nutrient and photochemical profiles of Noni have not been broadly studied.
Moreover, many health claims made in Noni juice advertising are not supported by scientific study in human clinical trials; only one cancer study completed under NIH peer-review in 2006 has been conducted, the results of which remain unpublished as of August 2007.
Similarly, in a university-based pilot study funded by the Noni juice producer, Tahitian Noni International, Inc., it was shown that Noni juice consumption may lower blood cholesterol levels. Completed in 2006, however, the results of this study have not been published under peer-review and have met critical judgment by specialists.
Laboratory studies have investigated none’s effect on the development of cancerous tissue in mice. One such study in vitro found that Noni reduced development of capillary vessels sprouting from human breast tumor explants and, at increased concentrations, caused existing vessels to deteriorate. It remains mysterious whether such effects occur in vivo in other animal models or in cancer patients.
Another study showed Noni juice to restrain formation of cancer cells in rats (using detection methods of biochemical markers called DNA adducts). It further showed a reduced number of DNA adducts in rats induced with a carcinogen. The same study showed valuable antioxidant properties of the Noni juice compared with those of vitamin C, grape seed powder, and pycnogenol. The results showed reduced carcinogen-DNA adduct formation in this laboratory model and antioxidant action that may be relevant to anti-cancer mechanisms.
As such discoveries have neither been confirmed by other laboratory trials nor demonstrated in expert-reviewed human clinical trials, no inference can be made about whether Noni juice has anti-cancer properties.
Laboratory trials showed that Noni juice may affect physical staying power of mice. A preliminary study of athletes showed potential benefit of Noni juice on work out stamina, an effect the authors attributed to increased antioxidant capacity.
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