Noni Juice - Regulatory Warnings and Safety Testing

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) . 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 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.

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.