In a warning letter sent to Hawaiian Organic Noni LLC, FDA took the company to task for a long laundry list of illegal drug claims on its products. These include a fruit leather, which is sold as a health supplement, as well as topical products and a product aimed at pets.
Laundry list of disease claims
According to FDA, the company had claimed that its products could relieve pain, kill parasites, relieve arthritis symptoms, and, “Help you fight off chronic diseases.” In one reference, the company claimed that noni’s pain relief effects were, “75 percent as strong as morphine, yet totally safe and side-effect free.”
FDA also cited numerous testimonials on the company’s website that made disease claims. Many legal experts have told NutraIngredients-USA that featuring a testimonial on a company’s website is tantamount to making that claim.
Among the claims in the testimonials that FDA cited were an ability of the product to lower blood pressure and to reduce cholesterol. Customers also claimed the product had cured their psoriasis, improved their visual acuity and cured their gum disease.
An unusual aspect of the letter was that FDA did not cite any GMP failures on the part of the company. Nor did it cite any labeling deficiencies outside of the impermissible disease claims on the labels. More often than not, companies that have transgressed on the claims side also have manufacturing shortcomings, too.
The claims the company has been making are perhaps not entirely without research backing. A recent article in the Journal of Traditional and Complementary Medicine, researchers from Ohio State University noted that the traditional uses of noni fruit include “mouth sores, toothaches, treatment of fever, diabetes, intestinal worms, fungal infections, tuberculosis.”
FDA also sent a warning letter to another noni producer located in Hawaii in 2014. In that case, the company was making extensive cancer claims on its products.
Mark Blumenthal, founder of the American Botanical Council, said he doesn’t believe that noni has for some reason risen on FDA’s radar.
“I don’t think FDA has got noni in their sights per se. But it’s logical that in doing research on one company they might come across another,” Blumenthal told NutraIngredients-USA.
Blumenthal said the story with noni is one that could be observed with other botanicals as well. People become so convinced of a product’s benefits that they naturally tend toward evangelism.
“There has been a history of ‘passionate’ or ‘enthusiastic’ claims on products made by people who really believe in them. This might be especially true of noni,” he said. “This goes back probably 15 or 20 years.”