Posted September 6, 2016

Seller on Noni Juice Warned for Manufacturing Violations, Drug Claims

On August 26, 2016, the FDA issued a warning letter to Healing Noni Co. L.L.C., following a facility inspection which found the noni juice products sold by the company, including HEALING Noni Brand: ORGANIC NONI JUICE 100% Pure noni juice and HEALING Noni Brand: all natural GOJI JUICE made with 100% PURE goji juice to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

The company failed to establish specifications for dietary supplement labels and packaging that may come in contact with its dietary supplements, as required by federal regulations. 

In addition, labeling claims made about the company's noni juice products were found to be drug claims. These claims include, "Antiinflammatory activity - Anecdotal accounts of antiinflammatory effects resulting from noni fruit consumption are too numerous to dismiss. The antiinflammatory effects of asperuloside, eugenol and scopoletin present in ripe noni fruit would support such a claim. Other agents may possess additional antiinflammatory activity," and "[A]ntitumor Activity - Hirazumi and Furusawa have described the activity of a polysaccharide-rich substance from the fruit juice of noni, noni-ppt. In studies, noni-ppt demonstrated ...antitumor activity. "

The manufacturer of these products, KCE, L.L.C., was also issued a warning letter by the FDA for several manufacturing violations.

(See ConsumerLab.com's Review article about Noni Juice for more information about noni .) 

See Related Warnings:

Seller of Whey Protein Warned for Manufacturing Violations, Drug Claims

Seller of Joint Health, Omega-3 Supplements & More Warned for Manufacturing Violations, Drug Claims

Seller of Turmeric, Milk Thistle and More Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Aloe, Weight Loss Supplements and More Warned for Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below