Recalls & Warnings
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Posted September 6, 2016
Seller on Noni Juice Warned for Manufacturing Violations, Drug Claims
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 .)
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To read the FDA's warning letter, use the link below