Recalls & Warnings
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Posted August 26, 2014
Seller of Immune Supplement Warned for Drug Claims
Immune Active Adult Formula contains a patented tea tree (Melaleuca Alternifolia) oil (FJ1) and was promoted with statements such as "Components in Compound FJ1 fight numerous virus infections" and "...inhibits inflammatory mediators TNF-A, IL-1 beta and IL-10. These mediators promote inflammatory response associated with rheumatoid arthritis, psoriatic arthritis, Crohn's disease, plaque psoriasis and asthma."
Immune Active Children's Formula also contains FJ1 tea tree oil and was promoted with statements such as "Components in Compound FJ1 fight numerous virus infections."
Immune Active Adult Formula and Immune Active Children's Formula were also found to be misbranded because the statement on labels that "Melaleuca Alternifolia is FDA GRAS-designated as safe" was found to be false or misleading. Tea tree oil has not been designated GRAS (generally recognized as safe), but is regulated as a food additive. In addition, the labels failed to provide information required by federal regulations.
See the Encyclopedia article for more information about Tea Tree.
See Related Warnings:
To read the FDA's warning, use the link below.