Posted August 26, 2014

Seller of Immune Supplement Warned for Drug Claims

On August 12, 2014, the FDA issued a warning letter to Ad-Med Biotechnology, following a review of the company's websites and product labels, which found statements made about Immune Active Adult Formula and Immune Active Children’s Formula to be 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:

Seller of Joint Supplement Warned for Manufacturing Violations and Drug Claims

Seller of Mineral and Joint Supplements Warned for Manufacturing Violations and Drug Claims

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

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