Recalls & Warnings
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Posted February 6, 2016
Seller of Turmeric, Milk Thistle and More Warned for Manufacturing Violations, Drug Claims
These violations include failure to prepare a written master manufacturing record (MMR) for each unique formulation of dietary supplement manufactured, and failure to establish and follow written procedures for the responsibilities of the quality control operations, as required by federal regulations.
In addition, statements about these products on the company's website were found to be drug claims. For example, Milk Thistle was promoted with statements such as "rebuilds & regenerates damaged liver cells." Turmeric was promoted with statements such as "remedy for arthritis." Herp-Eaze Formula was promoted with statements such as, "For those with chronic cold sores and/or herpes, our Herp-Eaze Formula will keep the virus at bay."
YeastEaze Vaginal Suppositories and Horse Chestnut Varicose Away Spray were also considered to be unapproved new drugs because they are designed to be inserted or used topically, while dietary supplements must be intended for digestion.
See Related Warnings:
To read the FDA's warning letter, use the link below