Feb 07, 2016
On January 15, 2016, the FDA issued a warning letter to Terra Firma Botanicals, Inc., following a facility inspection which found the company's products, including Horse Chestnut Varicose Away Spray, YeastEaze Vaginal Suppositories, Hawthorne Combo, Skin Combo, Milk Thistle, Turmeric, Turmeric/Ginger Combination, Depress-Shun, Bliss, Candida and Fungus Away -- Herbal Candida Relief and Herp-Eaze Formula to be adulterated because they prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.
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.