FDA WARNING_LETTER - Bio-Botanica, Inc. - April 30, 2013

The FDA issued a Warning Letter to Nature's Answer following a review of their website in April 2013, which identified several products promoted for conditions that classify them as unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

The products in violation are "Hi-B Homocysteine," "Goldenseal Root," "Nature's Answer Bio-Flavonoids with Rosehip," "Immune Boost TM," "Gingko Leaf," "Male Complex," "Sambucus Nigra," "Bio-Strath," "Greens Today for Women," and "Greens Today for Men." These products are marketed with claims of curing, mitigating, treating, or preventing diseases, including heart disease, stroke, Alzheimer's, diabetes, colds, flu, infections, senile dementia, impotence, and cancer. These claims appear on product pages and in customer testimonials. The letter also cites the commercial use of scientific publications to promote disease treatment, which serves as evidence of intended drug use.

Since these products are not generally recognized as safe and effective for their promoted uses, they are considered "new drugs" requiring prior FDA approval. Furthermore, "Hi-B Homocysteine," "Ginkgo Leaf," "Male Complex," "Sambucus Nigra," "Bio-Strath," "Greens Today for Women," and "Greens Today for Men" are deemed misbranded because they address conditions not amenable to self-diagnosis