FDA WARNING_LETTER - Fem Health

The FDA issued a Warning Letter to New Sun, Inc. after reviewing their websites, www.femhealth.com and www.superbherbs.com. The FDA determined that numerous products, including "New Sun NKC-C Agaricus Blazei capsules," "New Sun Green Tea," "New Sun Grape Seed Extract," "New Sun LIV Combination," "New Sun Flax Seed Oil," "New Sun Super Sam (Super Sam Generic Samento, Cat's Claw)," "New Sun Vital PR. & BR.," and "New Sun Yew/Olive Combination," are promoted for conditions that classify them as drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

The therapeutic claims on the websites, such as "Anti-tumor effect," "powerful antiviral agent," and claims related to treating cancer, diabetes, heart disease, and infectious diseases, establish the products as drugs intended for cure, mitigation, treatment, or prevention of disease, violating the Act. The letter provides extensive examples of these claims for each product.

Furthermore, the products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their promoted conditions and lack prior FDA approval. They are also misbranded under section 502(f)(1) of the Act due to inadequate directions for use.

New Sun, Inc. is required to take