FDA WARNING_LETTER - Herbal Remission

This FDA Warning Letter addresses Herbal Remission's marketing of "E-Mune" on www.herbalremission.com. The FDA determined that E-Mune is an unapproved new drug and is misbranded.

The product's website and metatags contain claims indicating E-Mune is intended to prevent, treat, or cure diseases, or affect body structure/function. Examples include "most effective home treatments for skin cancer," "treatment of cancer, periodontal disease, skin lesions," and "stimulates the immune system to recognize them as foreign and push them out of the body." A disclaimer on the site stating the product is not intended to diagnose, treat, cure, or prevent any disease is deemed insufficient to mitigate misleading information per 21 C.F.R. 202.1(e)(3)(i).

E-Mune is classified as a "drug" under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) due to its intended uses. It is also a "new drug" under section 201(p) because it is not generally recognized as safe and effective for its labeled uses. Introducing a new drug into interstate commerce without an FDA-approved application violates sections 301(d) and 505(a) of the Act.

Furthermore, E-Mune is misbranded under section 50