FDA WARNING_LETTER - Herb Time

This FDA Warning Letter, dated May 22, 2008, addresses Herb Time's marketing of several products, including C-Herb, C-4 Cream, Eye Drops, Eye/Ear Wash, Immune Max, Saw Palmetto Cream, and Wild Yam Cream, on their website, www.herbtime.com. The FDA determined that claims made on the website, despite disclaimers, indicate the products are intended to prevent, treat, or cure diseases or affect body structure/function, thus classifying them as drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Specific violations include: - **Unapproved New Drugs:** 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 labeled uses. Their introduction into interstate commerce without FDA-approved applications violates sections 301(d) and 505(a) of the Act. - **Misbranding:** The products are misbranded under section 502(f)(1) of the Act because they are offered for conditions not amenable to self-diagnosis and treatment, meaning adequate directions for safe use by a layman cannot be provided.

The letter cites numerous examples of therapeutic claims for each product, such as C-Herb's purported ability to remove cancers, warts, and moles, and treat HIV