TCHO Ventures, Inc. – FDA Warning Letter, May 24, 2011

On September 15, 2011, the FDA issued a Warning Letter to TCHO Ventures, Inc. following a website review in September 2011 and a facility inspection from May 17-24, 2011. The FDA found serious violations of the Federal Food, Drug, and Cosmetic Act.

The primary violations include: 1. **Unapproved New Drugs:** TCHO's chocolate products, particularly the TCHO-A-DAY line, are promoted with therapeutic claims on their website (e.g., "diabetes, anti-inflammatory effects," "lowers blood pressure," "alleviate depression," "prolong the lives of people with cirrhosis," "guard against brain injury from stroke"). These claims classify the products as unapproved new drugs under Section 201(g)(1)(B) and 201(p) of the Act, as they are not generally recognized as safe and effective for these uses and lack FDA approval. The TCHO 30 label also lists "active ingredients" like Theobromine and Love. 2. **Misbranded Drugs:** Due to the unapproved drug claims, the products are misbranded under Section 502(f)(1) because adequate directions for use by a layman cannot be provided for conditions not amenable to self-diagnosis and treatment. 3. **Misbranded Food:** The website features unauthorized health claims,