FDA WARNING_LETTER - Omega Supply

The FDA issued a Warning Letter to Omega Supply, specifically to Erick Del Rio, regarding the marketing of several products on www.laetrilesupply.com, including Amygdalin/Laetril tablets and injectable solution, Cyprenil/Selegiline, Hydrazine Sulphate capsules, Clodromax (Clodronate Disodium) capsules, and Cloracesium/Cesium Chloride capsules.

The FDA determined these products are unapproved new drugs and misbranded. Violations include: 1. **Unapproved New Drugs:** The website makes disease claims such as "ALTERNATIVE MEDICINE FOR CANCER THERAPY" and "fight cancer and other diseases," and uses metatags like "cancer." Listing "laetrile" as an ingredient also constitutes a disease claim, as laetrile is widely known for its claimed use in cancer treatment and has been regulated as a drug by the FDA. These claims cause the products to be considered drugs under Section 201(g)(1) of the FDCA. Since they are not generally recognized as safe and effective for their labeled uses, they are new drugs under Section 201(p) and lack FDA-approved applications, violating Sections 301(d) and 505(a). 2. **Misbranding (Inadequate Directions for Use):** The products are offered for conditions like cancer, which require professional medical diagnosis and treatment. Therefore, adequate directions