FDA WARNING_LETTER - Source-Omega LLC - August 08, 2023

The FDA reviewed Source-Omega.com in May 2023 and determined that products like Source Oil Rosemary Algae Omega-3, Source Oil Organic Lemon Algae Omega-3, and Source Oil Organic Orange Algae Omega-3 are marketed with claims establishing them as drugs under the Federal Food, Drug, and Cosmetic Act (the Act). Examples of drug claims include those related to "Alzheimer’s Onset" and "Anti-Cancer Benefits," as well as citations to publications suggesting medicinal uses.

These products are considered "new drugs" because they are not generally recognized as safe and effective for their intended uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the products are misbranded under section 502(f)(1) of the Act because they lack adequate directions for use. As they are intended for diseases not amenable to self-diagnosis or treatment, they require supervision by a licensed practitioner, making it impossible to provide adequate directions for layperson use. The introduction of these misbranded drugs into interstate commerce violates section 301(a) of the Act.

Source-Omega must respond in writing within 15 working days, detailing corrective actions taken, steps to prevent recurrence, and supporting documentation. Failure to address these violations may result in legal action, including seizure and injunction.