FDA WARNING_LETTER - Wholly Liquid Nutritional Supplements LLC - December 21, 2021

The FDA issued a Warning Letter to Wholly Liquid Nutritional Supplements LLC after reviewing their website and social media in November and December 2021. The FDA determined that products including SpiroLaze, BioLaze, LiquiLaurin, Vit-B12, DeStress, Omega Plus, and Ionized Silver are marketed with claims establishing them as drugs under the FD&C Act, intended for disease cure, mitigation, treatment, or prevention.

Specific violations include numerous claims on their website and Facebook page for treating conditions like Lyme disease, infections, inflammation, diabetes, high blood pressure, depression, anxiety, and various other ailments. These products are considered "new drugs" because they are not generally recognized as safe and effective for their stated uses and lack FDA approval, violating sections 301(d) and 505(a) of the FD&C Act.

Furthermore, these products are deemed misbranded under section 502(f)(1) of the FD&C Act because they lack adequate directions for use by a layperson, as their intended uses require supervision by a licensed practitioner. The introduction of these misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act.

Wholly Liquid Nutritional Supplements LLC must respond within 15 working days, outlining specific corrective actions, preventing recurrence, and providing supporting documentation. Failure to comply may result in legal action, including seizure and injunction.