doctor's signature sales and marketing international corp. – FDA Warning Letter, Jul 15, 2019

On March 27, 2020, the FDA issued a Warning Letter to Doctor’s Signature Sales and Marketing International Corp. d/b/a Life Force International, following an inspection on July 9, 11, and 15, 2019. The letter identified serious violations of the Federal Food, Drug, and Cosmetic Act related to their products Colloidal Silver and VitalSTART, which are marketed as unapproved new drugs and misbranded.

The FDA determined that claims on the company's website, www.LifeForce.net, for Colloidal Silver and VitalSTART establish them as drugs intended for disease treatment, prevention, or mitigation. Colloidal Silver was cited for claims like "natural antibiotic, antifungal, and antiviral substance," while VitalSTART was cited for claims such as "Maintains Blood Pressure" and "Avoid heart problems." These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses and lack FDA approval. VitalSTART is also misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson, as it is intended for conditions requiring professional supervision. Colloidal Silver is additionally misbranded under section 502 as an OTC drug product containing colloidal silver ingredients promoted for disease treatment/prevention, requiring an approved application per 21 CFR 310