APS BioGroup, Inc – FDA Warning Letter, Feb 16, 2017

The FDA issued a Warning Letter to APS Biogroup, Inc. on July 6, 2017, following an inspection from February 6-16, 2017. The letter states that the products "ProGI Soothe Gastrointestinal & Hepatic Support Formula" and "Pathogen Defense" are unapproved new drugs under section 201(g)(1)(B) of the Act due to therapeutic claims such as "combat viral activity" and "bind heavy metals." These products are not generally recognized as safe and effective for their claimed uses, making them "new drugs" requiring FDA approval before interstate commerce.

Additionally, several products, including "Children's DiaResQ," "Liver Defend," "Colostrum with Probiotics," and "DPS Throat Spray," are misbranded under section 403 of the Act. Violations include: - "Children's DiaResQ" lacking an appropriate common or usual name (403(i)(1)) and incorrect nutrition information format for children 1-3 years old (403(q)). - "ProGI Soothe," "Liver Defend," "Pathogen Defense," and "Colostrum with Probiotics" failing to declare common or usual names for all ingredients, including sub-ingredients of multi-component ingredients (403(i)(2)). - "Pathogen Defense" having an incorrect serving size declaration (40