FDA WARNING_LETTER - Market America Inc - May 28, 2019

The FDA conducted an inspection of a dietary supplement distributor in Greensboro, NC, from May 21-28, 2019, identifying serious violations of the Federal Food, Drug, and Cosmetic Act.

A primary violation was the failure to submit Serious Adverse Event Reports (SAERs) as required by section 761(c) of the Act. Two specific instances were cited: a March 15, 2018 complaint regarding TLS Nutrition Shake leading to prolonged hospitalization and physical therapy, and a January 28, 2019 complaint concerning TLS 21-Day Challenge Kit products resulting in inpatient hospitalization for various adverse reactions. The firm's July 11, 2019 response provided revised procedures for assessing adverse event severity but did not address a retrospective review of past events.

Additionally, several products (Isotonix OPC-3, Heart Health Essential Omega III, Isotonix Multivitamin, Isotonix Multivitamin with Iron, Isotonix Activated B-Complex) were deemed misbranded under section 403 of the Act due to non-compliance with 21 CFR 101 labeling requirements. Specific misbranding issues included incorrect serving size declaration (Isotonix OPC-3), improper presentation of nutrition information (e.g., declaring zero-amount ingredients, incorrect naming conventions for dietary ingredients), and failure to identify the plant part for botanical ingredients (Isotonix OPC-