FDA WARNING_LETTER - Morningstar Minerals LLC - November 21, 2019

The FDA issued a Warning Letter to Mr. McMahon following a November 2019 inspection of facilities in Farmington and Aztec, New Mexico, and a review of www.msminerals.com. This inspection was a follow-up to an April 2019 regulatory meeting.

The FDA identified serious violations of the Federal Food, Drug, and Cosmetic Act. Products "Got Arginine?" and "Energy Boost 70" are deemed unapproved new drugs and misbranded drugs because website claims (e.g., "Promoting wound healing," "improve cardiovascular health," "reduces high blood pressure," "rebuild the immune system") establish drug intent. These products are not generally recognized as safe and effective, lacking FDA approval, and are misbranded for failing to bear adequate directions for use, as they require professional supervision.

Additionally, "Silver Boost" and another dietary supplement product were found to be adulterated under 21 CFR Part 111 (CGMP). Violations include failure to verify finished product strength for "Silver Boost" (21 CFR 111.75(c)), failure to prepare and follow Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205(a), 111.210), and failure to establish complete Batch Production Records (BPRs) (21 CFR 111.255