FDA WARNING_LETTER - C R Supplements, LLC - December 10, 2021

The FDA inspected C-R Supplements' facility from December 6-10, 2021, and reviewed their website and Facebook page in March and April 2022. The inspection and review revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The products Calcium, 4X Calcium 4X, Copper, Molybdenum, Potassium, Selenium, Silver, Magnesium, Zinc, Alkalize-U, CR-Oxy+, and Immune Boost Pack are deemed unapproved new drugs and misbranded drugs. This is due to claims on their website and Facebook page indicating intended use for disease cure, mitigation, treatment, or prevention, making them "new drugs" under 21 U.S.C. § 321(p) without FDA approval. They are also misbranded under 21 U.S.C. § 352(f)(1) for lacking adequate directions for use, as they are intended for conditions requiring professional supervision.

Additionally, Silver and Magnesium products are adulterated dietary supplements under 21 U.S.C. § 342(g)(1) due to serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). Violations include: 1. Failure to establish specifications for components, in-process production, labels, packaging, and finished product identity, purity, strength, composition, and contamination limits (21