FDA WARNING_LETTER - Formulation Technology, Inc. - November 09, 2023

The FDA conducted an inspection of your facility at 571 Armstrong Way, Oakdale, CA, from October 24 to November 9, 2023. This letter, dated July 9, 2024, identifies significant violations of the Federal Food, Drug, and Cosmetic Act and applicable regulations.

The product (b)(4) is deemed an unapproved new drug under section 201(g)(1)(B) and 201(p) of the Act due to claims on its labeling indicating intent for cure, mitigation, treatment, or prevention of disease. Introducing this product into interstate commerce without FDA approval violates sections 301(d) and 505(a).

Additionally, dietary supplements manufactured at your facility are adulterated under section 402(g)(1) of the Act due to significant Current Good Manufacturing Practice (cGMP) violations (21 CFR Part 111). Specifically, you failed to establish component specifications for (b)(4) and (b)(4) regarding heavy metal contamination (21 CFR 111.70(b)(3)) and failed to establish adequate finished product strength specifications for (b)(4) (21 CFR 111.70(e)). Your December 5, 2023, response was deemed inadequate.

Furthermore, (b)(4) and (b)(4)