Bulletproof 360 Inc – FDA Warning Letter, Sep 6, 2019

On March 20, 2020, the FDA issued a Warning Letter to Bulletproof 360, Inc. following an inspection from August to September 2019. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering their dietary supplement products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Additionally, FDA's review of www.bulletproof.com in March 2020 found that "Curcumin Max" and "Mitosweet" are marketed with claims establishing them as unapproved new drugs under section 505(a) and misbranded drugs under section 502(f)(1) of the Act. Examples of drug claims include "Curcumin Max" for blocking inflammatory cells linked to cancer, heart disease, diabetes, and Alzheimer's, and "Mitosweet" for increasing ATP levels in heart cells, aiding heart failure patients, and lowering "bad" cholesterol. These products are not generally recognized as safe and effective for these uses and lack adequate directions for layperson use, as they are intended for conditions requiring professional supervision.

Regarding adulterated dietary supplements, specifically "Chocolate Collagen Protein" and "Vanilla Collagen Protein," Bulletproof 360, Inc. failed to establish adequate component specifications (21 CFR 11