FDA WARNING_LETTER - Moorish Science Temple The Divine and National Movement of North America, Inc; #13 The Moorish American National Republic - March 16, 2023
Discuss this record with AI
On August 1, 2023, the FDA issued a Warning Letter to Isaiah Orton-Bey and Maria LeMay-Bey, following an inspection of their manufacturing facility at 16136 W. 7 Mile Road, Livonia, MI, from February 13 to March 16, 2023, and a review of their website, https://moorherbs.com, in May 2023. The inspection and website review revealed serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.
The FDA determined that numerous products sold on their website, including "Full Body Antibiotic," "Anti-Viral," "Appendix Support," and "Tumor Release," are unapproved new drugs under section 201(g)(1)(B) and 201(p) of the FD&C Act due to therapeutic claims indicating their use in the cure, mitigation, treatment, or prevention of disease. These products are also misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson, and some are intended for conditions requiring supervision by a licensed practitioner.
Additionally, the dietary supplements manufactured at the facility are adulterated under section 402(g)(1) of the FD&C Act for failing to comply with Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part
- Inspection Date
- March 16, 2023
- Product Type
- Food
ID · 942a5fe9-07a6-4d9c-8e2d-5da242dbf21f
Full citation text and observation details available on the Dashboard.