Humaworm – FDA Warning Letter, Jul 19, 2019

The FDA issued a Warning Letter to Mrs. Bailey of 609 Lexington Street, P.O. Box 190, Carrollton, MS 38917, following an inspection of her facility at 109 Barnes Avenue, Carrollton, MS, from July 15-19, 2019, and a review of her website, humaworm.com, in March 2020.

The FDA identified serious violations of the Federal Food, Drug, and Cosmetic Act. The products "Humaworm Parasite Cleanse," "Humaworm Parasite Cleanse For Children," and "Candida & Fungi Cleanse," along with "Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”)," are deemed unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Act [21 U.S.C. 321(g)(1)(B), 321(p)] due to therapeutic claims on the website and product labeling for treating, curing, mitigating, or preventing diseases. These products are also considered misbranded drugs under section 502(f)(1) [21 U.S.C. 352(f)(1)] because they lack adequate directions for use by a layperson, particularly for conditions requiring professional supervision.

Furthermore