Aloe Man, Inc. (The) – FDA Warning Letter, Sep 3, 2014

The FDA issued a Warning Letter to Dr. Johnson, owner of "The Aloe Man" and "Dr. Johnson's" brand products, following an inspection from August 18 to September 3, 2014. The inspection and review of product labeling, including a brochure and the website www.aloeman.com, revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.

**Unapproved New Drugs:** Several products, including "The Aloe Man’s Super Bright," "Dr. Johnson’s Maximum Desire," "Dr. Johnson’s Body Healer," and "Dr. Johnson’s Formula C," are promoted with therapeutic claims (e.g., "Helps stop pain in the eyes," "helps…impotence," "stop toothache pain and gum infections," "Can help with: Kidney problems") that cause them to be defined as unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Act. These products lack FDA approval for safety and effectiveness. Additionally, "Dr. Johnson’s Maximum Desire" and "Dr. Johnson’s Body Healer" are misbranded under section 502(f)(1) because they are intended for conditions not amenable to self-diagnosis and lack adequate directions for layperson use.

**Adulterated Dietary Supplements (cGMP Violations):**