FDA WARNING_LETTER - Aloe Man International Corp - May 13, 2013

On March 21, 2014, the FDA issued a Warning Letter to Aloe Man International Corp. following an inspection from May 2-13, 2013, and a review of their website in January 2014. The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

Several products, including GAP Pills, GAP Liquid, The Body Healer, The Big C, Super Cleanser, Maximum Desire, SOC, High Thyroid Regulator, and Low Thyroid Regulator, were deemed unapproved new drugs due to therapeutic claims on their website, such as "cleanse the blood" to "Lower the blood pressure" or "fight off impotence." These products are not recognized as safe and effective for their claimed uses and lack FDA approval. Additionally, GAP Pills, GAP Liquid, SOC, Maximum Desire, and High Thyroid Regulator were cited as misbranded drugs for lacking adequate directions for layperson use. The Body Healer product was also noted as not being a dietary supplement due to claims of non-ingestion uses (e.g., topical, eye drops).

The company's dietary supplement products were found to be adulterated due to numerous Current Good Manufacturing Practice (CGMP) violations. These included failure to: conduct identity testing for dietary ingredients (e.g., Bayberry, Marigold, Ginger), qualify suppliers for non-dietary components, establish required specifications for components and finished products, prepare and follow written