FDA WARNING_LETTER - Set-N-Me-Free Aloe Vera Co. - June 30, 2012

The FDA issued a Warning Letter to Set-N-Me-Free Aloe Vera Co. following a May 2012 review of their websites, www.set-n-me-free.com and www.setnmefree.net. The FDA determined that several products, including "Aloe Milk Moisturizing," "Aloe Moisture Cream," and "Aloe Comfrey Gel," were promoted with therapeutic claims that cause them to be unapproved new drugs under sections 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act. These claims, such as "cancer fighting," "build skin immune functions," "stops acne eruptions," and "arthritis relief," indicate the products are intended for the cure, mitigation, treatment, or prevention of disease, or to affect the body's structure or function. As these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) and lack the required FDA approval under section 505(a). Furthermore, due to conditions not amenable to self-diagnosis, adequate directions for use cannot be written for a layman, rendering the products misbranded under section 502(f)(1). The introduction of these misbranded drugs into interstate commerce violates section 301(a). The company is required to take prompt action to correct these violations and prevent recurrence, notifying the FDA within fifteen working days with documentation of corrective steps. Failure to comply may result in regulatory actions, including product seizure and injunctions.