AloeElite – FDA Warning Letter, Mar 30, 2011

On March 30, 2011, the FDA issued a Warning Letter to Organic Ease, Inc., d.b.a. AloeElite, after reviewing their website, www.aloeelite.com, in March 2011. The FDA determined that the product "AloeElite" is promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], due to therapeutic claims for cure, mitigation, treatment, or prevention of disease.

Examples of claims cited include: "Ulcerative Colitis, Crohn's Disease, Diverticulosis, Diverticulitis, Irritable Bowel Syndrome, Ulcers, Peptic Ulcer… Gastroenteritis… Hepatitis… Interstitial Cystitis, Nephritis… Celiac Disease, Fibromyalgia, Dermatosis… Lupus, Arthritis, Rheumatoid Arthritis." The website also claimed AloeElite's main ingredient, Aloe Mucilaginous Polysaccharides, works as a "potent anti-inflammatory," provides "powerful healing for many auto-immune disorders," and contains "antibacterial, antiviral, antifungal, and antiparasitic properties." Testimonials on the website and a Facebook page also made disease treatment claims.

The FDA stated that AloeElite is a "new drug" under section 2