FDA WARNING_LETTER - Texas Aloe Corporation, Inc. - May 03, 2018

The FDA issued a Warning Letter to Texas Aloe Corporation, Inc. following inspections from April 25-May 3, 2018, and August 28-30, 2018, at their Mercedes, TX facility, and a review of their website, www.aloeking.com. The letter, dated April 3, 2019, identifies serious violations of the Federal Food, Drug, and Cosmetic Act.

The company's Aloe Vera Juice and Aloe Vera Leaves products are cited as unapproved new drugs and misbranded. Aloe Vera Juice is deemed an unapproved new drug due to claims on the website (e.g., "stopped my acid reflux problem") indicating intended use for disease treatment, making it a drug under 21 U.S.C. § 321(g)(1)(B). It is not generally recognized as safe and effective, thus a new drug under 21 U.S.C § 321(p), requiring FDA approval. It is also misbranded under 21 U.S.C. § 352(f)(1) for lacking adequate directions for use, as its intended uses (e.g., acid reflux) require professional supervision.

Aloe Vera Leaves are also an unapproved new drug due to claims like "treat wounds, skin infections, burns," making it a drug under 21 U.S.C