Posted July 13, 2012

FDA Warns of Aloe Drug Claims and Misbranding

On June 12, 2012, the FDA issued a warning letter to Set-N-Me-Free Aloe Vera Company concerning twelve of the company’s products. Based on how the products were promoted, the FDA regards the products as unapproved new drugs and misbranded, with labels that provided inadequate directions for use.

The FDA’s warning included the following products: Aloe Milk Moisturizing, Aloe Moisture Cream, Day-Night Emollients, Moisturizing Aloe Lotion, Aloe Comfrey Gel, Aloe Facial Cleanser, Aloe Stic, 99.5% Natural Aloe Liquid, Lavender Spa Bath, Aloe Heat Crème, Aloe Body Wash, and Set-N-Me-Free body wrap systems.

For more details regarding the FDA warning letter, use the link in red below.

You can learn more about aloe in the Natural Products Encyclopedia on ConsumerLab.com. Some of these products contain ingredients such as borage oil and vitamins A,B and E, in addition to aloe. See ConsumerLab.com’s Reviews of Borage Oil and Vitamins A, B and E for tests of other products containing these ingredients.