FDA WARNING_LETTER - Healthtime dba Deer Garden Foods - June 30, 2014

On July 24, 2014, the FDA issued a Warning Letter to Healthtime dba Deer Garden Foods, specifically addressing Mr. Evan J. Richards, following a June 2014 review of the firm's websites: www.rejuvenative.com and www.rawoils.com.

The FDA determined that products such as "100% Organic Evening Primrose Oil," "Spicy Kim-Chi," "Fresh Raw Almond Butter," and "Organic Ginkgo Green Caffeine Tea" were promoted with therapeutic claims, causing them to be classified as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Examples of these claims include "anti-inflammatory," "reduce irritable bowel flare-ups," "lessen joint pain and reduce swelling caused by rheumatoid arthritis," "prevent and in some cases reverse diabetes-associated nerve damage," "fight damage caused by multiple sclerosis," "reduce the symptoms of eczema," "cancer-fighting," "anti-bacterial," "antibiotic," "reduce the growth of cancer," "reduce cholesterol and the risk of heart disease," and "guard against cancer."

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates section 505