FDA WARNING_LETTER - Goosefoot Acres, Inc.

On November 19, 2008, the FDA issued a Warning Letter to Goosefoot Acres, Inc., regarding their product "Dandy Blend" promoted on www.dandyblend.com. The FDA determined that "Dandy Blend" is promoted for conditions that cause it to be an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act.

The product's website made therapeutic claims, including "Potentially Helpful For . . . Diabetics . . . High blood pressure, high cholesterol, heart disease . . . Liver and gall bladder ailments . . . Cancer sufferers . . . Asthma sufferers." These claims establish the product as a drug intended for the cure, mitigation, treatment, or prevention of disease. As a new drug, "Dandy Blend" requires prior FDA approval, which it lacks, making its marketing illegal. Furthermore, the product is misbranded because it is offered for conditions not amenable to self-diagnosis and treatment, meaning adequate directions for layperson use cannot be provided.

Even if not classified as a drug, "Dandy Blend" would be misbranded as a food due to unauthorized nutrient content claims like "mineral rich" and "rich in trace minerals." The product does not meet the regulatory requirements of containing 20% or more of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) per reference amount customarily consumed (RACC) for these claims. The