FDA WARNING_LETTER - Michelle's Miracle, Inc. - June 30, 2012

The FDA reviewed Michelle's Miracle, Inc.'s website in June 2012 and determined that four tart cherry concentrate products were promoted for conditions that classify them as unapproved new drugs under the FD&C Act. The products, including "Michelle’s Miracle® Joint Formula Tart Cherry Concentrate Dietary Supplement," were marketed with therapeutic claims for diagnosis, cure, mitigation, treatment, or prevention of diseases like gout, arthritis, joint pain, inflammation, and heart disease. Examples of claims included "relieve gout, arthritis and joint pain" and "inhibited COX enzymes comparable to ibuprofen and naproxen."

These products are considered "new drugs" because they are not generally recognized as safe and effective for their claimed uses and lack prior FDA approval. Additionally, they are misbranded because adequate directions for use by a layperson cannot be provided for conditions not amenable to self-diagnosis and treatment.

Furthermore, the products are misbranded as dietary supplements due to false and misleading labeling. The claim "Always fresh from the farm to the bottle" is false, as the products are flash-pasteurized and made from frozen concentrate. Nutrient content claims like "rich source of antioxidants" are also misbranded because they do not comply with regulatory requirements, specifically by failing to name the specific antioxidant nutrients or link them to the claim.

Michelle's Miracle, Inc. was required to notify the FDA within fifteen working days of the specific steps taken to correct these violations and prevent recurrence. Failure