Hail Merry, LLC – FDA Warning Letter, Oct 19, 2011

On October 17-19, 2011, the FDA inspected Hail Merry, LLC's food manufacturing facility in Dallas, Texas, and reviewed product labels and their website. The inspection revealed that Hail Merry's products, including Grawnola Orange Cranberry, Merry's Miracle Tart Chocolate, Almonds Vanilla Maple, and Sunflower Seeds Salt n Black Pepper, are in violation of the Federal Food, Drug, and Cosmetic Act.

The FDA determined that Hail Merry's products are promoted for therapeutic uses, such as improving cholesterol, reducing inflammation, treating Type 2 Diabetes symptoms, and aiding in recovery from Celiac Disease, autism, and other conditions. These claims classify the products as "unapproved new drugs" under section 201(g)(1) and 201(p) of the Act, as they are not generally recognized as safe and effective for these uses and lack FDA approval. Furthermore, the products are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson for their intended drug uses.

Even if not considered unapproved drugs, the products are misbranded foods under section 403 of the Act due to several labeling violations: - Merry's Miracle Tart Chocolate bears a false and misleading "good fats" claim due to high saturated fat content. - Nutrient content claims like "RICH IN OMEGAS," "Coconut oil is cholesterol free