FDA WARNING_LETTER - Hato Potrero Farm, Inc - November 07, 2007

On April 3, 2008, the FDA issued a Warning Letter to Hato Potrero Farm, Inc., following a November 7, 2007, inspection and subsequent review of product labels and the company's website (yogusto.com). The FDA identified serious violations of the Federal Food, Drug, and Cosmetic Act and 21 CFR.

The company's Yo Gusto? Smoothie Drinkable Yogurt products were deemed unapproved new drugs and misbranded drugs due to promotional claims on their website. Examples include claims that strawberries "kill certain viruses," peaches are "therapeutic particularly for cancer," guava "significantly reduce serum total cholesterol," and yogurt "combats yeast infections" and acts as an "anti-infection agent." These claims indicate the products are intended for disease diagnosis, cure, mitigation, treatment, or prevention, classifying them as new drugs requiring FDA approval. They are also misbranded for lacking adequate directions for use.

Furthermore, the yogurt products were misbranded foods due to unauthorized health claims, such as strawberries reducing cancer and guava reducing cardiovascular disease, which do not meet FDA requirements. Nutrition labeling deficiencies were also cited, including failure to declare trans fat, incorrect serving size expressions (e.g., 16 fl. oz. yogurt labeled as 1.5 servings instead of 1), improper indentation of nutrient names, and lack of hairline separators in the Nutrition Facts panel.

Additional comments included the misleading use of "