FDA WARNING_LETTER - Yummy Earth Inc - April 02, 2015

On April 2, 2015, the FDA issued a Warning Letter to Yummy Earth Inc. following a March 2015 review of their YumEarth Organics organic pops labels. The product is deemed misbranded under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 343(r)(1)(A)] because it bears an implied nutrient content claim, "YumEarth was born...to feed our families a diet rich in delicious healthful foods," in connection with "100% Daily Vitamin C," but does not meet the requirements for a "healthy" claim.

Specifically, while the product contains 100% Daily Value for vitamin C per serving due to added ascorbic acid, the fortification of snack foods like candies is inconsistent with the FDA's fortification policy in 21 CFR 104.20. Therefore, the product fails to meet the criteria for a "healthy" nutrient content claim as per 21 CFR 101.65(d)(2).

Additionally, the FDA noted that the label claims "Made with Real Fruit Juice," but the ingredient statement does not identify currant and apple ingredients as juices. Yummy Earth Inc. must respond within 15 working days, detailing corrective actions and prevention measures, with documentation. Failure to comply may result in regulatory action, including seizure