FDA WARNING_LETTER - Prollergy Corporation/Ready Set Food - October 20, 2020

The FDA issued a Warning Letter to Ready Set Food regarding their "Ready Set Food brand Introduction Stage 1" product, citing serious violations of the Federal Food, Drug, and Cosmetic Act. The FDA reviewed the product label and company website (www.readysetfood.com) in January, March, and April 2020.

The primary violation is that the product is marketed as an unapproved new drug. Claims on the website, social media, and promotional materials, such as "Prevention is possible," "Reduce the risk of your baby developing allergies by up to 80%," and "Protect Your Baby From Food Allergies," establish the product's intent for use in the cure, mitigation, treatment, or prevention of disease. Since the product is not generally recognized as safe and effective for these uses, it is considered a "new drug" under section 201(p) of the Act and lacks the required FDA approval for interstate commerce.

Additionally, the product is deemed a misbranded dietary supplement. Violations include unauthorized health claims on the label and website, such as "Exposing infants to allergenic foods early and often may reduce the risk of developing food allergies by up to 80%," which are not authorized by regulation or notification, and are impermissible for products intended for infants under two years of age. The claims also exceed the scope of FDA's limited enforcement discretion for qualified health claims related to peanut allergy in infants with