What happened
Original notice title
Prollergy Corporation/Ready Set Food MARCS-CMS 606913, October 09, 2020
From the archived source record
Based on our review, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). Unapproved New Drugs The claims on your company website, where products can be purchased, establish that the Ready Set Food! brand products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of some of the claims observed on your website that provide evidence that your products are intended for use as drugs include, but may not be limited to, the following: Website, www.readysetfood.com: •“Food allergies are on the rise, and all babies are at risk. . .Prevention is possible.” • “Three clinical studies show that up to 80% of peanut, egg, and milk allergies can be prevented.” • “[W]e developed Ready, Set, Food! for our children because we wanted to make food allergy prevention safe and easy. . .” • “Food allergies are a growing problem across the world. I'm excited to partner with Ready, Set, Food! to start to reverse this growing epidemic. . .” (partial quote from Mark Cuban, firm investor) • “Reduce the risk of your baby developing allergies by up to 80%. We recommend using Ready, Set, Food! for at least 6 months, or until your baby is regularly eating peanut, egg, and milk.” • “Start Today And Protect Your Baby From Food Allergies” • “A scientific breakthrough in childhood food allergy prevention” • “[W]e now know that exposing babies to common allergenic foods early and often can significantly reduce their risk of developing food allergies.” • “Continue for 6+ months. Our mission is to provide parents food allergy peace of mind with Ready, Set, Food!. . .” • Testimonials: o “I am so grateful to have a product that made it so easy to drastically reduce my child's risk of food allergies.” o “I recommend Ready, Set, Food! for my patients because it's the easiest and safest way for parents to reduce their baby's risk of developing food allergies.” • Blogs: o “Ready, Set, Food!
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- df213ad2ac13
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →