UAS Statement on Recent FDA Actions
“1. Our product is not under question. Our facilities were recently inspected by the FDA and our products are safe and effective. People do not need to worry about the probiotics they are taking.
“2. What is at issue with the FDA are certain statements made on our website that the FDA believes expand our labeling to imply that our products can be used to treat or cure certain health conditions. We are removing and/or modifying this language to be in compliance with FDA requirements and are working with the FDA to resolve this issue. We are in contact with our FDA representatives and expect to resolve this matter very soon. While we respect the FDA’s position, it is unfortunate that the matter could not have been resolved with a phone call or warning letter before taking action.
“A news release to address the situation will be issued soon.”