The FDA did not dispute the company's claims during the notice period
Hofseth BioCare submitted a notification to the FDA for the use of six structure function claims for ProGo’s bioactive peptides.
The claims on the US label are: “supports healthy ferritin and hemoglobin levels”, “helps maintain iron-rich blood”, “promotes energy utilisation”, “supports red blood cell production”, “supports gastrointestinal and immune system health” and “assists in iron absorption from your daily diet”.
The bioactive peptides are a non-iron containing product designed to maintain healthy levels of ferritin and hemoglobin. As such, Hofseth says, ProGo is free from the gastrointestinal (GI) effects seen with iron supplementation such as nausea, vomiting, constipation, and a metallic taste. These side effects can result in poor compliance and variable treatment outcomes with iron supplements.
“Our vision is to utilize all off-cuts from the fish farming industry to help develop tomorrow's diet and medicine, and now we are succeeding. Our research and procedures are strong. Hofseth BioCare is a unique example of how long-term investment results in world leading technology which enables the upcycling of waste into a valuable resource. We help the fish farming industry improve its sustainability, and at the same time we contribute to improving people’s lives through better health,” said Roger Hofseth, CEO of Hofseth BioCare.
The US structure function claims are based on two studies of ProGo in adults. Trial 1 was done with 48 otherwise healthy adults with iron deficiency anemia. Trial 2, a smaller, supporting study for safety, was done with 14 healthy adults with normal blood counts. Both trials used whey protein isolate (WPI) as the placebo. Unlike ProGo, WPI did not have a significant impact on ferritin or hemoglobin in either study.
Hofseth aims to identify the peptide fraction driving the positive effect on ferritin and hemoglobin by Q1 2021. This will enable encapsulation of the peptide fraction and the commencement of the next stage of clinical development of the bioactive peptides.
Currently dietary modification or iron supplementation, either via tablets or injection, are the only ways available to increase iron levels or absorption. Dietary modification is often impractical for social, economic or cultural reasons and iron supplementation frequently causes gastrointestinal side effects. Iron supplementation also carries the risk of toxicity from iron overload. As such, HBC believes that ProGo now provides a valuable non-iron containing option for the maintenance of healthy levels of ferritin and hemoglobin.