FDA June Announcements: New Qualified Health Claims and treatments approved
FDA has announced recent approvals in June. We would like to highlight the approval granted to EPA and DHA Omega-3 supplements as well as to a treatment for paediatric patients. The Victoza (liraglutide) injection is a form of treatment for paediatric patients who are 10 years and older and who are diagnosed with type 2 diabetes. Type 2 diabetes is the most common form of diabetes, occurring when the pancreas cannot make enough insulin to keep blood sugar at normal levels. Diabetes is a major cause of blindness, kidney failure, heart attacks, stroke and lower limb amputation. In 2016, an estimated 1.6 million deaths were directly caused by diabetes. Another 2.2 million deaths were attributable to high blood glucose in 2012**. Almost half of all deaths attributable to high blood glucose occur before the age of 70 years. WHO estimates that diabetes was the seventh leading cause of death in 2016.
The efficacy and safety of Victoza for reducing blood sugar in patients with type 2 diabetes was studied in several placebo-controlled trials in adults and one placebo-controlled trial with 134 paediatric patients 10 years and older for more than 26 weeks.
Lisa Yanoff, M.D, the acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Centre for Drug Evaluation and Research stated: “The FDA encourages drugs to be made available to the widest number of patients possible when there is evidence of safety and efficacy”.
Along with this the FDA has also announced New Qualified Health Claims for EPA and DHA Omega-3 Consumption and the Risk of Hypertension and Coronary Heart Disease. This was in a response to a health claim petition carried out by the Global Organisation for EPA and DHA Omega-3’s. The FDA determined that the overall evidence did not meet the “significant scientific agreement” standard required for an authorized health claim but did meet the “credible evidence” standard for a qualified health claim in the labelling of conventional foods and dietary supplements. To prevent consumer deception about the strength of the science underlying the new claim, the qualified health claim must be accompanied by a disclaimer or other qualifying language that accurately describes the level of scientific evidence supporting the claim.
Adherence to the principles of good clinical practice (GCP), including human subject protection (HSP), is universally recognized as a critical requirement to the ethical conduct of research involving human subjects. The Food and Drug Administration (FDA) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP.
At Atlantia, we are experts in delivering ICH-GCP standard clinical studies for functional foods & beverages, nutraceuticals, medical foods, dietary supplements, probiotics and live therapeutics. Contact us today to schedule a free clinical trial consultation with our experts!