The NDA found the product in question, OPC PremiumTM, which contains 40 mg oligomeric procyanidins (OPC) and 400 mg berry-blend per capsule, did not demonstrate causality despite the presence of 21 references and numerous human trials.
The NDA said all the studies were conducted on irrelevant substances and/or demonstrated irrelevant health outcomes to the claim in question.
The applicant, Dutch-based GP International Holding, forwarded a claim targeting males and females over the age of 30 that read: “Reduces blood cholesterol and may therefore reduce the risk of cardiovascular disease”.
The opinion can be found here .
