6 Oct 2022

What's the regulatory landscape for OTC products in Europe?

Nutraceuticals and over-the-counter (OTC) products are regulated by EFSA. The European Food Safety Authority (EFSA) states that human intervention studies are ‘central’ to health claim substantiation and are also the ‘top of the hierarchy’ that informs decisions. Just how much data is necessary to deliver a positive health claim opinion and what can we learn from tracking past published opinions of EFSA’s NDA Panel. What are the key deliverables for any human intervention study or package of human studies?

The key takeaways:

  • Health claims may not be quite as challenging to achieve as some people may think - as long as you design and deliver a consistent package of good quality human intervention studies.
  • Published scientific opinions from EFSA’s NDA Panel covering previous health claim applications offer a great resource to future health claim applicants.
  • The principle of GCP (Good Clinical Practice), is vital to delivering a study that will meet the expectations of EFSA reviewers.

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