History of Use Searches and Traditional Use Searches
The regulatory approval of nutraceuticals, OTC’s and herbal medicines in the EU and elsewhere, history of use (HoU) and Traditional use (TU) searches have become an important part of obtaining regulatory approval for OTC’s, supplements, herbal medicines and novel foods.
Over the past 20 years we have been involved in a large number of these types of searches and have become experts in research, information gathering and interpretation of the results in this area.
History of Use (HoU)
For history of use searches we use google and other search engines but these start to become a weak source of information once you need to collect information from before 1997 as in the case in the EU for novel foods approvals or proving a food is “not novel” and therefore does not need regulatory approval to be on sale in the EU.
For traditional food status as a novel food, 25 years of use needs to be demonstrated as part of the safety assessment and approval process. This kind of data can be found in specialist trade magazines, government databases, exporters, importers and distributors. This is often very time consuming as old records of sales invoices are hard to find, there are often “trust issues” to overcome and frequently a cultural and language barrier exists which needs to be tactfully and thoughtfully implemented to be successful in this type of information gathering.
We also design questionnaires and with the correct legal agreements in place, undertake surveys and video interviews. We also produce mini documentaries to provide a context and explanation of the HoU of a particular ingredient to support dossier submissions (often in interviews with the regulators) and also for promotion on companies websites, providing consumers with an historical perspective on particular ingredient or product. If the HoU requires interviews with indigenous or minority cultures, we use tried and tested ethnobotanical research methods to gather the information in a culturally sensitive way and arrange for IP agreements to be in place where necessary.
We have undertaken such work to trace ant farms in the Himalayas’s for proving the HoU of edible Chinese Ants, Interviews in Brazil on the use of exotic fruits and collecting HoU for Baobab fruit in Africa for approval as a novel food in the EU.
Traditional use searches (TU)
For traditional use to support medicinal claims and indications for herbal medicines in the EU, the “so called” 30/15 rule applies and detailed “traditional use” surveys are needed. Here the emphasis is on HoU for supporting medicinal claims rather than to support safety as in
the case of the regulatory approval of foods.
We have specialist knowledge in this area and can quickly gather information on existing and previous product licenses in the EU, collect data on “non licensed” products” in and outside of the EU (especially the USA, Asia and South America) and have access to specialist databases and archives to find relevant and often, difficult to find, information.
We apply expertise in pharmacognosy, phytochemistry, pharmacology and ethnobnotany and combine this with “state of the art” business intelligence techniques to gather information to support dossiers, regulatory approval and the assessment of competitor products.
We also have specialist knowledge in broadening medicinal claims under traditional and well-established use in the EU and South America as well as advising clients on the use of claims and wording with regard to labelling. This also includes very specialist areas such as claims for use in TV advertisements and the use of brands and “families of products” to increase and broaden claim substantiation.
We also undertake strategic consulting and innovative approaches (the company was awarded the prestigious TOPRA global award for “Innovation in regulatory affairs“ in 2017) in the above areas, helping companies in the early stages of new product development or wanting to broaden their existing brand or portfolio.
Please contact us to find out more about work in HoU, TU and claims for nutraceuticals, drinks, supplements, herbal medicines and novel foods.