The Development of New Health Claims -
covers nutraceuticals, exotic fruits, novel foods, supplements, functional foods, some botanical extracts, nutricosmetics and oral cosmeceuticals - but NOT Herbal Medicines and Cosmetics.
Recent EU legislation, 2003/0165/EC (EC Nutrition and Health Claims Regulation & EU Regulation 1924/2006), has come into force that regulates all health claims that are associated with food based products (see:
Examples of a well established health claim would be “calcium is good for your bones” while claims such "phytosterols maintain healthy cholesterol levels", "Prebiotics help aid digestion" are now under evaluation.
This positive list will also include minimum levels of the ingredient that are responsible for the associated health claims. At this point, the manufacturer of a particular foodstuff which contains the acceptable levels of the ingredient, will be permitted to use the associated health claim on their product.
Specific health claims, such as “product X lowers cholesterol”, require authorisation from the EU, either through article 13 or article 14.
In practice, this means that all health claims must now be supported by scientific evidence which will be in the form of a human trial(s) but can also be substantiated by the active constitiuents or phytochemicals present in the product. This evidence will be evaluated and verified by the EFSA (European Food Safety Authority), who will ensure that such health claims are warranted from the data presented.
We have already helped many companies with this new directive. We have submitted claims to the FSA under article 13. We are also helping companies with article 13.5 and article 14 submissions by generating the claims and the supporting dossiers.
We work closely with the client to develop a number of health claims that fit into the marketing strategy of the company. We then use the scientific literature or "in house" studies to support the health claims.
We are also working with companies with what Herbal Sciences terms "stretch claims". This is where a company may not have clinical data on their product but other similar products or similar compounds / extracts do.
We use "proof of persuasion " arguments to justify the use of such claims. This approach, while not matching EFSA's requirements exactly, is sometimes the only route that small to medium size companies have to register their health claims. It is based on some of the following components:
*Chemical components and their concentration in the product.
*Mechanism of action.
* Clinical data - e.g., human clinical trials.
*Anticpated intended use.
Herbal Sciences is working with companies to experiment and work on the creative development and use of health claims and achieving regulatory approval.
Herbal Sciences International can also design and undertake the necessary studies and clinical trials in order for your company to successfully obtain authorisation from the EU for making health claims on your products.
We can also advise you on the most appropriate health claims you can make and also write and submit the application for you.
We can also help with local issues such as Trading Standards and also the ASA Advertising Standards Authority, which also monitors claims made in the media for medicinal and health products.
Contact Dr Wilkinson on +44 1376 320 354; +44 794 169 6409
or call us for free from anywhere in the world via Skype (www.skype.com). Our username is Herbalsi
E mail: info@herbalsciencesinternational.com
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