Clinical Trials to support Health and Nutrition Claims on Food

Recent EU legislation, 2003/0165/EC (EC Nutrition and Health Claims Regulation), has come into force that regulates all health claims that are associated with food based products (http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm).

Over the next three years, well established health claims that are in use throughout the EU, are being collated onto an EU positive list. An example of a well established health claim would be "calcium is good for your bones".

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. 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). 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.

Herbal Sciences International can 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.

Clinical Trials to support Novel Food Approvals

Novel food is defined as "food that has no significant history of consumption within the EU prior to 1997" (http://www.food.gov.uk/gmfoods/). This regulation, EC 258/97, was initially introduced to deal with the imminent arrival of GM derived food into the EU marketplace, however, the definition used to identify novel food also covers fruit, vegetables, herbs and spices from outside the EU borders. For approval under the Novel Food regulation, the applicant must demonstrate that the food is safe for consumers within the EU. There are two routes for obtaining approval under the novel food regulation - a full application or a substantial equivalence application. Either route requires submitting a report to one of the relevant authorities designated to evaluate these applications. A positive report from this authority is then passed to each of the EU members relevant authorities for evaluation, before the novel food is granted authorisation.

Herbal Sciences International has experience of successfully obtaining approval for food products under the Novel Food regulations.

This includes identifying the appropriate route for submission; carrying out all necessary analyses, clinical trials and toxicity testing as required; researching, collating and writing the final reports for submission.

Clinical Trials to support Traditional Herbal Medicines Product Directive Approvals

Since 30 October 2005, herbal medicines in the UK (http://www.mhra.gov.uk) are now controlled under the EU regulation, 2004/24/EC (Traditional Herbal Medicines Product Directive). Under this regulation, there is a provision to demonstrate the safety and efficacy of the

herbal medicine through traditional use within the EU for at least 30 years (or 15 years within the EU and 30 years outside the EU). Further, the herbal medicine must be now manufactured under GMP (Good Manufacturing Practice), however, the Traditional Herbal Medicines Product Directive does allow limited claims to be made.

Herbal Sciences International can evaluate and carry out the necessary analyses and clinical trials of herbal medicine products; research, collate and write the common technical document for submission to the MHRA (Medicines and Healthcare Products Regulatory Agency).

Clinical Trials to support GRAS and NDI Notifications

Any substance that is intentionally added to food is a food additive and therefore subject to premarket approval by the FDA unless the

substance is "Generally Regarded As Safe" or GRAS under the conditions of intended use (http://www.cfsan.fda.gov/~rdb/opa-noti.html).

Whether a substance is GRAS is determined either by evidence from published studies or from a general recognition of safety through a significant number of people consuming the food over a long period of time.

New Dietary Ingredients or NDI's (http://www.cfsan.fda.gov/~dms/ds-ingrd.html) are defined by the Dietary Supplement Health and Education

Act (1994) as any ingredient that was not marketed in the USA before 15 October 1994. Generally, this means that any manufacturer wishing to

market an NDI must submit a notice to the FDA that demonstrates that the ingredient is reasonably expected to be safe when consumed.

Herbal Sciences International can carry out the required analytical work and clinical trials, research and submission of reports necessary for securing approval of NDI (New Dietary Ingredients) and GRAS (Generally Regarded As Safe) applications .

Whether you are looking for a clinical trial, clinical study or human volunteer study to be conducted on a nutraceutical,

cosmeceutical, cosmetic, nutricosmetic, novel food, functional food, dietary supplement, herbal medicine, botanical drug or phytomedicine or other natural products we can conduct the following studies on behalf of our clients: