DolCas Biotech has received GRAS (Generally Recognised as Safe) status for its BCM-95 turmeric extract for use in foods, dietary supplements and medical foods, following a comprehensive review by a panel of qualified experts. DolCas Biotech, in collaboration with Arjuna Natural Extracts, of India, conducted more than 24 clinical trials in the US, Europe, Japan and Australia, and has an ongoing clinical research programme on BCM-95's safety and application for health-related conditions.
The food ingredient safety evaluation was undertaken in accordance with US Food and Drug Administration (FDA) safety criteria whereby 'reasonable certainty of no harm under the intended conditions of use' must be established.
The GRAS evaluation was based on scientific procedures and substantial corroborative evidence derived from history-of-use considerations for related substances. Information obtained from animal studies, metabolism studies, estimated human exposure, in vitro studies, and refined chemical characterisation in the collective provided broad-based documentation of the safety of the chemical components of BCM-95.
Since curcumin is not well absorbed by the body, it benefits from an enhanced delivery system to increase its bioavailability. With BCM-95, the extracted curcumin is highly bioavailable thanks to the synergism between the curcumin itself and the compound ar-turmerone, an essential oil component of turmeric extract.
'The superior quality and analytical testing of the turmeric used for BCM-95 confirms the lack of contamination and ensures the finished product's purity,' says Nipen Lavingia, VP of Business Development of DolCas.
'DolCas has marketed BCM-95 in the US since 2006, enjoying a steady increase in demand,' adds KG Rao, CEO of Dolcas. 'Attaining GRAS status as a medical food is a strategic move that will position BCM-95 as a leading curcumin brand in the US market.'
The Expert Panel convened by GRAS Associates, concluded that BCM-95, when being used in accordance with the designated food uses and use levels, is GRAS when consumed as proposed at a maximum of 180mg per person per day in conventional foods, and at 1000mg per person per day in medical foods. The panel addressed chemical composition and purity of BCM-95 in detail, and evaluated the manufacturing process utilised to produce the subject material.
The panel determined that production in accordance with FDA Good Manufacturing Practices (GMPs) criteria yielded BCM-95 with an acceptable purity that met appropriate food grade specifications.
'We intend to promote BCM-95 for use in medical foods for various conditions, at a dose level of 500mg per serving,' explains Lavingia. 'If two servings of the subject medical food were consumed daily, the daily dietary exposure level of curcumin would be 1,000mg per person.'
