The application was submitted to the FSA – the UK competent authority – by UK-based firm K&L Gates, on behalf of US firm Telomerase Activation Science Inc (T.A Sciences) for the compound known as cycloastragenol.
Cycloastragenol (sometimes referred to as cycloastragenol-TA65 or TA65) is extracted from Astragalus trojanus, a perennial flowering shrub of the Fabaceae family, and has been subject to in vitro research linking it with telomerase activation activity and changes in metabolic and cardiovascular health markers in people.
“The applicant intends to restrict the use Cyloastragenol-TA65 to food supplements (single dose of 8mg/day) which will be targeted at adults >25 years old,” said the FSA. “The applicant also notes that the company is particularly interested in the use of Cycloastragenol-TA65 in regard to physiological processes and functions that may decline with age and that may be mediated by telomerase activity.”
The firm noted that other species of Astragalus also contain cycloastragenol, particularly Astragalus membranaceus – adding that extracts from these species are available in food supplements in the European Union.
“The applicant advises that Astragalus (A. membranaceus) is a herb that has traditionally been used in a wide variety of herbal blends and “natural” remedies in China or other regions of Asia,” stated the FSA documentation. “The dried root of A. membranaceus is used in traditional Chinese medicine primarily as a tonic, especially for the spleen and lungs.”
“The MHRA has confirmed that Cyloastragenol-TA65 has no major pharmacological effect that would result in products being classed as medicinal. Assessment as a novel food is therefore required before it can be marketed in the EU as a food supplement.”
The FSA is now inviting expert views on the application for the use of cycloastragenol in food supplements. The deadline for comments is Monday 31 March 2014.