US FDA approves Colorcon’s spirulina extract petition
Colorcon has announced the FDA’s approval of the colour additive petition (CAP 4C0300) submitted by Colorcon for the use of spirulina extract.
This approval will allow the use of spirulina extract in coating formulations applied to dietary supplements, drug tablets and capsules marketed in the United States.
Use of spirulina extract as a colour additive provides opportunities for a wider palette of exempt (typically referred to as 'natural') colours, from solid blues through to vibrant greens and purple shades.
Colorcon developed this petition in response to ever-increasing requests from dietary supplement manufacturers for more naturally derived pigment options, specifically stable blue colours, which are difficult to achieve.
The FDA, after their review of Colorcon’s updated safety assessment and additional product stability testing performed by Colorcon, agreed to expand the range of product categories in which spirulina Extract can be used to include all types of pharmaceutical and dietary supplement tablets in the United States.
'We are proud to be instrumental in expanding the use of spirulina extract, especially for use in the dietary supplement industry,' said Kelly Boyer, Colorcon’s Film Coating General Manager. 'Blue and green colours are difficult to achieve using previously approved 'natural' colourants. Incorporating pigments that are more 'natural' requires specialised formulation and extensive stability programmes to obtain the best quality results, including acceptable shelf-life for the final coated tablets.'
'With our globally recognised colour expertise, Colorcon will successfully utilise spirulina extract as a colourant across a broad range of applications, bringing an expanded spectrum of colours, with improved stability, to our customers,' she added.
Information related to the approval is referenced in the Federal Register, USA, Docket Number FDA-2014-C-1552.