Non-synthetic color spectrum expands as FDA approves Colorcon’s Spirulina Extract petition

Colorcon has announced the FDA’s approval of the Color 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 US. Use of Spirulina Extract as a color additive provides opportunities for a wider palette of exempt (typically referred to as “natural”) colors, 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 colors, 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 colors are difficult to achieve using previously approved “natural” colorants. Incorporating pigments that are more “natural” requires specialized formulation and extensive stability programs to obtain the best quality results, including acceptable shelf-life for the final coated tablets. With our globally recognized color expertise, Colorcon will successfully utilize Spirulina Extract as a colorant across a broad range of applications, bringing an expanded spectrum of colors, with improved stability, to our customers.”