FDA OKs Colorcon’s Color Additive

Colorcon, Inc. has received approval from the US Food and Drug Administration for its Color Additive Petition (CAP 4C0300) for the use of Spirulina Extract in coating formulations for dietary supplements, drug tablets,and capsules marketed in the United States.  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 its 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.

Source: Colorcon

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