FDA approves Colorcon’s iron oxide petition to expand colour spectrum

Colorcon, Inc. today announced the FDA’s approval of the Color Additive Petition (21 CFR 73.200) submitted by Colorcon for the use of iron oxide as a colour additive for use in dietary supplement tablets and capsules. The approval will allow the use of iron oxide in dietary supplement tablets and capsules (with a limit of 5 mg, the same as for US regulations for drugs), calculated as elemental iron, per day for labeled dosages, marketed in the United States. Colorcon currently offers a wide palette of colours with thousands of film coating formulation options. This now extends use into dietary supplements and supports the increasing drive for clean labelling.

Colorcon developed this petition in response to increasing requests from dietary supplement manufacturers for more stable pigment options, as they strive to meet consumer demand for more label friendly ingredients in their products. Iron oxides are widely used in the pharmaceutical and food industries around the world and are extremely stable to light and chemical interactions, improving colour stability for the end product. Extending the use of iron oxides into the USA nutritional arena enables an ever wider choice of colour for dietary supplements, providing distinct shades and hues to improve branding and product recognition.

Steve French, of the Natural Marketing Institute (NMI) explained: “As natural products across many product categories continue to gain momentum, it is clearly evident that this global trend is here to stay. This clean label phenomenon has permeated many consumer packaged goods, including dietary supplements and the use of ingredients such as iron oxide, among others, should benefit many manufacturers looking to meet increased consumer demand in the USA.”

The FDA, after their review of Colorcon’s requested amendment, agreed to expand the range of product categories in which iron oxide can be used to include dietary supplement tablets and capsules in the United States.

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“We are proud to be instrumental in expanding the use of iron oxides, especially for use in the dietary supplement industry," said Kelly Boyer, Colorcon’s Film Coating General Manager. “These highly stable colorants provide high opacity and good coverage when used for film coating of tablets. They provide a broader colour palette, widening the options available for branding and differentiation when used in combination with other pigments. With our globally recognised colour expertise, Colorcon will successfully utilise iron oxides as colorants across a broad range of dietary supplement applications, bringing an expanded spectrum of colours, with improved stability, to our customers.”