FDA approves Colorcon’s iron oxide petition for use in supplements

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, explained the company in a release.

The petition was filed in response to requests from dietary supplement manufacturers for more stable and more label friendly pigment options. Iron oxides, which are widely used in the pharmaceutical and food industries, are extremely stable to light and chemical interactions, improving color stability for the end product.

“These highly stable colorants provide high opacity and good coverage when used for film coating of tablets,” ​explained Kelly Boyer, Colorcon’s Film Coating General Manager.  “They provide a broader color palette, widening the options available for branding and differentiation when used in combination with other pigments.  With our globally recognized color expertise, Colorcon will successfully utilize iron oxides as colorants across a broad range of dietary supplement applications, bringing an expanded spectrum of colors, with improved stability, to our customers.”   ​

Steve French of the Natural Marketing Institute (NMI) added: “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.”​

Information related to the approval is referenced in the Federal Register, USA, Docket Number FDA-2017-C-6238​