The newly-approved pigments include metallic, satin and shimmery finishes, and different hues of red and gold. They are made by coating the mineral mica with titanium dioxide, iron oxide, or both in combination. The new ruling allows pigments to make up three percent or less of a drug's weight. The FDA says that "there is no toxic potential when ingested at levels estimated by the agency." It has allowed them for use in tablets, liquids and pills.
The pigments were previously approved only for use in cosmetics, ink, and automotive paint. A director for Cadurin Pigments at EMD Chemicals says the company "hopes pharmaceutical companies it supplies will seize on the technology to give their drugs a look that is unique and hard to copy." EMD hopes they will also be approved in the near future for cereals, candy, chewing gum, and other uses.
EMD Chemicals has been lobbying the FDA on the issue for the last eight years. There is no word on how the new branding could affect double-blind, placebo-controlled studies that rely on the visual anonymity of medicines to eliminate bias in doctors and study participants.
Mike Adams, a consumer health advocate and frequent critic of pharmaceuticals, wasn't surprised by the FDA's approval of these cosmetic chemicals. "When an industry's products harm people more than they help, it will inevitably turn to hype, propaganda and cosmetic appeal in order to manipulate consumer perception," Adams says. He also notes that the chemicals have never been tested in combination with prescription drugs to see if there are synergistic toxicities that may not be readily apparent. "With this decision, the FDA continues to treat Americans like guinea pigs to be exploited for commercial interests," he adds.