FDA Allows Use of Spirulina Extract in Drug Coating Formulations

The FDA is amending its color additive regulations to allow for the use of spirulina extract in coating formulations for drug tablets and capsules — giving drugmakers an alternative blue color that is exempt from safety certification requirements.

Currently, drug companies are limited to using FD&C Blue #1 or FD&C Blue #2, both of which require batch safety certification, says David Schoneker, director of global regulatory affairs at excipients maker Colorcon, which petitioned for the extract’s use.

In its petition, Colorcon referenced the safety determinations the agency relied on in August 2013 and April 2014, allowing spirulina extract to be used as a color additive in candy, chewing gum, ice cream, cereals and other food items, according to a final rule published last week.

Schoneker expects companies will be interested in using the color to produce a blue, green or purple made from all exempt colors, which wasn’t possible in the past.

The rule takes effect Sept. 21. Read it at www.fdanews.com/08-21-15-SpirulinaExtract.pdf. — Kellen Owings