FDA APPROVES NEW SPARKLE FOR Rx DRUGS

Published Online: Friday, September 1, 2006
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The FDA has approved new pharmaceutical pigmentation rules that are likely to give extra sparkle to the pills and tablets dispensed by American pharmacists. Under the new regulations, manufacturers will be allowed to use "pearlescent pigments" in virtually all oral human drugs, including tablets, pills, and liquids. Similar to the coloring agents used in many cosmetics, the new pigments can produce metallic or satiny finishes on drugs and can even be used to provide extra coloring.

The pigments are made by coating the mineral mica with either titanium dioxide or iron oxide—substances used to add luster to everything from lipstick to automobile paint. Under the new rules, the pigments cannot make up more than 3% of the weight of a drug.

According to the FDA, "there is no toxic potential when [pigments are] ingested at levels estimated by the agency."



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