This section is being revised and brought up to date because the FDA has responded to the "Premier" Cosmetic Ink cluster of reactions.

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Background
As I understand it, the FDA position in principle is that it is up to consumers to avoid products that cause allergic reactions. Isolated cases and harm not disabling or life threatening, no morbidity or mortality, though of great concern and distress to the party affected, does not constitute a population-based public health threat. 

For tattoo there seems to have been too few incidents reported and no clusters that would cause the FDA to investigate on a routine surveillance timetable.