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Food, drug, and cosmetic dyes
See also Hair dyes , Ocular dyes
General information
The US Federal Food, Drug and Cosmetic Act (1938) [ ] defined three classes of certifiable colors:
- 1.
FD&C colors: for use in coloring food, drugs, and cosmetics.
- 2.
D&C colors: for use in coloring drugs and cosmetics intended for internal application or ingestion.
- 3.
External D&C colors: for use in coloring drugs and cosmetics intended for external application only (excluding mucous membranes).
These dyes ( Tables 1 and 2 ), some of which also have E numbers, are used to color foods, cosmetics, and other substances, including pharmaceutical formulations and oral rehydration solutions [ ]. They are sometimes added to enteral feeds in order to detect pulmonary aspiration [ ]. Brilliant blue G has been used to stain the retinal surface during vitrectomy and macular surgery; adverse reactions have not been reported in association with this use [ ].
Table 1
Food, drug, and cosmetic (FD&C) dyes
| Dye | E number | Other names |
|---|---|---|
| FD&C Blue 1 | E 133 | Brilliant blue |
| FD&C Blue 2 | E 132 | Indigotine; indigo carmine |
| FD&C Citrus Red 2 | – | – |
| FD&C Green 3 | – | Fast green |
| FD&C Orange B | – | – |
| FD&C Red 3 | E 127 | Erythrosin |
| FD&C Red 40 | E 129 | Allura red |
| FD&C Yellow 5 | E 102 | Tartrazine |
| FD&C Yellow 6 | E 110 | Sunset yellow |
Table 2
Drug and cosmetic (D&C) dyes
| Dye | Other names |
|---|---|
| D&C Black 2 | Carbon black |
| D&C Black 3 | Bone black |
| D&C Blue 4 | Alphazurine FG |
| D&C Blue 6 | Indigo |
| D&C Blue 9 | Indanthrene blue |
| D&C Brown 1 | Resorcin brown |
| D&C Green 5 | Alizarin cyanine green F |
| D&C Green 6 | Quinizarine green SS |
| D&C Green 8 | Pyranin |
| D&C Orange 4 | Orange II |
| D&C Orange 5 | Dibromofluorescein |
| D&C Orange 10 | Diiodofluorescein |
| D&C Orange 11 | Erythrosine yellowish Na |
| D&C Red 6 | Lithol rubin B |
| D&C Red 7 | Lithol rubin B Ca |
| D&C Red 17 | Sudan III |
| D&C Red 21 | Eosin free acid |
| D&C Red 22 | Eosin YS |
| D&C Red 27 | Fluoran |
| D&C Red 28 | Phloxin B |
| D&C Red 30 | Helindone pink CN |
| D&C Red 31 | Brilliant lake red R |
| D&C Red 33 | Acid fuchsin |
| D&C Red 34 | Lake bordeaux B |
| D&C Red 36 | Flaming red |
| D&C Red 39 | Alba red |
| D&C Violet 2 | Alizurol purple SS |
| D&C Violet 2 Ext | Alizarin violet |
| D&C Yellow 7 | Fluoran |
| D&C Yellow 7 Ext | Napthol yellow S |
| D&C Yellow 8 | Uranine |
| D&C Yellow 10 | Quinophthalone, quinoline yellow, E104 |
| D&C Yellow 11 | Quinoline |
Most reports of adverse reactions to these dyes relate to tartrazine in pharmaceutical products, mostly allergic reactions [ ]. Indigo carmine has been associated with both hypertension and anaphylactoid reactions causing hypotension. Reports of adverse reactions to the D&C dyes are rare.
Organs and systems
Cardiovascular
Intravenous indigo carmine can cause transient alpha-adrenoceptor stimulation, increasing total peripheral resistance, diastolic and systolic blood pressures, and central venous pressure, and reducing cardiac output, stroke volume, and heart rate [ ]. Severe hypertension has been reported [ ], in association with a large increase in systemic vascular resistance index and a small increase in cardiac index [ ]. In one case acute left ventricular failure was attributed to peripheral vasoconstriction, with reduced cardiac output and increased pulmonary artery pressure [ ].
Cerebral vasoconstriction has also been attributed to indigo carmine [ , ].
In other cases hypotension has been reported, presumably due to acute histamine release as part of a non-IgE-mediated anaphylactic (anaphylactoid) reaction [ ].
Indigo carmine has been associated with atrioventricular block [ ] and polymorphous supraventricular bigeminy [ ].
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