Artificial color certified "FD&C" is permitted by the Food & Drug Administration (FDA) to be added to foods, drugs and cosmetics. "D&C" means the certified color may be used only in drugs and cosmetics. These colorings were originally manufactured from coal tar, but today they are made from petroleum. The FDA certification rules list the permissible amounts of contaminants and residues such as lead, mercury, arsenic, and certain carcinogens such as benzidine. It is interesting to note that the D&C colors permitted only in cosmetics and in medications (and given to sick children) are often allowed to have twice the amount of lead contaminant as colorings allowed in food.

In commercially available FD&C Yellow #5 and #6, benzidine (which causes cancer) has been found in amounts up to 200 times the officially allowed level of only 1 part per billion. FD&C colorings continue to be listed as "Generally Recognized As Safe" (GRAS) despite studies showing neurological effects, DNA damage, and elevated cholesterol.

In 2006, almost 19 million pounds of color additives were certified by FDA inspectors. The FDA receives a "user fee" from the manufacturer for each pound of food dye certified. Note, that means each pound approved, not each pound examined.

Take a look at the research below. If you want to see more about a particular study, you can find it at our Research Pages.

Whether or not you have symptoms, you may wish to avoid these dyes now that you know what they are. The Feingold Association can show you how to enjoy a "normal American diet" without them.

Research:

ABDEL-AZIZ 1997 - In mice, Red #3 reduced sperm count by 50%, reduced the number of moving sperms by 57%, and increased the number of sperm abnormalities.

ABOEL-ZAHAB 1997 - A combination of food colorings were fed to healthy adult rats. Results included:

Decreased body weight, hemoglobin, and red blood cells

Increased thyroid hormone, cholesterol, triglycerides

Increased liver enzymes

Brown pigment deposit in liver and kidney tubular cells

Areas of hemorrhage in both liver and kidneys

The balance between types of white blood cells was abnormal

ALLEN 1984 - For most people with food intolerance, symptoms are caused by small molecules in the food or additives. These reactions are pharmacological (like drug side effects) and do not show up on IgE allergy testing.

AOSHIMA 1997 - The effects of certain chemicals and additives on GABA (inhibitory neuron) receptors were measured. Results indicated that food additives can measurably modulate the neural transmission in the brain, which "changes the frame of the human mind, as alcohol or tobacco does."

ASHIDA 2000 - Artificial food colors may impair hepatic (liver) function.

AUGUSTINE 1980 - In frog nerves, Red #3 produced a dose dependent increase in neurotransmitter release.

BAMFORTH 1993 - Yellow #5 and the artificial flavoring vanillin inhibit the enzyme dopamine sulfotransferase. Vanillin also inhibits by 50% the metabolism of a birth control medication which is sulfated in the liver.

CESERANI 1978 - Yellow #5 causes bronchoconstriction in some aspirin-sensitive people, just like aspirin.

D'SOUZA 1987 - Aspirin, Indomethacin and Yellow #5 (0.1-2.0 mg/kg) induced dose-dependent increases in carotid-sinus nerve (CSN) activity, accompanied by increases in mean arterial blood pressure.

EL-SAADANY 1991 - Synthetic colorings and flavoring were given to adult rats. Serum protein, RNA and T4 (thyroid) hormone were increased. Nucleic acid enzymes were stimulated in all the organs studied. G-6-PD and 6-PGD activity increased. Coloring and flavoring together resulted in the highest increases.

FOOD & DRUG ADMINISTRATION (U.S.) - "The color certification program is self-supporting because the law requires manufacturers to pay FDA a user fee for each pound of color the agency certifies."

• Note: They get paid per pound PASSED, not per pound EXAMINED - certainly a conflict of interest. In 2006 FDA certified almost 19 million pounds of color additives.

Food & Drug Administration (U.S.) - The colorings are not certified to be safe. FD&C colors are certified to have no more than the following amounts of contaminants such as the following:

• Benzidine, not more than 1 part per billion.

• Lead, not more than 10 parts per million.

• Arsenic, not more than 3 parts per million.

• Mercury, not more than 1 part per million.

FOOD & DRUG ADMINISTRATION PUBLIC HEALTH ADVISORY 2003 - Letter warning physicians of blue discoloration of the skin, urine, and feces, of metabolic acidosis and death when Blue #1 is used to color enteral (tube feeding) solutions. FDA says that since Blue #1 is a mitochondrial toxin, it is "plausible but not proven" as the cause. FDA says Blue #1 has been used for tube feeding for 30 years but never evaluated for safety.

GROTEN 2000 - Combining unrelated additives is not a health concern because of the low doses involved. Authors claim no actual research is necessary.

• Note: This report was copyrighted by the International Life Sciences Institute, formerly known as the Nutrition Foundation, and composed of the major food, chemical, and pharmaceutical companies, listed in part on page 20.

HEDMAN 1981 - Tiny amounts of Yellow #5 cause contractions in the trachea smooth muscle tissue of guinea pigs.

KOUTSOGEORGOPOULOU 1998 - Results showed clear immuno-suppressive effects of Red #2 and Yellow #5.

LANCASTER 1999 - FDA allows only 1 part per billion (1 ng/g = ONE nanogram per gram) of benzidine in food dyes because it is so highly carcinogenic. Testing commercially available food colors, Lancaster found levels up to 270 ng/g - MUCH higher than the amount allowed by FDA's own regulations.

Lau 2006 - Inhibition of neuron growth indicates neurotoxicity during development. Testing the amount of additives often found in snack foods, Lau combined Blue #1 + MSG, and Yellow #10 + Aspartame. The combinations were synergistic, far more toxic than expected by adding up the effect of each one tested alone. Blue #1 + MSG was 4 times as toxic, and Yellow #10 + Aspartame was 7 times as toxic.

• Note: Although Yellow #10 is not used in snacks in the U.S., it is commonly used in medications, cosmetics, etc.

NATIONAL ACADEMY OF SCIENCES 1979 - From 2 weeks of data on 12,000 people, the NAS determined that 99% of people eat up to an average of 327 mg food dye per person per day. For reasons unknown, they divided this number by 5, to set the average daily intake of food dyes at 65 mg per day.

REYES 1996 - All food dyes tested inhibit mitochondrial respiration. The percentage of inhibition varied per color, and was dose related. Note: Mitochondria control the energy in your cells. Inhibition is not good.

ROSENKRANZ 1990 - In chemical studies, one of the aromatic amines obtained upon reduction (a part of digestion) of Red #40 was unexpectedly mutagenic (making mutations or changes in DNA).

SASAKI 2002 - Low levels of each of the food dyes caused DNA damage in the mouse stomach, colon and bladder.

SWEENEY 1994 - Intestinal bacteria "reduce" the azo bond in azo dyes, producing superoxide free radicals, thus confirming that azo dyes are a source of genotoxic agents (resulting in mutations or cancer).

TANAKA 1993 - 2 generations of mice were fed low doses of Red #2. The pups weighed more, had trouble turning over and finding a source of smell. Movement was affected, and more pups died.

TANAKA 1996 - Yellow #6 was fed to 2 generations of mice. There were some (unspecified) adverse effects on litter size, weight, and sex ratio. The pups had trouble with surface righting (turning over), negative geotaxis (crawling upwards), swimming direction, and swimming head angle. Their difficulty was dose-related.

TANAKA 2001 - Red #3 was fed to 2 generations of mice. Movement and other changes were dose-related.

TANAKA 2006 - When mice ate Yellow #5, activity and body weight increased, and some developmental milestones changed. "Nevertheless," says Tanaka, "the actual dietary intake of tartrazine (Yellow #5) is presumed to be much lower."

• Note: This conclusion of safety is based on nothing but conjecture.

TSUDA 2001 - Very low doses of 3 azo food dyes caused DNA damage in the colon, lung, bladder, etc., when fed to mice. Damage was observable as early as three hours after they ate it. Tsuda says, "more extensive assessment of azo additives is warranted."

VORHEES 1983 - When rats ate Red #40, it reduced reproductive success, parent and pup weight, brain weight, survival, and female vaginal development. Running wheel activity decreased, and open-field rearing activity increased. Red #40 produced physical and behavioral toxicity in pups at high doses (10%).

WARD 1990 - Yellow #5 reduced zinc in blood and saliva, and increased urinary zinc of the ADHD children but not the controls. The zinc loss corresponded to deterioration in behavior and emotional responses.

WARD 1997 - In hyperactive children, Yellows #5 and #6 significantly lowered zinc levels, causing one or more of the following symptoms: Overactivity, aggression, violence, poor speech, poor coordination, asthma, eczema. Hyperactive children were low in zinc and iron, but high in aluminum, cadmium and lead.

WORM 2001 - In people with atopic dermatitis and food intolerance, additives (Yellow #5, benzoate, nitrite, etc.) cause white blood cells to make more leukotriene, a chemical contributing to allergic reactions and asthma.