The United States Food and Drug Administration, the department tasked to ensure the safety the American food and drug supply, certifies over 11.5 million pounds of color additives a year. The use of coloring additives in food can be traced back to the Egyptians, but it has only recently become a real medical concern. Why the sudden problem? Progress and the 20th century boom in chemistry. Since the late 1950's, the food processing industries in North America have turned to using more exotic chemicals to color food, and in increasing doses. Perhaps the most famous case is that of the heavy use of suspected cancer-causing Red Dye #2.

During the 1800s, the birth of the processed food industry in North America also ushered in the age of food additives. Preservative chemicals saw heavy use in the new tinned food industry, as a means of preventing spoilage. Some preservation techniques discolored the products being packaged, so colorant additives soon came into widespread use. Chemicals previously employed in textile and chemical coloring where pressed into service with little or no human testing. At the dawn of the Twentieth century, a revolution in chemistry saw the bulk of food colorants being refined from petroleum and coal. Aniline, a chemical that is toxic in its unrefined form, was refined from bituminous coal and used extensively in the creation of the "coal-tar" family of colorants. Natural colorants, derived from plant, animal and mineral sources declined in popularity against these new chemical wonders, as they overcame the limitations inherent in their competitors: they could be used in very small amounts, they added no unwanted flavors and they could be made for a fraction of the cost.

In response to misuses of industrial textile dyes in food, and a growing concerns over an unregulated industry, the US Congress passed the Pure Food and Drugs Act in 1906, allowing the federal government to scrutinize and control colorant additive use. The government then went on to pass the Federal Food, Drug, and Cosmetic Act of 1938, which extended the FDA's mandate into the certification and regulation of all additives used in American foods, drugs and cosmetics. An "FD&C" label designates a chemical as being permitted for use in food, drugs and cosmetics within the United States. The famous labels applied to many coloring additives were assigned by the FDA after this law was passed. Red was the color used most often by food processors, and a purplish-red synthetic coal tar or azo dye called Amaranth was easily the most widely used. Designated Red Dye #2, it became the most widely used colorant overall. That was until 1960, when amendments to the Food, Drug, and Cosmetic Act of 1938 prohibited the use of potentially cancer causing chemicals in food products, even in minute amounts. The so-called "Delaney Clause" would have a direct impact on the industry in 1976.

FD&C Red Dye #2's true chemical name is Trisodium-2- hydroxyl -1-(4-sulphonato- 1-napthylazo) napthelene- 3-6-disulfonate. In 1969, Soviet scientists performing similar tests to those conducted by the FDA discovered that long-term usage of Red Dye #2, even at the low dosages found in foods, caused cancer in test subjects. Contrary to the Delaney Clause, the FDA conducted its own tests, following the Soviet guidelines. The results they received were inconclusive. Regardless, the word had gotten out to the public. The Health Research Group, a consumer action organization, launched a rabid campaign to have the dye banned. Giving into public and Congressional pressure, FDA banned FD&C Red No. 2 in 1976.

Even after the ban, the FDA refused to say the Red Dye #2 caused cancer. Within the FDA, The Toxicology Advisory Committee was tasked with finding a definitive link. Testing outside the parameters relayed to them by the Soviets, the Committee found "feeding FD&C Red No. 2 at a high dosage results in a statistically significant increase in malignant tumors in female rats."

This was still not absolute proof, but the sociological pressure to keep the ban in place remained. The FDA has since revised the wording of the ban to reflect the lack of overwhelming proof to note that the color cannot be proven definitely safe or nontoxic.

The effects of the ban where immediate and profound. People began to question exactly what the chemicals listed on food products actually were. A trend toward 'all-natural' foods, combined with a new awareness of how foods where being processed lead to manufacturers limiting the amount of additives they used in manufacturing. Preservative chemicals long assumed safe were reexamined. Some companies even reduced or halted marketing of red colored products after the ban, as consumers assumed they were unsafe.

It should be noted that this lack of definite proof has lead other countries to allow the use of the dye. The United Kingdom, Canada and a majority of the EU allow its use in products today. The stigma attached to the Red Dye #2 remains a uniquely American phenomenon. The ban also leads some food manufacturers to not ship their products to the US. The replacement for Red Dye #2 in the United States is FD&C Red #40, and it has become the most widely used colorant in food products worldwide, largely filling the niche left by its mysterious cousin.

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