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12 June, 2025 |
Food Safety
|
Prohibition of Red Dye N°3 – FDA.
Authors: D. Pena and C. Valenzuela. I Technical Developer
Recently, the US Food and Drug Administration (FDA) made a historic decision to ban
the use of the artificial color known as Red No. 3 in food and medicine. This coloring is
widely used to give a vibrant red color to a variety of products, including candies,
sweets, cereals, beverages, and drugs. But what led the FDA to make this decision, and
what implications does it have for the food industry and consumers?
What is Red Dye No. 3?
It is a synthetic dye that has been part of the food industry for decades, particularly in
products intended for children, such as candy and beverages, as well as in some oral
medications, including cough syrups. However, its popularity has been undermined by
concerns about potential health risks.
In animal studies, particularly in rats, the dye was shown to be potentially carcinogenic,
which eventually led the FDA to review its use.
The Prohibition: Why Did It Happen?
The primary reason behind the FDA’s ban on Red No. 3 is related to health risks detected
in scientific studies. Research conducted on rats exposed to this dye revealed a
possible link to cancer development. However, no direct link has been found between
Red No. 3 and cancer in humans. The FDA acted under the precautionary principle
(Delaney Clause), as public health is its top priority. In an official statement, the FDA
indicated that, although no definitive evidence has been presented on the risk to
humans, the precautionary principle in public health matters is fundamental, which led
to its decision to remove this colorant from the market.
Learn more at the following link: FD&C Red No. 3 | FDA
Impact on the industry.
This will affect not only food manufacturers but also the pharmaceutical and cosmetic
industries that use the colorant. Replacing the dye with safer alternatives is a logistical
and financial challenge, but it is an essential step toward improving food safety and
protecting consumer health.
Although the ban will be gradual, consumers may begin to see products without this
colorant on the market, which could contribute to greater awareness of artificial
additives in food.
The banning of Red No. 3 marks an important milestone in the regulation of food additives,
sending a clear message about the importance of safety in the products we
consume. Although the elimination of this colorant may have some impact on
organizations, this type of decision is essential to ensure consumer protection and
encourage innovation towards safer alternatives, promoting an environment where
food, pharmaceutical, and cosmetic products are more transparent and safer for
everyone.
References:
[1] FDA. FD&C Red No. 3. Viewed online at FD&C Red No. 3 | FDA on 02/20/2025.
consume. Although the elimination of this colorant may have some impact on
organizations, this type of decision is essential to ensure consumer protection and
encourage innovation towards safer alternatives, promoting an environment where
food, pharmaceutical, and cosmetic products are more transparent and safer for
everyone.
References:
[1] FDA. FD&C Red No. 3. Viewed online at FD&C Red No. 3 | FDA on 02/20/2025.