FDA Bans Red No. 3, Artificial Coloring Used in Beverages, Candy, and Other Foods

In a move aimed at prioritizing consumer safety, the U.S. Food and Drug Administration (FDA) has banned the use of Red No. 3, a synthetic food dye commonly used in candies, cakes, cookies, and frozen desserts. The decision comes after studies in male rats showed a link between high doses of Red No. 3 and cancer.

Red No. 3, also known as erythrosine, has been used in various food products since its approval in 1958. However, concerns over its safety have been raised due to its potential carcinogenic effects. While the FDA has deemed Red No. 3 safe for human consumption at current levels, the agency has taken a precautionary approach to protect public health.

The Delaney Clause: A Key Factor in the Ban

The FDA’s decision to ban Red No. 3 is based on the Delaney Clause, a provision in the Federal Food, Drug, and Cosmetic Act that prohibits the FDA from authorizing food additives that have been found to induce cancer in humans or animals. The clause is named after Rep. James Delaney, who championed the legislation in the 1950s.

In the case of Red No. 3, the FDA has determined that the dye poses a cancer risk to humans, albeit at high doses. While the agency acknowledges that the current levels of Red No. 3 in food products are unlikely to cause harm, it has taken a proactive approach to protect public health.

Implications for Food Manufacturers

The FDA has given food manufacturers until January 15, 2027, to reformulate their products and phase out the use of Red No. 3. This means that companies will need to find alternative coloring agents to replace Red No. 3 in their products.

While the ban may pose some challenges for food manufacturers, many companies have already begun to transition away from artificial coloring agents like Red No. 3. Instead, they are opting for natural coloring agents, such as beet juice or turmeric, which are perceived as safer and more appealing to consumers.

International Perspective

The FDA’s decision to ban Red No. 3 is consistent with actions taken by regulatory agencies in other countries. For example, Red No. 3 has been banned in cosmetics and topical drugs in the United States since 1990. Similarly, countries like Australia, Japan, and European Union member states have restricted or banned the use of Red No. 3 in food products.

The FDA’s ban on Red No. 3 reflects the agency’s commitment to prioritizing consumer safety and protecting public health. While the ban may pose some challenges for food manufacturers, it is a necessary step towards ensuring that food additives do not pose unnecessary health risks. As consumers become increasingly aware of the ingredients in their food products, the FDA’s decision is likely to be welcomed by those who prioritize health and wellness.