FDA bans use of Red No. 3 in food, ingested drugs
The Food and Drug Administration announced it is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act.
The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition.
The petition requested the agency review whether the Delaney Clause applied and cited, among other data and information, two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat specific hormonal mechanism. The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.
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The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals. This is not the first time the agency revoked an authorization based on the Delaney Clause. For example, in 2018, the FDA revoked the authorization for certain synthetic flavors based on the Delaney Clause in response to a food additive petition.
FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. The FDA estimates that FD&C Red No. 3 is not as widely used in food and drugs when compared to other certified colors based on information available in third-party food product labeling databases, food manufacturers’ websites and other public information, and the FDA’s certification data. FD&C Red No. 3 has been primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs.
Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until Jan.15, 2027 or Jan.18, 2028, respectively, to reformulate their products. Other countries still currently allow for certain uses of FD&C Red No. 3 (called erythrosine in other countries). However, foods imported to the U.S. must comply with U.S. requirements.
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In response to FDA's action, the National Confectioners Association issued the following statement,:"Food safety is the number one priority for U.S. confectionery companies, and we will continue to follow and comply with FDA's guidance and safety standards. Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework. We have been saying for years that FDA is the rightful national regulatory decision maker and leader in food safety."
The NCA continued, "For years, our industry has been calling for more transparency, more funding, and more staff resources for the FDA to continue fulfilling its mission, and it's time to put politics aside and work together to fund the FDA at levels that will allow it to continue this work. FDA's evaluation and risk assessment concluded that Red Dye 3 "meets the safety standard of a reasonable certainty of no harm required for a color additive. However, FDA revoked the use of Red Dye 3 in food and drugs because of a legal requirement known as The Delaney Clause."