The U.S. Food and Drug Administration (FDA) on Wednesday revoked the authorization for the use of FD&C Red No. 3 in food and beverage products, as well as in ingested drugs.
The FDA is amending its regulations in response to a 2022 color additive petition, which sought agency review on whether the Delaney Clause applied and cited two studies conducted on rats. The clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food or color additive if it has been found to cause cancer in humans or animals.
FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. It has been primarily used in products such as candy, cakes and cupcakes, cookies, frozen desserts and frostings/icings, as well as certain ingested drugs.
The FDA estimates that FD&C Red No. 3 is not as widely used as other certified colors based on information available in third-party food product labeling databases, food manufacturers’ websites, other public information and the agency’s certification data.
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In response to the ruling, the National Confectioners Association issued a statement, noting that “food safety is the No. 1 priority for U.S. confectionery companies” and that they will “continue to follow and comply with FDA’s guidance” and safety standards.
The statement continued, “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.”
Several companies were quick to share their pleasure with the news. Julie Chapon, co-founder of Yuka, an independent project that helps consumers make better choices for their health by analyzing product ingredients, stated it was “about time.”
“Red Dye No. 3 has long been banned in Australia and restricted to a single product category (candied cherries) in Europe,” she said. “The FDA’s decision is a step forward, but we must continue to push for stronger regulations – dozens of risky additives are still allowed in the U.S.”
Manufacturers that 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 allow for certain uses of FD&C Red No. 3 (called erythrosine in other countries). However, imported foods must comply with U.S. requirements.
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