FD&C Red No. 3 (Erythrosine) Food Color: U.S. Regulatory Changes

After the Food color regulations in the United States have been changing, and FD&C Red No. 3, also known as erythrosine, has become an important consideration for candy manufacturers, importers and distributors serving the U.S. market.

Fufaton Candy has been monitoring these regulatory developments closely. Since 2023, Fufaton has taken a proactive approach and has not used FD&C Red No. 3 in candy products supplied to the United States.

For international candy buyers, understanding food-color regulations is an important part of selecting a reliable confectionery manufacturer. Ingredients that may be permitted in one country may be restricted or subject to different requirements in another market.

What Is FD&C Red No. 3?

FD&C Red No. 3 is a synthetic food color that provides foods and confectionery products with a bright red or cherry-red appearance. It is also known as erythrosine in many countries.

The color has historically been used in certain foods, including confectionery products, because of its strong red color and suitability for creating attractive candy designs.

The U.S. Food and Drug Administration regulates color additives used in food. Under U.S. law, color additives are subject to FDA approval before they can be used in foods, unless an applicable exemption applies.

FDA Revokes Authorization for Red No. 3 in Food

The regulatory situation changed significantly on January 15, 2025, when the U.S. Food and Drug Administration announced that it was revoking the authorization for FD&C Red No. 3 in food and ingested drugs.

The FDA's action was based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. The agency explained that studies had shown cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 through a rat-specific hormonal mechanism. At the same time, the FDA stated that this mechanism does not occur in humans and that available studies in humans and other animals did not show the same effect.

For food manufacturers, the important practical issue is that FD&C Red No. 3 is no longer authorized for use in food in the United States after the applicable transition period.

The FDA established January 15, 2027 as the deadline for manufacturers to reformulate foods containing FD&C Red No. 3. The separate deadline for ingested drugs is January 18, 2028.

From State Restrictions to a Nationwide FDA Action

Before the FDA's 2025 decision, several U.S. states had already taken action or considered restrictions concerning certain food additives, including Red No. 3.

This created an increasingly complicated situation for food manufacturers and exporters because products could face different requirements depending on the destination state.

The regulatory environment has now moved beyond only state-level restrictions. The FDA has revoked the federal authorization for FD&C Red No. 3 in food, meaning that manufacturers supplying food to the U.S. market need to consider the federal requirement as well.

For exporters, this is an important distinction. A candy product intended for the U.S. market must comply with applicable federal FDA requirements, regardless of whether a particular customer is located in a state that previously had its own restriction.

Fufaton's Approach to Red No. 3

Fufaton began taking a precautionary approach to FD&C Red No. 3 before the FDA's 2025 nationwide action.

Since 2023, Fufaton has stated that it does not use Red No. 3 in candy products supplied to customers in the United States.

This proactive approach helps Fufaton reduce the need for customers to make last-minute formulation changes as U.S. food-color regulations evolve.

For B2B candy importers, wholesalers and distributors, ingredient compliance is an important consideration when selecting an overseas confectionery supplier. A product that meets requirements at the time of an initial order may need to be reformulated if regulations change during the product's commercial life.

By avoiding Red No. 3 in U.S.-bound candy products, Fufaton aims to provide customers with a more straightforward approach to U.S. market compliance.

Why Food Color Compliance Matters for Candy Importers

Color is an important part of confectionery products. Bright colors are commonly used to create attractive lollipops, gummies, marshmallows, hard candies and other products.

However, the use of a particular color additive must always be considered in relation to the regulations of the destination market.

For international B2B buyers, food-color compliance can affect:

• Product formulation
• Ingredient declarations
• Product labels
• Regulatory compliance
• Import clearance
• Retailer requirements
• Customer specifications
• Product reformulation
• Long-term marketability

This is particularly important for exporters supplying multiple countries because food-color regulations are not necessarily identical worldwide.

Red No. 3 and International Candy Export

FD&C Red No. 3 is known as erythrosine in many international markets. The regulatory status of erythrosine can differ from country to country.

The FDA notes that other countries may permit certain uses of FD&C Red No. 3 under the name erythrosine. Therefore, the fact that an ingredient is restricted in the United States does not automatically mean that it has the same regulatory status everywhere else.

For this reason, Fufaton reviews product requirements according to the destination market rather than applying one formulation to every export market.

When customers request candy specifically for the United States, Fufaton can work with the buyer on the appropriate product formulation and ingredient requirements.

Choosing Alternative Food Colors

When reformulating a candy product, manufacturers may need to consider alternative color additives that are permitted for the intended use.

The FDA has indicated that replacing Red No. 3 may involve the use of other authorized color additives or, where appropriate, color additives derived from other sources. In 2025, the FDA also announced measures encouraging the food industry to accelerate the transition away from petroleum-based synthetic food dyes.

The choice of an alternative color depends on factors such as:

• The type of candy
• Desired color intensity
• Product pH
• Processing temperature
• Storage conditions
• Flavor system
• Regulatory requirements
• Target country
• Customer specifications

Therefore, replacing one color with another is not always a simple one-to-one substitution. Product testing may be required to achieve the desired appearance and stability.

What U.S. Candy Importers Should Check

Companies importing candy into the United States should review the complete ingredient statement and confirm that all food colors used in the product are permitted for the intended use under applicable FDA requirements.

Importers should pay particular attention to:

• FD&C color additives
• Ingredient declarations
• Product formulation
• Food-color specifications
• Applicable FDA regulations
• Customer and retailer requirements
• Country-specific formulation requirements
• Changes to U.S. food regulations

Color additives are regulated individually, and their permitted uses, restrictions and labeling requirements can vary. The FDA maintains information on approved color additives and their regulatory requirements.

Fufaton Candy for the U.S. Market

Fufaton supplies a wide range of confectionery products for international B2B customers, including:

• Marshmallow candy
• Marshmallow lollipops
• Gummy candy
• Gummy and chewy candy
• Jelly lollipops
• Hard candy
• Toy candy
• Fruit-flavored candy
• Seasonal confectionery
• Customized candy products

For U.S. customers, product formulations can be discussed according to the intended market requirements.

Fufaton's goal is to provide international buyers with attractive and competitive candy products while paying close attention to food regulations and customer specifications.

Proactive Compliance for International B2B Customers

International food regulations continue to evolve, and responsible manufacturers need to monitor changes that may affect their products.

Fufaton believes that proactive compliance can provide advantages for both manufacturers and customers. Rather than waiting until a regulation becomes an immediate problem, manufacturers can consider upcoming regulatory developments when developing or supplying products.

Fufaton's decision to avoid FD&C Red No. 3 in candy products supplied to the United States is part of this approach.

For importers and distributors, this can make it easier to plan product sourcing and reduce the risk of having to reformulate an existing product after a regulatory deadline approaches.

Important Regulatory Note

Food regulations can change, and the requirements applicable to a particular candy product may depend on its formulation, ingredients, intended use, labeling and destination.

The information in this article is provided for general informational purposes and should not be considered legal or regulatory advice.

U.S. importers and food businesses should verify the latest requirements directly with the U.S. Food and Drug Administration and, where appropriate, with qualified regulatory professionals before importing or selling food products in the United States.