Goodbye to Red No. 3: New FDA Regulation
This week, the U.S. Food and Drug Administration (FDA) announced the revocation of authorization for the use of FD&C Red No. 3 in food and ingested drugs. The decision is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the approval of food additives or colorants linked to cancer in humans or animals.
The process leading to this resolution began in 2022, when the FDA was petitioned to review whether Red No. 3 violated the Delaney Clause. Studies revealed that male rats exposed to high levels of this dye developed cancer, which was sufficient for the agency to determine its prohibition, even though conclusive effects on humans have not been demonstrated.
Red No. 3, a synthetic dye widely used in candies, cakes, cookies, ice creams, and ingested drugs, will be phased out. Manufacturers have until January 15, 2027, to reformulate their food products and until January 18, 2028, for drugs containing this colorant.
Global impact on production and exportation
This measure not only affects U.S. producers but also international exporters. While many countries still allow the use of Red No. 3, any product containing this ingredient intended for importation into the U.S. must comply with U.S. regulations. Otherwise, exporters will face import alerts, customs detentions, economic sanctions, or even the destruction of their merchandise.
The FDA reinforces its commitment to consumer safety through the use of import alerts as a vital tool. Once this prohibition takes effect, any food or ingested drug containing Red No. 3 could be detained at the border.
How to prepare and comply with the regulations
For domestic manufacturers and international exporters, proactive measures are essential. Reformulating products in a timely manner not only helps avoid sanctions but also protects investments and brand reputation. The FDA has provided a window of time to make the necessary adjustments, but acting before the deadline is crucial to staying competitive in the U.S. market.
If you need to reformulate your products or ensure they comply with FDA regulations, contact us. Our team of experts can guide you through every step of the process to prevent sanctions, ensure compliance, and safeguard your market position. Act now to ensure your products remain competitive in the U.S. market.
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This week, the U.S. Food and Drug Administration (FDA) announced the revocation of authorization for the use of FD&C Red No. 3 in food and ingested drugs. The decision is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the approval of food additives or colorants linked to cancer in humans or animals.
The process leading to this resolution began in 2022, when the FDA was petitioned to review whether Red No. 3 violated the Delaney Clause. Studies revealed that male rats exposed to high levels of this dye developed cancer, which was sufficient for the agency to determine its prohibition, even though conclusive effects on humans have not been demonstrated.
Red No. 3, a synthetic dye widely used in candies, cakes, cookies, ice creams, and ingested drugs, will be phased out. Manufacturers have until January 15, 2027, to reformulate their food products and until January 18, 2028, for drugs containing this colorant.
Global impact on production and exportation
This measure not only affects U.S. producers but also international exporters. While many countries still allow the use of Red No. 3, any product containing this ingredient intended for importation into the U.S. must comply with U.S. regulations. Otherwise, exporters will face import alerts, customs detentions, economic sanctions, or even the destruction of their merchandise.
The FDA reinforces its commitment to consumer safety through the use of import alerts as a vital tool. Once this prohibition takes effect, any food or ingested drug containing Red No. 3 could be detained at the border.
How to prepare and comply with the regulations
For domestic manufacturers and international exporters, proactive measures are essential. Reformulating products in a timely manner not only helps avoid sanctions but also protects investments and brand reputation. The FDA has provided a window of time to make the necessary adjustments, but acting before the deadline is crucial to staying competitive in the U.S. market.
If you need to reformulate your products or ensure they comply with FDA regulations, contact us. Our team of experts can guide you through every step of the process to prevent sanctions, ensure compliance, and safeguard your market position. Act now to ensure your products remain competitive in the U.S. market.
This week, the U.S. Food and Drug Administration (FDA) announced the revocation of authorization for the use of FD&C Red No. 3 in food and ingested drugs. The decision is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the approval of food additives or colorants linked to cancer in humans or animals.
The process leading to this resolution began in 2022, when the FDA was petitioned to review whether Red No. 3 violated the Delaney Clause. Studies revealed that male rats exposed to high levels of this dye developed cancer, which was sufficient for the agency to determine its prohibition, even though conclusive effects on humans have not been demonstrated.
Red No. 3, a synthetic dye widely used in candies, cakes, cookies, ice creams, and ingested drugs, will be phased out. Manufacturers have until January 15, 2027, to reformulate their food products and until January 18, 2028, for drugs containing this colorant.
Global impact on production and exportation
This measure not only affects U.S. producers but also international exporters. While many countries still allow the use of Red No. 3, any product containing this ingredient intended for importation into the U.S. must comply with U.S. regulations. Otherwise, exporters will face import alerts, customs detentions, economic sanctions, or even the destruction of their merchandise.
The FDA reinforces its commitment to consumer safety through the use of import alerts as a vital tool. Once this prohibition takes effect, any food or ingested drug containing Red No. 3 could be detained at the border.
How to prepare and comply with the regulations
For domestic manufacturers and international exporters, proactive measures are essential. Reformulating products in a timely manner not only helps avoid sanctions but also protects investments and brand reputation. The FDA has provided a window of time to make the necessary adjustments, but acting before the deadline is crucial to staying competitive in the U.S. market.
If you need to reformulate your products or ensure they comply with FDA regulations, contact us. Our team of experts can guide you through every step of the process to prevent sanctions, ensure compliance, and safeguard your market position. Act now to ensure your products remain competitive in the U.S. market.
