This week, the U.S. Food and Drug Administration (FDA) announced the revocation of approval for the use of FD&C Red No. 3 in food and ingestible 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 began in 2022 when the FDA was asked 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 the effects on humans have not been conclusively proven.
FD&C Red No. 3, a synthetic dye widely used in candies, cakes, cookies, ice cream, and ingestible medications, will be phased out gradually:
This regulation affects not only U.S. producers but also international exporters. In many countries, Red No. 3 is still permitted, but any product containing this dye intended for import to the United States must comply with FDA rules. Failure to comply may result in:
The FDA reinforces its commitment to consumer safety using import alerts as a key enforcement tool. Once the ban is in effect, any food or ingestible drug containing Red No. 3 may be stopped at the border.
For both domestic manufacturers and international exporters, proactive action is critical. Reformulating products well in advance not only helps avoid penalties but also protects your investment and brand reputation.
The FDA provides a window to make necessary adjustments, but waiting until the last moment is risky. Staying ahead ensures your products remain competitive in the U.S. market.
If you need guidance on reformulating your products or ensuring compliance with FDA regulations, our team of experts at CORE can assist you every step of the way. Act now to safeguard your products, prevent sanctions, and maintain your presence in the U.S. market.
This week, the U.S. Food and Drug Administration (FDA) announced the revocation of approval for the use of FD&C Red No. 3 in food and ingestible 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 began in 2022 when the FDA was asked 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 the effects on humans have not been conclusively proven.
FD&C Red No. 3, a synthetic dye widely used in candies, cakes, cookies, ice cream, and ingestible medications, will be phased out gradually:
This regulation affects not only U.S. producers but also international exporters. In many countries, Red No. 3 is still permitted, but any product containing this dye intended for import to the United States must comply with FDA rules. Failure to comply may result in:
The FDA reinforces its commitment to consumer safety using import alerts as a key enforcement tool. Once the ban is in effect, any food or ingestible drug containing Red No. 3 may be stopped at the border.
For both domestic manufacturers and international exporters, proactive action is critical. Reformulating products well in advance not only helps avoid penalties but also protects your investment and brand reputation.
The FDA provides a window to make necessary adjustments, but waiting until the last moment is risky. Staying ahead ensures your products remain competitive in the U.S. market.
If you need guidance on reformulating your products or ensuring compliance with FDA regulations, our team of experts at CORE can assist you every step of the way. Act now to safeguard your products, prevent sanctions, and maintain your presence in the U.S. market.
