Did the FDA Ban Red Number 3?

FDA has taken action to prohibit FD&C Red Number 3 in foods and drugs. Red Number 3 is also known as erythrosine. On January 16, 2025, FDA published a notice in the Federal Register revoking the authorized use in food and ingestible drugs of FD&C Red Number 3. The prohibition on using Red Number 3 in foods is effective January 15, 2027. For drugs it is effective January 18, 2028.

Did the FDA ban Red #3?

Yes FDA has banned Red #3 in food and ingestible drugs.

When does the ban go into effect?

For food: January 15, 2027.

For drugs: January 18, 2028.

Why did FDA ban Red #3?

The Center for Science in the Public Interest and other organizations petitioned FDA to repeal the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. FDA grated the petition.

Can foods be imported and sold with Red #3 before January 15, 2027?

Yes.

What is the status of foods containing Red #3 after January 15, 2027?

Foods containing Red Number 3 after January 15, 2027, will be considered adulterated. It is a violation of the Federal Food, Drug and Cosmetic Act to introduce, deliver or receive adulterated foods in interstate commerce (21 USC § 331).

What happens if I try to import foods containing Red #3 after January 15, 2027?

Foods containing Red #3 that are presented for entry may be refused. You are required to export or destroy refused foods with 90 days. You also may be placed on import alert which subjects your shipments to Detention Without Prior Examination (DWPE). DWPE means your shipments within the scope of the import alert will automatically be held by FDA. More information on import alerts may be found here.

Can you help us avoid FDA refusals for prohibited color additives?

Yes, we can review your products for prohibited color additives and other banned ingredients before you ship them to the United States. Learn more about our services here.