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参考資料２－１ FDA to Revoke Authorization for the Use of Red No. 3 in Food andIngested Drugs［597KB］ (1 ページ)
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| 出典情報 | 薬事審議会 医薬品等安全対策部会安全対策調査会（令和6年度第11回 3／25）《厚生労働省》 |
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令和７年３月25日
令和６年度第11回医薬品等安全対策部会
安全対策調査会
参考資料２－１
FDA to Revoke Authorization for the Use of Red No. 3 in Food
and Ingested Drugs
Constituent Update
January 15, 2025
The FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on
the Delaney Clause (https://www.fda.gov/about-fda/changes-science-law-and-regulatoryauthorities/part-iii-drugs-and-foods-under-1938-act-and-its-amendments) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (https://www.fda.gov/regulatory-information/laws-enforcedfda/federal-food-drug-and-cosmetic-act-fdc-act). The FDA is amending its color additive regulations
(https://www.federalregister.gov/public-inspection/2025-00830/petition-color-additive-center-forscience-in-the-public-interest-et-al-request-to-revoke-color) to no longer allow for the use of FD&C
Red No. 3 in food and ingested drugs in response to a 2022 color additive petition
(https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=FAPCAP&id=CAP_3C0323&sort=Petition_Type_Number&order=ASC&startrow=1&type=basic&search=red).
The petition requested the agency review whether the Delaney Clause applied and cited, among
other data and information, two studies that showed cancer in laboratory male rats exposed to high
levels of FD&C Red No. 3 due to a rat specific hormonal mechanism. The way that FD&C Red No.
3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red
No. 3 for humans are typically much lower than those that cause the effects shown in male rats.
Studies in other animals and in humans did not show these effects; claims that the use of FD&C
Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available
scientific information.
The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act,
prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer
in humans or animals. This is not the first time the agency revoked an authorization based on the
Delaney Clause. For example, in 2018, the FDA revoked the authorization for certain synthetic
flavors (https://www.fda.gov/food/hfp-constituent-updates/fda-removes-7-synthetic-flavoringsubstances-food-additives-list) based on the Delaney Clause in response to a food additive
petition.
FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. The
FDA estimates that FD&C Red No. 3 is not as widely used in food and drugs when compared to
other certified colors (https://www.fda.gov/food/food-ingredients-packaging/color-additivesinformation-consumers) based on information available in third-party food product labeling
databases, food manufacturers’ websites and other public information, and the FDA’s certification
data. FD&C Red No. 3 has been primarily used in certain food products, such as candy, cakes and
cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs.
令和６年度第11回医薬品等安全対策部会
安全対策調査会
参考資料２－１
FDA to Revoke Authorization for the Use of Red No. 3 in Food
and Ingested Drugs
Constituent Update
January 15, 2025
The FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on
the Delaney Clause (https://www.fda.gov/about-fda/changes-science-law-and-regulatoryauthorities/part-iii-drugs-and-foods-under-1938-act-and-its-amendments) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (https://www.fda.gov/regulatory-information/laws-enforcedfda/federal-food-drug-and-cosmetic-act-fdc-act). The FDA is amending its color additive regulations
(https://www.federalregister.gov/public-inspection/2025-00830/petition-color-additive-center-forscience-in-the-public-interest-et-al-request-to-revoke-color) to no longer allow for the use of FD&C
Red No. 3 in food and ingested drugs in response to a 2022 color additive petition
(https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=FAPCAP&id=CAP_3C0323&sort=Petition_Type_Number&order=ASC&startrow=1&type=basic&search=red).
The petition requested the agency review whether the Delaney Clause applied and cited, among
other data and information, two studies that showed cancer in laboratory male rats exposed to high
levels of FD&C Red No. 3 due to a rat specific hormonal mechanism. The way that FD&C Red No.
3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red
No. 3 for humans are typically much lower than those that cause the effects shown in male rats.
Studies in other animals and in humans did not show these effects; claims that the use of FD&C
Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available
scientific information.
The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act,
prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer
in humans or animals. This is not the first time the agency revoked an authorization based on the
Delaney Clause. For example, in 2018, the FDA revoked the authorization for certain synthetic
flavors (https://www.fda.gov/food/hfp-constituent-updates/fda-removes-7-synthetic-flavoringsubstances-food-additives-list) based on the Delaney Clause in response to a food additive
petition.
FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. The
FDA estimates that FD&C Red No. 3 is not as widely used in food and drugs when compared to
other certified colors (https://www.fda.gov/food/food-ingredients-packaging/color-additivesinformation-consumers) based on information available in third-party food product labeling
databases, food manufacturers’ websites and other public information, and the FDA’s certification
data. FD&C Red No. 3 has been primarily used in certain food products, such as candy, cakes and
cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs.