On January 16, 2025 the federal Food and Drug Administration (FDA) issued notice requiring manufacturers to reformulate their products removing Red Dye No. 3 by January 15, 2027 for food (21 CFR §74.303) and January 18, 2028 for drugs (21 CFR §1303). Use of the substance in cosmetics and applied drugs was not authorized in 1990.
The action by FDA was in response to a 2022 color additive petition citing decades-old data showing cancer “induced” in laboratory male rats exposed to high levels of Red Dye No. 3. FDA states that a repeal requires “new data”, yet the only “new data” is a 2020 World Health Organization (WHO) report which cited the decades-old literature and, with respect to the estimated lifetime exposure “the Committee concluded that dietary exposures to erythrosine (Red No. 3) for all age groups do not present a health concern.”
In revoking the authorization, the FDA focused on provisions of the Food Drug and Cosmetic Act known as the Delaney Clause (21 U.S.C. §379e and §348(c)(3)), which were enacted in 1960 and prohibit authorization of a food or color additive found to “induce cancer” in humans or animals. The FDA found that the Delaney Clause limits its discretion to determine the safety of color additives that are intended to be ingested “if it has been found to induce cancer when ingested by humans or animals, regardless of the probability, or risk, of cancer associated with exposure to the additive or of the extent to which the experimental conditions of the animal study or the carcinogenic mode of action provide insight into the health effects of human consumption and use of the additive in question.”
While FDA revoking a food and drug additive authorization may be rare and alarming for the consuming public, in this instance it does not mean that exposure has or will cause cancer or serious adverse health outcomes in humans or animals. What it does mean for the food and drug industry is that use of the additive beyond the deadline will render products misbranded and adulterated, and that may cause significant civil and criminal liability.
While FDA is a science-based organization, Congress is not and it may be time to revisit the Delaney Clause standards to be more precise in allowing FDA to apply its scientific and technical expertise to assess the “probability, or risk, of cancer [or other adverse health outcomes] associated with exposure” to a substance particularly where, as here, use of the additive use goes back more than 100 years, to the formation of the FDA itself in 1906.
Worldwide, many other countries still allow for certain uses of Red Dye No. 3, called erythrosine, and when imported to the U.S. must comply with U.S. requirements, and failure to comply is a criminal offense.
This publication is intended for general informational purposes only and does not constitute legal advice or a solicitation to provide legal services. The information in this publication is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this information without seeking professional legal counsel. The views and opinions expressed herein represent those of the individual author only and are not necessarily the views of Clark Hill PLC. Although we attempt to ensure that postings on our website are complete, accurate, and up to date, we assume no responsibility for their completeness, accuracy, or timeliness.
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