Color Us Intrigued: Staying Ahead of FDA’s Regulatory Changes for Colors
The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) are actively reviewing and updating regulations covering color additives used in food, drugs, and cosmetics. Given the numerous regulatory changes taking place, it is more important than ever for companies to stay informed about these developments and the reasons for these changes, while also understanding the implications of these regulatory shifts.
Historical Regulation of Color Additives
Color additives are often used to make products visually appealing, therefore enabling consumers to more easily differentiate between various flavors of food and dosages of pharmaceuticals. The responsibility for ensuring the safe and appropriate use of these additives rests with FDA, which has overseen their regulation since the inception of the Pure Food and Drug Act of 1906. This historic regulatory framework has evolved into the statutory framework that exists today, which provides that only those additives deemed “suitable and safe” may be utilized in consumer goods. Additionally, color additives are subject to a rigorous evaluation process that mandates premarket approval and prohibits the approval of any color additive demonstrated to induce cancer in humans or animals. FDA’s regulatory framework also includes a certification process for certain additives, which ensures they meet safety and identity specifications.
FDA considers an array of factors when evaluating the safety of novel color additives or new applications for existing ones, including anticipated consumption levels, cumulative dietary impacts, expert assessments, and methodologies for determining purity and acceptable impurity levels. Stakeholders have the opportunity to petition FDA to introduce a new color additive or amend existing listings, necessitating comprehensive data regarding the additive’s identity, properties, manufacturing processes, intended uses, safety studies, and exposure estimates. FDA reviews this petition data alongside public commentary and pertinent information before promulgating new regulations or modifying existing ones. FDA possesses the authority to take enforcement actions as needed to protect public health, such as issuing warning letters or initiating recalls. Furthermore, FDA provides guidance on the appropriate use of color additives, ensuring ongoing oversight and timely regulatory adaptations as warranted.
The Road Thus Far
As Buchanan previously reported, in January 2025, FDA published an order to repeal the color additive regulations that permit the use of FD&C Red No. 3, also known as erythrosine, in foods (including dietary supplements) and ingested drug products. This order will be effective January 15, 2027, for food products and January 18, 2028, for ingested drug products. However, on April 22, 2025, HHS and FDA announced a series of measures to phase out all petroleum-based synthetic dyes from the nation’s food supply including:
- Requesting that food companies remove FD&C Red No. 3 ahead of the previously established 2027-2028 deadlines.
- Stating that FDA will establish a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
- Initiating a process to revoke the authorization of two rarely used synthetic dyes, Citrus Red No. 2 and Orange B, “within the coming months.”
- Aiming to phase out the six remaining certified colors—Green No. 3, Red No. 40, Yellow Nos. 5 and 6, and Blue Nos. 1 and 2—from the food supply by the end of 2026.
FDA is authorizing four new natural color additives and accelerating the review and approvals of others, while also partnering with the National Institutes of Health (NIH) to research the impact of food additives on children’s health and development.
FDA has not specified how it plans to revoke the color additive regulations for Citrus Red No. 2 and Orange B, but its statements imply that it intends to pursue formal rulemaking to revoke these authorizations (e.g., a color additive petition, a proposed rule, or other expedited actions if done in accordance with the Federal Food, Drug, and Cosmetic Act). However, while recent statements from FDA and HHS officials have raised concerns about the health impacts of certified colors, no new reliable data or information has been presented to substantiate the claims being made apart from a May 22, 2025 report titled, “The MAHA Report: Make Our Children Healthy Again.” For other color additives deemed to be “unsafe,” FDA currently appears to be relying on the industry to voluntarily phase out their use by the end of 2026, meaning companies are not legally obligated to stop using such certified colors until FDA/HHS issues an official directive and/or sets a specific deadline.
In addition to these federal regulatory shifts, a number of states have also been banning certain color additives, with some state laws taking effect as early as mid-to-late 2025. Thus, while federal law currently creates no obligation on companies as it relates to certain colors, state laws and regulations are likely to advance the transition away from using certified colors, albeit in a piecemeal fashion.
Strategies and Best Practices
Regardless of whether your company makes, supplies, or uses colors for the food and pharmaceutical industries, understanding the federal and state implications of these regulatory shifts is essential. There are several measures companies can take now in response to this changing regulatory environment:
Be Informed. Stay vigilant and well-informed about the evolving regulatory landscape, ensuring you understand which products across your entire portfolio—whether pharmaceuticals, foods, medical foods, or dietary supplements—may be impacted by color additive regulatory changes. This includes ensuring all supply chain partners are not only in compliance with current regulatory requirements but are also prepared for changes that may affect them in the future. By assessing the potential effects of these changes on your company and your supply chain, you can devise proactive strategies to mitigate risks and adapt accordingly.
Be Part of the Conversation. Ensure your perspectives are effectively communicated by collaborating with your legal counsel and government relations teams to amplify your message about product safety. These efforts will help build trust among stakeholders and regulatory bodies.
Decide on the Best Course of Action. Assess whether you want to actively engage in challenging the regulatory changes, or observe and monitor developments as they unfold. If you choose to get engaged, ensure you have the necessary data to support your position and the right internal and external teams to champion your cause alongside you.
Be Prepared for Change. Be ready to address any potential changes that may emerge from federal or state law and regulation, and remain adaptable to modifying your product formulations to ensure continued compliance.
Be Proactive. While the focus is currently on the use of colors in food, FDA has already indicated its intention to phase out certain color additives from all products, including pharmaceuticals. FDA recently released a draft guidance entitled “Replacing Color Additives in Approved or Marketed Drug Products” stating that drugs must conform to color additive regulations and that replacing a color additive “can generally be considered a moderate change for which a changes being effected in 30 days (CBE-30) supplement is appropriate.” Regardless of the type of FDA submission used to effectuate a color additive change, modifying a drug formulation is a time-consuming and complex process that is influenced by the drug’s specific characteristics. Changes in color could lead to patient confusion, potentially compromising medication adherence and therapeutic outcomes. Companies must not wait until a particular color additive is banned to begin the process of testing and seeking approval for a necessary change.
Taking proactive steps now will help ensure compliance and continuity in product availability. Buchanan’s Life Sciences Industry Group is adeptly navigating the continually evolving color additive regulatory landscape. We are poised to address any questions you may have and assist in developing a strategic plan to maximize your company’s opportunities and reduce its risks.