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Synthetic dyes, once regarded as harmless ingredients that simply made foods more visually appealing and marketable, are now the subject of a dynamic bipartisan movement for reform. Thousands of food items in grocery stores in the United States utilize synthetic dyes, which have been linked to potential health risks, including behavioral effects in children and carcinogenicity in animal tests. One of these items, Red Dye No. 3—which is commonly used in candy and cereal—has been identified as carcinogenic by the FDA based on rat studies. Abroad, the EU mandates warning labels, while Australia and Japan restrict or ban them.

As of October 2025, federal voluntary initiatives and state mandates are driving a synthetic-to-natural shift. This overview highlights key developments and offers insights for manufacturers navigating compliance and exposure liability issues.

The Current Status of State and Federal Food Dye Regulation

In April 2025, the FDA and HHS announced a comprehensive plan to phase out all petroleum-based synthetic food dyes by the end of 2026. This initiative targets the most common synthetic dyes, including FD&C Red No. 40 (candy reds), Yellow No. 5 (soda yellows), and Blue No. 1 (drink blues.)

In support of this initiative, the FDA approved four natural options by mid-2025: Galdieria extract blue (algae for beverages), butterfly pea flower extract (pH-sensitive for yogurts), calcium phosphate (white for candies/poultry), and gardenia blue (heat-stable for baking).

Meanwhile, lawmakers in at least twenty states have introduced nearly forty bills aimed at restricting or banning synthetic dyes and other food additives. Some states have focused on labeling requirements. For example, Texas will soon require that foods containing more than 40 additives display prominent warning labels, starting in 2027. Other states have adopted broader or more targeted bans. Three states—California, Utah, and West Virginia—have passed landmark legislation restricting the use of certain color additives in foods, but each state’s law has its unique quirks and requirements. For instance, California’s legislation will prohibit the sale of foods containing six specific synthetic dyes in school meals starting in 2027, whereas West Virginia’s will target the distribution and sale of products with artificial dyes, implementing a phased approach that begins in schools in August 2025 and will extend statewide by 2028.

The potential for federal preemption of these divergent state approaches will be impactful for manufacturers navigating the regulatory landscape. Likewise, the misalignment between federal and state regulations is already causing confusion for food manufacturers. Without clear federal mandates, state laws are becoming the main battleground for legal and regulatory challenges. Critically, there are some federal legislative bills in the early stages that could potentially preempt (and simplify) the varied state regulations of food dyes. One notable example is the Grocery Reform And Safety (GRAS) Act, introduced by Representative Frank Pallone (D-NJ). This bill would strengthen FDA oversight and require regular safety reassessments of all food additives, not just dyes. Meanwhile, Representative Grace Meng (D-NY) has introduced the Ban Harmful Food Dyes Act, which would prohibit the use of several widely used synthetic dyes—including Red No. 40, Yellow No. 5, Blue No. 1, and Titanium Dioxide—in food products. However,  until one or more federal bills are enacted, companies will need to monitor and address state-level rules wherever they transact business.

Industry Implications

The evolving regulatory landscape presents both challenges and opportunities for the food industry. In the absence of formal federal rulemaking, the FDA’s recent announcements rely heavily on the industry’s voluntary compliance. Major companies, such as Hershey’s, WK Kellogg, Nestle, General Mills, PepsiCo, Campbell, and Kraft Heinz, have expressed willingness to phase out synthetic dyes in line with FDA guidance. Moreover, Walmart has recently announced a plan to eliminate dyes from its store brands, citing consumer preference for natural dyes.1

However, even manufacturers that are attempting to be proactive face several hurdles. The initial hurdle is ensuring compliance with the patchwork of state laws and federal regulations that have recently been approved as well as anticipated future laws. Manufacturers also face difficulty in reformulating their products. Any alternative color additives must be approved by the FDA, and finding suitable, cost-effective natural substitutes can be complex despite the FDA’s approval of several substitutes. Reformulation efforts also risk disrupting supply chains, especially as demand for natural colorants surges. Establishing relationships with new suppliers of natural colorants is another critical step. The process of vetting suppliers, conducting audits, and testing product performance can take months, particularly when dealing with international vendors.

Consumers and their preferences are a primary concern for food manufacturers. Although many consumers are becoming aware of the alleged risks of synthetic food dyes, companies should also be mindful of consumer expectations regarding the appearance and aesthetic qualities of food products. Natural dyes often do not achieve the same bright hues as synthetic dyes, so food manufacturers will need to strike a balance between product appeal and consumer preferences for natural ingredients. Marketing and advertising will likely be a critical step in maintaining the popularity of certain foods and drinks that may look different than expected.

Looking Ahead

The debate over food dyes reflects a broader transformation in the regulatory approach to food safety, public health, and consumer rights, and underscores proactive governance in food safety. The coming years will reveal whether the U.S. can achieve a balance between innovation, safety, and transparency in the food supply, while ensuring that consumer health remains a top priority. Food manufacturers may wish to examine their strategies for addressing the regulatory changes on the horizon, in preparation for the finalization of currently proposed rules.

  1. “Walmart to eliminate synthetic food dyes from store brands.” https://www.nbcnews.com/business/consumer/walmart-eliminate-synthetic-food-dyes-store-brands-rcna234489. ↩︎
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Photo of Audrey Allen Audrey Allen

Audrey focuses her legal practice on resolving mass toxic tort and product liability litigation for clients.

As a member of the firm’s Toxic Tort team, Audrey concentrates her practice on the defense of oil refineries and premises defendants involved in asbestos exposure claims

Audrey focuses her legal practice on resolving mass toxic tort and product liability litigation for clients.

As a member of the firm’s Toxic Tort team, Audrey concentrates her practice on the defense of oil refineries and premises defendants involved in asbestos exposure claims nationwide. She also focuses on products liability and complex commercial litigation matters. Audrey works closely with clients throughout all stages of litigation, including drafting motions and pleadings, completing discovery, taking and defending depositions, arguing motions and negotiating settlements. She is also experienced in analyzing and summarizing medical records and conducting research to retain experts.

Photo of Alexandra Cantamessa Alexandra Cantamessa

Alix is extensively experienced with all phases of asbestos litigation, from inception through resolution, including pleadings, deposition, discovery, investigations, and drafting and arguing motions, including appellate motions and briefs. She provides both nationwide and local defense for major clients and is known for…

Alix is extensively experienced with all phases of asbestos litigation, from inception through resolution, including pleadings, deposition, discovery, investigations, and drafting and arguing motions, including appellate motions and briefs. She provides both nationwide and local defense for major clients and is known for devising novel legal theories and strategies to remove clients from cases.

While she has focused on toxic tort in recent years, Alix’s broad background litigating securities, contract, labor and employment, intellectual property, and pharmaceutical product liability matters has made her extensively familiar with procedure and strategy. Alix also draws on her time representing plaintiffs in medical device product liability cases at a previous firm. The experience helps her understand opposing counsel’s goals, plans and strategies, often leading to faster resolutions in the cases she defends today.

Alix is particularly passionate about the intensive research required in the asbestos field and loves to be the one to find the argument that will win a case. She also appreciates that toxic tort cases usually allow her to fully get to know clients, learning about their products and business structure. Alix aims for clients to view her as a true part of their company.

Photo of Jackson Otto Jackson Otto

Jackson defends midsize and large corporations in litigation involving toxic tort and product liability claims, advising manufacturers, petrochemical companies, suppliers and premises owners nationwide on pleadings, filings and depositions.