What’s Red-Hot in Food Dye Substitutes?

A walk down any supermarket’s candy, bakery, or beverage aisles is a journey surrounded by the upbeat vibrancy of synthetic colors. To food scientists, it should come as no surprise that many of these usual suspects—candies and confectionaries, potato and veggie chips, beverages, and baked goods—contain synthetic colors. We also know that synthetic colors can be hidden in a variety of other foods that aren’t necessarily obvious to consumers, many of whom are looking for clean label products. They may not think of salad dressing, strawberry applesauce, or boxed dinners, but the truth is that any of these items might have synthetic food coloring. The only way to know is to check the ingredient statement. 

Synthetic colors are added to a variety of foods for many different reasons, though they are often thought of as making products more vibrant. Sometimes synthetic colors get added to products to help meet consumer expectations, especially when consumers associate a flavor with a specific color. Other times, synthetic colors can be added to keep a product’s appearance consistent when there is natural variation in the color of the ingredients or if the product might lose color during processing or shelf life. Today, many food companies are determining how best to meet consumer expectations when formulating with synthetic colors while keeping an eye on changing state and federal legislation and bans.

U.S. History in Color

So, where did these colors come from and how did they become so prevalent in the United States? In the 1850s, colors derived from byproducts of the coal industry began to be added to food. This led to one of the nation’s first public initiatives in 1881: the U.S. Department of Agriculture’s (USDA) evaluation of the use of food colors, including those used in butter and cheese. In 1927, this endeavor was handed to the U.S. Food and Drug Administration (FDA), a young agency at the time (FDA 2003).

There have been quite a few regulations in this space over the years, and to understand where we are today, it may be helpful to have a high-level knowledge of what some of these were. In 1906, the government passed the Pure Food and Drugs Act that, among other new legislation at the time, prohibited interstate commerce of food containing known toxins or foods with colors used to hide damage or poor quality. By the 1930s, there were 15 synthetic colors approved, including six of the seven currently approved for use in various food applications. Food, Drug & Cosmetic (FD&C) Red 40 was the last to be approved in 1971. In 1938, it was mandated that color batches of the FD&C synthetic colors be evaluated and certified. In the 1950s, the color additives review was completed following children becoming ill after consuming Orange 1 (no longer permitted). In 1960, 200 provisional exempt colorants were listed to be evaluated before being permanently listed as approved for use. To achieve permanently listed as approved status, color manufacturers were required to list the specific intended use of the colorant and scientific data showing the colorant’s safety. Approximately half of the 200 have been permanently listed.

Where Are We Now?

Today, food colors are viewed in two categories: certified color additives and exempt color additives. Certified color additives are those that are synthetically produced and each batch made must be evaluated and approved by the FDA. We have seven FD&C colors that are certified color additives: FD&C Blue No. 1, Blue No. 2, Yellow No. 5, Yellow No. 6, Green No. 3, Red No. 40, and Red No. 3. Exempt color additives do not have a batch approval requirement and typically are derived from plants, minerals, animals, and other “natural” sources. It is important to note that “artificial color” is defined by the FDA as any color additive that colors a food, drug, or cosmetic and is not necessarily only referring to synthetic colors.

In 2023, the California Food Safety Act (CFSA) was passed, which prohibits four food additives, including FD&C Red 3, from manufacture, sale, and distribution in California, beginning in 2027 (State of California 2023). And earlier this year, the FDA announced that Red 3 will be banned for use in food as of January 15, 2027. In addition, California Assembly Bill 2316 was signed by Governor Newsom in September 2024 banning the other six FD&C colors from being sold within foods in schools except for the purposes of school fundraisers (State of California 2023–24). The law goes into effect on the last day of 2027. While California has taken action to ban these additives, the FDA and international food safety organizations such as the European Food Safety Authority (EFSA) and Food Standards Australia New Zealand (FSANZ) continue to review the available research and have not banned the synthetic colors, with the exception of Red 3, which the FDA has now banned.

The FDA has known that FD&C Red 3 shows carcinogenicity within male rats, producing thyroid tumors. The mechanism behind this has been studied and does not apply to the human population, which led to the agency’s earlier conclusion that FD&C Red 3 does not raise safety concerns in humans (FDA 2023). In 2007, The Southampton Study was published looking at a potential link between children’s behaviors and consumption of synthetic colors, causing an international review of synthetic colors. Food safety agencies around the world started reviewing the data, prompting the FDA, EFSA, and FSANZ to release statements to the effect that no link between synthetic colors and behavioral effects was supported by the data released (FSANZ 2008). In 2021, the State of California published another study looking at the link between synthetic colors and childhood behaviors with contributions from University of California, Berkeley, and University of California, Davis, that became the basis for the decision to ban synthetic colors within schools.

So, You Want To Reformulate

This legislation will necessitate a reformulation for some food and beverage products and will likely come with development hurdles. Synthetic colors provide very vibrant and consistent hues and work in a wide variety of applications. They also tend to blend easily and predictably, and synthetic colors have longer shelf life and often are able to retain vibrancy throughout a product’s shelf life. When synthetic colors are replaced with other colorants, considerations such as pH, water activity, and temperature must all be considered. A common example of this is a red pigment synthesized from berries that may appear red in products with a low pH but may look more like magenta in color as the pH rises. Beet powder also may provide an alternate red color but can be less stable and degrade in higher water activity (Cohen and Saguy 1983).

When reformulating, the first thing that companies will need to do is to understand consumer expectations. Two important expectations to keep in mind are cost and the target color range that the product must hit throughout its shelf life. This might be a very small range of acceptable shades, or it might have more wiggle room. Some products might not achieve the same vibrancy if the synthetic colors are replaced and products with a longer shelf life might lose color over time. Synthetic colors tend to have a lower price point, so in reformulation, it is important to consider what the final product price point must be with the understanding that the price may increase.

The attributes of the product, such as pH, will help determine what artificial colors can be used. There are a wide range of exempt colorants on the market with a variety of companies specializing in this sector. Some colors, such as red or orange, may have more colorant options while blue shades can have fewer. It is possible that a few colorants might be used to achieve the desired shade, but it is important to note that unlike synthetic colors, blending exempt colors does not always produce the expected color. Colorants may also be layered to prevent color degradation through shelf life. It will be important to trial different colorants in the formulation to see what responds best to the product’s composition.

It is also necessary to consider shelf life and whether shelf-life testing is needed. Many exempt colorants have a shorter shelf life than their synthetic counterparts, both in storage and application. Reducing the shelf life of the color can necessitate a reduction in the product shelf life to the duration the product is in the consumer’s acceptable color range under normal storage conditions. Waste may increase if a reduction in shelf life is necessary, which could impact price. A reduction in shelf life might limit run sizes to prevent an increase in waste-reducing processing efficiency, which can also impact price. If testing needs to be performed to provide confidence in the product’s appearance throughout its shelf life, the reformulation timeline also will need to be extended. This is especially true if the product does not pass the first round.

Hues of the Future

Some companies are reformulating products to remove the FD&C colors from food and have stated initiatives to do so. Some companies have already removed these colors. Many companies are watching the proposed legislation as well as the perception within their customer base to determine the right decision for their product. In addition, colorant companies continue to create pre-blended exempt colors for specific application types that may make reformulation easier.

While the industry has taken a variety of different approaches to both public perception and the new regulations, innovation continues to expand as new products and processes emerge. It is important to remember that foods are colored for a reason. Consumer expectations may shift slightly, but at the end of the day, consumers want consistently pink strawberry ice cream and yellow honey mustard dressing. Navigating a changing landscape in how we enhance food with color will come with a plethora of challenges as well as opportunities.ft