Recently two separate plaintiffs filed cases against Mars Incorporated (Mars), the maker of the popular candy, Skittles. The plaintiffs argue that Mars misled Skittles consumers because the candy contains the chemical titanium dioxide. Although the federal food safety and labeling laws and regulations do not grant a private right of action, plaintiffs in false and misleading food labeling lawsuits often point out that defendants are not in compliance with these laws and regulations. However, the plaintiffs’ complaints in the Skittles cases do not mention the Food and Drug Administration’s (FDA) regulations. This blog post chiefly explains FDA’s color additive regulations, and then reviews the claims the plaintiffs are bringing against Mars.
Color Additive Regulations
Before a manufacturer uses a color additive in an FDA regulated product (food, drugs, cosmetics, and medical devices), it must ensure that color additive is FDA approved. FDA’s color additive regulations are similar to, but different from, it’s Generally Recognized as Safe (GRAS) regulations. For example, titanium dioxide is not on FDA’s list of GRAS substances, but it is on FDA’s list of color additives exempt from certification.
FDA’s regulations include two lists for color additives. The first list, which includes titanium dioxide, are the chemicals exempt from certification. See 21 C.F.R. § 73.575. According to FDA, the color additives exempt from certification “include pigments derived from natural sources such as vegetables, minerals or animals.” Titanium dioxide is a naturally occurring mineral which is obtained through mining. Currently, there are 40 food color additives exempt from certification. Some of the chemicals on this list have certain tolerance levels. For example, although food manufacturers can use titanium dioxide, titanium dioxide cannot make up more than 1% of the food item.
The other list includes the substances which are subject to certification. These color additives are typically “synthetically produced (or human made) and used widely because they impart an intense, uniform color, are less expensive, and blend more easily to create a variety of hues.” When manufacturers use certifiable color additives, the manufacturer must only use a batch that FDA has certified. According to FDA, “this means that FDA chemists have analyzed a sample from the batch and have found that it meets the requirements for composition and purity stated in the regulation—called a ‘listing regulation’—for that color additive.” If a manufacturer uses a color additive from an uncertified batch and that color additives is one that requires certification, then the product that contains that substance is considered adulterated under the law. Currently, there are nine food color additives subject to certification. These include Blue No. 1, Red No. 40, and Yellow No. 6.
Although anyone can petition FDA to add a color additive to either list, usually color additive manufacturers take part in this process. Color additive manufacturers are also the ones who send batch samples to FDA for certification. Food manufacturers will then buy the certified batch of food color additives from the color additive manufacturer. When a color additive manufacturer sells color additives to food manufacturers, the color additive packaging is subject to strict labeling requirements. These labels must include the name of the color additive as it appears in FDA’s regulations, general limitations for use, any other limitations or tolerances, and the FDA certification lot number if it is a certifiable color additive. 21 C.F.R. § 70.25.
When a food manufacturer includes a color additive in its product it must follow FDA’s food labeling regulations. If a food contains a color additive exempt from certification, then in the ingredients list, the food manufacturer can list the color additive simply as “artificial color” or “colored with ____”, where the blank is the name of the color additive as it is listed in the regulations. 21 C.F.R. § 101.22(k)(2). Therefore, foods that contain titanium dioxide can either state “artificial color” or “colored with titanium dioxide” in the ingredients list. If a food contains a certifiable color additive, then the ingredients list must list the color additive by the color’s name as it appears in the regulations. 21 C.F.R. § 101.22(k)(1). Meaning, if a product contains Red 40, then the ingredients list must include Red 40.
The Lawsuits Against Skittles
Currently there are two separate cases against Mars and its use of titanium dioxide in Skittles. The first, Thames v. Mars Inc., 3:22-cv-04145, was filed in the Northern District of California on July 14, 2022. The second, Mignin v. Mars Inc., 1:22-cv-04243, was filed in the Northern District of Illinois on August 11, 2022. Neither case argues Skittles’ packaging violates FDA’s regulations or that the use of titanium dioxide violates the regulations. Nevertheless, both plaintiffs claim that the Skittles packaging is false and misleading. Primarily, both plaintiffs argue that they, and their fellow Skittles consumers, were misled into thinking that Skittles were safe for consumption. The plaintiffs argue that Skittles are not safe for human consumption because Skittles contain titanium dioxide. To argue this point, the complaints point to how the European Union recently determined that titanium dioxide is not safe for human consumption.
The complaints also point to a statement Mars made in 2016 that it would stop using titanium dioxide in its confectionaries. In its statement, Mars said that “[a]rtifical colors pose no known risks to human health or safety, but consumers today are calling on food manufacturers to use more natural ingredients in their products.” The complaints point to this statement, the research the EU relied on in making its decision to ban titanium dioxide, and the fact that other candy makers have stopped using the chemical to argue that Mars knew about the alleged harms of titanium dioxide. By arguing that Mars knew that titanium dioxide is harmful to consumers, yet continued to use it in its products, plaintiffs claim Mars partook in unlawful, fraudulent, and unfair conduct.
The plaintiffs do not mention FDA’s food color additive regulations. This is likely because the Skittles label complies with the regulations. In the Skittles ingredients list, titanium dioxide is listed by name, even though Mars could simply state “artificial color”. Nonetheless, plaintiffs argue that they were misled into thinking that Skittles did not contain chemicals such as titanium dioxide. They argue that Mars purposefully made the ingredients list hard to read. They point out that the color of the text of the Skittles ingredients list blends into the background packaging color. The next step in the litigation process, for both cases, is for Mars to file either an answer or a motion. In both cases Mars has yet to file anything.
Under FDA’s regulations, FDA must approve all ingredients used as a color additive. Most color additives, including titanium dioxide, do not require FDA testing before food manufacturers may use them in their products. However, certain color additives require FDA batch certification. Neither of the two recently filed cases against Mars, and its use of titanium dioxide in Skittles, mentions the FDA or its regulations. Mars could possibly argue that its labels are not false and misleading because it follows FDA’s regulation. However, Mars has yet to file answers or motions in either case.
To read more about FDA’s food ingredient, additive, and color regulations, click here.
To read FDA’s summary of color additive use, click here.
To learn more about FDA’s color certification process, click here.
To learn more about food labeling, generally, visit the NALC’s food labeling reading room, here.
**This article was written by former NALC Staff Attorney Jana Caracciolo.