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FDA’s Rainbow Rules: An Overview of Color Regulations

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by Antonio Gallegos -

The FDA regulates ingredients used for color more closely than it does ingredients used for taste, nutrition or other non-color purposes. In fact, the Federal Food Drug and Cosmetic Act (FD&C) considers all ingredients used to add color (known as “color additives" under the law) to be unsafe unless used according to FDA-approved specifications.

Some good news for the natural products industry is FDA has approved many color additives derived from natural sources. These are subject to one fewer layer of regulatory scrutiny than most synthetic color additives. But less regulation does not mean unregulated or even minimal regulation. So, it is important to understand the regulatory framework when considering ingredients for adding color to products.

Color Additive Definition

The law defines “color additive" as:

Ingredients not used for color purposes, but that contribute their own natural color to a food, are not considered color additives. The FDA regulations provide a few examples such as cherries, chocolate and orange juice.

But where a food substance is deliberately used as a color—like beet juice in pink lemonade—it is a color additive. This is the case even where the ingredient provides nutritive or other functional value, and even if color is not its primary purpose. The ingredient is a color additive unless used in a way that any color imparted is unimportant to the food’s appearance, value, marketability or acceptability to consumers.

FDA’s color additive regulations apply to any substance that meets these criteria, regardless of whether it is synthetic or derived from a natural source. Fortunately, product labels don’t need to use this term in their list of ingredients.

FDA-Approved Color Additives

FDA issues a regulation for each color additive the agency approves. Annatto extract, caramel, grape color extract, fruit juice, vegetable juice, paprika, saffron, spirulina extract, tomato lycopene extract and turmeric are some FDA-approved food, beverage and dietary supplement color additives derived from natural sources. There are also numerous FDA-approved cosmetic color additives such as annatto, caramel, henna, silver and zinc oxide also derived from natural sources. The regulations set forth requirements for identity specifications, permitted uses and restrictions on their use.

If there is no regulation affirmatively authorizing an ingredient’s use for color, it is considered unsafe and cannot be used. The manufacturer can seek FDA approval by filing a color additive petition, which must include extensive scientific support to establish the ingredient’s safety.

Names like Blue No. 1, FD&C Yellow No. 5 or Orange B are commonly in a list of ingredients. Brands that use color additives like these (i.e., named by color and number or letter) must verify the additive has been approved for use in that type of product. A color additive approved for foods might not be approved for cosmetics, or vice versa. Or it could be approved for use in a drug or medical device, but not in a food or cosmetic. Also, brands should have the color additive manufacturer verify each batch is FDA-certified for compliance with regulatory specifications. Of course, all food and cosmetic color additives must meet FDA’s specifications. But the agency requires batch certification only for this category of color additives.

Disclosure on Product Labels

The ingredient lists on product labels don’t need to use the terms “color" or “additive." Only the ingredient’s common or usual name is required, which is typically the name identified in the regulation authorizing its use. Brands are permitted, but not required, to indicate that the ingredient is being used for color, for example “colored with turmeric" or “beet juice (for color)."

On the subject of labeling, notice the language of “colors derived from natural sources" instead of “natural colors." The labeling of foods, beverages and cosmetics as “natural" has been the source of numerous lawsuits, in large part because there is no legal definition or widely-recognized standard for what natural means. Do not assume using a color additive that is not a synthetic chemical is a green light to say the product is “all natural."

FDA’s current guidance on use of the term “natural" in food labeling includes the example of beet juice used for color in pink lemonade. The agency said beet juice is not an ingredient normally expected in lemonade, so the product should not be labeled as natural. The guidance is not binding law, and FDA has requested public comments on whether it should formally define natural and, if so, what does it mean, and how can it be used in labeling? The outcome and timing of that process is uncertain. But there is another regulatory obstacle.

A formal FDA regulation defines “artificial color" to include all color additives, even those derived from natural sources. This makes even the label statement “no artificial color" problematic. On the bright side, a color additive ingredient is not required to be identified as artificial.

FDA’s color additive regulations may reach a bit further than the natural products industry would like. On the bright side, FDA-approved options might be palatable to health-conscious consumers.

Antonio Gallegos, of counsel, Greenberg Traurig LLP, Denver office, provides regulatory compliance, dispute resolution and trial strategies for the food, dietary supplement and medical device industries. He represents businesses and individuals in lawsuits, arbitrations, mediations, government investigations and regulatory enforcement actions. Gallegos also advises on compliance with regulations administered by FDA, FTC, USDA, DEA and similar state-level agencies.

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