FDA Reviews Color Additives for Use in Food, Drug, Cosmetic and Medical Device Products in the United States

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FDA released a new list of food and color additives that are under review. Registrar Corp reports on the definition of color additives and FDA regulations affecting manufacturers selling to the United States.

Registrar Corp Assists Companies with U.S. FDA Regulations
FDA can deny entry to any product deemed "adulterated," causing havoc in a supply chain and enormous expense to the manufacturer.

Over the past year, the U.S. Food and Drug Administration (FDA) has issued Final Rules to amend the color additive regulations to provide for the safe use in foods, drugs, cosmetics, and medical devices. In 2013, FDA approved the safe use of additives, including spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis) as a color additive in candy and chewing gum and the use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in distilled spirits containing not less than 18 percent and not more than 23 percent alcohol by volume [1]. FDA has issued these Final Rules in response to color additive petitions filed by Mars, Inc. and E. & J. Gallo Winery. This month, FDA released a new list of food and color additives that are under review. Registrar Corp reports on the definition of color additives and FDA regulations affecting manufacturers selling to the United States.

A color additive, as defined by regulation, is any dye, pigment, or other substance that can impart color to a food, drug, or cosmetic or to the human body. FDA has regulatory oversight for color additives used in foods, drugs, cosmetics, and medical devices. Color additives used in foods, drugs, cosmetics, and medical devices must comply with individual listing regulations issued by FDA.

The use of an unlisted color additive, the improper use of a listed color additive, or the use of a color additive that does not conform to the purity and identity specifications of the listing regulation may cause a product to be adulterated according to the provisions of the FD&C Act. FDA may take enforcement action against such products. Most products contain only a small amount of color additive, so it takes only a small quantity to potentially adulterate a large amount of product.

When FDA determines that a color additive violation has occurred, the agency can take a number of actions to enforce the FD&C Act in order to protect the public health. In the absence of voluntary action (e.g., product recall) by the responsible firm to correct the problem, FDA has several advisory, administrative, and judicial options which include warning letters, detentions, issuance of import alerts, and seizures. FDA has recently sent warning letters for undeclared FD&C Red No. 40 and FD&C Yellow No. 5 in fish products. FDA has also issued import alerts for food containing illegal and/or undeclared colors for cosmetics containing illegal colors.

These requirements apply to any food (including dietary supplements), cosmetics, drugs, and medical devices imported into the United States. A product containing an illegal color additive may be deemed "adulterated" by FDA. In addition, if a legal color additive is not declared properly, a product may be deemed "misbranded" by FDA. FDA can deny entry to any product deemed "adulterated," causing havoc in a supply chain and enormous expense to the manufacturer. Likewise, a mislabeled product may be deemed "misbranded" and denied entry into the United States.

Companies that want more information about the regulatory status of the color additives in their products should contact Registrar Corp. Registrar Corp's Label & Ingredient Review service will research how all these regulations will impact your product and assist you in ensuring compliance as you export to the United States. For more information about food ingredients, labeling and other FDA regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or phone: +1-757-224-0177.

[1] FDA Food Additives Pending Review 2014
[2] FDA Food Additives Review 2013

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David Lennarz

Liviana Callahan
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