Generally speaking, FDA regulates color additives in all FDA-regulated products, including in medical devices. However, because of the different nature of medical devices compared to the other products FDA regulates, the agency has a special approach to determining when color additives must be approved for use in devices. Even to a layman, it would make sense that the oversight necessary for the color in a toothbrush handle would not need to reach the level of a food, drug, or cosmetic that is applied to or is entering the body.

Device manufacturers should familiarize themselves with FDA’s policies for color additives in medical devices to ensure that their products do not encounter compliance issues. Keep reading for more information about how FDA regulates color additives in medical devices.

Color Additive Regulations for Medical Devices

The Federal Food, Drug and Cosmetic (FD&C) Act defines a “color additive” as “a dye, pigment, or other substance… capable of imparting color when added or applied to a food, drug, cosmetic, or to the human body.” It is notable that “device” is not specifically included in the definition. Elsewhere in the Act, it is clarified that a color additive used in a device is exempt from listing unless it comes in direct contact with the body “for a significant period of time.”  The Act does not define what is meant by “significant period of time,” leaving that interpretation to FDA. FDA has stated that it does not consider use of a color additive to be for a significant period of time if the contact duration is 30 days or less.

Colors that have been approved by FDA for use in medical devices are found in the Code of Federal Regulations (CFR). Once determining that their color is subject to FDA approval, manufacturers should review these regulations carefully, as FDA lists colors as approved based upon the specific device in which it is incorporated.  A review of the CFR shows most of the approvals are specific to only a few types of devices: contact lenses and sutures being the most prevalent. Certain colors are also subject to the “batch certification” requirement, such as D&C Violet No. 2 in contact lenses.

Colors for some devices that are subject to premarket notification (such as the 510(k)) may also be referenced in FDA guidance documents for those submissions. An example would be colors in medical gloves. FDA discusses the use of colors in these gloves, citing the need for biocompatibility testing, particularly for colors that have not been approved for any other use (such as food) by the agency.

Batch Certification

FDA’s requirements for color additives and dyes vary based on the additive. FDA often requires color additives be reviewed by the agency through batch certification. In this process, FDA analyzes submissions of batch samples to determine whether a color additive complies with requirements for composition and purity set forth by the color additive’s listing regulations. Manufacturers are required to submit applicable documentation to FDA for batch certification, along with the samples of the color additive and a fee.

Batch certification is not required for every color additive. FDA determines if the batch certification process is needed to protect public health based on impurity levels that might be present in the color additive. Once certified, these colors are identified using “FD&C” or “D&C” as part of their names.

To ensure that a color additive is from a certified batch, you should check that the label:

• Ensures the name of the color additive is as it appears in the Code of Federal Regulations
• Includes general limitations for use and any other limitations or tolerances, and
• Lists the FDA unique lot number assigned to the certified batch

If a color is a mixture of certifiable colors, the colors must be certified prior to mixing. The manufacturer should ensure that they have the FDA lot number assigned to each color prior to the mixture taking place.