While labeling must be truthful and not misleading, the use of trade puffery is generally accepted within limits. However, implying “natural” for ingredients such as color additives, which by statute must be listed via a petitioning process, may invite regulatory scrutiny.
A color additive is a dye, pigment or other substance capable of imparting color when added or applied to a food, drug, cosmetic or to the human body. The legal definition can be found in Section 201(t) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and provides exclusions as well. Color additives for use in food, drugs and cosmetics require premarket approval.
FDA has stated all color additives are synthetic. Of course, we must consider whether the color is “added.” For example, consider a lotion formulated with cosmetic ingredients not intentionally added for color versus a lotion to which a color is intentionally added, e.g., D&C Red No. 33. The first situation would not require a declaration of the presence of color. On the other hand, the intentional addition of a coloring agent such as D&C Red No. 33 means the color must be declared in the ingredient declaration.
To elaborate, one may consider “natural color” as the inherent color of an ingredient not intentionally added for coloring and which is unimportant insofar as appearance, value, marketability or consumer acceptability. Meeting such a labeling designation can be a difficult challenge. To avoid regulatory attention, the wise policy is to ensure all color additives are appropriately listed in the ingredient declaration.
Learn more about using natural colors in natural product formulations in this full article in INSIDER’s Colors and flavors digital magazine.
EAS independent consultant, Catherine Bailey, is a former director of FDA’s Division of Cosmetics and Compliance, where she oversaw the voluntary cosmetic registration program (VCRP) and provided oversight of federal regulation and research related to cosmetics. Catherine Bailey had a 32-year career with FDA, starting as a chemist in the Division of Color Technology, oversight of federal regulation and research related to cosmetics in the U.S. and working as a project manager for food and color additive petitions. Following her retirement from FDA, she joined the Personal Care Products Council as a staff scientist. Catherine Bailey assists EAS clients with cosmetic labeling issues and color additive petitions.
John Bailey, Ph.D., is EAS Consulting Group’s independent advisor for colors and cosmetics. John Bailey is a former director of FDA’s Office of Cosmetics and Colors, a position he held from November 1992 through August 2002. His 34-year agency career began as a chemist in the Division of Colors and Cosmetics. He soon moved to the Division of Color Technology and advanced to become a senior research chemist. He went on to serve in other prominent agency positions, including that of director of the Office of Applied Research and Safety Assessment in the Office of Science. After his retirement from the agency in 2002, he joined the Cosmetic, Toiletry and Fragrance Association as director of cosmetic chemistry, and later joined the Personal Care Products Council as executive vice president for science.