FDA Announces “No Artificial Colors” Enforcement Discretion
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EmailThe FDA has informed food manufacturers that the agency will exercise enforcement discretion to allow “No artificial colors” and similar claims in many situations. Prudent manufacturers will continue to comply with the law until it is revised.
The Food and Drug Administration (FDA) has sent a “Dear Industry” letter informing food manufacturers that the agency will exercise enforcement discretion to allow “No artificial colors” and similar claims if artificial color is added, so long as it is not an FD&C certified color. “Enforcement discretion” means that the FDA plans to take no action for violation of the law should a firm use the claim “no artificial color” to signal the absence of FD&C certified color.
The FDA Commissioner states that the purpose of this change is to facilitate the transition away from FD&C-certified colors. No mention is made of a plan to revise the law. More notable is that no determination is made that such “no artificial” claims are no longer considered misleading, only that the FDA will not prosecute them under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA), the prohibition of false or misleading labeling.
There is a long-standing rule that any color added to a food that is not a normal part of that food is artificial coloring (21 C.F.R. § 101.22(a)(4)). For example, beet juice added to produce pink lemonade is artificial color; carmine added to strawberry yogurt is artificial color. Prudent manufacturers will continue to comply with the law until it is revised (or if it is). The FDA’s enforcement policy can change back in the little time it takes to write a new letter. Revising labels can be much more time-consuming and costly.
Moreover, the FDA’s discretion in enforcing violations of 403(a)(1) of the FDCA provides no shield against lawsuits by competitors, consumers, or states under other laws for what may be found to be false or misleading.
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