|December 16, 2011|
Previously published on December 15, 2011
While the FDA has not officially defined “natural” for use in connection with food and dietary supplements, a recent warning letter provides guidance on what it deems to be an improper use of the term under 21 U.S.C. 343(a)(1). The FDA sent a warning letter to a food manufacturer asserting that the use of “All Natural” was false and misleading because the product contained a synthetic chemical preservative, and such use of the term is inconsistent with FDA’s understanding of “natural” to mean “nothing artificial or synthetic... has been included in, or has been added to, a food that would not normally be expected to be in the food.”
The FDA cited, as support, the discussion of the term “natural” in 58 Federal Register 2302 at page 2407 (January 6, 1993) (Notice). Interestingly, the Notice cited by the FDA, which announced definitions for certain terms, did not define “natural.” At page 2407 of the Notice, the FDA expressly disclaimed any intention to adopt a definition of natural, stating: “Although the use of the term ‘natural’ on the food label is of considerable interest to consumers and industry, FDA’s intent was not to establish a definition for ‘natural’ in this rulemaking.” The FDA further stated:
The agency will maintain its current policy ... not to restrict the use of the term “natural” except for added color, synthetic substances, and flavors as provided in [21 C.F.R.] § 101.22. Additionally, the agency will maintain its policy - regarding the use of “natural,” as meaning that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.
This “current policy” language was incorporated into the recent warning letter.
Despite the fact that the FDA expressly did not adopt a definition for “natural,” the discussion in the Notice is now being cited as such in a warning letter that: alleges a violation of the Food, Drug and Cosmetic Act; demands “prompt action to correct the violations cited in this letter;” recommends that the manufacturer “review all of your product labels to be consistent with our policy to avoid additional misbranding of your food products;” and requests a written response within fifteen days that “outline[s] the specific actions you are taking to correct these violations and to prevent similar violations.”
Food manufacturers or marketers or anyone involved in food labeling decisions should consider whether their use of “natural” on or in connection with foods satisfies the standard of “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.” The risk posed is not limited to a potential FDA enforcement action, but also includes the threat of an ever-increasing number of class action lawsuits aimed at food products claiming to be “All Natural” or the like. As we noted in an Alert published in October, there is a growing number of consumer class actions being filed over the use of the word “natural” in connection with food. Class action lawyers may begin citing this warning letter as setting forth FDA’s definition of “natural” and asserting fraud and other types of consumer claims against food products that do not satisfy this standard. Those involved in the labeling and marketing of food products should review their use of the word “natural” in light of this recent FDA action.