Apparently, persistence does pay off. FDA has finally solicited comment on the meaning of “natural”. We previously reported on repeated requests from relevant industries, consumers, and the courts for FDA to take this action (see some of our previous blog posts here and here).

On November 11, 2015, FDA published a request for comments on the use of the term “natural” in the labeling of human food products. FDA is taking this action partly in response to three citizen petitions from the Grocery Manufacturers Association, Sarah Lee Corp., and The Sugar Association requesting that FDA define the term “natural” for use in food labeling. A citizen petition from the Consumers Union has also requested that FDA prohibit use of the term “natural” to describe any food product.

This, of course, is not FDA’s first bite at the “natural” apple.  FDA previously addressed “natural” claims in the 1990s, at which time FDA requested comment on several questions, including whether the agency should define the term “natural” or prohibit “natural” claims entirely.  FDA ultimately decided to not answer the question through formal rulemaking and instead elected to maintain its informal enforcement policy to not restrict “natural” except for added, color, synthetic, substances, and flavors.  In explaining its decision, FDA noted that, while it received many comments on the subject, “[n]one of the comments provided FDA with a specific direction to follow for developing a definition regarding the use of the term ‘natural.’” 

One can only hope that the 2015-2016 round of comments will provide FDA the direction that it needs to produce a different result, especially given recent litigation and consumer confusion surrounding the issue (e.g., here). 

Interested parties have until February 10, 2016 to submit comments to FDA regarding the definition of natural.  While not an exhaustive list, topics of interest to FDA include:

Should FDA define, through rulemaking, the term “natural”? Why or why not? Should FDA prohibit the term “natural” in food labeling”? Why or why not? If the agency defines the term “natural,” what types of food should be allowed to bear the term “natural”? Should certain production practices used in agriculture, for example, genetic engineering, mutagenesis, hybridization, the use of pesticides, or animal husbandry practices, be a factor in defining “natural”? Why or why not? Should manufacturing practices be considered in determining when a food can bear the term “natural”? Why or why not? Should the manner in which an ingredient is produced or sourced affect whether a food containing that ingredient may be labeled as “natural?”; and What can be done to ensure that consumers have a consistent and accurate understanding of the term “natural” in food labeling to ensure that it is not misleading?

FDA has also requested information regarding whether consumers associate, confuse, or compare the term “natural” with “organic” or “healthy,” as well as if there are any public benefits of defining the term “natural” at all.

FDA will be consulting with US Department of Agriculture (USDA) and the USDA's Food Safety Inspection Service (FSIS) on “natural” claims.  Historically, USDA and FSIS have applied a more stringent standard to the permitted use of the term “natural” than FDA, requiring that a “natural” product both (a) not contain any artificial flavor or flavoring, coloring ingredient, chemical preservative, or any other artificial synthetic ingredient and (b) be no more than minimally processed. 

It should come as no surprise that there are many diverging opinions on this issue, so any and all stakeholders should speak now or forever hold their peace.