The U.S. Food and Drug Administration (FDA or the Agency) issued today a pre-publication version of its request for information on use of the term "natural" in the labeling of human food products, which includes dietary supplements. FDA's request is a bit of a surprise, given that the Agency has previously declined to weigh in, when requested by the courts, with regard to whether and the circumstances under which food products could be labeled "natural." There are a large number of pending and threatened lawsuits over this very issue, a litigation trend which would necessarily be impacted by the Agency's formal adoption of a "natural" labeling standard.
FDA is asking the public to provide information and comments to the Agency on questions such as:
- Whether it is appropriate to define the term "natural";
- If so, how the Agency should define "natural";
- How FDA should determine the appropriate use of the term on food labels;
- Whether the Agency should prohibit the term "natural" in food labeling;
- If FDA defines the term "natural," what types of food should be allowed to bear the term;
- Whether only raw agricultural commodities should be able to bear the term;
- Whether only single ingredient foods (e.g., bottled water or bagged spinach) should be able to bear the term;
- If multi-ingredient foods should be able to bear the term, what type(s) of ingredients would disqualify the food from bearing the term;
- Whether the term "natural" on food labels is perceived by consumers in the same way that they perceive the term "organic";
- Whether certain production practices used in agriculture (e.g., genetic engineering, mutagenesis, hybridization, the use of pesticides, or animal husbandry practices) should be a factor in defining "natural";
- Whether the term "natural" on food labels is perceived by consumers in the same way that they perceive the term "healthy";
- Whether manufacturing processes should be considered in determining when a food can bear the term "natural" (e.g., whether food manufacturing processes, such as drying, salting, marinating, curing, freezing, canning, fermenting, pasteurizing, irradiating, or hydrolysis, should be a factor in defining "natural");
- Whether the term "natural" should be applied only to "unprocessed" foods, and if so, how "unprocessed" and "processed" should be defined for purposes of bearing the claim;
- Whether the manner in which an ingredient is produced or sourced affects whether a food containing an ingredient may be labeled as "natural";
- What, if any, are the public health benefits of defining the term "natural" in food labeling;
- Whether "natural" should have some nutritional benefit associated with it; and
- How FDA should determine whether foods labeled "natural" comply with any criteria for bearing the claim.
FDA is issuing this request, in part, because it received three Citizen Petitions asking the Agency to define the term "natural" for use in food labeling and one Citizen Petition asking the Agency to prohibit the term "natural" on food labels. In its announcement regarding the request for comments and information, FDA also noted that some federal courts, as a result of private-party lawsuits, have requested administrative determinations from FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high-fructose corn syrup may be labeled as "natural."
Despite the fact that the Agency has not engaged in rulemaking to formally define the term "natural," its policy has been that "natural" means 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 that food. However, the Agency's policy was not intended to address food production methods (e.g., the use of pesticides) or food processing or manufacturing methods (e.g., thermal technologies, pasteurization, irradiation). FDA's policy also does not consider whether the term "natural" should describe any nutritional or other health benefit.
It is worth noting that the Agency is working with the United States Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) and Food Safety and Inspection Service (FSIS) to also examine the use of the term "natural" in descriptions of meat, poultry, and egg products, and is considering areas for coordination between FDA and USDA.
The Agency is accepting public comments beginning on November 12, 2015. It is interesting that FDA has not specified a closing date for the comment period. However, the comments that will be filed, especially by consumer groups, will give industry a window into how consumers view this term, and whether such a view differs dramatically from the views of various market segments that will also be submitting comments. These comments will likely find their way into litigation over this term. Moreover, FDA's action could very well lead to stay requests under the primary jurisdiction doctrine, which some courts might grant, as several courts did in response to FDA's evaporated cane juice docket.
If you have questions regarding the issues raised in this alert, or if you would like to submit comments or information to FDA in response to its request, please contact one of the authors.