FDA asks for comment on ‘natural’ food label claims

In a notice published in the Federal Register on November 12, 2015, FDA requested comments from the public on the appropriate use of the term on the labeling of food; specifically, human food products.

The Association of American Feed Control Officials (AAFCO) defined the feed term "natural" and provided considerable guidance as it applies to pet food and other animal feed quite a few years ago (early 2000s). This was done predominately to put a measure of control over the prolific and sometimes misleading use of the term on pet food labels. The US Department of Agriculture (USDA) also defines "natural" as it pertains to meat and poultry products for human consumption. However, the US Food and Drug Administration (FDA) never followed suit. Although use of the term is also rampant on human foods under its jurisdiction, FDA never saw fit to engage in any formal rulemaking to officially define the term. Apparently, that is now changing.

In a notice published in the Federal Register on November 12, 2015, FDA requested comments from the public on the appropriate use of the term on the labeling of food; specifically, human food products. Reportedly, it is being done now in response to several citizen petitions asking for a definition (or to simply prohibit its use) as well as to facilitate a few federal court requests for administrative determinations. Initially, the comment period was set for 90 days post-publication of the notice, but due to the great interest in the topic, FDA has extended the deadline for comment to May 10, 2016. FDA wants to be sure all interested parties have an opportunity for input.

Notwithstanding the lack of a formal definition, FDA does have a long-established policy regarding the term. Several decades ago, it opined "natural" to mean "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." Frankly, that brief description is open to considerable interpretation. Certainly, it goes into far less detail than AAFCO's definition, and offers little practical guidance to those opting to use the term.      

FDA is not proposing any new regulations in its notice. Rather, at this juncture FDA is only asking for information and public comment on the concept of a definition, such as:

  • Whether it is appropriate to define the term “natural”
  • If so, how the agency should define “natural”
  • How the agency should determine appropriate use of the term on food labels

While FDA leaves the door open for comment on any aspect, there are some indications as to the agency's initial thoughts on the matter. It points out that its existing policy was not intended to address production methods, such as use of pesticides. FDA also touches on other processing and ingredient issues that may be addressed by the new definition, including pasteurization, irradiation, inclusion of genetically engineered ingredients and even use of high fructose corn syrup.

How does this affect pet foods? Again, the request expressly limits comments to how use of the term would apply to human food product labeling. The Center for Food Safety and Applied Nutrition (the arm of FDA that is requesting comments) is not considering promulgation of new federal regulations affecting the labeling of animal feeds. However, if a definition for human foods was put into place, it is not out of the realm of possibility that FDA's Center for Veterinary Medicine and/or AAFCO would want to review it for potential application to animal feed labels, as well. Although AAFCO's definition has served the pet food industry well for many years, there's always the chance that animal feed regulators will see a new FDA definition as an appropriate opportunity to update AAFCO's.

So, it may be prudent for an interested party, including anyone in the pet food industry, to take advantage and submit comments on this issue at this early stage. Comments to Docket #FDA-2014-N-1207may be submitted electronically to the Federal eRulemaking Portal (www.regulations.gov) before May 10. 2016. For those who prefer submission by mail, comments (with the docket number on each page) may be sent to: Division of Dockets Management, HFA-305, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland, 20852.

In any event, any new FDA regulation defining "natural" is likely to come to fruition only after very long deliberation. After the comment period closes, the agency would have to review all the submissions and address them in any published proposal of a new regulation. FDA then would allow time for comment on the proposal, and only after consideration of the new comments could it even think about issuing a final regulation. In other words, it will likely take years until anything comes of this. So, if you don't feel the urge to comment at this juncture, there likely will be other opportunities.


Further insights

More columns by Dr. Dzanis: www.petfoodindustry.com/authors/2

More information on FDA’s request: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm456090.htm

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