In an update posted this morning, the FDA said: “Because of the changing landscape of food ingredients and production, and in direct response to consumers who have requested that the FDA explore the use of the term ‘natural,’ the agency is asking the public to provide information and comments on the use of this term in the labeling of human food products.”
The move comes in part because the FDA has received several citizen's petitions asking that it define the term ‘natural’ on food labels, plus others asking that it prohibit the term on food labels, said the agency.
“We also note that some federal courts, as a result of litigation between private parties, have requested administrative determinations from the FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high fructose corn syrup may be labeled as ‘natural’.”
FDA policy on 'natural' was not intended to address food production methods
The FDA published non-binding guidance in 1993 saying 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 the food”.
However, it did not clarify the status of foods containing high fructose corn syrup (more on this HERE ), GMOs and a raft of other ingredients that many stakeholders believe do not belong in a product labeled as ‘all-natural’, it acknowledged.
“This policy was not intended to address food production methods, such as the use of pesticides, nor did it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation. The FDA also did not consider whether the term “natural” should describe any nutritional or other health benefit.”
Specifically, the FDA wants answers on:
- Whether it is appropriate to define the term ‘natural’
- If so, how it should define ‘natural’
- How it should determine appropriate use of the term on food labels.
It has also asked respondents for data on whether consumers view 'natural' and 'healthy' as "synonymous terms", and whether shoppers confuse the terms 'natural' and 'organic'.
Attorney: This is big news
Attorneys contacted by FoodNavigator-USA this morning said the move came as a big surprise given that the FDA wrote to three federal judges handling civil cases over natural claims last year to “respectfully decline ” their request to come to an administrative determination of whether GMOs belong in ‘all-natural’ foods
“In a world with limited resources”, said the agency, the FDA had more pressing priorities relating to “public health and safety matters”.
David Biderman, a partner in Perkins Coie’s Consumer Class Action Defense practice, told FoodNavigator-USA that the move was “unexpected” as the FDA “had earlier declined to act on petitions and court referrals to address the issue”.
The issue of whether GMOs belong in ‘all-natural’ products - which is at the center of a growing number of class action lawsuits against big food brands - has featured heavily in the debate over GMO labeling, with some state-led GMO labeling initiatives stipulating that products containing GMOs should not be described as ‘natural’.
I would expect all-natural litigation to be stayed pending the FDA’s action
He added: “This is big news. It is an exciting development and it will be good to have clarification of the term natural in light of the hundreds of lawsuits that have been brought over the term.”
Asked what this might mean for the scores of lawsuits currently moving through the courts over ‘natural’ claims, he said: “I would expect the litigation to be stayed pending the FDA’s action.”
Speaking at FoodNavigator-USA's Natural & Clean Label online forum last year, food law attorney Steve Gardner (now of counsel at Stanley Law Group) said the only sure fire way to restore consumer trust and stop the deluge of lawsuits over ‘natural’ would be to define what it actually means.
“A definition would never be perfect but we shouldn’t let perfect be the enemy of the good," he argued.
And to those arguing that the term ‘natural’ is so subjective that trying to define it in relation to food would be well-nigh impossible, he said: “It’s disingenuous to say there is no definition of natural. Every dictionary I open has one, and those definitions pretty much comport with consumer understanding of natural. A clear definition would cut down the consumer deception and eliminate the lawsuits.”
Alternatively, of course, marketers could just stop using the word ‘natural’ altogether, he said (“consumers would be perfectly well off”), or simply accept that they are very likely to get sued if they use it on products that contain ingredients that many consumers - reasonably or otherwise - don’t like the sound of.
Speaking to us this morning, Gardner said: "I am both surprised and pleased that FDA is finally doing something that CSPI has urged it to do for years. As I’ve told folks, all FDA really needs to do is photocopy USDA’s position—it’s imperfect but gets the job done."
Decision could not have been taken lightly... expect a tidal wave of comments
Ivan Wasserman, partner in the Washington DC office at law firm Manatt, Phelps and Phillips, added: “While issuing this request for comments does not in any way obligate the Agency to actually issue a rule or guidance on the claim 'natural,' it certainly does obligate it to consider the issue and to review what could very well be a record number of comments submitted by everyone with a stake in this, including all parts of the food and perhaps other industries (supplements, personal care, textiles, etc), trade associations, consumers, other regulators (FTC, USDA) and, of course, lawyers.
“FDA always has a lot on its plate and limited resources, so the decision to even begin to consider tackling this issue could not have been taken lightly.”
“It’s about time that natural be defined by experts and not Madison Avenue ad executives... While there are several courts waiting for FDA to define the term, we see the need for the federal government to develop one overarching definition for natural as it is the most litigated claim out there in the natural products industry today... Americans have a right to know what’s in the products they buy, and having an accepted definition of what is and isn’t natural is a strong step forward.” Dan Fabricant, Ph.D., Executive Director and CEO of the Natural Products Association.
Attorney: Expect to see a flurry of motions to stay 'natural' cases currently moving through the courts
Robert S. Niemann, a partner at Keller and Heckman LLP, noted that the FDA did "not mention the Vermont GMO labeling legislation [which comes into force in July 2016] or national legislation [click HERE ], but that probably stimulated their action as well".
He added: "The word 'natural' is an emotional term in food labeling and has interpretation spanning many interest groups that are polarized. I think the first question they ask (whether is is appropriate to define the term 'natural') might indicate that they are considering abandoning the definition all together unless they can get some consensus on the definition."
While the FDA notes that its current guidance does not address manufacturing methods, health benefits, or the introduction of ingredients like HFCS, added Niemann, "It seems that this is way beyond any future definition upon which a consensus could be reached. As a litigator, I imagine many of the courts will be getting motions to stay existing cases on Primary Jurisdiction until the 'new natural' definition is created, if at all."
"This is definitely big news, and should be welcome news to the food industry. It will likely put an end to the many class actions over 'natural' labeling – the same way many lawsuits over 'evaporated cane juice' labeling were dismissed on the basis of primary jurisdiction after the FDA asked for comments on that term.
"I am not entirely surprised, however. In September, I co-chaired a conference where an FDA branch chief, in response to audience question, pronounced that the agency was planning to define 'natural' now that FSMA rules had been issued."
The FDA is accepting public comments from November 12, 2015 HERE (type FDA-2014-N-1207 in the search box).
Click on the following link to read our 2014 VOX POP on natural claims:
Click HERE to read a more detailed statement from the FDA.