How Should FDA Define the Word Natural? Should It Be Different from Organic? Or Non-GMO?

September 16, 2016

As FDA looks to define the term "natural" on food labeling, industry leaders are split on what exactly the term should mean.

Take a stroll down any aisle in the grocery store and you’ll find one marketing term used as much as or more than any other: natural. Thousands of U.S. food and beverage companies parade their products under the banner of natural, but with no official definition for the word, each one is free to march to the beat of its own drum.

Despite what a large swath of Americans believe, FDA has never established a formal definition for the term natural on food labeling. That’s made it one of the most ambiguous words on the market, much to the chagrin of food companies embroiled in class action lawsuits attacking their use of natural or allnatural claims.

Even more troubling is the fact that many consumers still appear to place great stock in the nebulous word. According to a 2015 survey1 conducted by the Natural Marketing Institute on behalf of the Organic & Natural Health Association (ONHA; Washington, DC), 46% of consumers believe the U.S. government regulates use of the term natural, while 36% of consumers think there is no difference at all between natural and organic, which is officially defined through USDA’s National Organic Program. Other 2015 surveys suggest majorities of consumers also mistakenly believe “natural” foods must be produced without pesticides or the genetic engineering of crops.

In short, natural remains an influential, widespread term on food labeling that essentially means nothing. But that may not be the case for much longer.

 

FDA Dives In

After years of complaints from courts, consumers, and the food industry, FDA announced last November it was seeking public comment on how natural should be defined on food labeling, if at all. FDA spokesperson Siobhan DeLancey told Nutritional Outlook the agency finally decided to consider the issue after it received three citizen petitions and multiple requests from federal courts asking for a formal definition. By the time the comment period closed on May 10 this year, FDA had received more than 7,600 individual comments, DeLancey said.

One look at the comments and it immediately becomes clear why FDA waited so long to address the issue. Even just among trade groups in the natural products industry, the range of fundamentally different approaches to defining natural makes this one of the most challenging regulatory issues FDA has tackled in a decade.

 

The GMO Conundrum

As you might expect, the “naturalness” of genetically modified organisms (GMO) is one of the biggest fault lines running through this debate. Many industry groups, such as the American Herbal Products Association (AHPA; Silver Spring, MD), the Organic Trade Association (OTA; Washington, DC), and ONHA, believe natural should mean non-GMO. Others, including the Natural Products Association (NPA; Washington, DC) and the Grocery Manufacturers Association (GMA; Washington, DC), say GMO foods should still be considered natural.

On one level, where industry leaders stand on GMO foods being “natural” comes down to how much significance they place in current consumer attitudes.

“If you go ask consumers about what they think natural includes, they don’t think it includes genetically engineered ingredients,” explained Michael McGuffin, president of AHPA. “We think that the whole concept of federal labeling regulations is that consumers should not be fooled.”

Several recent surveys do seem to suggest a majority of consumers perceive natural to mean non-GMO. (The exact percentages vary significantly from survey to survey.) On the high end, an OTA survey2 of 3,400 parents conducted in December 2015 found that 70% of respondents believed “natural” products are produced without the use of GMOs. Meanwhile, a Consumer Reports phone survey3 of 1,005 U.S. adults, also conducted in December 2015, indicated that number was closer to 60%. The aforementioned Natural Marketing Institute survey,1 commissioned by ONHA, suggests it’s more like 50% of consumers who believe natural means non-GMO.

With such wide-ranging consumer data, NPA CEO and executive director Dan Fabricant, a supporter of including GMO foods in the natural definition, has called for more research to be done. But even then, Fabricant expressed “skepticism” toward relying solely on what consumers believe about GMO foods right now.

“Have you ever seen that [“Jimmy Kimmel Live!”] bit on GM [foods] when he asked people what GMO was? He asked 10 different people and he got 11 different answers, and one was goofier than the next,” Fabricant said. “How about having a dialogue with the consumer versus just asking them gotcha questions?”

Unlike AHPA and NPA, the Council for Responsible Nutrition (CRN; Washington, DC), chose not to weigh in on the GMO issue. But Duffy MacKay, ND, senior vice president of scientific and regulatory affairs for CRN, also stressed the importance of additional consumer research.

“If there was an official consumer survey done by FDA, and it became evident that the overarching understanding was consumers think natural means non-GMO, well then that makes sense to use that data to help shape the definition,” MacKay said. “But without that we’re just running with people’s opinions and emotions and feelings about where GMO sits.”

FDA’s DeLancey said it was premature for FDA to speculate on next steps, such as FDA conducting a survey of its own. But she noted that “in the past, on select issues, the FDA has employed a variety of different consumer research methods.”

Nutritional Outlook also asked the FTC whether it might weigh in on the process of defining natural, given the marketing implications of the debate; however, Michelle Rusk, senior staff attorney for FTC’s Division of Advertising Practices, said the agency currently has no plans to become “formally involved.”

 

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Making Natural Different from Organic

Aside from consumer perspectives, there’s also the issue of how natural should be different from the term it’s most often confused with-organic-which already includes non-GMO in its official definition. That’s another reason why NPA argues consumers are best served by a natural definition that’s distinct from anything else already defined on the market.

“If natural became synonymous with non-GMO, there would be no difference between the terms natural and organic, and it would be pointless for FDA to undertake defining natural through federal rulemaking,” NPA said in its comments to FDA.

But even if both terms were to mean non-GMO, there could still be other places where natural and organic diverge, AHPA’s McGuffin pointed out. The USDA Organic Program, for instance, requires companies submit a farm plan that details sustainable farming techniques. Most of the proposed natural definitions, on the other hand, do not include this added element.

“Informed consumers should be aware that organic doesn’t just mean ‘absence of’ [non-organic ingredients]. It means affirmative and active and positive stewardship of that farm,” McGuffin said. “And that would not be included in natural as any of us have perceived it. If natural only means ‘absence of,’ then it won’t be the same as organic, to at least the sophisticated consumers.”

Permitted levels of chemical pesticides could also be a point of difference between the two terms, although surveys have suggested most consumers also believe natural already indicates an absence of chemical pesticides, AHPA noted.

Another distinguishing factor might be that USDA Organic is an actual certification. CRN, AHPA, and NPA have all called for FDA to define natural through rulemaking, rather than establish another, separate certification program for natural. The Organic Trade Association (OTA) disagreed, suggesting a third-party certification would be more appropriate than rulemaking for natural. (But OTA also took the position that natural should not be used on food labeling at all given the issue’s complexity and the time it will take to reach a definition.)

Considering FDA’s reluctance to address the issue for so many years, it’s likely the agency will go through rulemaking anyway, the simpler option of the two, McGuffin suggested. That could potentially ensure organic remains the more powerful of the two terms.

 

A More Accessible Option

Still, for NPA’s Fabricant, those differences aren’t enough to distinguish natural from organic. For natural to be useful, Fabricant said, it should be defined as a more accessible, lower-tier version of organic. And that’s only possible if GMOs are the main point of difference between the two terms, he argued.

“It’s too much black-or-white thinking, versus good, better, best thinking,” Fabricant said, explaining that natural ingredients should be defined as “better” than most food ingredients, but not be defined so strictly as to be conflated with organic, the “best” standard on the market. In his view, a natural definition that bans GMOs would “castigate those people who can’t meet USDA Organic.”

Fabricant also cautioned that a strictly non-GMO natural definition would make “natural” products more expensive and drive up the price of non-GMO seeds already in limited supply. The power of organic might even be “diluted” by a natural definition that also means non-GMO, Fabricant said, if food companies saw natural as a slightly less expensive option that is comparable enough to organic.

AHPA’s McGuffin said that kind of merging of the two terms would be an “unfortunate outcome,” although he said he suspected the added elements of a farm plan and third-party certification would be enough to maintain organic’s status as the
gold standard.

“I can’t help but think that there’s still going to be a price premium for organic,” McGuffin said.

 

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What’s Next?

To say that FDA has opened a can of worms would be putting it lightly. On top of the conflicting opinions from major industry associations, FDA has to consider all the comments submitted by consumer advocacy groups and others invested in natural. So what should we expect next, if anything?

“FDA wants nothing to do with this. That’s the impression I’m getting,” said CRN’s MacKay. He added that FDA knows that “no matter what, they’ll make a lot of people upset.” Also, as FDA’s mandate is public health and safety, while the natural debate largely revolves around marketing issues, it’s likely to be lower on the agency’s list of priorities, MacKay suggested. But NPA’s Fabricant, who formerly served as director of the Division of Dietary Supplement Programs at FDA, was more optimistic about the agency’s timeline. “I would anticipate in the next 12–24 months they’ll have a proposed rule out there,” he said.

Once the proposed rule is announced, FDA will likely open another comment period for 3–6 months, followed by a process of drafting the final rule that could take anywhere from 12–24 months, Fabricant suggested. He added that there’s also pressure from Congress to move the rulemaking process along.

“So you’re looking at a good two- to three-year cycle to get a final rule out there,” Fabricant said. “But I think having a proposed rule at this point is incredibly important for the industry because then people can start going, ‘Okay, this is kind of where the tea leaves are going.’”

And even with the disparity of industry opinions on natural, Fabricant added that NPA is excited that industry and consumers finally have the chance to arrive at a technical standard.

“We haven’t had a scientific dialogue on natural, on GMO,” Fabricant said. “It’s all been emotional. It’s all been charged. This finally gives us the chance to talk about the technical aspects of what natural is.”

 

Sidebar: Organic 2.0

Not everyone thinks natural should be a lower-tier version of organic. In ONHA’s comments to FDA, it argued that natural should actually go a step further. In addition to including everything in the USDA Organic definition, “natural” products should be required to contain at least 95% organic ingredients, come from covered crops with no exposed soil, and, for meat products, come from animals that are pastured, ONHA said.

“Our position is that the only reason to define natural is to improve upon the current organic standard,” said Karen Howard, CEO and executive director of ONHA. “Rather than consider the organic standard to be the Holy Grail, we advocate agriculture and industry comment to improve the current organic standard. Creating federal regulations that create a lesser category is not of value to consumers or to the health of the planet.”

 

Sidebar: A Tiered System

One point many industry associations did agree on is the importance of having a tiered system for labeling different categories of “natural” products. NPA, CRN, AHPA, and other commenters recommended FDA adopt a multi-tier approach to natural that’s similar to what already exists under the USDA Organic program.

“To foster transparency and flexibility, a definition for natural should include a tiered system for labeling different categories of ‘natural’ products,” CRN wrote in its comments to FDA. “For example, USDA Organic products can bear claims in four defined categories: ‘100% Organic’; ‘Organic’; ‘Made With’ organic; or identification of organic ingredients in the ingredients list.”

CRN added that the tiered organic system “allows companies to provide truthful and non-misleading information to consumers. A similar scheme should be established for ‘natural’ food products.”

 

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Sidebar: “Natural” Processing Techniques

Debating which ingredient sources are “natural“ is a first step, but what about the processes those ingredients undergo after harvest? In its request for public comment, FDA also asked whether the term natural should be applied to processed foods, and if so, which processing methods are considered natural.

The response from industry groups was relatively unanimous; simple, traditional processing techniques such as dehydration, distillation, fermentation, and water or alcohol extraction should be considered natural.

“We do want to allow foods that have been subject to traditional food processing, like extraction or fermentation,” said AHPA’s Michael McGuffin. “Those are natural processes. We’ve been doing them for thousands of years or more.”

But food processing that includes non-traditional steps, such as the use of certain extraction solvents or fermentation inoculates, should not be permitted in “natural” foods, according to AHPA.

Based on their recommendations, many commenters, including NPA, urged FDA to create a definitive list of processes that are permitted in the manufacturing of “natural” foods.

 

Sidebar: Natural in Corporate Identity

Natural doesn’t just refer to the state of ingredients in a particular product; many food and beverage manufacturers also use the term as part of their corporate identity. Some companies, such as Nature’s Way or Nordic Naturals, feature the word in their actual brand name, while others just use natural in general marketing materials. The question is, if FDA defines what a “natural” ingredient is, will it also define whether a company’s corporate identity can include natural?

“If FDA does not separate those [issues] and allow for people who have invested decades into their identity being around that term, that will be a huge problem for the industry,” said Duffy MacKay, CRN’s senior vice president of scientific and regulatory affairs.

FDA has not suggested it intends to restrict the use of natural in corporate identities, and the agency’s recent ruling on the KIND company’s use of the term healthy might indicate its thinking on the matter. After first warning KIND against using the term healthy on its products in 2015, FDA announced in May that KIND could continue to use the term because it is a statement of “corporate philosophy,” rather than a health claim, so long as healthy is not used in the same panel as the nutrition information. It’s possible FDA would take a similar approach to natural.

“There are no proposals on the table that would suggest FDA wouldn’t allow those companies to continue [using natural in their corporate identity], but it’s just something to keep an eye on,” MacKay said.

 

Also read:

FDA Requesting Comments on Use of the Term "Natural"

What’s the Difference Between Natural and Organic Foods? Don’t Ask Consumers

What If FDA Regulates “Natural” Claims on Food Labels?

 

References:

  1. Organic & Natural Health Association, Consumer Insights on Organic and Natural, February 2015: http://organicandnatural.org/wp-content/uploads/2015/10/Consumer-Insights-on-Organic-and-Natural-A-Research-Study.pdf
  2. Organic Trade Association, Natural Claims Comments to FDA, May 10, 2016:
  1. Consumer Reports National Research Center, Natural Food Labels Survey, December 2015:  https://www.consumerreports.org/content/dam/cro/magazine-articles/2016/March/Consumer_Reports_Natural_Food_Labels_Survey_2015.pdf
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