FDA’s ‘Natural’ wonder

someone say natural?

For obvious reasons, the word natural” brings to mind nature. It’s a word that most of us associate with a product that comes from the earth, as opposed to humans. Now, take a stroll through your local supermarket and take note of the number of times natural” is used on a product label. What does it mean when natural” is used on a food product? The answer is different depending on whom you ask. And, from a regulatory perspective, it’s hard to pin down because the conditions for its use are ambiguous. Unlike the term organic,” a formal definition doesn’t exist.

Although both the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) are statutorily mandated to protect consumer interests by prohibiting false and misleading labeling, both agencies have refused to formally define the term through rulemaking. As a result, food manufacturers have been able to use it without a clear definition and without consistent oversight. The tides, however, may be turning, albeit slowly.

FDA requests comments

Spurred by citizen petitions, federal court requests and decades of debate and indecision, FDA in November announced an open comment period on the use of the term natural” in the labeling of human food products. FDA explained in a Federal Register notice that it is taking this action in part because it received three Citizen Petitions asking that the agency define the term natural” for use in food labeling, and one Citizen Petition asking that the agency prohibit the term natural” on food labels. FDA also noted that as a result of litigation between private parties, some Federal courts have requested administrative determinations from FDA regarding whether food products containing ingredients produced using genetic engineering (GMOs) or foods containing high fructose corn syrup may be labeled as natural.

FDA is currently working with USDA’s Food Safety and Inspection Service (FSIS) to examine the use of the term natural” in meat, poultry, and egg products, and is considering areas for coordination between FDA and USDA.

[Note: FDA regulates the labeling of all food products except for meat, poultry and egg products, which fall under the jurisdiction of USDA’s FSIS.]

How did we make it without a definition?

FTC Since the 1970s, several federal agencies have attempted to define natural” as it relates to food. The Federal Trade Commission (FTC), which regulates the use of false and misleading advertising, was the first agency to try. FTC proposed the adoption of a rule establishing natural” foods to be those which were minimally processed and free of artificial ingredients.” However, in 1983, FTC terminated its rulemaking, concluding that it was unable to establish a definition for natural” due to the wide variety of products and industries involved in food production. FTC has not attempted to address the natural” issue since its abandoned effort in 1983.

FDA FDA attempted to define the term natural” in 1989 but didn’t make it further than adopting an informal policy. In 1993, FDA initiated rulemaking, but citing resource limitations and other priorities, it formally abandoned this effort. FDA also stated that it would maintain its policy regarding the use of ‘natural’ as meaning 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 in food.”

Despite not having a formal regulatory definition of natural,” FDA still refers to its general guidelines put forth in the 1993 Federal Register notice.

USDA — Unlike FDA, USDA’s FSIS maintains a premarket approval system where each label is evaluated against FSIS policy. FSIS implemented an informal policy regarding natural” labeling in 1982, and in 2003, outlined its definition of natural” and the conditions for its use in the Food Standards and Labeling Policy Book.

FSIS’s natural” policy definition requires that:
1) the product not contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 C.F.R. § 101.22), or any other artificial or synthetic ingredient; and
2) the product and its ingredients be not more than minimally processed. Although the policy provides further guidance on meaning of  minimally processed,” a precise definition has not been pinned down, and the meaning continues to be a moving target.

OTA’s Natural Claims Task Force

In response to FDA’s request for comments, OTA convened a task force to take a deep look at the issue. Its mandate is to protect and uphold the meaning of organic claims in the marketplace. The task force is focused on identifying the risks and impacts that a formal definition may have on the organic label.

FDA’s request for comments includes a long list of questions, one of which is pointed directly at organic. FDA is interested in any data or other information to suggest that consumers associate, confuse, or compare the term natural” with organic.” It asks if the term natural” on food labels is perceived by consumers the same way as organic,” or if natural” is perceived by consumers to be better” (or not as good as) organic?”

As mentioned earlier, FDA is statutorily mandated to protect consumer interests by prohibiting false and misleading labeling. The questions then surrounding consumer perception of naturalvs. organic” become relevant to FDA’s overriding question of whether it should define, through rulemaking, the term natural” or whether it should prohibit the term. If in fact consumers confuse the term natural” with organic” and they are misled into thinking it means something that it does not, FDA would logically need to step in and either set the record straight with a formal definition or prohibit its use all together.

developing A position

In addition to reviewing and summarizing existing survey data on consumer perceptions, OTA partnered with Kiwi Magazine to field a survey on parents’ understanding and perception of the meaning of the terms natural” and organic.”

The data collected demonstrate that many consumers falsely believe that organic” and natural” have similar meaning or at least share several attributes. More specifically, consumers falsely believe that the term natural” comprises multiple attributes, such as no toxic pesticides or fertilizers, no GMOs, no artificial colors or flavors, no artificial ingredients, minimally processed, and enforced according to a government standard. The survey data in totality clearly indicate that consumers are confused by the term natural,” they associate the term with organic,” and they are misled by its use. OTA agrees that natural” has no clear meaning, and FDA should take action.

Although OTA is still in the process of finalizing its comments, some guiding objectives are solidly in place. Our comments set out to:

  •  Demonstrate to FDA that consumers are confused and misled by the natural” claim and they associate it with organic.”
  •  Describe a solution that would result in the most consistent and accurate understanding of the term natural” in food labeling and uphold the meaning of the organic label.
  •  Prevent any policy or definition regarding the use of the term natural” on food labels from duplicating and/or conflicting with the organic regulations and the definitions therein.
  •  Prevent the creation of a natural” definition that would have an unfair market advantage over the organic” label.

The task force has also identified some absolute no-goes:”

  •  When used on food labels, FDA should not extend the term natural” to production methods (such as how something is grown) because this would be duplicative of the organic regulations and only create further consumer confusion.
  •  The term natural” should not be allowed on ingredients or food products that were genetically modified through the use of modern biotechnology (GMOs).
  •  Use of the term natural” on food labels should not extend beyond the scope of the source of the ingredient/product (plant, animal, mineral); the composition or ingredient content of the product (what the product contains); and the extent to which the product is processed.

The work of the task force to-date has brought us to the conclusion that consumer perception and expectation of natural” are largely consistent with USDA’s organic regulations, and efforts to create an FDA definition through rulemaking would not only be extremely difficult for FDA to adequately enforce given its limited resources, it would also be duplicative of the organic regulations and could create regulatory conflicts if definitions and requirements are not aligned.

The task force believes that the best course of action for eliminating consumer confusion and upholding the meaning of the organic label is for FDA to clarify its preference that the term natural” should not be used. Instead, FDA should focus on defining the single attributes that may be used (no artificial colors or flavors,” “no synthetic ingredients,” “minimally processed,” “produced without the use of GMOs”) and engage in label guidance for their use on labels and marketing materials. If the term natural” is to be used on labels and marketing materials, then the term must include a statement on the package label explaining its meaning. For example: Natural—no artificial flavors or colors.” This would be the most definite way to eliminate consumer confusion surrounding the terms naturalvs. organic” and the misleading use of the term natural” in the marketplace.

What do you think?

Member feedback is requested! To view OTA’s complete draft comments, visit OTA’s advocacy webpage. The comment deadline is May 10. Please send your feedback or questions to Gwendolyn Wyard.  //

Gwendolyn Wyard is OTA’s Senior Director of Regulatory and Technical Affairs.