During the past decade, the “natural” claim for foods, dietary supplements and personal care products has become more prominent. In fact, it was called “THE trend to watch in 2012” by Nutraceuticals World. But what does it mean and, most importantly, can companies use the claim and still reduce associated risk? This article will explore existing definitions of “natural,” the potential legal consequences of using such a claim to promote foods, dietary supplements and personal care products, and ways to reduce the risk associated with such claims.
The Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) both recognize that consumers can be misled by the term “natural.” As early as the 1970s, FTC stated that as consumers have become more concerned about health, many advertisers have “blatantly abused” the term “natural.” Consequently, FTC staff proposed to define the term “natural,” citing factors, such as, the “existence of conflicting claims and obvious consumer confusion, the implications of superiority fostered by [such] characterizations and the fact that the foods so characterized are considerably more expensive than ordinary foods . . . .” FDA has similarly stated: “Data suggest that uses of ‘natural’ claims are confusing and misleading to consumers and frequently breach the public’s legitimate expectations about their meaning.” In light of this, both agencies set out to define and, in turn, regulate the use of the term “natural.”
However, developing a regulatory definition of the term “natural” for foods and dietary supplements has proved elusive, however. FTC began its attempt in 1974 and completely abandoned it almost 10 years later. FDA began its most recent attempt in 1991. But after less than two years, it gave up and reaffirmed its informal policy on “natural” claims for food:
The agency will maintain its current policy . . . not to restrict the use of the term “natural” except for added color, synthetic substances, and flavors as provided in [21 CFR] § 101.22. Additionally, the agency will 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 to be in the food. Further, at this time the agency will continue to distinguish between natural and artificial flavors as outlined in § 101.22.
Put more simply, when determining whether a “natural” claim is false or misleading, FDA would likely evaluate whether the food bearing a “natural” claim contained any added color, artificial flavor or synthetic substance that would not normally be found in the food or dietary supplement.
FDA Enforcement: Where the Rubber Meets the Road
FDA has not often enforced its “natural” policy, but the agency has issued Warning Letters to companies whose products bear a “natural” claim and also contain (1) a synthetic chemical preservative; (2) added color; or (3) a synthetic substance. It does not appear that FDA has enforced its “natural” policy against companies that advance such a claim for products that contain an artificial flavor.
FDA’s most thorough public analysis of the “natural” status of a food was the recent case of high fructose corn syrup (HFCS). In informal letters responding to a media inquiry, FDA initially found HFCS—and any food to which it is added—to be not natural, but reconsidered its position when additional facts regarding one method of processing HFCS became known to the agency.
As background, HFCS is prepared from a high-dextrose-equivalent corn starch hydrolysate by partial enzymatic conversion of glucose (dextrose) to fructose using an insoluble glucose isomerase enzyme preparation that is rendered insoluble, or fixed. FDA was concerned that these synthetic fixing agents come into contact with the HFCS, rendering it, and any food into which it is incorporated, not natural under FDA’s policy. FDA subsequently learned that, at least in some cases, the synthetic fixing agent does not come into contact with the HFCS. Accordingly, the agency reversed course and found that the specific HFCS manufacturing process may not be inconsistent with its “natural” policy, depending on the natural status of the acids used in the process.
Absent from the above discussion is cosmetics. FDA has not applied its “natural” policy to cosmetics and is unlikely to do so. Nevertheless, some of the concepts that underpin the policy may apply to any determination of the “natural” status of cosmetics.
The Reach of FDA’s ‘Natural’ Policy
The practical effect of FDA’s “natural” policy is limited. It does not independently have the force and effect of law, as would a statute or regulation. Nevertheless, it is FDA’s informal interpretation of the misbranding provisions of the Food, Drug and Cosmetic Act and should FDA find product labels and labeling that run afoul of the policy, it can take enforcement action. Importantly, however, the agency’s “natural” policy does not have a preemptive effect on state law claims. Thus, FDA may find a product to be “natural” under its policy, but that does not stop consumer protection lawyers from filing lawsuits against food companies, alleging that the public is being misled based on different interpretations of “natural” claims.
FDA’s reluctance to act has provided consumer protection plaintiffs’ attorneys an opportunity to use state consumer protection statutes to fill the regulatory void. State consumer protection statutes regulating claims on consumer products vary, but California statutes can serve as an example. California has three laws that are typically used in its courts to attack label claims a plaintiff’s lawyer believes are misleading: The Unfair Competition Law (UCL), the False Advertising Law (FAL) and the Consumer Legal Remedies Act (CLRA). None of these statutes expressly regulates “natural” claims on food, dietary supplement or cosmetic product labels, but they do contain general prohibitions that can be applied to such claims.
The UCL prohibits “unfair competition,” which is defined as “any unlawful, unfair or fraudulent business act or practice and unfair, deceptive, untrue or misleading advertising and [false or misleading advertising under the FAL].” The CLRA prohibits, among other things, representing that “goods or services have sponsorship, approval, characteristics, ingredients, uses, benefits, or quantities which they do not have…”. Those general prohibitions allow plaintiffs’ attorneys to argue to a court that food, dietary supplement or cosmetic “natural” claims are unfair, false, deceptive or misleading.
The meaning of the word “natural” when used on a product label is subject to debate and it is difficult to know exactly when a substance derived from a natural source may be challenged as no longer natural because of the degree of processing. FTC and FDA abandoned their previous attempts to further define the term “natural” (in a regulation), not because of a lack of interest, but because of the inherent difficulty in developing such a definition. Those agencies’ lack of action on this point, however, has essentially created a patchwork of de facto “regulations” by lawsuit. Thus, the definition of “natural” becomes what a court’s ruling says it is and, in the case of companies that wish to avoid defending lawsuits, the definition often becomes whatever a plaintiff’s attorney may allege in a complaint
The Center for Science in the Public Interest (CSPI) is a good example of this point. CSPI advocates its policy positions to Congress and to government agencies and occasionally files or threatens to file lawsuits against companies regarding product claims. CSPI has adopted its own definition of “natural”—“foods that do not contain artificial ingredients and are minimally processed (and that are not deceptive for any other reason)”—and it seeks to persuade food companies and FDA to adopt that definition.
CSPI’s use of the phrase “minimally processed” is worth exploring here, as it is also used by the USDA’s Food Safety Inspection Service (FSIS) to partially define the term “natural” when used to describe meat and poultry products. Importantly, it has been adopted in several consumer protection lawsuits.
Under the FSIS definition, a meat or poultry product can be described as “natural” if “(1) the product does not contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 CFR 101.22), or any other artificial or synthetic ingredient; and (2) the product and its ingredients are not more than minimally processed.”
The first prong of this definition is very close to FDA’s “natural” policy, but the second prong adds the new element of “minimal processing.” FSIS further explains that minimal processing “may” include: “(a) those traditional processes used to make food edible or to preserve it or to make it safe for human consumption, e.g., smoking, roasting, freezing, drying, and fermenting, or (b) those physical processes which do not fundamentally alter the raw product and/or which only separate a whole, intact food into component parts, e.g., grinding meat, separating eggs into albumen and yolk, and pressing fruits to produce juices.” The FSIS policy also states that “[r]elatively severe processes, e.g., solvent extraction, acid hydrolysis, and chemical bleaching would clearly be considered more than minimal processing.”
Unfortunately, the different definitions of the term “natural” from FDA, FSIS and CSPI do not allow food companies regulated by FDA to determine with certainty that their “natural” claims will withstand scrutiny from the plaintiffs’ bar and, in any event, plaintiffs’ attorneys are free to disregard them.
Nevertheless, understanding the difference between FDA’s “natural” policy and CSPI’s definition demonstrates how the same claim might be acceptable to FDA, but not acceptable to plaintiffs’ lawyers. For example, FDA’s concern with “natural” claims on HFCS-containing products was whether a synthetic fixing agent or other synthetic ingredient came into contact with the sweetener, but it was not concerned with the other processing steps. CSPI, on the other hand, goes beyond the fixing agent and finds that the very process of making HFCS yields a sweetener that is not “natural”. CSPI describes the processing of HFCS as follows: “Cornstarch molecules are chemically or enzymatically degraded to glucose and oligosaccharides, and then some of the glucose molecules are converted to fructose.”
The takeaway here is that FDA’s “natural” policy does not provide a safe harbor from lawsuits filed against a company making “natural” claims for a product. Generally, a preemptive effect on state law actions related to “natural” claims has been found only if the term has been specifically defined by regulation, such as in the case of the term “natural flavor.”
So far most of this article has been devoted to foods and dietary supplements, with little attention paid to cosmetics. Partly to blame is FDA’s “natural” policy, which does not apply to cosmetics. In addition, “natural” claims are less prevalent on cosmetics compared to foods. Consequently, lawsuits alleging false or deceptive “natural” claims on cosmetics are proportionally less common. Nonetheless, any “natural” claim for cosmetics should be supported by the same general substantiation as such claims for foods and dietary supplements.
Substantiating Natural Claims
While there are no safe harbors for “natural” claims, the following can help reduce the risk of such claims.
Conform to FDA’s “natural” policy. For food and dietary supplements, the first step in analyzing a “natural” claim is to ensure that the claim complies with FDA’s “natural” policy. A food or dietary supplement that bears a “natural” claim should not contain:
• Artificial flavors
• Synthetic preservatives
• Color, from any source, including natural sources, such as, beet powder and paprika
• Anything artificial or synthetic that has been included in, or has been added to, a food that would not normally be expected to be in the food
• Synthetic substances
The first two items need no further explanation, but the latter three benefit from further commentary. Many colors are from natural sources and are added to foods to avoid listing artificial colors, such as Yellow No. 5, in the ingredient declaration. However, FDA considers the act of coloring food, regardless of the source of the color, to be not natural. Accordingly, even if a food is colored with vegetable juice, turmeric or saffron, FDA will not consider it to be natural.
The fourth item—that nothing artificial or synthetic has been included in, or has been added to, a food that would not normally be expected to be in the food—has an uncertain definition. FDA has not often, if ever, initiated official enforcement action based on this prong of its “natural” policy. However, the comments of some FDA officials suggest that this prong does not offer much protection to food companies that claim their foods are natural. The fifth item—synthetic substances—has not been defined by FDA and, like the elusive definition of the term “natural,” it is subject to debate.
Review the source and processing steps for all ingredients. This step is critical to analyzing any “natural” claim. Each ingredient should be carefully scrutinized to ensure that it is consistent with a “natural” claim. All ingredients are sourced from natural substances. However, almost every ingredient is subjected to some processing before it becomes incorporated into a finished food, dietary supplement or cosmetic. Review each processing step for the ingredient to determine if the source ingredient has been rendered not natural. Chopping, grinding, heating and simple dehydration, for example, will not likely disqualify a product from bearing a “natural” claim. However, processes such as, esterification, cation exchange and hydrogenation might render the ingredient not natural. Ingredient suppliers should have ingredient processing information available for review.
Avoid making “natural” claims for products that contain previously targeted ingredients. FDA and plaintiffs’ attorneys have targeted specific ingredients for enforcement action and lawsuits, respectively. Risk can be reduced by not making natural claims for products that contain these ingredients, which include, among others, ascorbic acid, citric acid, genetically modified/bioengineered ingredients, alkalized cocoa, high fructose corn syrup, xanthan gum, lecithin, disodium phosphate, potassium carbonate, sodium acid pyrophosphate, sodium molybdate, steviol glycosides, phytonadione, sodium selenite, magnesium phosphate, niacinamide, calcium carbonate, calcium phosphate, calcium pantothenate and pyridoxine.
Beware of implied “natural” claims. Implied “natural” claims can carry the same risks as express claims. Strictly speaking, claims such as “naturally good” might not be a claim that a product itself is natural. However, it is the reasonable consumer’s takeaway that is important and such claims can often be interpreted as “natural” product claims.
Each of the above can help to reduce the risk associated with a “natural” claim. However, until FDA defines “natural,” there will be uncertainty regarding the lawfulness of almost all “natural” claims. Consequently, any “natural” claim will carry risk, except for a small group of indisputably natural products.
References furnished upon request.
About the author:
Eric Lindstrom is counsel in the law firm Keller and Heckman LLP (www.khlaw.com), San Francisco, CA. He assists companies on a wide range of FDA, FTC and USDA regulatory matters for foods, dietary supplements, cosmetics and other consumer products. He can be reached at firstname.lastname@example.org.