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Organic & Natural / Regulations & Claims

Article: Regulations: Natural Claims, with Caution -- June 2008

June 1, 2008
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In the current regulatory environment, a producer who wishes to promote a “natural” claim for its products must proceed with caution. All monitors of food labeling and advertising have opined on the definition of “natural.” The recent, informal response to the Sugar Association’s Citizen Petition regarding natural cannot be considered a final agency action, as it does not add much to the body of knowledge of what constitutes “natural.” However, the informal response puts more arrows in the quivers of groups most inclined to challenge “natural” claims.

Historical Perspectives

The FDA first codified a definition of “natural” in terms of artificial and natural flavors and colors (see 21 CFR 101.22). The public policy rationale was apparently economic, as discussions of health implications (allergies or sensitivities) did not manifest until the Nutrition Labeling and Education Act (NLEA). The natural/artificial definitions included in 101.22 are not particularly helpful to the current discussion; they mandate the anomaly of a “natural” ingredient being used to “artificially flavor” a food (see 101.22[i] [1] [ii]), and they include the potential that the method of extraction of an oil from a natural source could involve more than “minimal processing,” thereby resulting in an “artificial” finished product (see USDA and NAD definitions of “natural,” below).

The Federal Trade Commission (FTC) took its turn at defining “natural” in the early 1980s and concluded it was unable to establish a definition or meaning of “natural” (see 48 Federal Register 23270; 5/24/1983).

In 1991, the FDA proposed to consider a definition of “natural” (see 56 Federal Register 229, 60421, 60466; 11/27/1991). Perhaps, unfortunately for future discussions, the proposal injected the potential that “natural” could be more than a claim of origin: “...that a food is composed only of substances that are not manmade and is, therefore, somehow more wholesome.” The FDA went on to suggest “that nothing artificial or synthetic...is included in, or has been added to, the product that would not normally be expected to be there” (emphasis added). "Just like grandma used to make” is not an effective regulatory standard, especially if grandma was a terrible cook. If grandma’s recipe for canning vegetables called for adding lemon juice to increase acidity (one would not expect to find lemon juice in vegetables), were grandma’s home-canned vegetables still “natural,” or had they become “not-natural,” and/or does the addition of citric acid (for acidity) to a “natural” vegetable for commercial canning render that product not-natural? In practice, the resulting commercial product is likely to be labeled “With Natural Ingredients” (but not a “natural product”).

The USDA, through the Food Safety Inspection Service and its label approval authority, implements its own Food Standards and Labeling Policy Book. Therein, “natural” means no artificial ingredients and minimal processing.   USDA’s interpretation of “minimal processing” exempts “smoking, roasting, freezing, drying and fermenting...(and) processes that do not fundamentally alter the raw product...(but) solvent extraction, acid hydrolysis, chemical bleaching and other such relatively complex processes...” are not minimal processing. The policy includes the seeds of its own demise--to the extent that “the decision of the Agency to approve or deny the use of a ‘natural’ claim may be affected by the specific context in which the claim is made,/I>” (emphasis added) (see 71 Federal Register 70503; 12/5/2006).

“Natural” Means...?

In Advertising Nutrition & Health, “Evidence from Food Advertising 1977-1997,” the authors include “natural/no artificial/real/pure” together as “general nutrition claims,” defining those as “statements or terms, other than nutrient content claims or health claims, that indicate a potential health or nutrient advantage of an advertised food” (page E-7). The NLEA mandate resulted in a definition by regulation of some “general nutrition claims,” such as “healthy,” “light” and others, but did not define “natural” and others.

An integral byproduct of “natural” labeling, as with other general nutrition claims, is the potential for the development of negative labeling--i.e., the benefits of the use of natural vs. non-natural ingredients, and perhaps extending to the “wholesomeness” the FDA espoused in 1991. Any regulatory definition of “natural” must be careful to deal with the potential for a general categorization or implication of artificial/synthetic as unwholesome or unhealthy or, at least, to be avoided. A package of Thomas’ brand Light English Muffins proclaims, “NOW WITH NO HIGH FRUCTOSE CORN SYRUP.” (The product does not claim to be “natural.”)

In any event, FDA decided, “Because of resource limitations and other agency priorities, FDA is not undertaking rulemaking to establish a definition of ‘natural’ at this time” (see 58 Federal Register 2407; 1/6/93). The FDA did note, “Because of widespread use of this term, and the evidence that consumers regard many uses of this term as non-informative, the agency would consider establishing a definition.” (Perhaps if a term is “non-informative,” i.e., does not function as a competitive point-of-difference, the practical regulatory approach is to allow it to die a natural death in the marketplace.) Neither FDA nor the comments included by FDA raised the “wholesomeness” perspective. 

Both the FSIS and the Agricultural Marketing Service (AMS) have recently initiated conversations and proposals for comment as to the meaning of “natural” and “naturally raised.” Comments directed to both agencies continue to indicate broad disagreement among the interested public about the meaning of “natural.” Definitions included concepts of “lifestyle,” “diet,” “processing” and “marketing.” To date, neither proposal has received public follow-up from the issuing agency.

Self-regulation of “Natural”

The National Advertising Division (NAD) is perhaps as active and, certainly as important, as anyone in the interpretation of “natural.” Regularly reviewing advertising and resolving claim disputes with the voluntary participation of the advertisers, the NAD has interpreted claims of “natural” as any not-natural ingredient; indeed, “a minute (i.e., 1%) part of the overall product may preclude an advertiser from sending the message that the finished product is ‘natural’ and constitutes a deception because of consumers' ‘significant interest’ in the naturalness of product ingredients” (see NAD Case Report #3470 June 1, 1998). The NAD has noted, “...there is no single definition of the term ‘natural’... [therefore,] meaning of the term will depend on factors that include the origin of the ingredients; how the term ‘natural’ is presented in the context of the challenged advertising; and reasonable consumer expectation as to the meaning of the term.” The NAD does not appear to account for “minimal processing” in its analysis of “natural” claims in advertising, although chemically identical citric acid can be “natural” or not natural, the latter the result of fermentation of a carbohydrate source.

 The NAD stance parallels the FTC’s standards of a “reasonable basis” for claims. The FTC’s Deception Statement provides that the FTC will find an advertisement to be actionable, if it contains a representation likely to mislead consumers acting reasonably, and if the representation is material. For regulatory purposes, can a “non-informative” claim be “material?” If, in fact, no genuine food safety issues are involved, perhaps the best forum(s) for resolution of the “natural” issue is the marketplace?

No advertiser can ignore the participation of the Center for Science in the Public Interest (CSPI) in the “natural” debate. For example, the CSPI challenged the use of “natural” on a soft drink containing high-fructose corn syrup (HFCS) on the basis that consumers interested in avoiding HFCS would not look past a label claim of “natural” to the ingredients panel. The CSPI joined in support of The Sugar Association petition to define “natural” and has supported the USDA’s two-pronged definition of “natural.” However, the CSPI’s position (that the USDA definition “is consistent with consumer expectations and what has been accepted in the marketplace”) would not seem to track with the public comments to the USDA’s most recent call for comments on “natural” and “naturally raised.”

And the Future Holds…?

Understanding of the claim “natural” does not appear to have advanced over time. In fact, the passage of time may only exemplify the apparent futility of trying to use one word, “natural,” to express consumer expectations for the cultivation, processing and marketing of food products. In the face of the significant regulatory issues facing FDA and USDA, there would seem to be no compelling reason for either agency to act now to define “natural.” The reality of priorities and resources is as real today for food safety monitors as it was at the passage of NLEA. As the USDA has comments pending for “natural” and “naturally raised,” FDA is unlikely to act independently of the protein side of the food supply.

Until a current or future proposal and comment rulemaking process settles the discussion, consumers and regulators should expect advertisers to provide appropriate disclosures of the factual basis of their “natural” claims. With principal display or ingredients panel information, consumers can evaluate the stated basis of the claim and make their own reasoned purchasing decision. In any event, any producer who wants to make a claim of “natural” should proceed with an awareness that a range of definitions are in play, and an abundance of challengers are watching…naturally.

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