What Does “Natural” Mean, Anyway?

The term “natural” may be found on labels of a variety of products, from food, to dietary supplements. But how is the term “natural” defined by the regulatory agencies in the U.S., and by what criteria is this term substantiated for food? The Food and Drug Administration (FDA) has yet to define the term “natural” or its derivatives. Historically, over the past 20 years various agencies have attempted to define the term “natural.” In the 1970s the Federal Trade Commission (FTC) proposed defining “natural” foods as “those with no artificial ingredients and only minimal processing.”[1] However, FTC dropped this definition in 1983, although the agency stated that it would evaluate “natural” claims on a “case-by-case” basis. FDA tried to define the term “natural” in 1989, but formally abandoned this effort in 1993, citing resource limitations and other priorities.[2] In closing this effort, FDA did state 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”.

Currently, FDA has indicated that, from a food science perspective, many processed (even minimally processed) food products are technically no longer “the product of the earth.” However, FDA has not objected to the use of the term “natural” if the food does not contain added color, artificial flavors, or synthetic substances. In general, FDA still utilizes the general guidelines provided at the closing of the formal effort in 1993 to define “natural.” FDA’s only formal definition of “natural” is in the FDA natural flavor regulation, which focuses on the source and the processing method of natural flavors. The regulation states:

“The term natural flavor or natural flavoring means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.”[3]

The United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) oversees the safety of meat, poultry, and egg products (and ingredients added to these products), issued a policy memo on November 22, 1982 (“FSIS Policy Memo 55”) that has formed the basis for the USDA policy on the term “natural” and provides guidance during FSIS’ review of labels. However, FSIS outlined its definition of “natural” and the conditions for the use of this term in 2003 in the Food Standards and Labeling Policy Book (updated in 2005)[4] that officially cancelled FSIS Policy Memo 55.  The policy states that the term “natural” may be used on labeling for meat products and poultry products, provided that the applicant of the label demonstrates that:

  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.

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 meant, separating eggs into albumen and yolk, and pressing fruits to produce juices). FSIS also indicated that relatively severe processes, such as solvent extractions, acid hydrolysis, and chemical bleaching “would clearly be considered more than minimal processing.”

To add to the complexity, FSIS stated that:

“[H]owever, the presence of an ingredient which has been more than minimally processed would not necessarily preclude the product from being promoted as natural. Exceptions of this type may be granted on a case-by-case basis if it can be demonstrated that the use of such an ingredient would not significantly change the character of the product to the point that it could no longer be considered a natural product.”

FSIS stated that in such cases, the natural claim must be qualified, such that the qualifying language must clearly and conspicuously identify the ingredient (e.g., “all natural or all natural ingredients except dextrose, modified food starch, etc”). The 2005 FSIS Policy Book also stated that sugar and natural flavoring from oleoresins or extractives are acceptable for “all natural” claims. FSIS later (2009) issued an Advance Notice of Proposed Rulemaking (ANPR) to assist the Agency in defining the conditions under which FSIS will permit the voluntary claim of “natural” for meat and poultry product labels.[5] The public comments that were received included requests for FSIS to work with USDA’s Agricultural Marketing Service (AMS) to codify an expanded definition of “natural” that addresses the treatment and living conditions of animals raised for food before their slaughter. FSIS currently[6] defines “natural” as:

“A product containing no artificial ingredient or added color and is only minimally processed. Minimal processing means that the product was processed in a manner that does not fundamentally alter the product. The label must include a statement explaining the meaning of the term natural (such as ‘no artificial ingredients; minimally processed’).”

As consumers request foods with fewer “synthetic” ingredients and more products that may be considered more “wholesome”, the regulatory nature of the term “natural” and its implications has come to the forefront. While FDA has not provided clear guidance on the use of the term “natural” as it applies to food products, USDA has provided statements that help the consumer (and manufacturer) of certain products understand the context of the term “natural” when utilized on product labels.

References

[1] 39 Federal Register 39,842(November 11, 1974); 40 Federal Register 23,686 (May 28, 1975); 41 Federal Register 8980 (March 2, 1976).

[2] 54 Federal Register 32,610 (August 8, 1989); 58 Federal Register 2302 (January 6, 1993).

[3] Code of Federal Regulations (CFR) §101.22 Foods; labeling of spices, flavorings, colorings and chemical preservatives (2011)

[4] http://www.fsis.usda.gov/oppde/larc/policies/labeling_policy_book_082005.pdf; site last visited March 27, 2012.

[5] 74 Federal Register 46,951 (September 14, 2009)

[6] http://www.fsis.usda.gov/Factsheets/Meat_&-Poultry_Labeling_Terms; site last visited March 28, 2012.