Global Regulations: Why is FDA reluctant to define "natural"?

It was somewhat shocking to observe the issuance of an FDA warning letter earlier this year that addressed, among other violations, a company’s alleged improper use of the term natural. In that warning letter, issued on March 11, 2011, to Shemshad Food Products, FDA declared that use of the term natural in association with a food product that contained a synthetic chemical preservative was false and misleading. The shock does not stem from FDA’s position on the matter; the shocking part is that FDA addressed the use of the word natural at all-a topic that the agency has notoriously avoided over the last decade.

The real question raised by this warning letter is whether it signifies a movement in FDA’s inclination to address the topic of “natural” claims, especially in light of the ever-increasing number of such claims-or whether the issuance of this warning letter is just an isolated case. If FDA’s history of action-or more accurately, inaction-in this area is any indication, the answer is likely the latter.

Natural is not defined in the central body of laws, the Federal Food, Drug and Cosmetic Act, enforced by FDA. Furthermore, despite repeated requests from various organizations and entities, FDA has expressly declined to define natural in any regulation or formal policy statement. In 2002, the Center for Science in the Public Interest (CSPI), a public advocacy group that has been very aggressive in taking on companies making what it perceives to be improper “natural” claims, requested that FDA take action against Ben & Jerry’s-only to have FDA respond that “natural” was “not among the FDA’s current enforcement priorities.” In 2006, the Sugar Association petitioned FDA to define natural, and FDA likewise declined to do so. In 2010, a number of U.S. District Courts issued six-month stays of pending litigation over the use of natural in beverages containing high-fructose corn syrup, in the hopes that FDA would formally define natural. Not surprisingly, FDA declined to do so.

Instead, when questions over “natural” arise, FDA usually refers back to a statement made in a January 6, 1993, guidance regarding labeling.(1) Essentially, FDA’s informal policy based on that statement is that the term natural means “any food in which nothing artificial or synthetic has been included or has been added to a food that would not normally be expected to be in the food.” With only this informal policy statement on which to rely as the definition for natural, FDA has taken little action against companies for improperly using the term. In fact, since 2001, FDA has issued exactly two warning letters to companies that even address the use of the term natural: the March 2011 letter mentioned earlier and a 2009 warning letter to a seafood-processing facility in which FDA, almost as an afterthought, issued a one-sentence statement about the use of the term natural for a product containing synthetic ingredients.

As FDA has shown little inclination to consistently regulate use of the term natural, it may appear that companies have license to use the term freely and haphazardly, with no consequences. Not so fast.

Due to the fact that FDA has essentially taken a “hands-off” approach to this issue, competitors, organizations, and consumers have waged war against purveyors of questionable “natural” claims, in a variety of forums. The National Advertising Division of the Better Business Bureau has handled disputes between advertisers over use of the term natural, including a 2009 case involving artificial sweeteners. CSPI has initiated litigation over companies such as Ben & Jerry’s, Snapple, and 7-Up for “natural” and “all-natural” claims. Consumers, often following the lead of CSPI, have also sued companies for making improper and unsubstantiated “natural” claims, resulting in lengthy and costly litigation to the companies.

Until FDA adopts a more formal policy or regulation on use of the term natural, it is unlikely that the warning letter issued earlier this year represents a dramatic departure from the agency’s historical reluctance to address “natural” claims. However, despite the likely inaction from FDA, companies must still exercise caution when using the term natural, lest they face possible action from a variety of other sources. Such action could result in substantial economic consequences that may have a more direct effect on a company than any regulatory action from FDA.

 

References

1.    Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food, 58 Federal Register 2,302, 2,397 (January 6, 1993).