Ingredients and Formulation / Food Safety / Regulatory Compliance

FDA Needs to Define ‘Natural’ Food

Despite the close of the public comment period, the FDA has not committed itself to a definition of 'natural.'

By David L. Wallace of Herbert Smith Freehills New York LLP

Last November, the FDA signaled it might finally settle the debate over what is "natural" by calling for comments from industry stakeholders and the public on the appropriateness of defining the term for food-labeling purposes. Referencing its long-standing "informal policy" concerning use of the word "natural," the agency explained that it "was not intended to address food production methods" or the labeling of foods derived from genetic engineering or containing high fructose corn syrup.

The comment period closed in May, leaving the FDA to make sense of a welter of contradictory and conflicting views -- a task suggestive of the labors of Sisyphus.

In the meantime, food and beverage labeling statements like "all natural," "100 percent natural" or "natural" are by no means indefensible, but defending them in proposed consumer class-action litigation against claims of deception -- or relabeling an entire product line to avoid or end such lawsuits -- can be an expensive proposition. Just look at the prevalence of food-labeling litigation over the past decade or so. Initially restricted to the California court system, it is now widespread, and typically centers on disputes over a product's "naturalness."

This begs the question, why bother? All too often the answer is, because it sells and the competition is doing it, which usually means that competitors have blindly followed one another into litigation -- revealing in the process a considerable amount of uncertainty over what the term "natural" means. It seems that natural, like beauty, is in the eye of the beholder, ultimately hinging on unquantifiable subjective standards.

As a result, defending "natural" claims in either the court of public opinion or one of law quickly leads down the proverbial rabbit hole. What makes a food or beverage unnatural: its ingredients or processing? What about the use of genetic engineering? Or the presence of trace levels of a chemical element like lead, or a pesticide residue like glyphosate? The lack of a governing legal definition, or even a common consumer understanding of what "natural" means, compounds the difficulty, making for a very sticky wicket indeed.

For decades and various reasons (including resource constraints and other priorities), the FDA in the past has declined to adopt a formal rule for use of the term "natural," opting instead for an "informal policy" issued in 1991. According to this policy aimed solely at ingredients, "natural" means:

"…that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there."

This language, however, raises more questions than it answers, and consumer advocacy groups, industry trade associations, and plaintiff's class-action bar have exploited its gaps to advance their own (often conflicting) agendas. Among other things, whose "expectations" determine the ingredients "that would not normally be expected to be" in a food product? If the measure is consumer expectations, how realistic might those be, given how far removed the average person is from modern food production technologies, not to mention the land and the kitchen?

And the FDA's "natural" policy says nothing about processing, allowing litigants plenty of room to squabble over how much and which types of processing make a food product not "natural." The GMO debate further clouds the picture. While many insist that foods derived from genetic engineering are man-made and consequently not natural, this view doesn't account for either the fact that humankind has been modifying food crops for about 10,000 years, or the recent scientific discovery that the genome of cultivated sweet potatoes contains Agrobacterium transfer DNA -- an example of a naturally transgenic food crop.

By sidelining itself so long in this debate, the FDA has left it to competing interest groups, and the court system, to say what "natural" means on an ad hoc basis -- "not with the goals of complying with any legitimately created standard, but [rather] to suit … standards created by consumer advocacy groups and class action plaintiffs," which do not necessarily "reflect an appropriate balance between industry practice, consumer expectations, and health concerns" (Faris, 2010). It's a fine mess.

Critically, the FDA has not actually committed itself to adopting a formal rule or amending its "natural" labeling policy. And probably for good reason, since a uniform definition capable of fitting so many different categories of FDA-governed products seems unlikely to emerge from the process. Rather than leave things as they are, one option would be to adopt standards like those the agency uses to regulate nutrient-content and health claims. Time will tell.