The Food and Drug Administration (FDA) has steadfastly refused to officially define the term “natural,” instead issuing only non-binding guidance as to the meaning of the term. Accordingly, companies were left to their own judgment to determine whether a “natural” claim was appropriate. In the last several years, class action lawyers have filed cases around the country challenging numerous products labeled as “natural.” The challenges include products containing genetically-modified ingredients, including grains and sugar, foods that are processed (even if the ingredients are natural), and containing artificial additives, including artificial sweeteners that come from a natural source.
A common defense to these cases has been preemption or primary jurisdiction: that the FDA, rather than the courts, should determine what “natural” means. Recently, however, in response to a referral by several courts, the FDA officially declined to exercise primary jurisdiction over the issue, referring instead to its non-binding guidance. The FDA cited its limited resources, and indicated its intent to direct those resources to other priorities. Thus, it is very unlikely, at the present time, that the jurisdictional defense arguments of preemption or primary jurisdiction will succeed. Instead, what “natural” means will be sorted out in various state and federal district courts. In the mean time, companies considering an “all natural” claim should proceed with caution.
It should be noted that products falling under USDA jurisdiction may have somewhat more protection than those under FDA jurisdiction. A California district court found that state law challenges to the natural claim on Campbell’s chicken tortilla soup were preempted, as that product falls under USDA/FSIS jurisdiction and part of the agency’s label approval process includes an inquiry into whether a label is false or misleading. In contrast, state law claims against the natural claim on Campbell’s vegetable soup was not preempted, in light of the FDA’s historical restraint in regulating the term “natural.” Nevertheless, even for products under USDA jurisdiction, it would be prudent to carefully consider the ingredients and processes prior to making a “natural” claim.