Dashing the hopes of many in the food industry that the federal government might put an end to the dozens of class actions challenging “Natural” claims for food products, the Food and Drug Administration (FDA) told three federal judges that it “respectfully decline[s]” to determine what food products may or may not be labeled “Natural” or “All Natural” or “100% Natural.” While the January 6, 2014 letter was directed to judges hearing food cases, the issue also impacts cosmetic manufacturers and others.
In July 2013, several federal judges stayed class actions against food manufacturers and asked the FDA to weigh in on whether and under what circumstances food products containing ingredients produced using bioengineered ingredients may be labeled “Natural,” “All Natural,” or “100% Natural.” See our earlier blog posts here and here. The third judge, sitting in the District of New Jersey, administratively terminated a case pending a response from the FDA.
The FDA has consistently declined to define the term “Natural” and has not issued any binding regulations governing the use of that term. The FDA’s nonbinding policy considers “Natural” to mean “that nothing artificial or synthetic (including color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.”
In the letter, FDA Assistant Commissioner for Policy Leslie Kux emphasized that “[i]f the FDA were inclined to revoke, amend, or add to this policy, we would likely embark on a public process, such as issuing a regulation or formal guidance, in order to determine whether to make such a change; we would not do so in the context of litigation between the parties.”
FDA’s decision paves the way for continuing litigation and piecemeal decisions that could be inconsistent or otherwise confusing. The FDA stressed in its letter that defining the term “Natural” would involve the interests of the United States Department of Agriculture and require consideration of “the vast array of modern food production technologies in addition to generic engineering (e.g., use of different types of fertilizer, growth promotion drugs, animal husbandry methods)” and “the myriad food processing methods (e.g., nanotechnology, thermal technologies, pasteurization, irradiation).”
This same complexity is evident in the variety of consumer class actions that challenge the use of the term “Natural” on labels. In the absence of any formal regulatory guidance from the FDA, these class actions will continue to move forward, and courts will begin to decide whether and when a product is “Natural” on a case-by-case basis.