- State Actions Grounded in “Source” Claims: Preempted or Not?
- September 3, 2013 | Author: Ricardo Carvajal
- Law Firm: Hyman, Phelps & McNamara, P.C. - Washington Office
Is the word “source” (just “source” - not “good source” or “excellent source”) a nutrient content claim? FDA seems to think so, as reflected in a paragraph in this warning letter that escaped our attention when it issued in March 2011. FDA stated:
Your Organic Clover Sprouts product label bears the claim “Phytoestrogen Source[.]” Your webpage entitled “Sprouts, The Miracle Food! - Rich in Vitamins, Minerals and Phytochemicals” bears the claim “Alfalfa sprouts are one of our finest food sources of . . . saponin.” These claims are nutrient content claims subject to section 403(r)(1)(A) of the Act because they characterize the level of nutrients of a type required to be in nutrition labeling (phytoestrogen and saponin) in your products by use of the term “source.” Under section 403(r)(2)(A) of the Act, nutrient content claims may be made only if the characterization of the level made in the claim uses terms which are defined by regulation. However, FDA has not defined the characterization “source” by regulation. Therefore, this characterization may not be used in nutrient content claims.
The issue resurfaced in class action litigation via a couple of recent California federal district court decisions filed on the same day. In Clancy v. Bromley Tea Co., Plaintiff alleges that Defendant made unlawful and deceptive claims for certain tea products. Defendant argued preemption on the ground that Plaintiff sought to impose requirements greater than those imposed under the FDCA and its implementing regulations. Defendant argued that the claim “source of” (as in “natural source of antioxidants”) was not defined as characterizing the level of a nutrient, and therefore was not prohibited under federal law. The court agreed that the claim was undefined, but pointed to the above-quoted warning letter’s conclusion that “source” claims are nutrient content claims - albeit ones that are undefined - and refused to dismiss Plaintiff’s claim as preempted.
In Trazo et al. v. Nestle USA, Inc., Plaintiffs allege that Defendant makes false and misleading claims for certain of its products. As in Clancy, Defendant raised preemption. Defendant argued that its product labels claimed only that the products were a “source” of antioxidants - not a “good source.” Therefore, the requirements applicable to “good source” nutrient content claims were inapplicable to Defendant’s claims. The court agreed: “To the extent that Plaintiffs seek to regulate the term ‘source’ in the same manner as ‘good source,’ going beyond the boundaries of the regulation, this claim is preempted.”
Perhaps these cases illustrate how the technical nature of food labeling regulations, and differences in how counsel interpret those regulations and frame the issues for the court, can lead to divergent results.