Petition Challenges FDA’s View on “Qualified Nutrient Content Claims”June 26, 2008
On June 5, 2008, a citizen petition was submitted to FDA requesting that the Agency “initiate rulemaking proceedings addressing the authoritative statement nutrient content claim provisions” of the Federal Food, Drug, and Cosmetic Act (“FDC Act”). The petition takes issue with FDA’s November 27, 2007 proposal to prohibit nutrient content claims for Eicosapentaenoic acid (“EPA”) and Docosahexaenoic acid (“DHA”).
A nutrient content claim characterizes the level of a nutrient in a food, e.g., “high,” “more,” or “good source.” Until the FDA Modernization Act of 1997 (“FDAMA”), foods could carry only nutrient content claims that were authorized by FDA. Moreover, only nutrients of the type required to be in nutrition labeling were eligible for nutrient content claims. FDAMA amended the FDC Act to authorize nutrient content claims based on an “authoritative statement” published by “a scientific body of the United States with responsibility for public health protection or research directly relating to human nutrition,” or by the National Academy of Sciences (“NAS”) which “identifies the nutrient level to which the claim refers.” Notice of the claim must be submitted at least 120 days before its use. The notified nutrient content claim may be made until FDA issues a regulation prohibiting the claim.
Between 2004 and 2006, FDA received three nutrient content claim notifications for the omega-3-fatty acids Alpha-linolenic acid, EPA, and DHA. All three notifications stated that the claims were based on authoritative statements in a prepublication copy of a report by the NAS Institute of Medicine (“IOM”). In November 2007, FDA proposed to prohibit the notified nutrient content claims for EPA and DHA. The Agency concluded that the IOM publication did not identify a “nutrient level” for EPA and DHA within the meaning of the FDCA, and thus the statements cited as authoritative in the notifications did not meet the statutory requirements.
The newly filed petition challenges FDA’s view that a notified nutrient content claim must be based on an established reference value such as a Dietary Reference Intake or Daily Value. According to Petitioners, Congress “intended the phrase ‘nutrient level’ to apply in situations when a Daily Value had not been established and to be broad enough to include any appropriate references to nutrient levels.”
The petition also argues that FDA’s narrow interpretation of “nutrient level” conflicts with the First Amendment, and that before prohibiting a notified nutrient content claim, FDA must consider the use of disclaimers “to appropriately qualify authoritative statement nutrient content claims.”
Considering its limited resources and the fact that notified nutrient content claims have not been a high priority for FDA, a prompt response to this petition does not appear likely. However, FDA faces a number of the same issues in comments submitted in response to its proposed prohibition of EPA and DHA nutrient content claims.