The notice served on the food industry by the Food and Drug Administration is here. My column yesterday on this potentially enormous new regulatory scheme is here. The FDA is targeting "Front of Package" ("FOP") labeling, and it is not hiding its regulatory club:
It is important to note that nutrition-related FOP and shelf labeling, while currently voluntary, is subject to the provisions of the Federal Food, Drug, and Cosmetic Act that prohibit false or misleading claims and restrict nutrient content claims to those defined in FDA regulations. Therefore, FOP and shelf labeling that is used in a manner that is false or misleading misbrands the products it accompanies. Similarly, a food that bears FOP or shelf labeling with a nutrient content claim that does not comply with the regulatory criteria for the claim as defined in Title 21 Code of Federal Regulations (CFR) 101.13 and Subpart D of Part 101 is misbranded. We will consider enforcement actions against clear violations of these established labeling requirements.
FDA is also developing a proposed regulation that would define the nutritional criteria that would have to be met by manufacturers making broad FOP or shelf label claims concerning the nutritional quality of a food, whether the claim is made in text or in symbols. FDA's intent is to provide standardized, science-based criteria on which FOP nutrition labeling must be based.
We also intend to continue to improve our understanding of how consumers view and use such labels. Research suggests that the proliferation of divergent FOP approaches is likely to be confusing to consumers and ultimately counter-productive. We want to work with the food industry - retailers and manufacturers alike - as well as nutrition and design experts and the Institute of Medicine, to develop an optimal, common approach to nutrition-related FOP and shelf labeling that all Americans can trust and use to build better diets and improve their health.
The recent experience with FOP labeling in the United Kingdom demonstrates the potential of voluntary initiatives to provide consumers helpful FOP labeling. In that instance, the government set certain criteria for the use of such labeling, and retailers took the initiative to implement FOP labeling in their stores. The agency wants to explore the potential of that approach. If voluntary action by the food industry does not result in a common, credible approach to FOP and shelf labeling, we will consider using our regulatory tools toward that end. This effort will include research to assess through consumer studies the likely effects of FOP symbols on information search behavior related to the Nutrition Facts label, which in turn can affect consumer understanding of the full nutrition profile of a product. The foundation of that approach should be a common set of mandatory nutritional criteria that consumers can rely on when they view FOP labels, even if no one symbol is ultimately selected as superior.
Ah yes, Great Britain's approach.
Comments on this guidance are to be sent to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and to be marked as concerning the "Guidance for Industry Letter Regarding Point of Purchase Food Labeling."
Every manufacturer of food should file comments, and each should begin with the objection that the FDA is greatly exceeding the regulatory role intended for it by Congress and potentially opening the floodgates to a new tidal wave of plaintiffs' lawsuits and market hobbling, government-dictated packaging. FDA Commissioner Margaret Hamburg simply asserted the agency's authority to undertake this new and powerful expansion of its regulatory role, but that assertion is at best controversial. If Congress wants the FDA to control FOP labeling, it should say so clearly in response to an explicit FDA request for the authority preceded by a presentation of the "science" referred to in this notice.
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