The pending proposal recently issued by the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA FSIS) that would expand the universe of what it terms “generically approved” labels reflects that agency’s most recent effort to more closely align its oversight of the labeling of meat and poultry products with its current goals, priorities and resources.
Unlike the U.S. Food and Drug Administration (FDA), FSIS maintains a prior label approval program for the segment of the food industry that it regulates. This reflects its reading of its statutory mandate, but more fundamentally, is an outgrowth of basic differences in the inspection programs maintained by the two agencies. FSIS, unlike FDA, maintains an ongoing inspection presence in food packing and processing facilities that ultimately leads to the application of the USDA-Inspected and Passed seal on the packaging of the products that are shipped, an act that serves as certification by FSIS that the product in question is wholesome, not adulterated and not misbranded. As such, in some sense FSIS is unavoidably placed in a position where it must sanction the use of such labeling materials, leaving only the question of exactly how this is to be accomplished.
For decades, FSIS’ position was simply to mandate that establishments needed to supply the agency with any and all labeling materials it planned to use, along with related formulation information, and thereby obtain official approval prior to use. But, beginning in the 1980s, it began a process driven by a recognition of the fact that this requirement caused the agency to frequently become inundated with materials raising issues of no meaningful regulatory concern, limiting its ability to more effectively focus upon those labeling materials that might generate controversy or otherwise require more careful consideration.
This is when the term “generically approved” first worked its way into the regulatory lexicon. In this particular context, it means FSIS is willing to take whole categories of labeling materials and remove them from this item-by-item, case-by-case review system. Instead, a particular category is classified, by regulation, as being comprehensively approved and if a manufacturer’s label fits within it, he can eliminate this step from the process. For example, under current regulations, if a company wants to take a label already approved by FSIS and, during the holiday season find an open space upon which to print a picture of Santa Claus, it does not need to ask for anyone’s official permission. The current proposal represents FSIS’ third and most recent effort to expand this generically approved universe. Factors driving this, beyond the agency’s experience with, and belief in the basic utility of the concept, include current budget pressures, problems with backlogs driven by inadequate resources, and, more broadly, its growing self-concept as a public health agency, a mindset that tends to place its continuing responsibilities to regulate misbranding and related economic concerns further into the background.
While past initiatives have focused upon the elimination of the sort of trivia noted above, as well as upon well-defined categories of product such as those captured by a regulatory standard, the principal focus within the current proposal is claims. Until now, the addition of virtually any type of nutrition or other specialized claim to any product label otherwise generically approved served to effectively eliminate the label from this category.
What FSIS is essentially suggesting through its current proposal is that there is enough mutual experience, on the part of both the regulator and regulated, with claims such as “low fat” that the agency has managed to define, that generic approval has now become a safe bet.
An initial review of comments currently on the public record indicates that not everyone agrees. Arguments to the contrary include assertions that the expansion of generically approved categories leads to more misbranding, that FSIS has never effectively audited or otherwise assessed the program’s track record, and that it is somehow abandoning its responsibility to maintain the proverbial level playing field in this area.
These concerns notwithstanding, both prior history and the agency’s current mindset strongly suggest that a wider universe of generically approved labels is about to be created. While misbranding and economic issues may be of diminishing importance to FSIS, this is hardly the case within a highly competitive industry. In the short term, this suggests that anyone with an interest on either side of this debate would be well advised to weigh in. In the longer term, the industry should be prepared for changes along these lines to, in fact, occur, as well as for both the opportunities and challenges that such changes will create.
Robert Hibbert, a partner in K&L Gates’ Washington DC office, focuses on federal regulation of the food and agricultural industries, with emphasis on USDA. His areas of particular concern include food safety, food security, animal health, biotechnology, labeling, advertising and new product development.