Like the broader federal inspection program in which it is housed, the Food Safety and Inspection Service’s (FSIS’s) prior labeling approval system continues to evolve away from its history of extensive command and control. There is evidence now that, at least in some cases, the agency wants regulated companies themselves to clarify their label claims, rather than making those calls itself.
FSIS’s recent finalization and implementation of new rules for the so-called generic approval for labels is perhaps the agency’s final step in transitioning from a system that, some 30 years ago, essentially insisted on the review and approval of every single label and labeling change associated with all products within its inspection jurisdiction to a far more carefully targeted program. The final rule took effect on January 6, 2014.
While prior review and approval continues to attach to a few minor categories—such as labels for products produced under religious exemptions—the agency is now essentially in the business of leaving labeling determinations in the hands of regulated companies. One major exception is in cases of new claims not specifically defined by existing regulation. A significant window into this new era is afforded by a document recently circulated by the FSIS’s labeling staff as a response to recent claim-based submissions. To date, it has yet to appear on the agency’s website or otherwise be made publicly available, but it states as follows:
Sustainable farming, Environmentally Raised, Sustainable Agriculture, Humanely Raised claims have come under great scrutiny. They are undefined claims with different meanings within industry. FSIS has regulations in 9 CFR 317.8 that requires all labeling features to be truthful, accurate and not misleading. To ensure the meaning of “sustainably raised” or “Humanely Raised” is clear for consumers, it would only be acceptable as a claim if a statement includes on the label showing ownership explaining its meaning based on the producer or processing establishment, e.g., "ABC Company Defines Sustainably Raised or Humanely Raised as (explain the meaning of the claim ‘sustainable’ ‘humanely,’ ‘environmentally’ on the label).”
The agency is attempting here to work itself out of a very difficult box. There is an unavoidable subjective dimension to all such claims and plenty of room for reasonable people to disagree as to the proper limits or scope of any applicable definition. But unlike their counterparts at FDA, so long as the use of such terminology remains within the province of prior approval, FSIS personnel must make the tough calls. They need to explain to a processor why they have a legitimate basis to deny a proposed use of a “humanely raised” claim while, at the same time, adequately supporting their willingness to let a competitor do so. The document suggests that there will be both more room to, and more of a necessity for, explaining such subjectivity away. Rather than being drawn into endless hair-splitting over the exact meaning of such terms, and thereby being obligated to effectively and uniformly enforce such meanings, FSIS’s document indicates that much of the requisite clarification is now to be outsourced to the manufacturer or other proponent of the claim.
This new policy has yet to be tested. Will there be, as would seem necessary, some type of laugh test that clarifying language must pass? Even if there is, will companies tend to overreach, and, if they do, will the marketplace itself provide the necessary corrective balance? And, interestingly, will such a “one size doesn’t fit all” policy now start to permeate the agency’s mindset in its review of other subjective claims not covered by this particular document? Time, and the case-by-case reality of the prior approval system, will tell.