By Ricardo Carvajal –
FDA has issued a letter to industry stating that the agency intends to take enforcement action against front-of-package ("FOP") or shelf labeling that provides false or misleading information (including implied nutrient claims that don't comply with regulatory requirements). Further, the letter states that FDA is developing a proposed regulation to "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." If the regulation becomes final, manufacturers and retailers would remain free to develop and use their own labeling systems, but the systems would have to satisfy the nutritional criteria specified in the regulation. If that effort doesn't result in a "common, credible approach," FDA is signaling that it may establish a single, uniform system for FOP and shelf labeling.
In April, FDA and USDA jointly issued a letter directed to the Smart Choices ProgramTM, an FOP labeling system that features symbols and other information intended to “help guide consumers in making smarter food and beverage choices.” That letter stated that the agencies would be monitoring implementation of Smart Choices and would be “concerned if any FOP labeling systems used criteria that were not stringent enough to protect consumers against misleading claims; were inconsistent with the Dietary Guidelines for Americans; or had the effect of encouraging consumers to choose highly processed foods and refined grains instead of fruits, vegetables, and whole grains.” Since then, Smart Choices has come under attack from several quarters, most notably Connecticut’s Attorney General (see here).
It is too soon to know if this latest action by FDA is more bark than bite. However, the fact that the agency is prepared to wade into a controversial arena with a proposed rule suggests that whatever reticence there may have been at FDA about grappling with voluntary labeling issues is rapidly dissipating.