Guest Commentary

Joseph J. Lewczak and Tiffany A. Towers, Davis & Gilbert LLP

In a somewhat surprising development, the Food and Drug Administration (FDA) appears to be moving toward issuing a regulation requiring food manufacturers to display nutritional information on the front of food packages.  Such a move would have a material detrimental impact upon food manufacturer’s and producer’s ability to communicate with and reach consumers over the cacophony of competing products on supermarket shelves.  

In October 2009, the FDA issued a Guidance for Industry Letter Regarding Point of Purchase Food Labeling, in which the FDA stated that it was developing a proposed regulation that would define the nutritional criteria that would have to be met by manufacturers making voluntary front-of-package (FOP) nutritional claims.  The FDA stated in the Guidance Letter that its intent in developing the proposed regulation was to provide standardized, science-based criteria on which FOP nutrition labeling must be based.  There was little indication in the Guidance Letter that the FDA was contemplating requiring FOP labeling at that time.  In fact, the FDA seemed to indicate its opposition to FOP nutrition labeling, stating that it had found through research that with FOP labeling people are less likely to check the Nutrition Facts label.  At that time, the FDA indicated that it merely wanted to explore a voluntary system, but did warn that if a voluntary system did not result in a common, credible approach to FOP labeling it would consider issuing regulations.

The FDA wasted no time in changing its approach, however.  By March 2010 Commissioner of Food and Drugs Margaret Hamburg, M.D. published an open letter to the industry in which she stated that “we now have … an opportunity to make a significant advancement in public health if we can devise a front-of-pack labeling system that consumers can understand and use.”  Then on April 8, 2010 Secretary of Health and Human Services Kathleen Sebelius clearly stated that the FDA is developing a new regulation that would require food manufacturers to display nutritional information on the front of packages.

The FDA’s approach is surprising, given how quickly it changed course, and is very troubling.  The amount of real estate left on a food product package for voluntary messaging is already scarce.  For the FDA to mandate that a significant portion of the prime real estate be used to make additional disclosures, especially if any such information is already required to be disclosed elsewhere on the package, may exceed FDA’s regulatory authority and violate food manufacturer’s First Amendment rights.  Indeed, with consumers already adequately informed of the caloric and nutritional content of food based on current regulations, it’s hard to see how such new regulations would not be considered more extensive than necessary under the United States Supreme Court’s Central Hudson test for assessing the constitutionality of restrictions on commercial speech. 

What’s more, the FDA has demonstrated that existing regulations are sufficient to ensure that voluntary FOP labeling meets FDA standards.  In March 2010, in connection with the open letter to industry from Dr. Hamburg, FDA issued warning letters to 17 manufacturers advising firms that their products violated provisions of the Federal Food, Drug and Cosmetic Act (the “Act”) requiring labels to be truthful and not misleading.  The FDA also made the case itself in its Guidance Letter, stating that FOP labeling is subject to provisions of the Act that prohibit false or misleading claims and restrict nutrient content claims to those defined in FDA regulations.

The industry will be watching and listening closely to future FDA communications for clues as to where the FDA might be taking its FOP labeling initiative.  As a first step, the FDA needs to listen to those in the industry advocating voluntary FOP labeling initiatives.  In a free market economy, self-regulation is always the first best step, especially for a mature and responsible industry that has already demonstrated a willingness to devise, implement, and enforce such guidelines in other contexts. 

Note: Mr. Lewczak recently authored a Washington Legal Foundation Legal Backgrounder with Davis & Gilbert associate Anne DiGiovanni entitled “Enhanced FCC Regulation of Product Placement Would Breach Free Speech Rights.”