By Bruce Silverglade
The election is over and the current Administration will stay in the White House.
Food labeling may not have been among the top issues on the minds of American voters. But the election results will have an impact on food manufacturers, retailers, and restaurant operators who are concerned about the prospect of new FDA regulations, enforcement actions, and “voluntary” guidance documents.
The following FDA food labeling initiatives are likely to move during the next four years. Some are on a “fast track” while others, let’s say are “on track” with no specific time frame for action.
Inside the Washington Beltway, the term “fast track” can mean that proposed regulations could still take more than a year to be finalized, but that final rules are likely to appear in the Federal Register in the foreseeable future. They include regulations required by an Act of Congress, or relatively non-controversial rules that have been moving towards completion for a period of time. I have “taken out the crystal ball” and here is what it says:
- “Fast Track” – Menu Labeling
Congress, in a short passage tucked into the Patient Protection and Affordable Care Act (enacted in December 2010) required FDA to issue a proposed regulation requiring restaurants and “similar retail food establishments” with 20 or more locations to provide on menus or menu boards (including menu boards at drive through locations) calories for each standard menu item along with a succinct statement of suggested daily calorie intake. Congress also told the FDA to require that establishments covered by the law provide a succinct statement of the availability of additional nutrition information similar to that found on Nutrition Facts labels on processed food packages.
Within a relatively short time frame of about four months, the FDA announced a proposed rule to implement the requirement in April, 2011. A major controversy ensued over the Agency’s definition of the statutory term “similar retail food establishment.” In addition to restaurants, the Agency proposed that grocery stores, convenience stores, coffee shops, and retail confectionary stores that sell restaurant type food were subject to the law, as well. Movie theaters, however, were exempted.
A related proposed rule by the FDA would require calorie information for vending machine food. The agency stated that visible nutrition information at the point of purchase includes front-of-pack (FOP) nutrition symbols, provided they include calories. More on FOP labeling below.
Consumer and health groups are pressuring the Administration to expand the scope of the proposed restaurant rule to cover movie theaters, bowling alleys, concession stands, school and hospital cafeterias, hotels, buses, trains, and planes.
Curiously, the Act gave FDA a deadline to issue a proposed rule, but did not contain a date by which the proposed rule must be finalized. In light of the Administration’s overall goal of promptly implementing all aspects of the new health care law, it is likely that publication of a final rule is on a “Fast Track” and will appear in the Federal Register in the foreseeable future.
- “Fast Track” – “Gluten Free” Claims
The FDA published a proposed rule on “gluten free” claims in the Federal Register in 2007 as required by the Food Allergen Labeling and Consumer Protection Act of 2004. Essentially, the proposed rule stated that “gluten free” means less than 20 ppm gluten. However, the FDA reopened the comment period in 2011 to take additional comments on a safety assessment examining tolerable daily intakes and results of a consumer survey studying reactions to various types of label statements. This is the type of rulemaking that could gather dust during a change in administrations, but probably will be finalized in the foreseeable future, given the agency’s long term interest in the issue and the stability among political appointees working in the Commissioner’s office.
- “Slow Track” but Still Chugging Along – Updating the Nutrition Facts Panel
The Nutrition Facts Panel (NFP) is now 20 years old. That’s old for a nutrition labeling scheme. FDA, since 2007, has been kicking around possible changes. Potential changes include changes to the nutrients required to be declared (e.g., requiring declaration of “added sugars,” revising the micronutrients of concern declared), updating the Daily Values for certain nutrients (e.g., changing the DV for sodium from 2,400 mg to 2,300 or, more drastically, 1,500 mg), and graphic changes (e.g., displaying calories more prominently, eliminating elements of the label that are rarely used by consumers, such as calories from fat). .
Amendments to the NFP of one sort or another are certainly needed. The FDA career staff would like the reform initiative to move to the proposed rulemaking stage. The matter is “on track,” but for better or worse, appears to be on the slow track. In 1990, it took an Act of Congress to convince the Agency, which had been pondering the issue for years, to complete the first regulations for mandatory nutrition labeling by a set date — November 1992. Arguments within the George H.W. Bush administration were so intense that the issue ultimately found its way into the Oval Office. The President himself reviewed various options and personally chose the NFP that we see today. The FDA published final rules for mandatory nutrition labeling and related matters about two months past the statutory deadline, in January 1993.
- “Slow Track,” and fate indeterminate – Front of Pack (FOP) Nutrition Symbols
During the first term of the Obama Administration, policing FOP nutrition symbols used by the food industry and considering a uniform recommended FOP nutrition symbol was an agency priority. One of the first industry-wide labeling enforcement actions taken by the Obama FDA was a Warning Letter sent to the director of the now defunct Smart Choices program. Further, in 2010, the Institute of Medicine (IOM) issued a report on the topic, and in 2011, made official recommendations to the Agency.
But in the interim, FDA’s interest in the issue faded. The enactment of the Food Safety Modernization Act forced a shift in agency priorities to food safety, and the food industry’s development of the “Facts Up Front” FOP symbol effectively preempted an FDA-designed FOP label. In December 2011, FDA sent a letter of enforcement discretion to the Grocery Manufacturers Association (GMA) and the Food Marketing Institute (FMI) about their “Facts Up Front” FOP nutrition symbols program. The program is now scheduled to be rolled out officially sometime in 2014.
FDA has previously expressed a preference for an FOP symbol that rates the nutritional value of food rather than one that simply summarizes key information from the Nutrition Facts panel. FDA has before it IOM recommendations for an FOP label rating based on a rating system that takes into account a food’s calorie, saturated/trans fat, sodium, and added sugars content. If the agency decides to turn its attention back to FOP nutrition labeling, it will likely test consumer comprehension of a system based on IOM’s recommendations against the industry’s Facts Up Front program. That may not occur, however, until 2015, after Facts Up Front has been in full use for a year. Should FDA’s studies suggest that a FOP labeling system based on IOM’s recommendations more effectively communicate nutrition information to consumers, we should expect the announcement of a model government program — unless the clock runs out. Consumer studies take time to conduct and evaluate, and guidance programs take time to develop and be written up for publication in the Federal Register. It may well be 2016 until the agency has something to say on the issue. And guess what, we will then be back in a new election year cycle.
Information from the United Kingdom, however, may be instructive. The UK Food Standards Agency (FSA) pioneered the development of a voluntary “traffic light” labeling system for use on the FOP in 2007. Initially, the model system was rejected by manufacturers, and most retailers. A change in governments (from liberal to conservative) took the model traffic light system off the FSA main web site for a time and placed it under a hard to find “archives” link. But despite political trends, market forces ultimately prevailed. Gradually, retailers began using the government scheme on private labels and freshly prepared items sold in stores. The result is that most major food retailers in the UK, including ASDA owned by Wal-Mart, and TESCO, the largest retailer in the UK, have agreed to use the system, with smaller retailers following in their wake, .
The development of an official FDA model FOP system, even in the last days of the President’s second term, could eventually lead to similar developments in the U.S.