This comment is in response to the Food and Drug Administration Docket No. FDA-2017-N-5094. The request for comment seeks input to identify existing regulations and requirements for review, modification, or repeal. A significant body of the FDA’s rule docket is implementation of the Nutrition Labeling and Education Act of 1990 (NLEA). Specific changes to food labeling have not been retrospectively reviewed to determine whether their intended benefits were ever realized. For the FDA to meet its public health mission, any regulatory action must show both a significant impact on consumer behavior and improvement to individual health.
The Program for Economic Research on Regulation at the Mercatus Center at George Mason University is dedicated to advancing knowledge about the impact of regulation on society. As part of its mission, the program conducts analyses of the regulatory process from the perspective of the public interest. This comment, therefore, does not represent the views of any particular affected party or special interest group but is meant to assist the US Department of Health and Human Services and the FDA in reviewing its body of regulations.
Review of labeling rules represents an opportunity for the agency to reevaluate the burdens imposed by regulation and the distortionary effect of these burdens on the development of the industries they regulate. Our research has found that the regulatory impact analyses developed in support of packaged food labeling, beginning with the NLEA rules, used flawed models of consumer behavior that resulted in inflated predictions of health benefits from consumer label use. Neither the predicted changes in behavior, particularly for the 1990 NLEA rules and subsequent modifications, nor the resulting improvements in health outcomes have been realized.
Since the inception of nutrition labels in 1973 (for foods with claims), the evidence has failed to support the predictions that labels would positively impact consumer food choices and health outcomes. For example, per capita fruit and vegetable consumption has declined 5.5 percent between 2004 and 2014 (total vegetable consumption is down 6 percent). In addition, since the early 1990s, obesity rates have risen from about 28 percent to over 35 percent, and one in six children ages 2 to 19 is now obese.
With the first required nutrition labeling for packaged foods in 1973, former FDA Commissioner Charles C. Edwards noted that the “experience under this new regulation is required before expansion to all foods on a mandatory basis can be considered.” This advice was not heeded before implementing regulations pursuant to the Nutrition Labeling and Education Act, but now, with more than 40 years of data, it is time to take a broad look at the current approach. In particular, does it really make sense to ask consumers to track and heed individual nutrients, macronutrients, and calories as well as doing the necessary math to make Daily Values work for them?
Below we have addressed some specific questions asked in the request for information.
Is the regulation still current, or is it outdated or unnecessary in some way?
The ideas promoted by current nutrition labeling appear to go beyond scientific consensus on diet-health relationships. For example, at best, the results are mixed as to whether posting calorie counts has public health benefits. In addition, it is by no means clear that added sugars (as opposed to total sugars) information will be useful to consumers, and an increasing number of studies challenge saturated fat guidelines associated with the Nutrition Facts Panel (NFP).
Food labeling standards are ineffective and unnecessary if consumers (1) do not process label information reliably, (2) have little interest in nutritional information, (3) have little concern about health effects that may only be realized decades in the future (i.e., the temporal discounting of alleged health claims), or (4) lack information on the acute or long-term health effects of the labeled product for them personally.
In order for the standards to achieve positive health outcomes, the following conditions must be met:
- Some percentage of consumers must see the label.
- Some percentage of those consumers must read the label.
- Some percentage of those must understand the label.
- Some percentage of those must act on the label.
- The information on the label must be correct.
- Some percentage of consumers must not use compensation mechanisms to offset the action they take.
There is some percentage (probability) that applies to each of the above steps. Those percentages must be multiplied together to calculate the probability of a positive outcome. If we assume a 50 percent chance for most of them—a generous assumption—then there is only about a 1.6 percent chance (50 percent applied to each) that there will be a positive outcome.
Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?
Research subsequent to the enforcement of the NLEA shows that consumers are selective in their use of NFPs, using either front panel claims or information on one or two macronutrients to determine the overall healthfulness of a product rather than making holistic decisions that balance their consumption of all nutrients. Many consumers who claimed to use nutrition facts were not observed actually using the nutrition facts label when selecting foods. While many people (65 percent) said in the 1990s that they used the food label to avoid certain contents, that figure has declined through 2006 and dropped to 48 percent in 2013—although this could mean that consumers now knew what they wanted to eat and had no more need for labels.
Have regulated entities had difficulties complying with the current regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.
The difficulty with the proposed labeling changes, for firms, would generally be the costs of complying with the regulations. Such costs would have to be paid for out of retained earnings, as it is difficult to borrow for changes that are not expected to increase sales. These additional costs would be the most burdensome for smaller, less established firms, but all packaged-food product manufacturers would be affected because they would be required to retest their products to update their labels. By its own analysis, the FDA shows that 74 percent of private-label food products, 78 percent of branded dietary supplements, and 84 percent of private-label dietary supplements would require label changes to be in compliance. If rules were expanded to require restaurants to provide calorie counts on menus, the number of producers impacted would increase even more.
Longer compliance periods offer higher net benefits and a reduction in regulatory burdens, which would translate into lower food prices for consumers. At a 3 percent discount rate, a four-year compliance option would provide $500 million in additional net benefits, as opposed to a two-year compliance period.
Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection? If yes, provide examples of alternatives that may reduce costs to industry while retaining the same level of public health protection.
The only alternatives that have been considered in previous changes to labeling rules are (1) longer periods for firms to become compliant and (2) small changes in the specific levels suggested for a particular nutrient. The FDA should consider alternatives that allow for voluntary standards and innovation in labeling that could produce more useful labeling than the FDA currently produces. There are many voluntary front-of-package symbols that have been privately developed in the US and evaluated in two consensus studies by the Institute of Medicine. One such system has been developed by the American Heart Association (Heart-Check), but the FDA sent out a general warning letter in 2008 telling manufacturers that they must be careful not to make an implied claim. First Lady Michelle Obama urged the FDA to create a national system that would replace the vast number of such voluntary symbols, but such an initiative has yet to be undertaken by the agency.
What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
The FDA should prioritize review of rules that have not been retrospectively reviewed to determine whether their intended outcomes have been realized. Within this body of rules, those that have the largest compliance cost should be considered first. These include all of the incremental changes to the nutrition facts panel and other food labeling standards that comprise 21 CFR § 101.
Before any further labeling rules are considered for modification, the FDA must understand the impacts of current rules on consumer health (i.e., heart disease, cancer, obesity, and diabetes). We recommend that the FDA commission a comprehensive study that examines the overall impact of nutrient-based food labeling. Numerous experts agree that labeling of nutrients has been a poor approach since the beginning. Consumers don’t eat nutrients, they eat food. Alternatives to current labeling should be considered that are more easily understood by consumers, lead to more holistic decisions about what is healthy for an individual to consume, and better follow the scientific consensus on behaviors that lead to improved individual health.
As discussed above, one alternative to consider might be to replace or supplement current food labels with front-of-package symbols that are easy to understand and are based on the entire food rather than nutrients and macronutrients.