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The decision by the Food and Drug Administration to revamp food labels, to improve disclosure of added sugars and serving sizes, is an important step by an agency that has been singularly effective in recent years at improving the information consumers get about the foods they eat. Implementing this sort of change isn’t easy — both operationally and politically. The agency’s commissioner, Peggy Hamburg, deserves credit for spearheading these efforts.
For her next initiative, she might revisit the FDA’s stance when it comes to health claims made on food labels. This is one area where FDA has gotten its policy wrong. It represents a big opportunity to change the healthiness of food products, and American diets.
At issue here is FDA’s longstanding discomfort with health claims made on food labels, particularly those touting the medical benefits of certain diets and ingredients. FDA staff worries when food health claims aren’t backed by the same kind of rigorous science that supports the medical claims made on drug labels. By their estimation, health claims made about food should require the same sort of scientific proof as claims made on medical products — randomized, prospectively controlled clinical trials. They argue, in effect, that there’s a single truth standard when it comes to health claims. A health claim is a health claim, regardless of where it is made. Foods shouldn’t be treated much differently than drugs.
There are problems with this logic, not least of which is that the courts have strongly disagreed with FDA’s position. In Pearson v. Shalala (1999), the D.C. Circuit Court of Appeals chastised the FDA, stating that it was “skeptical the government could demonstrate with empirical evidence” that health claims made with appropriate disclaimers would “bewilder” consumers, as the FDA claimed. The FDA has largely ignored this, and other similar federal court rulings, by arguing that the cases were wrongly decided — an unusual revision of traditional civics.
Nonetheless, there’s an even larger problem with FDA’s position — one that isn’t a matter of law, but science. Developing the same sort of scientific evidence about diet that’s required for a new drug is hard, if not impossible. You can’t prospectively randomize people to different diets, and tightly control what they eat (like you would do in a drug trial). For that reason, science about diet has often depended on large epidemiological studies, where people’s behaviors aren’t as tightly controlled, as they would be if scientists were studying a new medical product.
The courts have also told FDA that there’s less at stake when it comes to food, which should enable a more relaxed standard. So long as the strength of the scientific evidence supporting a particular food health claim is properly disclaimed (to inform the consumer about how believable the science is) the courts also reason that the claim itself constitutes permissible speech protected by the First Amendment.
Moreover, in the case of a drug, there are often big risks at stake from a claim that isn’t sufficiently validated. It might prompt someone to opt for a less effective treatment, and forgo alternative, and perhaps curative therapy. What the courts have said is that the same risks aren’t apparent when it comes to food. The same stakes don’t apply. If a claim suggests that eating Cheerios might confer certain heart benefits, even if that evidence is strongly suggestive but not definitive, the worst outcome is that people might opt to eat more Cheerios instead of Corn Flakes.
As a result of the difficulty in making health claims, food labels today mostly carry assertions about taste, portion size, or packaging. As I wrote in the Wall Street Journal, this is precisely because FDA doesn’t regulate claims made about these attributes – the Federal Trade Commission does. Far fewer foods compete on the ability to improve health because they can’t make claims about these features. When they do, the FDA now often forces food makers to construct claims that are so weak and convoluted that the information is unusable for consumers, and marketers.
Yet science is giving us unique opportunities to leverage diet in health. For example, the emerging science of nutrigenomics seeks to combine insights from genome research with our understanding of how diet choices affect health. By adjusting food content, the diet choices we make could play a prominent role in mitigating disease. We are at a point in science where we can identify people at risk for certain conditions like cancer and perhaps use nutrition as a tool for chemoprevention.
But FDA makes it so hard to get health claims into food labels that few companies try. Even fewer invest in research to develop food products (and diets) that can confer health benefits. If food makers cannot talk about these benefits (and compete against each other based on this science) why would they invest in the research?
The FDA has legitimate concerns when it comes to translating medical claims onto food labels. But its impulse to apply its standards for drug promotion to all manner of products blurs important distinctions between the more significant risk that “P” doesn’t equal “.05″ when it comes to a new drug used to treat a life threatening disease, versus the risk that the same statistical bar isn’t met when it comes to a breakfast cereal. But mostly FDA is worried about adopting a different standard for health claims depending on the context. In the agency’s mindset, a health claim is the same regardless of where it’s being made. But this is precisely the wrong position. The strength of evidence required to make a claim should be considered in the context of where the claim is made, and the public health goal being pursued.
In 2003, FDA briefly allowed qualified health claims to appear on food labels so long as manufacturers included a disclaimer that described the reliability of the scientific evidence supporting the association between food and health. This concession was made in direct response to the Federal Court’s rulings in the Pearson cases.
The policy established four different levels of evidence, from highly reliable to highly improbable, and graded health claims from A to D. The notion was food makers would invest in developing good evidence linking diet and health. No food company would want to be forced to disclose their medical claims were sketchy and graded a “D” by the agency. But unfortunately FDA scrapped this framework only a few years after it was first implemented and went back to requiring large, drug-like trials for health claims made on food labels. The effect is predictable. Few food companies are trying to develop evidence – or improved food products — to support these claims.
As FDA seeks additional ways to advance the anti-obesity campaign launched by Michelle Obama, it might revisit that 2003 policy for enabling graded claims on food labels. Or it could go a step further and create a dedicated section on labels to display properly disclaimed information about the evidence supporting a food’s health benefits, when such science exists.
Consumers would pay more notice to products with health benefits, especially foods that help prevent the causes and consequence of disease. And food companies, for their part, would focus more of their money and attention on making products that confer these positive attributes.
You can follow Dr. Scott Gottlieb on Twitter @ScottGottliebMD
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