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Lester M. Crawford, D.V.M., Ph.D. - Harvard Medical School

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Speech before
Harvard Medical School

6th Postgraduate Nutrition Symposium



Lester M. Crawford, D.V.M., Ph.D.

Acting Commissioner of the FDA

March 10, 2004

Thank you, Allen (Walker, MD, director of the Division of Nutrition) for the introduction, and good afternoon. I am very happy to participate in this fascinating discussion on how to help Americans lose weight. For us, at the Food and Drug Administration, the obesity epidemic is an urgent public health issue, and we highly appreciate symposia of this nature that are engaged in the search for solutions.

The topic that I've been asked to discuss -- the experience of the Food and Drug Administration regarding the utility of food labeling as a dietary guide -- is certainly well worth our consideration as an important component of a blueprint for a healthier United States.

The FDA's attempt to use the food label for dietary advocacy goes back to 1989. By that time, the food label had not been updated for almost 20 years, its format was practically anybody's choice, and labeled health claims were both exuberant and undocumented. The FDA therefore decided to make a clean sweep by developing a brand new food label that would be uniform, science-based and rigorously truthful. Moreover, the redesigned label would inaugurate a new era in food labeling by telling shoppers not only what are the main ingredients in practically every manufactured food item, but also suggest how much of that food is good for their health.

After Congress endorsed this effort in the Nutrition Labeling and Education Act of 1990, FDA launched one of the most extensive programs in its history. The agency held nationwide hearings to gather facts and expert views; considered scores of scientific documents and studies; drafted nearly 900 pages of proposed regulations; analyzed 40,000 comments submitted by the entire Who's Who in food science and industry; and in 1993 produced a food label that was designed to help the public chose a low-fat, high-fiber daily diet of 2,000 or 2,500 calories.

The climax of the effort was a coast-to-coast, multi-lingual educational campaign -- launched ten years ago, in March, 1994 -- that delivered the message into virtually every American household. It was projected at that time that the new label would save the nation up to $26 billion in health care costs over twenty years, and prevent many of the 300,000 deaths a year that were then attributed to diseases associated with unhealthy diet.

Needless to say, the results have not lived up to these expectations -- but they have not been uniformly bleak, either. After initially objecting to the cost of the project, the food industry embraced it, helped carry out much of the research, and rapidly put the new label on practically every package or can of food regulated by FDA -- which means everything we eat except for meat, poultry and a few egg products.

The FDA has run periodic checks on the labeled nutritional data, and generally has found them to be accurate. Moreover, food manufacturers have responded to the new emphasis on healthy diet by creating more than a thousand new low-fat, high-fiber, and low-sodium products. And in survey after survey, 60%-80% of food shoppers said that they'd read the food label before buying a new food item, and 30%-40% said the label had influenced their choice.

The surveys, however, also revealed frequent misunderstanding of the meaning of the daily/value column that shows how each nutrient fits into a healthy diet. Considerable confusion was also caused by the frequently conflicting dietary advice by nutritionists, fad diet advocates, and in studies reported by the media. Not surprisingly, this bewilderment has generated distrust of all dietary recommendations, and a corresponding desire for nutrition information that would be clear, authoritative, and easy to understand.

A little over a year ago, we therefore decided to go back to the drawing board and try to make the food label a more effective vehicle for dietary messages. Our first step was a proposal, issued in December 2002, to relax the enforcement of a provision of the Nutrition Labeling and Education Act requiring that all health claims on food labels be supported by a "significant scientific agreement."

This standard has been so difficult to achieve that in the last ten years, the FDA has approved only 12 unqualified cause & effect health claims such as the linkage between calcium and osteoporosis, fat and cancer, and folic acid and neural tube defects. Two more health claims were added under a new law that allows such labeling based on an "authoritative statement" from the National Academy of Sciences or a scientific body of the federal government.

But except for these 14 claims, the legislated restrictions prevented manufacturers from labeling claims based on emerging, and therefore incomplete, scientific evidence -- such as, for example, the well-documented findings that omega 3 fatty acids in certain kinds of fish can help reduce the risk of coronary heart disease.

In our opinion, labeling statements of this type should be permissible because they can bring two important benefits: they can make consumers better informed and more health conscious when they shop for food; and they can motivate industry to develop more healthful products, and use their potential health effects as a competitive factor, alongside with price, taste, and convenience of packaging.

We therefore proposed to allow food firms to make -- in addition to the unqualified health claims authorized by the law -- certain qualified health claims that would be truthful, non-misleading, and pre-approved by the FDA on the basis of a new standard defined as "the weight of scientific evidence."

Last July, we took two additional steps to upgrade the food label: we issued a requirement for the listing of transfatty acids on the nutrition facts panel, and we described the four categories of health claims we intend to allow on food packages.

The top category, A, is for unqualified claims supported by significant scientific agreement; next category, B, is for qualified claims that are supported by substantial but inconclusive evidence; C category covers claims based on evidence that is limited and not conclusive, and D, the lowest category, is for claims for which there is little scientific evidence.

Moreover, we reached the conclusion that the obesity epidemic is likely to require additional measures, both by our agency alone, and in concert with others -- including the government, academia, industry, health care providers and consumers. Last August, Commissioner McClellan therefore appointed an Obesity Working Group and charged it with the development of a comprehensive blueprint of the steps that could and should be taken to confront this public health issue. This project was subsequently endorsed and given department-wide scope by Secretary Thompson.

Specifically, our group was asked develop proposals for the following:

  • an effective public health message about the need to balance food intake with expended energy;
  • a consumer education program with the same aim;
  • better food labeling;
  • research on consumer behavior in regards to food consumption; and
  • enhancement of the development of effective weight-loss and weight-control drugs and devices.

The Obesity group has studied the issues, discussed them with the involved FDA stakeholders, and its report is about to be submitted to 

Secretary Thompson. Until he sees and approves it, I can't discuss what actions the report recommends; however, I can tell you that the inquiry has been a very useful and productive exercise.

We learned many things, including that numerous consumers and some health professionals attribute to the FDA an unrealistic amount of authority and competence. For example, at our big stakeholder meeting, last October, our agency was asked to create a "seal of approval" for weight-management foods, and to address stress in society as a factor driving obesity. It was also suggested that the FDA take sides in the current debate about the nature of obesity, and rule that it is a disease.

But we also heard many intriguing ideas that are well worth careful consideration and research. For instance, it's been suggested that the FDA regard weight gain as an adverse side effect when evaluating the safety and effectiveness of regulated drugs, foods and dietary supplements. In other words, we were asked to decide whether weight gain is an outcome that casts doubt on the product's safety. A related question is whether our agency should try to evaluate the long-term health effects of weight gain, and consider the results in its assessment of food safety.

Another issue that calls for exploration is the so-called developmental imprinting hypothesis, which suggests that childhood obesity is, in part, the result of the mother's diet. According to this theory, the mother's poor nutrition or exposure to some toxic agent during the perinatal period can create in the fetus and neonate a dysfunctional metabolic pathway that, in the child's later years, can contribute to overweight or obesity.

These are just a few examples of the gaps in knowledge that need to be filled if our agency is to be able to develop a truly comprehensive program for confronting obesity. But for the most part, our working group, as well as the stakeholders whose advice we've sought, have focused on the more immediate question of how to best persuade consumers to keep their food intake in balance with their output of energy. And most of the suggestions and information we received confirmed that the best hopes for achieving this goal are linked with our ability to use food labeling as a vehicle for raising the public's consciousness of the importance of calories when making dietary decisions.

Some of the proposed approaches call for the cooperation of the restaurant industry by listing the caloric values of meals on the printed menus, or the menus that are posted above the service counters of fast-food outlets. But most of the suggestions we heard were focused on improving the effectiveness of the labeling of food packages, which is generally recognized as potentially the consumers' most influential dietary guide.

For example, we were urged to encourage manufacturers to list on the food label the total caloric content of the entire package, if it is likely that it will be consumed at one sitting, which happens a lot. There were other suggestions: for example, we were asked to urge food firms to print the caloric count in bold digits on the face of each food package; to encourage labeling statements suggesting alternative food choices with fewer calories; and to develop labeling statement that would inform the consumer how much exercise it will take to burn the calories in the food package.

A proposal was also raised for a label that would list the health consequences of eating too much -- something, I guess, similar to the Surgeon's General warning on packs of cigaretts. Although some of these ideas may appear to be attractive, virtually all of them require a substantial research on consumer attitudes.

And on that subject, I want to use this opportunity to cordially invite any and all present behavioral scientists who are interested in these issues to give the FDA a hand. We need to know how Americans feel about such matters as weight management, and food labeling by restaurants. Another subject that calls for thorough exploration is what motivates the dietary choices of the various ethnic and racial groups that make up our population.

Without solid scientific findings bearing on these and many other issues involving the epidemic, all proposals would be drawn up in the dark. Another consideration of which we're mindful is that some aspects of the current food label -- for example, its size, appearance, and organization -- would be hard to improve upon, and therefore it should not be tampered with much.

Last but not least, we need to recognize that changing the food label on a myriad of food packages is a multimillion-dollar endeavor, the cost of which is eventually borne by the public. The required resources have to be carefully balanced against the probable public health benefits.

To sum up, the use of food labeling for dietary advocacy is, for the FDA, very much a work in progress -- a work that we intend to advance very intensively, imaginatively, and as efficiently as possible, but also with great care.

Thank you.