• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

News & Events

  • Print
  • Share
  • E-mail

Lester M. Crawford, D.V.M., Ph.D. - Soyfoods Association

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
Soyfoods Association of North America
Conference on
Creating a Healthier America – The Role of Soy

Remarks by
Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of the FDA


October 14, 2004

Thank you John (Becherer, executive director, United Soybean Board) for your kind introduction. It's a pleasure for me to be here and to share with you along with my colleague from USDA (Dr. Eric Hentges) some of the new federal policies that we hope will set the stage for helping American consumers identify healthier foods.

You have just heard from Dr. Hentges, about the work that the Department of Health and Human Services (DHHS), and the U.S. Department of Agriculture (USDA) have done jointly in revising the Dietary Guidelines , and about USDA's work in revamping the Food Guide Pyramid to complement the new guidelines. In my time with you this afternoon I would like to highlight FDA’s major efforts in revamping the food label to help consumers develop healthier lifestyles by making it easier for them to identify healthy food choices.

Obesity Working Group Update
As I’m sure many of you know, in August 2003 in response to the growing epidemic of obesity in this country FDA established an Obesity Working Group (OWG) that was charged with the task of determining what FDA could do to help combat this growing problem within its areas of authority.The group was to deliver its report and recommendation in six months. It was my privilege to chair this group. FDA released the final report of its Obesity Working Group in March 2004.

This report was comprehensive, and offered a number of compelling recommendations on how to combat obesity. The recommendations came under five major areas: Food Labeling, Enforcement, Education, Therapeutics, and Research. Today I want to focus primarily on the recommendations relative to the food label, and also talk about several other initiatives that will impact the food label and FDA’s outreach efforts to help educate consumers about these important changes.

The cornerstone of the Obesity Working Group (OWG) report is the idea that America must get back to basics and that “Calories Count.” In other words, there is no substitute for the simple formula that ‘calories in must equal calories out’ in order to control weight. The report builds on these nutrition fundamentals through a comprehensive, science-based and consumer-friendly set of initiatives.

The first critical set of recommendations from the OWG involved enhancing the food label. The report recommended that FDA evaluate how the Nutrition Facts panel (NFP) could be revised to highlight the critical role calories play in consumers’ diets. The goal in modifying the food label is to arm consumers with more of the information they need to make sound food choices.

One of the key recommendations on possible changes to the food label center around serving size. FDA encourages the revision of certain labels as single-servings.

The National Labeling Education Act (NLEA) established reference amounts commonly consumed (RACC) based on data from USDA Food Consumption surveys. But these RACC give manufacturers an option for products that contain 150-200 % of the RACC to be labeled as either one or two servings, so food manufacturers could immediately alter the way they present serving size information on products that can reasonably be consumed in a single serving. This change will allow consumers to have a more realistic picture of the number of calories they are actually consuming in one eating episode. There are other opportunities within existing regulations for food manufacturers to provide better information on the food label. For example, current labeling regulations also allow for the inclusion of dietary guidance messages.

FDA encourages manufacturers to use comparative labeling statements that would make it easier for consumers to make healthy substitutions. FDA has worked closely with the FTC on this particular aspect.

Another important change to the food label recommended by the OWG report has do with the appearance and prominence on the label of the calorie content. FDA is currently working on an advanced notice of proposed rule making (ANPRM) that will be published in the Federal Register before the end of the year. Part of the proposal relative to calories, is to increase the font size so that it is more readily visible on the label, to use boldface type, and to put the % DV for calories on the same line. We will also be publishing an ANPRM to provide for nutrient content claims related to the carbohydrate content of foods, and responding to petitions to provide definitions and guidance for use of the term ‘net’ in relation to carbohydrate content in the very near future. The purpose of these ANPRMs is to solicit the input of stakeholders such as you in a wide range of areas relative to the best ways to provide consumers the information on the food label they need to determine food choice.

Hand in hand with these efforts to improve the value of the food label to consumers is the need for consumer research to determine how consumers currently use the calorie information on the food label, and how or if proposed changes to labeling of calories would affect consumer awareness of the calorie content of packaged foods. We also need information on consumer understanding of serving size and how best to present information on serving size to allow comparison of calories for foods of different portion sizes.

Another major element of this report involves initiating an education campaign focused on the “Calories Count” message. Because the obesity epidemic is particularly alarming in children, we are focusing our education efforts to children and young adults. FDA and the DHHS have developed collaborations with various private and public sector groups including Girl Scouts of America, NASULGC (National Association of State Universities and Land Grant Colleges) through their 4-H program, and the Department of Education. FDA is also developing new education materials on Healthy Weight Management in coordination with the Dietary guidelines. We are also convening a national policy dialogue (Keystone conference) to be held before the year is over. This dialogue will focus on childhood obesity and education and will include industry and consumer stakeholders.

As a part of the education campaign to help consumers make more informed dietary choices, FDA is encouraging restaurants to provide nutrition information. American consumers now spend approximately 46 percent of their total food budget on food consumed outside of the home, and these foods account for a significant portion of total calories consumed.

FDA is urging the restaurant industry to launch a nation-wide, voluntary, and point-of-sale nutrition information campaign for customers. FDA also encourages consumers to routinely request nutrition information when eating out. In addition, FDA will work with the restaurant industry to develop options for providing voluntary, standardized, simple, and understandable nutritional information, including calorie information, at the point-of-sale in a restaurant setting.

We are pleased that a number of restaurants and specialty chains have already stepped up to provide this information to consumers and we encourage others to do likewise.

The fourth set of recommendations involves various enforcement activities to ensure the accuracy of the information in the Nutrition Facts Panel and ensure that consumers can monitor their intake of calories and nutrients. FDA has issued a general letter to food manufacturers , encouraging them to review nutrition information and ensure that the serving size declared is appropriate for the commodity in question. The report also calls for stricter enforcement activities against those manufacturers that declare inaccurate serving sizes, and we intend to follow this guideline to make sure Americans have the best, safest information about the foods they are consuming.

Taken together, these various recommendations from the OWG Final Report provide a comprehensive action plan for FDA that, when implemented, will go a long way towards helping us confront the Nation’s obesity epidemic and helping consumers lead longer, healthier lives through better nutrition.

Another major FDA initiative that is inextricably linked with our efforts to combat obesity, have to do with the addition of qualified health claims to food labels. As you know there are a variety of food-labeling claims that are currently available to the food industry. These include the dietary guidance messages that I mentioned earlier, that provide a health message referring to a general category of foods; structure-function claims that describe the role of a nutrient or dietary ingredient that affects a structure or function in humans; nutrient content claims that are based on the nutrient profile of the food product; and health claims that describe a relationship between a food substance and a disease or health-related condition.

Health Claims focus on prevention or reduction of risk, NOT treatment, cure, or mitigation of a disease, and according to the Nutrition Labeling Education Act a health claim must be based on significant scientific agreement and be preapproved by FDA.

As a part of our Consumer Health Information for Better Nutrition Initiative, FDA established a Health Claims Task Force to define a process and long-term regulatory alternatives to help consumers get more information about the health consequences of their food choices.

Our Health Claims Task Force issued its final report in July 2003. This report outlined an interim process for improving health claims and food labeling, and also encouraged FDA to issue an interim guidance for industry on qualified health claims in the labeling of conventional foods and dietary supplements, which we issued in July 2003. FDA also issued an interim guidance regarding a new evidence-based ranking system for scientific data. Under this Guidance, FDA reviews quality and quantity of the scientific evidence supporting a substance/disease relationship claim and gives the evidence a ranking.

The difference between a health claim based on significant scientific agreement and a qualified health claim is the level of evidence, NOT the quality of the science. By allowing qualified health claims, FDA is providing consumers with information about the relationship of nutrition and health along the continuum between emerging evidence and consensus and provides a ranking system to help consumers make informed judgments about their food selections.

To date, FDA has approved eight qualified health claims. About 15 other qualified health claims are currently under review, including one on soy protein and cancer.

The past year also witnessed a major change in the nutrition label on foods to include a separate listing of trans fatty acids. This was the first significant change on the Nutrition Facts panel since it was established in 1993.

The inclusion of trans fat on the food label offers considerable benefits to consumer health and safety. Not only does it provide more useful information to consumers seeking a healthy diet, but it also helps consumers avoid a high intake of trans fats, which (along with saturated fat and cholesterol) is associated with an increased risk of heart disease. This is expected to reduce significantly the costs of illness and disease for Americans – FDA estimates that the changes in labeling will save between $900 million and $1.88 billion each year in medical costs, lost productivity and pain and suffering.

Food Allergen Labeling
Finally, let me just mention briefly where we are in terms of implementing the recently approved Food Allergen Labeling and Consumer Protection Act of 2004 , also known as the Food Allergy Bill. This is a piece of legislation that will help millions of Americans who suffer from food allergies by providing them with additional information on the food label to assist in identifying food allergens that may be a concern. This legislation requires that food labels identify in plain language if a product contains any of eight major food allergens: milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, and soybeans. These eight allergens cause about 90 % of food allergic reactions. Food allergens and certain other food ingredients are now recognized as a hazard for sensitive individuals. FDA is currently developing the petition process for the labeling of these ingredients.

In closing, let me just say that FDA is focused on getting the latest and safest science-based information to consumers, helping them to make smarter decisions about the foods they eat.

As producers of soybeans and soybean processors and soy foods manufacturers, you may view FDA’s activities relative to food labeling as a good news/bad news situation. On one hand, soybeans are one of the top eight food allergens, and their presence in a food product must be labeled. On the other hand, soybeans are naturally trans fat free and soyfood products may be considered for qualified health claims.

In either case, be assured that we are utilizing the full range of our resources and enforcement tools to crack down on false products and false promises, and to protect and promote the public health

Thank you.