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Lester M. Crawford, D.V.M., Ph.D. - Obesity Policy, Regulation, and Litigation

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
2nd National Forum on
Obesity Policy, Regulation, and Litigation

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

Acting Commissioner of Food and Drugs

May 11, 2005

Good Morning. Thank you, Richard (Richard J. Leighton, Esq., Partner, Keller and Heckman LLP, and Chair of the Obesity Forum) for your kind introduction. I'm honored to be with you this morning at your 2nd National Forum on Obesity Policy to address FDA's and the Department of Health and Human Services' current and planned obesity-related activities.

I commend all of you here today, as representatives of the food industry, for your focus on this national epidemic and your willingness to participate in efforts to reverse this trend of increasing obesity.

I'm sure you are aware of the media attention to a recently published study indicating that deaths attributable to obesity were less than 100,000, rather than the 400,000 that had been reported previously by the CDC. I think you can also appreciate that these kinds of numbers are notoriously difficult to pinpoint, and that estimates can vary widely based on what factors or diseases were considered to be obesity related.

One thing we do know for certain is that heart disease is still one of the leading causes of death for both men and women in this country and obesity is a significant risk factor for heart disease. So regardless of the actual number of deaths attributed directly to obesity, it is quite clear that obesity remains a very significant public health problem, a problem that the Department of Health and Human Services (DHHS), and FDA take very seriously.

DHHS INTIATIVES
Just last week, HHS Secretary Michael Leavitt announced his 500-Day plan identifying his priorities and where he intends to focus his energies in fulfilling this Administration's vision of a healthier America . One of those priorities is to implement a comprehensive plan for obesity research that will maximize collaboration among HHS stakeholders to develop comprehensive and novel early prevention and detection strategies to reduce the incidence of obesity and its consequences such as diabetes, heart, and vascular diseases.

Because the burden of obesity and its co-morbidities are even higher in the African-American and Hispanic populations than in the white population in this country, last month, Secretary Leavitt launched a major new initiative on African-American obesity. This initiative will be followed shortly by another initiative focused on the Hispanic community. The African-American obesity initiative involves HHS partnerships with the National Association for Equal Opportunity in Education (NAFEO), the National Urban League, and the National Council of Negro Women that will include prevention, education, public awareness and outreach activities intended to bring about a greater understanding of the impact of obesity on other health conditions in the African-American community. These activities will focus on physical activity, nutrition and disease prevention.

As I'm sure most of you in this room are well aware, in January HHS in conjunction with USDA released the 2005 Dietary Guidelines. For the first time, the Dietary Guidelines included recommendations on weight management and physical activity. Clearly, reversing the tide of increasing overweight and preventing obesity is a major public health priority for HHS.

FDA OBESITY INITIATIVE
In March of 2004, FDA's Obesity Working Group released its comprehensive report titled "Calories Count". This report outlined a series of key recommendations on ways that FDA could help stem the rising tide of obesity in areas within its authority. This report offered a number of compelling recommendations on how to combat obesity. The recommendations also track closely with our priorities for 2005, in particular our goal of providing patients and consumers with better information to help them lead healthier lives through better nutrition and healthy diet choices.

I'm going to spend the remainder of my time with you this morning in providing an update of FDA's progress in implementing the various recommendations from the "Calories Count" report. Intertwined within this update I'll also give you some brief highlights on other, related FDA initiatives.

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. However, achieving that goal is far more complex. We at FDA are counting on you, the food industry, to play a crucial role and partner with us in getting this message to consumers, through your advertising and through current options available to you relative to food labels.

Food Labels
The first critical set of recommendations in the OWG report involved enhancing the food label. The report recommended that FDA evaluate how the Nutrition Facts panel (NFP) can 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.

I'm pleased to report that on April 5 th 2005 , FDA published in the Federal Register its advance notice of proposed rulemaking (ANPRM) to seek comment on how to give more prominence to calories on the food label. Some ideas for how to do this include increasing the font size for calories on the label, adding a percent "Daily Value" column for calories on the Nutrition Facts panel and possibly eliminating the column listing calories from fat. There is a 75-day comment period for this notice and I strongly urge all of you to review the announcement and submit your comments.

In conjunction with this ANPRM on the prominence of calories on the food label, on the same day (April 5, 2005) we also published our ANPRM asking for comment on issues regarding the labeling of serving size on food packages. That is, either requiring dual column nutrition labeling for multiple serving packages that could reasonably be consumed as a single serving or simply requiring such packages to be labeled as single servings.

Since serving sizes are based on reference amounts commonly consumed (RACCs) that were established in the early 1990s as part of the implementation of the Nutrition Labeling and Education Act (NLEA), FDA is also seeking comment on which, if any, RACCs for particular food categories have changed the most over the past decade and therefore may require updating. Again, this ANPRM is open for comment for 75 days and I encourage you to submit your comments.

In numerous speeches and meetings with industry, FDA officials, myself included, have strongly encouraged food manufacturers to take advantage of existing flexibility in the serving size regulations to label as single servings those packages where the entire contents can reasonably be consumed in one eating occasion. We also strongly encourage you to use dietary guidance messages on your food labels, particularly on "reduced/low calorie" foods, and to use appropriate comparative labeling statements to provide consumers with information on healthy substitutions.

I can tell you that some manufacturers are already starting to make voluntary label changes. In fact, I commend Kraft Foods for announcing last June that beginning in October 2004 they would provide both single serving and entire package nutrition labeling for their snack items containing up to four servings per package. The Coca Cola Company also plans to provide dual column labeling for their 20 oz. sodas to display information for both the 8 oz. serving and the full 20 oz. container.

Another issue both of great interest to consumers, and affecting information provided on the food label is that of carbohydrates. At the time that the "Calories Count" report was released, FDA filed three petitions -- from Kraft Foods, ConAgra, and the Grocery Manufacturers of America (GMA) -- requesting that FDA define carbohydrate terms for use on the food label. These terms included "low", "reduced", and "-free". Since then, FDA has received and filed three additional similar petitions from Unilever, Frito-Lay, and the Center for Science in the Public Interest (CSPI). In response to these petitions, we are working on an ANPRM to define these terms.

To assist us in the proposed rule-making process, Last month ( April 8, 2005 ) we published a notice on a planned study of carbohydrate content claims on food labels to enhance FDA's understanding of consumer response to such claims.

Education
The second major element of the OWG report involves initiating an education campaign focused on the "Calories Count" message. FDA recognizes that education is an essential component of efforts to address obesity, and we are focusing our education strategies to influence behavior, as well as impart knowledge, in the context of healthy eating choices for consumers. Because the obesity epidemic is particularly alarming in children, we are focusing our education efforts to youth-oriented organizations -- through collaborations with various private and public sector groups. In fact, in October of 2004, the Department signed a Memorandum of Understanding with the Girl Scouts of America, and the Secretary has asked FDA to take the lead on this partnership. Our Center for Food Safety and Applied Nutrition (CFSAN) is currently working with the GSA on a "Healthy Living" Initiative.

Our Florida District Office is involved in a Seminole County (FL) Healthy Kids Partnership to promote positive opportunities for school-aged children in Seminole County to learn healthy nutrition and the value of increased physical activity via Boys and Girls Clubs. Our goal is to develop education programs that emphasize caloric balance and proper diet for weight management.

In addition to these educational initiatives, CFSAN has recently revised its web site to provide more information to consumers on using the food label, including the Nutrition Facts Panel (NFP), to make more healthful food choices. CFSAN is also developing educational material on using the NFP for healthy weight management that will be coordinated with the Dietary Guidelines for Americans. FDA has posted a "Power of Choice" link on the CFSAN website. This is a joint USDA-FDA educational program designed to guide young adolescents to a healthier lifestyle.

Foods Eaten Away from Home
A third major set of recommendations from the OWG "Calories Count" report called upon FDA to urge the restaurant industry 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 urged the restaurant industry to launch a nation-wide, voluntary, point-of-sale nutrition information campaign for customers, to include information on calories. As a companion to this effort, and in response to input from the restaurant industry that they do respond to consumer demands, FDA continues to encourage consumers to routinely request nutrition information when eating out. The OWG report calls upon FDA to work with a third-party facilitator to begin a national policy dialogue to seek consensus-based solutions to specific aspects of the obesity problem involving foods consumed away from home.

To implement this recommendation, FDA signed a contract last June with the Keystone Center , a nationally recognized facilitator for policy and scientific issues, to begin the dialogue on this, and the pediatric obesity (education) issue. One of the goals of this dialogue is to develop a series of options for providing voluntary, simple, and understandable nutrition information at the point-of-sale to consumers in restaurants.

Keystone conducted initial interviews with a broad range of key stakeholders, formed a steering committee, involving FDA and others, held several planning meetings to more clearly focus the dialogue, and held the first of several Forums just two weeks ago on April 26-27 in Washington . The focus of this Forum was on Away-from-Home Foods and the opportunities that exist in that venue for preventing weight gain and obesity.

I'm pleased to report that we had excellent attendance at this forum, with representatives from the food industry, academia, consumer groups and other federal agencies. Some of the issues that were explored included:

 

  • Market trends, consumer demands, and changes in eating out over time
  • Key Operational characteristics within the away-from-home foods sector
  • Nutritional similarities and differences of at-home versus away-from-home foods
  • Extent of the knowledge base regarding away-from-home foods
  • Effects of food composition (e.g. energy density, proportion of macronutrients) on energy intake
  • Effects of food composition on cost and consumer choice
  • Industry experiences on changing the energy and nutrient density of a menu or products
  • Lessons that could be applied to future product formulation, pricing approaches, and portion size decisions
  • Policies, incentives and other actions that could have a positive effect on future product formulations

Keystone is planning two additional forums on this topic, one to be held this summer, and the third in the fall of 2005.

Enforcement
The fourth major set of recommendations from the "Calories Count" report involved various enforcement activities to ensure the accuracy of the information in the NFP so that consumers can accurately monitor their intake of calories and nutrients. FDA 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 called 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, most accurate information about the foods they are consuming.

The report also called on FDA to increase enforcement efforts against weight loss products with false and/or misleading claims in collaboration as appropriate with the Federal Trade Commission (FTC). Last spring we sent letters to 16 firms regarding false claims for weight loss on dietary supplement products. In August we sent warning letters concerning misbranding and unsubstantiated claims regarding weight loss to the manufacturer of Corti-slim and Corti-stress dietary supplements, and in October the Federal Trade Commission (FTC) issued a press release about action it was taking against the marketers of these supplements.

FDA and the FTC formed a Dietary Supplement Enforcement Group to closely coordinate our enforcement efforts against health care fraud. As a part of its effort to curb Internet health fraud, FDA has conducted several "surfs" to identify fraudulent marketing of health care products, including dietary supplements, over the Internet.

I'm pleased to report that with the appointment of the Honorable Deborah Majoras, who I understand you will hear from tomorrow, as the new Chairman of the FTC, FTC has renewed its commitment to working closely with FDA to increase enforcement against weight loss products making false and misleading claims.

In a major initiative announced in November of 2004, FDA developed a four-pronged approach for ensuring the safety of dietary supplements, including supplements promoted for weight loss. This approach includes guidance on assuring the safety of new dietary ingredients, development of good manufacturing practices guidelines for dietary supplements, guidance on the scientific evidence needed to substantiate label claims on dietary supplements, and diligent enforcement.

Unlike most foods, some dietary supplements may contain ingredients that may be pharmacologically active, and we have become increasingly aware of the potential health problems some of these products pose. FDA is committed to taking enforcement action against unsafe products.

Our process of enforcement will begin with "signal detection", or identifying an issue of concern. Signals of possible safety concerns may come from Federal, state and local counterparts, adverse event reports; foreign regulatory actions; media reports; information from consumer groups; and consultation with experts. In other words we will be monitoring a variety of sources for any early indications of potential problems with a dietary supplement product or ingredient.

Any FDA regulatory action will be based on the totality of the scientific evidence available, this evidence may include the pharmacology of the substance, the scientific literature, adverse event reports and evidence-based reviews. We also want to encourage manufacturers of dietary supplements to report adverse events.

FDA will target those products that pose the greatest risk to consumers. We will obtain and analyze samples of dietary supplements in the marketplace to verify that contents are consistent with labeling, and we will review Supplement Facts panels to determine whether the substances listed as ingredients can be lawfully marketed in dietary supplements. FDA will take immediate action if a dietary ingredient poses a safety hazard as we did with the recent bans on supplements containing ephedra and adrostenedione.

We feel that this process will give consumers access to reliable information about the safety of dietary supplement ingredients and products so they may make informed choices.

Our strategy for enforcement, which includes cooperation with the FTC and other federal, state, and international organizations, targets adulterated substances such as ephedra, and products marketed as dietary supplements making claims for treatment of serious diseases such as cancer and diabetes.

Some high-profile enforcement accomplishments include the final rule prohibiting the sale of dietary supplements that contain ephedra, which went into effect in April 2004. You may have heard that a recent judicial ruling has overturned the ban for products that contain 10 mg or less of ephedra, but the ban is still in effect for all other ephedra-containing products.

FDA was granted a permanent injunction by the U.S. District Court against Lane Labs-USA, Inc. to prohibit the marketing of three dietary supplement products that were deemed to be unapproved new drugs; and the eight-count indictment obtained by the District Attorney for the Southern District of California against MetaboLife International, Inc and its founder Michael J. Ellis for making fictitious and fraudulent representations to FDA and corruptly endeavoring to obstruct and impede proceedings concerning the regulation of dietary supplements containing ephedra.

Therapeutics
While diet and exercise are mainstays for weight management, FDA recognizes that obese, particularly morbidly obese, individuals are likely to need medical intervention to reduce weight and mitigate associated diseases and other adverse health effects. Thus the "Calories Count" report also addressed the therapeutics for obesity.

Just prior to release of the report in March of 2004, we reissued for comment our 1996 draft "Guidance for the Clinical Evaluation of Weight-Control Drugs". In September of this year we convened a meeting of the Metabolic and Endocrinologic Drugs Advisory Committee to address the comments/suggestions that we received on the Guidance as well as the challenges, and gaps in knowledge, about existing drug therapies for obesity. Our goal is to revise and reissue the 1996 draft guidance b the end of this year.

Although the weight-loss drugs currently on the market are few, and their effectiveness limited, FDA was heartened by the fact that the OWG report identified a host of recently identified potential metabolic targets for new weight-loss drug development. In fact, our Division of Metabolic and Endocrine Drugs in the Center for Drug Evaluation Research (CDER) currently has about 10 INDs for new obesity drugs under review. Whether any of these new drugs will have demonstrably better efficacy remains to be seen.

The development of new medical products to treat obesity and its associated diseases will benefit greatly from another landmark FDA initiative, our "Critical Path" Initiative.

Like the OWG report, our Critical Path Initiative for Medical Product Development was published in March of 2004. A docket was opened to receive stakeholder comments on the proposed initiative and extensive discussions with both internal and external stakeholders were held. A tremendous number of opportunities were identified in the comments received, but some common themes were identified that will apply directly to development of new weight-loss drugs. These common themes included improving the clinical phase of product development, which coincides nicely with our intent in reissuing the guidance on Clinical Evaluation of Weight-Loss Drugs that I mentioned a moment ago.

Research
The final set of recommendations in the OWG report focused on increased collaboration on obesity research. One outcome of this recommendation is that FDA helped plan and participated in a USDA-sponsored obesity prevention conference with a research focus, held on October 25-27, 2004 . In particular, FDA has identified five areas for further obesity research: better information to facilitate consumers' weight management decisions; the relationship between overweight/obesity and food consumption patterns; incentives for product reformulation; the potential for FDA-regulated products to unintentionally contribute to, or result in, obesity (e.g. drugs); and, the extension of basic research findings to the regulatory environment.

There is one other important activity currently on-going at FDA that I would like to mention just briefly. This initiative closely parallels our Critical Path Initiative for medical-product development. We refer to it as our Foods Critical Path. This initiative is just getting underway, and will culminate in the publication of a white paper. The premise underpinning our Foods Critical Path is that targeted research in specific areas of nutrition and food science has the potential ability to accelerate progress in using nutrition to achieve public health goals.

The paper will identify what we believe are critical food and nutrition research, technology, and information gaps, and encourage applied research and the development of evaluative tools in several areas. Underpinning these endeavors is the need for FDA to be positioned with the proper knowledge, skills, and tools to endorse and promote the science behind advances in nutrition, and assure that the benefits are real and that food products based on these advances are safe.

A major focus of the initiative will be to enhance the long-term health and well-being of the American consumer by identifying ways to develop a more effective scientific and social knowledge base, within the framework of a holistic approach to analyzing risks and benefits, which integrates both nutrition and food safety, and to apply that knowledge to foster innovation that helps establish healthy nutrition and dietary patterns throughout life.

CONCLUSION
I believe that FDA has made significant progress to date in implementing the recommendations of the report from our OWG final report, and that as we continue towards full implementation of the comprehensive action plan provided in the report, we will go a long way towards helping confront the Nation's obesity epidemic and helping consumers lead longer, healthier lives through better nutrition and safe and effective medical products.

Thank you. I look forward to a continued close working relationship with the food industry in implementing our OWG action plan and I will be happy to take some questions.