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Lester M. Crawford, D.V.M., Ph.D. - Health Care Research

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
Health Care Research and Innovations Congress

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

Acting Commissioner of the FDA

December 1, 2004

Good Afternoon. Thank you, Ken, (Dr. Kenneth M. Borow, President and CEO, Covalent Group, Inc.) for your kind introduction. I’m honored to be with you this afternoon at this joint session of the Health Care Research and Innovations Congress, the Emerging Technologies and Healthcare Innovations Congress, and the Consumer Directed Health Care Conference to address the important topics of obesity and metabolic syndrome.

As you can see from the program, I have been asked to update you on an FDA initiative that is certainly of great importance to me personally, as the person who chaired the group; that is FDA’s Obesity Working Group, and it is my privilege to do so. But intertwined within this update I’ll also give you some brief highlights on other, related FDA initiatives.

As you may know, in March of 2004, FDA released a comprehensive report from its Obesity Working Group entitled “Calories Count” that 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 Progress on Priorities report published in September of this year, in particular our goal of providing consumers with better information to help them lead healthier lives through better nutrition.

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. The OWG report builds on these nutrition fundamentals through a comprehensive, science-based and consumer-friendly set of initiatives.

The first critical set of recommendations 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 FDA is currently working on the 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.

In conjunction with this ANPRM, our Center for Food Safety and Applied Nutrition (CFSAN) is also working on an ANPRM to ask 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 require updating.

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 serving those packages where the entire contents can reasonably be consumed in one eating occasion.

I can tell you that some manufacturers are already starting to make voluntary label changes. In fact, Kraft Foods announced in 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.

I’m delighted to report that both of these ANPRMs are currently undergoing review by our parent department, the Department of Health and Human Services (DHHS) and the Office of Management and Budget (OMB) and should be published in the very near future.

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 as well as another ANPRM on use of the term “net” in relation to carbohydrates.

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 including Girl Scouts, NASULGC (Nat’l Assoc of State Universities and Land Grant Colleges) through their 4-H program, and the Department of Education. Our goal is to develop education programs that emphasize caloric balance and proper diet for weight management. DHHS is now actively engaged with the Girl Scouts of America on this issue.

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, 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.

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, and 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 also encourages consumers to routinely request nutrition information when eating out. As with the recommendations on education, 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 in June of this year 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 will be to develop a series of options for providing voluntary, simple, and understandable nutrition information at the point-of-sale to consumers in restaurants.

To date, Keystone has conducted initial interviews with a broad range of key stakeholders and has now formed a steering committee, involving FDA and others, with a planning meeting scheduled for early December to prepare for the actual dialogue meetings to come.

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 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 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).

In a major initiative announced on November 4, FDA has 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.

We are working collaboratively with federal and other partners to develop the scientific evidentiary base that FDA will use to make safety and enforcement decisions. FDA’s own Center for Food Safety and Applied Nutrition, and our National Center for Toxicological Research are partnering with other Federal agencies, including the National Institutes of Health’s Office of Dietary Supplements and National Center for Complementary and Alternative Medicine, and the National Toxicology Program in the Department of Health and Human Services. We are also partnering with the University of Mississippi’s National Center for Natural Products Research, as well as others.

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.

When the quality or quantity of these signals indicates that there may be a public health concern, FDA may then seek a third party review. 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.

FDA’s primary mission is to protect the public health, but FDA shares with the FTC the mutual goal of consumer protection from false and misleading advertising. FDA and 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. Just recently, (October 22, 2004) we sent nine warning letters to dietary supplement manufacturers/distributors for unsubstantiated claims on dietary supplement products promoted for weight loss over the Internet. Because these claims lacked substantiation, they were considered false or misleading, and therefore the products were misbranded.

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 recent enforcement accomplishments include the final rule prohibiting the sale of dietary supplements that contain ephedra, which went into effect in April 2004; the permanent injunction granted to FDA 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. In early October, the FTC announced it was taking action against the marketers of Corti-slim and Corti-stress dietary supplements for false claims that the products can cause weight loss. FDA also took action and sent a warning letter to the firm concerning misbranding and unsubstantiated label claims.

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, we reissued for comment our 1996 draft “Guidance for the Clinical Evaluation of Weight-Control Drugs”. Just recently, in September of this year we convened a meeting of the Endocrinologic Drugs Advisory Committee to address challenges, as well as gaps in knowledge, about existing drug therapies for obesity. Our goal is to revise and reissue the 1996 draft guidance.

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.

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 this year. 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.

Another common theme in comments received on our Critical Path Initiative was the importance of accelerating development and regulatory acceptance of biomarkers and surrogate markers for drug safety and efficacy. Progress in this area will also facilitate the development of medical products for weight loss and weight control.

I’m pleased to tell you that FDA will begin work in both of these areas – improved clinical evaluation processes and development of biomarkers and surrogate markers – this fiscal year (FY 05).

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 before answering any questions you may have. 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 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.

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.