Commercial Weight Loss Products and Programs What Consumers Stand To Gain and Lose

Commercial Weight Loss Products and Programs
What Consumers Stand To Gain and Lose

A Public Conference on the Information Consumers Need to Evaluate Weight Loss Products and Programs

Report of the Presiding Panel

This is the Presiding Panel's report of the conference proceedings. The views expressed herein by individual government participants do not necessarily reflect the views of their respective government agencies.

Conference Sponsors:

Bureau of Consumer Protection
of the Federal Trade Commission

The American Society for Clinical Nutrition

The National Institute of Diabetes and Digestive and Kidney Diseases

The Centes for Disease Control and Prevention

October 16-17, 1997
Federal Trade Commission Building
Sixth Street & Pennsylvania Ave., N.W.
Washington, D.C.

The Panelists:
 
Richard Cleland, J.D., Assistant Director, Division of Service Industry Practices, Federal Trade Commission
 
Dean C. Graybill, J.D., Associate Director, Division of Service Industry Practices, Federal Trade Commission
 
Van Hubbard, M.D., Ph.D., National Institute of Diabetes & Digestive & Kidney Diseases, National Institutes of Health
 
Laura Kettel Khan, Ph.D., National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention
 
Judith S. Stern, D.Sc., Departments of Nutrition and Internal Medicine, University of California, Davis
 
Thomas A. Wadden, Ph.D., University of Pennsylvania, School of Medicine
 
Roland Weinsier, M.D., Dr. P.H., University of Alabama- Birmingham; Coalition for Excess Weight Risk Education,
 
Susan Yanovski, M.D., National Institute of Diabetes & Digestive & Kidney Diseases, National Institutes of Health
 
Editors
 
Walter C. Gross, J.D., Senior Attorney, Division of Service Industry Practices, Federal Trade Commission
 
Matthew Daynard, J.D., Senior Attorney, Division Of Service Industry Practices, Federal Trade Commission

INTRODUCTION

On October 16-17, 1997, representatives from academia, government, the weight loss industry, and consumer advocacy groups met in Washington, D.C. for a conference -- “Commercial Weight Loss Products and Programs -- What Consumers Stand to Gain and Lose.” The subject of the conference was the continuing rise of obesity in this country, estimated to cost consumers over $100 billion in health care costs and money spent on weight loss products and services. The conference was conceived as a coordinated effort by all concerned groups to better understand the problem and to explore ways to improve the information that consumers routinely receive about the nature of obesity and weight loss products and programs.

The approach was an unprecedented one -- the first time that representatives of the weight loss industry, members of the scientific and academic community, agencies from state and federal government, and public interest consumer groups met together to explore voluntary approaches addressing issues regarding weight loss products and programs. This Report is a summary of the conference discussions and does not reflect the official view of any government agency.

TABLE OF CONTENTS

Executive Summary

I. INTRODUCTION: Combating the Prevalence of Overweight/Obesity -- Meeting the Challenge Through Better Information For Consumers

A. An Overview of the Problem

B. Paradox: Many Consumers, Experienced in Making Weight Loss Choices, Continue to Make Bad Ones.

C. Information Revealing Value and Efficacy of Weight Loss Products
and Programs is Not Readily Available.

D. Recent Events in Response to the Marketing of Weight Loss Products
and Programs

  1. Congressional Hearings
  2. FTC cases
  3. NIH Technology Assessment Conference
  4. Institute of Medicine: Weighing the Options
  5. CSPI Rulemaking Petition
  6. FDA Recall of Fenfluramine and Dexfenfluramine

II. The Public Conference: Commercial Weight Loss Products and Programs -- What Consumers Stand to Gain and Lose -- Overview

A. Sponsors

B. Issues

C. Panelists

III. Proceedings

A. Consumer Issues -- Needs and Expectations ("The Consumer Panel")

  1. Consumers Are Not Receiving Needed Information about Costs, Duration, Risks, Staff Credentials and Outcomes (Average Weight Lost, Weight Loss Maintained)
  2. Why Consumers Make the Choices They Do -- What We Know

B. Weight Loss Products and Services Providers -- Responding to Consumer Needs ("The Provider Panel”)

  1. Outcome Information

a. Barriers to Disclosure
b. Consumer Information Needs, Experiences, and Expectations

  1. Other Disclosures

C. The State-of-the-Art. What Do We Know About Various Types of Weight Loss? ("The Science Panel")

  1. Lessons Learned from the Fen/phen Experience
  2. The Surgical Treatment of Obesity: Results of Studies
  3. The Risks of Rapid Weight Loss
  4. Moderate Weight Loss: The Realities of Weight Loss Do Not MatchDieters’ Expectations

D. Government’s Role in the Weight Loss Marketplace ("The Government Panel")

  1. Centers for Disease Control and Prevention Tracks the Prevalence of Overweight/Obesity through the NHANES Survey
  2. National Institute of Diabetes and Digestive and Kidney Diseases Promotes and Funds Research in the Treatment of Overweight/Obesity
  3. U.S. Food and Drug Administration Approves New Drug Applications and Regulates the Labeling of Over-the-Counter and Prescription Drugs

a. Memorandum of Understanding with FTC
b. Authority over Dietary Supplements

  1. Federal Trade Commission Addresses Deceptive and Misleading Advertising of Weight Loss Products and Programs
  2. State Attorneys General Address Fraudulent Weight Loss Products and Services
  3. Interagency Cooperation

IV. Models for the Disclosure of Consumer Information on Weight Loss Programs

V. Areas Where Research is Needed

A. Consumer Behavior Research

B. Weight Loss Efficacy Research

VI. Plan of Action -- Where Do We Go From Here?

A. Voluntary Disclosures

B. Consumer Education

C. Research

Executive Summary

The prevalence of overweight and obesity in the United States continues to increase at alarming levels. One third of the adult population is currently overweight or obese,(1) and preadolescent and adolescent overweight/obesity is also increasing. Obese persons are at a higher risk of developing coronary artery disease, certain forms of cancer, hypertension and type II diabetes. Overweight/obesity has become a national epidemic. According to leading experts, overweight/obesity is the second leading cause of preventable death in the country. In spite of the widespread promotion and marketing of thousands of treatments, devices, therapies, programs and products that purport to induce weight loss and prevent regain, the most remarkable aspect of most of them is their failure rate. Compounding the problem is the fact that so many treatments, hailed initially as "breakthroughs," are found eventually to result in significant health risks themselves. This problem is all-the-more tragic because many clinicians believe that overweight/obese persons could realize significant health benefits from losing as little as five to ten percent of their weight and keeping it off -- a goal that seems far more realistic than attempting to reach some arbitrary, aesthetic "ideal" of size and weight.

The issue of weight, and more specifically, losing weight, is of critical importance to many American consumers, but consumers often lack the information necessary to make informed decisions about available treatment options. Recognizing this need, representatives of the weight loss industry, consumer groups, health professionals, academics, and state and federal agencies with responsibilities in the weight loss marketplace convened on October 16-17, 1997 in Washington, D.C. at the Conference on Commercial Weight Loss Products and Programs -- What Consumers Stand to Gain and Lose. The conference was hosted by the Federal Trade Commission, and jointly sponsored by the FTC, the American Society for Clinical Nutrition, the National Institute of Diabetes and Digestive and Kidney Diseases ("NIDDK"), and the Centers for Disease Control and Prevention ("CDC"). Its purpose was to explore ways to improve the information that consumers routinely receive about weight loss products and programs.

Four expert panels addressed issues pertinent to improving the availability of information about weight loss programs and products. The goal was to identify areas where mutual cooperation toward clearly defined goals was possible. Panels addressed the following topics: "Consumer Issues -- Needs and Expectations" ("the consumer panel"), "Weight Loss Products and Service Providers -- Responding to Consumer Needs" ("the provider panel"), "The State of the Art -- What Do We Know About Various Types of Weight Loss?" ("the science panel"), and "Government’s Role in the Weight Loss Marketplace," ("the government panel").

Consumer Panel

Consumer panelists identified areas where providers of weight loss services need to be more forthcoming with information about their weight loss programs. Arguing that many commercial weight loss programs often withhold information, fail to collect data, or make only partial disclosures, panelists representing consumer groups were unanimous in expressing the need for complete and accurate data in the following areas:

  • program costs and duration,
  • health risks and complications associated with any weight loss regimen,
  • staff credentials, and
  • outcome data that reveal average weight loss by participants and
  • short and long-term maintenance success.

Most consumer panelists agreed that, if providers were not willing to provide this information voluntarily, the government should require them to disseminate it, either by enacting legislation or by promulgating mandatory regulations pursuant to the Federal Trade Commission Act. The consumer panel also served as the forum for presenting evidence of consumer behavior, more specifically, what motivates consumers to lose weight and why they choose one form of weight loss over others. Panelists generally agreed that evidence in this regard is dated and sparse, and that additional research is needed to better understand why so many consumers continue to choose options that fail them.

Provider Panel

Representatives of commercial weight loss centers agreed that some of the information consumer groups wanted -- costs, program duration, health risks, and staff credentials -- was readily available and would not be difficult to disclose. Attrition data and outcome data, particularly maintenance data, were more problematic. Arguments against disclosing such data included the difficulty and the cost of collecting such data, the possibility that low long-term success outcomes might discourage people from trying to lose weight, the differing views of what constitutes "success" in weight loss, and the need for a "level playing field" among all providers of weight loss products and services.

Panel members representing producers of protein supplement formulations for physician- supervised very-low-calorie diets expressed the view that collecting data on patient outcomes was not only possible economically, it was also good business. They were opposed, nonetheless, to mandatory disclosure laws or regulations.

The provider panel unanimously subscribed to the notion that a post-conference follow- up initiative should pursue adoption of guidelines or standards that, as a start, would provide for the voluntary, up-front disclosure of all program costs, staff qualifications or credentials, and health risks and complications associated with a particular program or treatment. It was also agreed that the working group should address the types of success or outcome data that consumers need and the feasibility of voluntarily providing it.

The Science Panel

The science panel heard presentations on prescription drugs, the results of studies of new prescription drug combinations, and the cautionary lessons that should be taken from the "fen/phen" experience. Panelists also presented information on the results of clinical studies of the surgical treatment of obesity and the increased risk of gallbladder disease that has been associated with weight loss that exceeds three pounds per week. Finally, evidence of how weight loss of as little as five to ten percent of initial body weight significantly decreases co-morbidities of overweight/obesity and how these "realistic" weight loss outcomes failed to coincide with dieters' expectations, engendered the suggestion that the message to encourage weight loss in overweight/obesity consumers should be refined to emphasize the healthful benefits of modest weight loss.

The Government Panel

Panelists from CDC, NIDDK, FDA, FTC, and the offices of the Attorneys General of Connecticut and Texas provided descriptions of their varied responsibilities in the weight loss marketplace. The Centers for Disease Control and Prevention chart the prevalence of overweight/obesity through collection and analysis of the National Health and Nutrition Examination Survey (NHANES) and the Behavioral Risk Factors Surveillance System (BRFSS); NIDDK promotes and funds research in the treatment and prevention of overweight/obesity; the U.S. Food and Drug Administration regulates the labeling of prescription and over-the-counter weight loss drugs and approves new drugs; and the FTC and the state attorneys general combat misleading advertising claims for weight loss products and programs. Presentations from representatives from each of these federal agencies, as well as from representatives of the Attorneys General of Connecticut and Texas, outlined recent developments. In addition, George L. Blackburn, M.D., described the activities of the Massachusetts Medical Society, Committee on Nutrition, in developing guidelines for the prescription of weight loss drugs by physicians in that state.

Models For Information Disclosure

In a separate presentation, Dr. Judith S. Stern presented for discussion various models for disclosure of weight loss information to consumers. Disclosure models included those adopted in New York City, Connecticut, Michigan, and Texas, as well as mechanisms for disclosure proposed in the Institute of Medicine’s (IOM) report, Weighing the Options, and in the petition of the Center for Science in the Public Interest for Federal Trade Commission rulemaking. Common elements of most of the various models include information about costs, risks and, often, outcomes.

Open Forum (Research Needs)

Through the medium of an open forum, several panelists and conference attendees listed areas where further research and study were needed in order to combat overweight/obesity, promote better understanding of overweight/obesity as a disease, change attitudes of how obese persons are perceived by the general public, and better educate consumers as to the implications of overweight/obesity and the need to lose weight and exercise more. Some of the areas identified were: (1) the effect of weight loss on mortality; (2) the safety and efficacy of various drug combinations; (3) the effect of diminished incidental physical activity on the increased prevalence of overweight/obesity; (4) consumer response to various advertising claims for weight loss products and programs; and (5) the effect of discrimination toward overweight/obese persons on their motivation to lose weight.

Action Plan

Acknowledging that the prevalence of overweight/obesity has increased in the U.S. population and that better informed consumers are needed to reverse this trend, conference participants agreed to work to: (1) develop and disseminate consumer and industry education materials; (2) develop voluntary means for providing consumer information; (3) improve the collection, interpretation and dissemination of outcome and risk data; and (4) identify and conduct needed research in the areas of consumer behavior and outcomes assessment.

Conference participants adopted a three-pronged action plan that includes: (1) the formation of a coalition to develop guidelines or standards for the voluntary disclosure of information deemed necessary for consumers to evaluate weight loss programs and products; (2) the formation of a coalition to develop an effective message for educating consumers and corresponding consumer education materials; and (3) an agreement to explore further sources for research initiatives identified at the conference.

I. INTRODUCTION: Combating the Prevalence of Overweight/Obesity -- Meeting the Challenge Through Better Information For Consumers

A. An Overview of the Problem

Over the next day-and-a-half, we will address one of the most tragic, costly, and preventable public health problems facing this country today -- an epidemic of obesity that drains our economy of billions of dollars annually in direct medical expenses, disability, and lost productivity, and . . . together with a sedentary life style contributes to over three hundred thousand excess deaths each year. Next to smoking, obesity is the second leading cause of preventable death in the United States. Welcoming remarks of George L. Blackburn, M.D., President, American Society for Clinical Nutrition.

Statistics that reveal the extent of overweight/obesity in the United States are a sobering reminder of the dark side of prosperity and the industrial and technological advances of the twentieth century. According to survey data accumulated by the CDC through the National Health and Nutrition Examination Survey (NHANES), the prevalence of overweight and obesity among the adult population has continued to increase, from approximately 25 percent of the U.S. adult population by the late Seventies (1976-80) to a startling 33 percent by 1991.(2) According to the latest NHANES data, overweight/obesity prevalence has continued to increase from 1988 to 1994 by 3.3 percentage points for men and 3.6 percentage points for women from 1988-1994. Similar trends are indicated for children and adolescents. Latest NHANES figures show overweight/obesity levels of approximately 11 percent for both children and adolescents. Overweight/obesity prevalence increases annually by nearly one percent.

Twenty-five percent of men and close to forty percent of women are currently trying to lose weight. The prevalence of overweight/obesity is of great concern because it has been associated with the increased risk of several chronic and life-threatening diseases including type II diabetes,(3) coronary artery disease, hypertension, and certain types of cancer. The importance of controlling overweight/obesity and promoting safe and effective weight loss treatments is heightened by the existence of clinical studies demonstrating that even modest amounts of weight loss (5-10 percent of body weight) can result in significant improvement of these co- morbidity factors (i.e., diseases associated with obesity). As it is, health problems related to overweight/obesity account for $70 billion annually in health costs. Consumers spend an additional $33 billion per year(4) trying to lose weight or to prevent weight gain. Thus, the basis for the oft-quoted figure that the cost of overweight/obesity is $100 billion annually.

B. Paradox: Many Consumers, Experienced in Making Weight Loss Choices, Continue to Make Bad Ones.

People who have unrealistic notions about how much weight they can lose or can keep off over time can face devastating blows to self-esteem when they experience repeated failures. When they start out with unrealistic expectations, they may then choose methods that are either unproven or over-hyped. Remarks of Dean Graybill, Associate Director, Division of Service Industry Practices, Federal Trade Commission

In spite of the best efforts of the medical and academic community, the state and federal government, the public interest sector, and many providers of weight loss products and services, too many consumers continue to make choices that promise miracles that are not achievable and, in many instances, threaten the health of the users. The size of the market for fraudulent weight loss products and services, an estimated five billion dollars annually, supports this conclusion. This occurs among a group of consumers who, on average, have attempted to lose weight two to three different times using different methods. Some providers of weight loss products and services argue that dieters are very sophisticated consumers, and, through the experience of several attempts at weight loss, know what works for them and what does not. Why then do so many consumers continue to make bad choices among available treatment options? As Dr. Blackburn observed in his opening remarks:

In the ideal world of free enterprise economy, consumers have access to everything there is to know about every given subject and always make decisions in their own best interests. But in the real world, fear and hype are most likely to generate sales that damn the full disclosure of scientific data.

The working hypothesis of the conference was that better-educated consumers with access to better information about the options available to them can improve their chances for success and help reduce the prevalence of overweight/obesity. The more consumers understand about what is reasonably attainable and the consequential benefits, the less likely they will be to opt for the next pill or gimmick that promises easy weight loss without dieting or exercise. As the majority of conference participants concluded, accomplishing these outcomes depends upon a cooperative effort to explore how information consumers need can be enhanced and how the message about the need for, and benefits of, weight reduction can be improved.

C. Information Revealing Value and Efficacy of Weight Loss Products and Programs is Not Readily Available.

Before the conference, the Center for Science in the Public Interest and other parties alleged that commercial weight loss programs typically failed to provide information that consumers need to evaluate the suitability of the weight loss programs. This information gap was said to include information in the following categories: (1) the cost of the program and its duration, (2) the qualifications and credentials of program staff, (3) the risks associated with the program; and (4) program outcomes in terms of both weight loss achieved and weight loss maintained short term and long-term. At the conference, most consumer group representatives reiterated the unavailability of this information and its importance to consumers. Significantly, the commercial firms at the conference did not take serious issue with the allegation that providers of treatment options for overweight/obesity need to be more forthcoming with relevant information. Providers indicated general willingness to disclose information in the first three categories, but cited obstacles such as costs and the difficulty of collecting data to making other information disclosures, especially those concerning outcomes. The challenge to all participants -- providers, scientists, government and consumers -- is to devise means by which value and performance data about weight loss options are readily available at an acceptable cost and in a format that does not discourage obese consumers from attempting to lose weight.

D. Recent Events in the Response to the Marketing of Weight Loss Products and Programs

1. Congressional Hearings

Throughout the nineteen nineties, the commercial marketplace for the treatment of overweight/obesity has been a high-profile topic among policy makers, the media, academia, the scientific community, and government regulators. In 1990, hearings before the House Subcommittee on Small Business, focused principally upon the marketing of commercial diet clinics and physician-supervised, very-low-calorie weight loss programs. The hearing’s subtext was that beneath the glitter and the hype that comprised so many advertising campaigns for weight loss products and programs lay the sobering reality that too many consumers ultimately failed in losing weight and keeping it off. The hearings stressed the need for increased government scrutiny of the weight loss marketplace to police such deceptive advertising claims as unsubstantiated success claims and atypical user testimonials.

2. FTC Cases

Partially in response to those hearings,(5) the Federal Trade Commission initiated concurrent investigations of the advertising and promotion of the largest commercial weight loss clinics and physician-supervised programs. This undertaking resulted in the entry of more than twenty consent orders that address such advertising practices as unsubstantiated weight-loss and weight-loss maintenance claims, atypical consumer testimonials, and misleading staff credentials and endorsements. In addition to these cases, the Commission staff continued to monitor and challenge deceptive advertising for weight loss pills, potions and devices.

3. NIH Technology Assessment Conference

Understanding the likelihood of success is a key element in making informed choices from among the dietary, exercise, and behavioral options for weight loss. . . . For most weight loss methods, there are few scientific studies evaluating their effectiveness and safety. The available studies indicate that persons lose weight while participating in such programs but, after completing the program, tend to regain the weight over time. NIH Technology Assessment Conference Panel, "Methods for Voluntary Weight Loss and Control," Annals of Internal Medicine, v. 119, p.766 (October, 1993).

In April 1992, the National Institutes of Health convened a Technology Assessment Conference on Methods of Voluntary Weight Loss and Control. The conference was charged with (1) identifying the practices used to achieve weight loss and weight control; (2) evaluating the evidence of success for various methods of weight loss and weight control; and (3) assessing the beneficial and adverse effects of weight loss. Among the critical findings of the Conference were the following:

  • One quarter to one third of Americans are overweight(6), and approximately 40 percent of women and 24 percent of men are trying to lose weight at any given time;
  • In controlled settings, participants who remain in weight loss programs lose approximately 10 percent of their weight, but one third to two thirds of the weight is regained within one year, and almost all is regained within five years; and
  • Successful weight loss improves several cardiovascular risk factors and diabetic control; however, effects on mortality are unclear.

The conference report called for further research in the treatment of overweight/obesity and indicated that consumers should be able to obtain critical information about outcomes and risks (See Section IV, infra). Ann Intern Med. 1993;119 (v.7 pt 2): 764-770.

4. Institute of Medicine: Weighing the Options

[T]he definition of success that is applied in evaluating weight loss programs [should] be broadened and made more realistic based on the research findings that small weight losses can reduce the risks of developing chronic diseases. Specifically, the goal of obesity treatment should be refocused from weight loss alone, which is often aimed at appearance, to weight management, achieving the best weight possible in the context of overall health. Weighing the Options: Criteria for Evaluating Weight Management Programs, Food and Nutrition Board, Institute of Medicine, Thomas, P.R., ed., p. 5, (National Academy Press, 1995).

In 1994, with funding provided by the National Academy of Sciences, the Food and Nutrition Board (FNB) of the Institute of Medicine (IOM) undertook a one year study to evaluate the effectiveness of various approaches to the prevention and treatment of overweight and obesity. The study objectives as stated by the FNB were, among others:

  • Identify direct measurements of overweight/obesity treatment and prevention programs as well as their priorities and special uses.
  • Identify program characteristics that should be specified and measured in program evaluation.
  • Identify appropriate uses of indirect measurements of outcomes (especially risks of specific diseases) of large-scale weight loss programs.

In 1995, IOM published the FNB findings and recommendations in its report, Weighing the Options, (National Academy Press, Washington, D.C., 1995). Among the recommendations of the report were up-front program disclosures to consumers that include the following:

  • A statement of the approach and goals of the program,
  • A brief description of staff credentials, with detailed information provided on request,
  • A statement of client population and experience over a period of nine months,
  • A full disclosure of costs, and
  • A statement of pre-program procedures recommended for clients (e.g., seeing a physician and need for physician-monitoring of certain patients with chronic diseases, such as hypertension and diabetes).

The report also set out recommendations for detailed data collection to support the recommended disclosures. As the report stated, "Information on program disclosure should be sufficient to enable the client to make informed choices among the program options and, we hope decrease unrealistic expectations."

5. CSPI Rulemaking Petition

In 1995, the Center for Science in the Public Interest (CSPI), joined by other parties, including the American Society of Bariatric Physicians, the National Consumers League, and George L. Blackburn, M.D., petitioned the Federal Trade Commission to issue a trade regulation rule(7) applicable to commercial weight loss program providers. Citing the failure of commercial

weight-loss programs to provide consumers with information necessary to evaluate the effectiveness of the programs or their full costs, CSPI, adopting the disclosure model recommended by IOM in Weighing the Options, proposed that the programs be required to disclose needed information prior to purchase. The CSPI proposal included total program costs, program duration, staff credentials, health risks associated with given programs, and outcome information as to average weight loss as well as short-term and long-term weight loss maintenance experience. The Commission denied the petition, opining that the possible added benefits of conducting the proposed rulemaking would not outweigh the costs, and citing the substantial improvements in truthful advertising already achieved through case-by-case enforcement. As an alternative, the Commission directed its staff to assess the merits of convening a public conference to explore with petitioners and other interested groups options for increasing the availability of truthful and non-deceptive information of the type addressed in the petition.

6. FDA Recall of Fenfluramine and Dexfenfluramine

The 1990s also saw the emergence of prescription drug therapy for overweight/obesity as a potent marketing force rivaling the appeal of commercial weight loss centers and causing some of the largest and most market-driven programs to include a drug therapy component. The FDA approval of dexfenfluramine (marketed as Redux), an appetite suppressant, and the prior much- heralded study of the effectiveness of two previously FDA-approved appetite suppressants, fenfluramine and phentermine, when used in combination ("Fen/phen") for the treatment of overweight/obesity, were responsible for the burgeoning market demand for these drugs.(8) Fueling the demand was extensive coverage in the popular press and saturation advertising campaigns by programs, obesity clinics, and individual physicians offering access to these "miracle" drugs for persons seeking solutions for heretofore unsuccessful efforts to lose weight and prevent weight regain.

Dexfenfluramine had already been associated, in 1996, with a rare and often fatal cardiopulmonary condition, primary pulmonary hypertension, but considering the life- threatening complications known to be associated with overweight/obesity, use of the drug to treat high obesity categories (BMI of >27 with co-morbidities and >30 without them) appeared justified.(9) The announcement in July 1997 by the Mayo Clinic, however, of a possible association of at least one of the components of fen/phen, fenfluramine, with a potentially serious cardiac-valvular disease, caused alarms to sound across the country. Subsequently, when the FDA announced that a preliminary analysis from a survey of echocardiogram results in patients who had used fen/phen or dexfenfluramine revealed a 30 percent prevalence of the rare disease, it asked the drug manufacturers to voluntarily withdraw both fenfluramine and dexfenfluramine from the market, and they did so. The fen/phen phenomenon thus served to highlight dramatically the overweight consumer's desperation to find successful means of weight control.

II. The Public Conference: Commercial Weight Loss Products and Programs -- What Consumers Stand to Gain and Lose -- Overview

A. Sponsors

Representatives of the weight loss industry, consumer groups, health professionals, academics, and state and federal agencies with responsibilities in the weight loss marketplace convened on October 16-17, 1997 in Washington, D.C. at the Conference on Commercial Weight Loss Products and Programs -- What Consumers Stand to Gain and Lose. Hosted by the Federal Trade Commission, and jointly sponsored by the FTC, the American Society for Clinical Nutrition, the National Institute of Diabetes and Digestive and Kidney Diseases, and the Centers for Disease Control and Prevention, the purpose of the conference was to explore ways to improve the information that consumers routinely receive about weight loss products and programs.

B. Issues

Panels addressed the following topics: "Consumer Issues -- Needs and Expectations" ("the consumer panel"), "Weight Loss Products and Service Providers -- Responding to Consumer Needs" ("the provider panel"), "The State of the Art -- What Do We Know About Various Types of Weight Loss?" ("the science panel") and "Government’s Role in the Weight Loss Marketplace" ("the government panel"). Among the issues that panelists were asked to address were the following:

What do we know about motivating factors that lead people to attempt to lose weight?

How are overweight/obese consumers’ needs and expectations affected by perceptions of overweight/obesity in the general population?

What consumer research has been done in the weight loss area? What more needs to be done?

What additional information do consumers need to evaluate products/programs?

What should consumers’ responsibilities be in shopping for weight loss products/ programs?

How can consumers be better educated to seek/demand the information that will be useful in evaluating programs?

What are the barriers to collecting information about programs and outcomes and disseminating it to consumers?

What outcome data do programs routinely collect already? What information is readily available but disseminated only upon request?

How can consumers effectively evaluate competing products/programs without access to outcome data?

What steps are providers taking to assure responsible use of prescription drugs?

What can consumers reasonably expect to achieve from various types of weight loss regimens?

What are the risks that consumers need to know about these regimens?

Who should be treated with drug therapy? Are there limitations on duration of safe therapy?

What is the current state of weight loss advertising? What factors appear to be driving current marketing of weight loss products/programs?

What lessons have we learned from the fen/phen experience?

What has been the result of recent efforts (post-1990) to deal with deception in the weight loss marketplace? What has been the effect of these transactions on the market place?

Are there non-regulatory alternatives (e.g., industry guidelines) to encourage the dissemination of more and better information? Who should develop them and how should they be implemented?

C. Panelists

Four panels addressed these and other issues before a permanent presiding panel comprised of Van S. Hubbard, M.D., Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health; Laura Kettel Khan, Ph.D., Centers for Disease Control and Prevention; Judith S. Stern, D. Sc., Departments of Nutrition and Internal Medicine, University of California-Davis; Thomas A. Wadden, Ph. D., University of Pennsylvania, School of Medicine; Roland Weinsier, M.D., Dr. P.H., University of Alabama-Birmingham, Coalition for Excess Weight Risk Education; and Susan Yanovski, M.D., National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health; and two FTC representatives, Dean Graybill, J.D., Associate Director, Division of Service Industry Practices and Richard Cleland, J.D., Assistant Director for Service Industry Practices.(10) The panels were structured to encourage the free exchange of ideas and information between panelists and attendees and to identify areas where mutual cooperation toward clearly defined goals was possible.

III. Proceedings

A. Consumer Issues -- Needs and Expectations ("The Consumer Panel")(11)

Whether it is a homemade sign tacked up on a telephone pole proclaiming you can lose 30 pounds in 30 days or a nationally advertised diet program, consumers are left to guess about the cost, the safety and the efficacy. Essential information is not disclosed in a timely manner, if at all. For example, what is a "nutritional counselor," and just because you wear a white coat, does that make you one? . . . We should at least have the same level of disclosure for the weight loss industry as we have for car leasing. Prepared remarks of Leslie Byrne, Special Assistant to the President and Director, U.S. Office of Consumer Affairs.

1. Consumers Are Not Receiving Needed Information about Costs, Duration, Risks, Staff Credentials and Outcomes (Average weight Lost, Weight Loss Maintained)

Representatives of consumer groups participating in the consumer panel (Center for Science in the Public Interest, Consumers Union, National Consumers League, American Obesity Association) agreed with Ms. Byrne that prospective purchasers of diet plans offered by commercial weight loss firms are entitled to receive basic information about the program including total cost and duration of the program, the credentials of the program staff, the risks associated with the particular treatment offered, and the efficacy of the program in terms of weight loss and maintenance. The consumer panelists were also in agreement about the overall failure of commercial programs to provide such information. According to the research conducted by several panelists, a few programs were better than others in providing some of the information at issue, but no program provided all of the information, with information as to program efficacy (outcome information) the least available. The panel heard anecdotal evidence (Farzan, Pappas) of program counselors offering inaccurate nutritional advice and the substitution of atypical testimonials when shoppers asked for outcome information. Some consumer panelists (Byrne, Farzan) were of the opinion that the weight-loss industry should be given the opportunity to voluntarily respond to this need for information by adopting voluntary guidelines, but if a voluntary solution should prove to be impractical, mandatory measures such as federal legislation or regulations prescribing what information programs must provide should be adopted. According to Leila Farzan of the Center for Science in the Public Interest:

This conference is focusing on an industry that not only affects people financially, but also affects their physical and psychological health. Many people who go to commercial weight loss programs are desperate to lose weight, and companies should not be allowed to prey upon their vulnerability.

Lynn McAfee, representing the Council on Size and Weight Discrimination, stressed the need for understanding that people are motivated to lose weight not only for health concerns but also for appearance concerns so that large-sized people can escape social prejudice. She also questioned whether it was appropriate to rely upon losing weight as the only solution to social prejudice. Ms. McAfee suggested that while many obese people would clearly realize health benefits from weight loss, it is not clear that all people do so. She stated that the current approach by many health care professionals who try to "scare" people into losing weight is ineffective and offensive, arguing that, for many people, overweight/obesity is more than a failure of will power; it is a product of a "very complex mechanism that we clearly do not understand yet." She called for a new approach to consumer information disclosures, suggesting that the commercial weight-loss industry should be recast as "commercial health programs," so that benefits of dieting and exercise can be stressed in terms of improving health, regardless of whether they produce weight loss.

2. Why Consumers Make the Choices They Do -- What We Know

Much of the motivation for dieting is based upon a dissatisfaction with appearance that cannot be fixed by dieting. For most people, no amount of weight loss will transform their bodies to look like models or movie stars. Too much emphasis is placed on weight loss, and not enough emphasis is placed on improving health and well-being. Prepared statement of David Schlundt, Ph.D., Professor of Psychology, Vanderbilt University.

Research on consumer behavior and motivation in the weight loss area is mostly sparse and dated, according to panelists who spoke on the subject (Heaton, Pappas). The information presented at the conference was based mainly upon surveys by the FDA and Consumer Reports Magazine as well as some summary information from a proprietary Weight Watchers survey conducted in 1996. Using published studies, Dr. Schlundt summarized the extent of our knowledge of consumer behavior and motivation.

Generally, what we do know about consumer behavior is that as many persons are attempting to lose weight (40 percent of women, 25 percent of men) as are actively seeking to maintain current weight (30 percent each) (Schlundt). Additionally, most people have attempted to diet using more than one method. On average, according to Heaton, dieters try one method or another for about six months at the rate of more than one per year for two years. The Weight Watchers study indicates that dieters have used three diets within the last three years. Appearance (29%), and concern for current health (16%) or future health (21%), were the most important motivators for weight loss among women (Heaton). Among men, future health (29%) and current health (16%) were primary motivating factors, but appearance (18%) was also important.

The Consumer Reports survey indicated that about 20 percent of persons who attempted to lose weight used commercial weight loss programs. Heaton reported this figure to be about 13 percent for women and five percent for men. According to Heaton, among all dieters, the methods they use to try to lose weight, in addition to joining commercial programs, are weighing oneself regularly, walking, taking diet pills, using meal replacement plans, counting calories, skipping meals, eating frequent small meals, and keeping food diaries. More than two-thirds reported that they were combining modified diets with exercise to lose weight. Additionally, Heaton found that there were an alarming number of women attempting to lose weight who, based on height/weight ratios, did not appear to be overweight.

Significantly, the Weight Watchers survey asked dieters for the attributes they look for in a weight loss program. The top five attributes were (1) keeping weight off, (2) providing safe and healthy weight loss, (3) inexpensive costs, (4) good value, and (5) ease of following the program.

There has got to be education on what are appropriate goals in getting people to understand that there are biological roots, social/cultural roots, and behavioral roots to the problem [of controlling overweight]. [Consumers need to understand] that it takes concerted effort to change eating and exercise behavior in the face of those biological and environmental/ cultural pressures. It requires a considerable amount of discipline, and that is a word that Americans do not like to hear. Remarks of David Schlundt, Ph. D., Vanderbilt University

The panel reached general agreement that there is a need for educating consumers away from reliance on losing all of one's excess weight to more realistic goals of partial weight reduction and the considerable health benefits that ensue. The importance of reducing risk factors of obesity and overweight need to be emphasized over appearance. Some panelists (Schlundt and Pappas) stressed the need for placing more emphasis on increasing physical activity both in consumer education materials and in weight loss program content, especially in view of the lost opportunities for incidental physical exercise in an environment structured around convenience, ease and time conservation. The need to change attitudes about overweight/obese people and the discrimination they perceive as motivating them to attempt weight loss was also emphasized (McAfee). It was also suggested (Downey) that overweight/obesity is the only chronic disease where measures of treatment success were set so high as to be unattainable, and that more modest measures along the paradigm of stroke rehabilitation should be considered.

Consumer panelists (Farzan, Byrne, Golodner) agreed that redirecting consumer motivation is an important goal, but argued that, because of the difficulty and uncertainty of success in achieving it, getting commercial weight loss centers to disclose outcome measures in terms of weight loss and weight loss maintenance must be the paramount goal. There was also discussion (Cleland, Byrne) of whether all segments of the weight-loss industry (programs, products, medical providers) should be subject to disclosure requirements.

Finally, assuming agreement as to disclosures that should be made, the panel took up means for creating incentives for voluntary adoption of disclosure standards. Using consumer organizations to disseminate "report cards" on what organizations were complying was suggested (Weinsier) and received some support.

B. Weight Loss Products and Services Providers -- Responding to Consumer Needs ("The Provider Panel")(12)

With some sort of collaborative effort with the medical community and government agencies, it is possible to leverage [the marketing advantages of the commercial weight loss industry] to make a difference. Whether we consider weight loss a business challenge, an educational issue, a marketing challenge, or a medical problem, it is clear that we are failing. . . . In this collaborative effort what we should be striving for is to somehow simplify the information, to create a common language for consumers, to standardize our practices, to standardize our methods of evaluation, and to work together to try to address the problem. . . . What we perhaps need to do is teach people that weight loss isn't hard; it's different. And we need to start with simple basic values and simple tenets that make the language easier for people to understand. Comments of Gail Montgomery, President of Diet Workshop, Inc. before the consumer panel.

Providers represented on the panel generally agreed that certain basic information concerning costs, credentials and risks should be routinely provided to consumers prior to sale. Outcome information (weight loss and maintenance success) was generally considered to be more problematic, but some provider panelists supported better information in that area as well.

1. Outcome Information

a. Barriers to Disclosure

The panel cited several barriers to providing consumers with weight loss and weight maintenance statistics. Cost was a primary deterrent, but concern about delivering a potentially negative message to dieters about their ultimate success was also mentioned. Barriers to providing outcome information included the following:

  • Collecting the data, particularly maintenance data, is difficult and expensive.
  • Inasmuch as long-term outcome results are likely to be poor, disclosing those results may discourage persons from attempting to lose weight.
  • The definition of "successful weight loss" is unresolved.
  • There is a need for a "level playing field" so that all products and programs are subject to the same guidance.

Not all providers agreed that the cost and difficulty of accumulating data to support disclosures about weight loss outcomes are insurmountable barriers. Some representatives (Stifler, Drawert) of programs that already routinely collect and disseminate data argued that it was good business. Other representatives of commercial programs, however, (Montgomery, Klausman) maintained that their portion of the weight loss market was shrinking significantly and that data accumulation was unsupportable in businesses that operated on small margins of profit. Calling the undertaking difficult rather than impossible, they suggested that data should be accumulated cooperatively and disseminated about programs generically rather than on a program specific basis.

b. Consumer Information Needs, Experiences and Expectations

Some members of the provider panel questioned the importance and usefulness of outcome data by objecting that consumers either did not need the data or that they would ignore it. The provider panel heard often contradictory messages about the typical dieter, such as:

  • All the dieter cares about is the quick fix or the magic bullet.
  • The typical dieter is experienced and wary, knowing by experience what works and what does not.
  • The typical dieter has grown cynical and does not believe the information that is provided.
  • Dieters will be discouraged if they are provided with realistic outcome data.
  • Dieters are motivated to do better when outcome results are periodically provided them.
  • Many dieters are successful in losing weight and keeping it off.

We need to remember that many people are successful with weight loss. Recently, a large study was published from the National Weight Control Registry of hundreds of people that have maintained weight successfully for a period of many years. These people consistently cite changes and commitment to diet and exercise as their keys to weight maintenance. As clinicians and as providers of therapy, everything that we can do to ... [get] people to follow diets [and to stick with exercise] is really the key. Remarks of Sue Drawert, M. Ed., R.D., Manager of Sales and Marketing, Novartis Nutrition.

Panelists disagreed about the usefulness of emphasizing smaller amounts of weight loss providing significant health benefits. At least one (Miller-Kovach) took the position that such a message was negative and would discourage consumers from attempting to lose weight. Panelists (Miller-Kovach, Montgomery) argued instead for positive and reinforcing messages that did not serve to dispel "the dream" that significant weight reduction was possible. Others (Stifler) agreed with Dr. Wadden who suggested that the message of the health benefits to be derived from losing only small amounts of weight is a positive one.

You can get people to change their lifestyle health habits easier -- from a learning perspective -- if you focus upon health and not just weight. Someone who exercises more and changes their diet and sees that their cancer risk has gone down and that their medical risk factors have come down can be reinforced by that even if they have only lost 25 pounds or 15 pounds instead of 60 pounds. So an emphasis on health management is not just good for health in America, it also helps people get a better understanding of why they entered the program. Remarks of Lawrence Stifler, Ph.D., President, Health Management Resources, Inc.

One panelist (Miller-Kovach) advocated disclosures only if reliable evidence demonstrated their utility to consumers.

I.Information that "consumers need to know" must be developed based on an understanding of the current behavior and attitudes of the dieters in the U.S. so that they will be meaningful to the consumer. Furthermore, it must be understood that the typical dieter in America is an experienced dieter who has tried different methods. Dieters are, therefore, very knowledgeable about the programs and services that have been available to them over the last decade.

II.Decisions on what information "the consumer needs" cannot be based upon opinion. They must be based on evidence that this information has proven to be a pivotal determinant in helping people make better choices in weight loss products and services.

III.A consensus must take into account the diversity of products and services in the weight loss industry. The scope of information required must be tailored to the type of intervention under consideration and the routine business practices of the company or the manufacturer. The New York City legislation requiring appropriate disclosures for weight loss centers . . . could serve as a model.

From written statement of Weight Watchers International, Inc. prepared for presentation at the conference.

2. Other Disclosures

The content and format of some of the less controversial informational disclosures was also debated. Disclosure of total costs, for example, raised several issues concerning how such costs should be disclosed. The total cost of a program depends upon several variables including initial fees, mandatory food purchases (in some programs), weekly visits, weight-loss goals and consumer willingness to complete a program. Given these factors, it was suggested (Wadden) that cost data could be given out as initial visit cost, weekly costs and average total cost. Similarly, while no one objected to disclosure of the credentials and experience of program staff who work with clients, the significance of advanced degrees and the meaning of certification and registration was raised as potentially misleading to consumers unaware of the meaning of such credentials. Dr. Wadden also expressed the concern that emphasis on credentials, specialization, and advanced degrees should not supplant experience as an indicator of competence of staff to work with typical clients having no special needs for monitoring or guidance.

Despite disagreement as to the utility of performance data and the ease of collecting it, panelists expressed no difficulty with providing information about costs, staff credentials and risks. They subscribed to the concept proposed by Dr. Weinsier of convening a working group organized under the aegis of the Federal Trade Commission and comprised of representatives of the weight loss industry, academia, government agencies and consumer groups to adopt standards or guidelines for the voluntary disclosure of such information. As to performance data (retention rates, average weight loss, short and long-term maintenance) the panel agreed that the working group should consider issues concerning core data that consumers need, methods for collecting it and formats for disseminating it.

C. The State-of-the-Art. What Do We Know About Various Types of Weight Loss? ("The Science Panel")(13)

The goal of the federal “Healthy People 2000“ project is to reduce by the year 2000 the proportion of the population that is overweight. The message needs to be: reduce the health consequences of obesity by increasing fitness. To that end, we need to refocus consumers, many of whom go to diet programs to improve their appearance. In addition, we need to encourage the increased use of databases and interactions between diet program providers and researchers, for the mutual benefit of all and the advancement of science. Introductory Remarks of Van S. Hubbard, M.D., Ph.D., NIDDK, Moderator

Science panelists offered data on and discussed several issues concerning the state-of-the- art of diet research. The primary issues addressed included what consumers reasonably can expect to achieve from various types of weight loss regimens and how those outcomes compare with consumer expectations; the risks that consumers need to know about these regimens, including the risks of rapid weight loss and who should be treated with drug therapy; and what information, in light of the state-of-the-science, is essential to consumers initiating weight loss regimens.

1. Lessons Learned from the Fen/phen Experience

"...when properly prescribed and used, appetite suppressant medications can be an extremely beneficial adjunct in the treatment of patients with obesity. On the other hand, these same medications have been shown to be a convenient and highly profitable product for entrepreneurs wishing to cash in on a vulnerable group of consumers. The most disturbing aspect of this unintended use of medications is that individuals who should not have been prescribed drugs in the first place, may have been harmed. Equally distressing, however, is the possibility that seriously overweight patients who may benefit from adjunctive medication may be deprived of an effective therapy...

" Prepared Remarks of Robert Kushner, M.D., Pritzker School of Medicine, University of Chicago

Dr. Kushner provided the following, more complete evaluation of the phen-fen (phentermine/fenfluramine) experience, which culminated in the voluntary withdrawal from the market of fenfluramine and dexfenfluramine. Although diet drugs have been available for over 35 years, it is only within the past 5 years that their use has been generally accepted among the medical community. This shift in acceptance came about in accordance with a changing view of overweight/obesity. No longer thought to be a weakness of willpower or a character flaw, overweight/obesity is now viewed as a chronic disease due to genetic, biological, behavioral and psychosocial factors. Pharmacotherapy and surgery have both been shown to benefit patients who are unresponsive to lifestyle counseling alone. For many patients with a life long history of overweight/obesity complicated by several co-morbid conditions (e.g., hypertension, diabetes, heart disease) appetite suppressants have allowed them to gain control of their dietary intake and body weight for the first time in their lives. Although follow-up has been limited to only about 3 years, the achievement, on average, of a 10% to 15% weight loss is associated with a concomitant improvement in medical co-morbidities.

If overweight/obesity were like any other disease, such as diabetes or hypertension, physicians would prescribe a medication only to their own patients, taking into account the potential risks and benefits as they pertain to that specific individual. Moreover, the patient would be reluctant to take a prescription from another clinician, one who may not be aware of his/her personal background and medical problems. If this were the case, diet drug usage would be well controlled and monitored. But overweight/obesity is not like any other disease, said Dr. Kushner. The drive to thinness is fueling a $33 billion weight loss industry. Out of desperation, the public turns to any and all quick-fix weight reduction promotions.

According to Dr. Kushner, many physicians established overnight diet-pill clinics, and attracted a vulnerable public into their offices with advertisements exclaiming medical breakthroughs with quick, safe and permanent results. In addition, commercial weight loss programs entered into the medical prescriptive market. Through medical consultant employees, the programs prescribed diet drugs in the program center.

Dr. Kushner concluded that there is a role for pharmacotherapy in the treatment of patients with obesity, stating that, if anorexiant medications were prescribed selectively and appropriately by the patients' physician, as is done with any other disease, there would be very little misuse of these drugs. Unfortunately, Dr. Kushner continued, a vulnerable public is easy prey to opportunists who make unsubstantiated claims. In light of the fen/phen experience, Dr. Kushner concluded that we have a unique opportunity and responsibility to ensure that new anti- obesity drugs are not misused or falsely advertised.

Dr. Richard L. Atkinson, Professor of Medicine and Nutritional Sciences, University of Wisconsin, added his view that new diet drugs, such as sibutramine and orlistat, and other claimed appetite suppressant combinations, such as ephedra and St. John’s Wort, are coming to the fore without the benefit of long-term data, and with safety concerns. Dr. Atkinson suggested that clinical, controlled studies for these preparations, and physician/program restraint in prescribing them, are necessary to avoid the problems associated with the fen/phen experience.

Ida Laquatra, Ph.D., representing Shape Up America, concurred that appetite suppressant medications can be helpful in the management of weight control, but opined that consumers have been receiving the wrong message about their use and limitations.

2. The Surgical Treatment of Obesity: Results of Studies

Dr. Walter Pories, Professor of Surgery and Biochemistry, School of Medicine, East Carolina University, presented the results of long-term, clinical studies of surgical(14) patients. He reported that post-surgery follow-up of morbidly obese patients (those patients with a BMI over 40, or patients with a BMI over 35 with co-morbidities) revealed an average weight loss of 100 pounds after 14 years. Those same patients experienced a significant reduction in co- morbidity factors, particularly type II diabetes. In light of these results, panelists agreed that, for future research purposes, post-surgical follow-up may be the best method to study the effects of long-term weight-loss maintenance on mortality.

3. The Risks of Rapid Weight Loss

Dr. Roland Weinsier, M.D., Dr. P.H., Department of Nutritional Sciences, University of Alabama-Birmingham, presented a summary of the scientific knowledge on the health risks of rapid weight loss. Dr. Weinsier stated that, although rapid weight loss is widely advertised, significant health complications can result. Specifically, he presented data that rapid weight loss of three pounds per week can cause the rapid development of gallbladder disease, particularly the formation of gallstones, within four weeks. The formation of gallstones occurs exponentially after the rate of weight loss reaches three pounds per week. The risk of developing gallstones, Dr. Weinsier concluded, is 15 to 25 times higher in patients experiencing rapid weight loss than in the general obese population.

4. Moderate Weight Loss: The Realities of Weight Loss Do Not Match Dieters’ Expectations

A sea change has occurred in the scientific thinking about weight loss -- from reaching "ideal weight" to a modest, 5-15% reduction in weight. Modest weight reduction improves co- morbid conditions. The typical patient can lose 10-15% [of total weight], and that is success, not failure. We have to help [consumers] modify their expectations [about success]. The message is that therapeutic weight loss is a success. The message is that there are significant health benefits of modest weight reduction and increased physical activity.

Remarks of Thomas A. Wadden, Ph.D., University of Pennsylvania School of Medicine.

Dr. Wadden presented the results of various studies, indicating that the best results that science can achieve for dieters are modest (and contrary to consumers’ expectations), but produce significant health benefits. Research to date supports the conclusion that scientifically- supported diet regimens can produce weight loss of 9-13% of total body weight at 52-72 weeks, and that programs aided by pharmacotherapy can result, at most, in a 10-15% weight loss, even over the long-term. Although these results for the typical diet patient are modest, Dr. Wadden concluded that weight loss of 10-15% of body weight represents success, not failure, because research indicates that such modest weight loss significantly reduces co-morbidities. The question Dr. Wadden then posed is "what do consumers think about this?"

Dr. Wadden presented the results of a consumer perception study to answer this inquiry. In the study, consumers averaging 220 pounds were asked, prior to losing any weight, what they would consider to be an acceptable level of weight loss. The results were as follows: respondents "dream weight" was 135 pounds, a 38% reduction. Respondents would be "happy" with a 32% reduction, would "accept" a 25% reduction, and would be "disappointed" with a 17% reduction. According to Dr. Wadden, 67% of dieters under this study would be "disappointed," or worse, with the 10-15% reduction achievable under the current state-of-the-art program.

In light of this evidence that dieters’ expectations about weight loss do not match the realities of obtainable results, Dr. Wadden suggested that researchers and others need to help dieters modify their expectations. Modest, therapeutic weight loss is a success because it has health benefits, and, if so characterized, would ease existing consumer pressure on the weight loss industry to offer unrealistic goals. Dr. Wadden concluded that the message we need to give prospective dieters is that sustained, modest weight reduction has significant health benefits, and, coupled with increased physical activity, improves health and well being. Other panelists strongly concurred with Dr. Wadden’s proposed consumer education message.

Panelists representing Weight Watchers and Slim Fast Foods Company provided data relating to their companies’ programs that tended to confirm the benefits of moderate weight loss. Dr. Myron Winnick, M.D., medical consultant to Weight Watchers International, presented data that lifetime members of Weight Watchers have a greater than 50% chance of maintaining modest weight loss for two years, and a greater than 30% chance of maintaining that loss for five years. Similarly, Dr. Harry Greene, Medical Officer, Slim-Fast Foods Company, presented the results of a study of a portion-controlled meal-replacement program conducted in Germany. Of the 63% of patients completing the two-year maintenance program, patients on the meal-replacement program maintained an average weight loss of 10% of their original body weight. Patients on the low-fat diet program maintained an average 5% weight-loss. For both groups, patients who sustained weight loss of 5-10% of initial body weight showed reductions in disease-associated biomarkers.

Also concurring with Dr. Wadden’s analysis, Rebecca Reeves, Dr. P.H., R.D., Assistant Professor, Baylor College of Medicine, representing the American Dietetic Association, suggested that the 70,000 food and nutrition professionals -- registered dieticians -- need to refocus overweight/obesity treatment to emphasize "weight management for best achievable health, and sustainable and enjoyable lifestyle changes." This change will require continuous contact and follow-up between nutrition professionals and patients, said Dr. Reeves.

Peter Vash, M.D., a bariatric physician in private practice, agreed that dieters’ demand for the "magic pill" eclipses the reality of achievable weight reduction, and that a refocusing of priorities is necessary. To that end, Dr. Vash suggested an action plan consisting of a public health campaign geared to adolescents, strict accountability for advertising claims and the collection of industry data, school program incentives, increased research, and the creation and use of economic incentives.

Dr. Weinsier summarized the panel’s consensus that the message to dieters needs to be refocused to emphasize health and fitness, and that a sustained, 5-10% loss of body weight produces significant benefits. To get this redefined message out to consumers, all those with responsibilities in the weight-loss arena need to partner with diet program providers in changing the definition of success.

D. Government’s Role in the Weight Loss Marketplace ("The Government Panel")(15)

Panelists from CDC, NIDDK, FDA, FTC, and the offices of the Attorneys General of Connecticut and Texas provided descriptions of their varied responsibilities in the weight loss marketplace. Presentations from representatives from each of these agencies outlined recent developments. In addition, George L. Blackburn, M.D., described the activities of the Massachusetts Medical Society, Committee on Nutrition, in developing guidelines for the prescription of weight loss drugs by physicians in that state.

According to Dr. Yanovski, the moderator of the government panel, the role of the government in the weight loss marketplace is as diverse as the government itself. For example, the Centers for Disease Control and Prevention (CDC) charts the prevalence of overweight/obesity while the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) promotes and funds research in its treatment and prevention. The U.S. Food and Drug Administration (FDA) regulates the labeling of prescription and over-the-counter weight loss drugs and approves new drugs. Finally, the Federal Trade Commission (FTC) and the state attorneys general combat misleading advertising claims for weight loss products and programs.

This particular conference is operating on the premise that a better informed consumer is more likely to be successful in combating overweight/obesity. Thus, determining how to promote better information should be the ultimate goal. This dialogue, then, should serve to concentrate our focus on how we can work cooperatively both inside and outside the government to improve the message that consumers receive about overweight/obesity and the quality of the information they rely upon to fight it. Statement of Susan Yanovski, M.D., National Institute of Diabetes and Digestive and Kidney Diseases, NIH.

In the face of the increasing prevalence of overweight and obesity, Dr. Yanovski challenged the various government agencies to assess their roles and consider how they might better work together to address this serious national epidemic. In particular, the agencies were urged to focus on how they can work cooperatively to develop a more effective message for consumers about overweight/obesity and its risks.

1. Centers for Disease Control and Prevention Tracks the Prevalence of Overweight/Obesity through the NHANES Survey

Dr. Khan, representing the CDC, emphasized the dual roles of her agency: to chart the prevalence of various diseases and to educate the public in combating them. Hence, CDC periodically accumulates data through such methods as the National Health and Nutrition Examination Survey (NHANES) and the Behavioral Risk Factors Surveillance System (BRFSS) and then disseminates resulting data and its implications to the public. The CDC is interested in effectively communicating to consumers the need for preventive measures to combat disease and welcomes the proposed initiatives of the conference to focus on means for educating consumers about the dangers of overweight/obesity and how to best reduce the risk factors associated with it.

2. National Institute of Diabetes and Digestive and Kidney Diseases Promotes and Funds Research in the Treatment of Overweight/Obesity

Dr. Yanovski, speaking for NIDDK, described the mission of her Institute in reviewing research proposals and approving them for funding. She indicated that there was a need to fund more research in overweight and obesity related studies. Dr. Yanovski also described the considerable consumer education incentive of NIDDK through the "WIN" (Weight-Control Information Network) program. WIN is a national source of information on weight control, overweight/obesity, and weight-related nutritional disorders for health professionals and the public. One program that WIN has sponsored, "Sisters Together: Move More, Eat Better," is a community-based program to encourage African-American women to maintain their weight through healthful eating and increased physical activity.

3. U.S. Food and Drug Administration Approves New Drug Applications and Regulates the Labeling of Over-the-Counter and Prescription Drugs.

a. Memorandum of Understanding with FTC

The FDA and the FTC share statutory authority over the promotion and advertising of drugs and supplements. Under a memorandum of understanding between the two agencies, the FDA has primary jurisdiction over prescription drug advertising by manufacturers or on behalf of manufacturers as well as jurisdiction over drug labeling. Prescription drug manufacturers may only promote uses for which the drug has received FDA approval. Promotional materials must not be false, deceptive or lacking in fair balance. The FTC has primary jurisdiction over advertising for over-the-counter drugs. The memorandum of understanding does not address secondary advertising of prescription drugs, e.g., advertising by professional health care providers of the availability of prescriptions for the drugs. FDA jurisdiction over such providers advertising unapproved uses for the drug is particularly problematic.

b. Authority over Dietary Supplements

The recently enacted Dietary Supplement Health and Education Act has changed significantly the way the FDA treats the labeling and advertising of dietary supplements. Unless such supplements are promoted as cures or treatments for diseases or symptoms, the FDA must carry the burden of demonstrating that such products are unsafe or ineffective before it can remove the product from the market.

4. Federal Trade Commission Addresses Deceptive and Misleading Advertising of Weight Loss Products and Programs

The Federal Trade Commission regulates the advertising of weight loss products and programs, including dietary supplements for weight loss under Section 5 of the Federal Trade Commission Act. The FTC has filed more than 150 cases against such products and programs since 1927, and 75 of these have been filed since 1990. Most of these cases were filed administratively, but in nearly a dozen of them, the agency sued directly in federal district court to obtain injunctions and monetary redress.

Issues that the FTC addressed in the program cases of the early 1990s included misleading use of consumer testimonials, deceptive claims about costs and credentials of program staff, misleading comparisons of programs, and failure to substantiate success claims for weight loss or weight loss maintenance. Consent orders entered in those cases include remedies that require substantiation for weight loss or weight maintenance claims, disclosures triggered by maintenance claims ("For many dieters, weight loss is temporary"), disclosure of total costs, and prohibitions against misrepresenting staff credentials. As a result of monitoring compliance with the consent orders, the agency is seeing in general that companies are avoiding broad-based maintenance claims, and where maintenance claims are made, they are narrowly focused on discrete subgroups of dieters. Also companies appear to be making the order-required disclaimers that are intended to limit the applicability of testimonials. The agency continues to work with companies to assure that such disclaimers are featured in a clear and prominent manner.

5. State Attorneys General Address Fraudulent Weight Loss Products and Services.

The offices of the state attorneys general have played a prominent role in pursuing advertisers and promoters of fraudulent pills, nostrums and devices -- the bottom-feeders of the weight-loss industry -- as well as more mainstream companies. According to Robert Reyna, Assistant AG for the State of Texas, states review diet ads under both their false and deceptive practices statutes as well as state food and drug laws. In addition, some states, such as Texas, have statutes that apply to advertising by medical professionals and prohibit false advertising and advertising for unsubstantiated treatments. The AGs have established a multi-state task force on health care fraud, and a major interest of this group is diet products. Mr. Reyna sees advertising of bogus weight-loss products and devices aimed at minorities as a particularly troublesome aspect of the problem.

The state of Connecticut has adopted one of the few mandatory disclosure laws on the books for weight loss programs.(16) Megan O’Neil, Assistant AG for Connecticut, explained its application. To date, no actions have been brought under the disclosure law, but two matters are currently under investigation. No data has been developed that would measure the impact of the disclosure law -- whether it has improved consumer understanding and motivation or whether it has resulted in reducing overweight/obesity levels.

6. Interagency Cooperation

There was general agreement about the need for a coordinated interagency effort that incorporates outside participation to develop plans of action for information disclosures as well as consumer education about overweight, obesity and weight loss alternatives. Two problems that were raised as obstacles to success for these initiatives were consumer distrust of messages received from both providers and the government and the difficulty of assuring a level playing field, particularly with regard to the treatment of dietary supplements promoted for weight-loss.

IV. Models for the Disclosure of Consumer Information on Weight Loss Programs(17)

The following summaries represent disclosure models, either in place or recommended, for providing information to prospective clients/patients of weight loss programs. Two states (Michigan and Connecticut) and at least one municipality (New York City) have adopted standards for information disclosure. Additionally, the FTC (through triggered disclosures in individual case-generated consent orders) has defined information consumers should know about weight loss methods in order to understand certain efficacy and success claims. The Association of Bariatric Physicians has issued practice guidelines for its membership that include guidance for information that patients should receive. Both NIH and the Institute of Medicine have identified information that providers should disclose about their programs. Finally, the Center for Science in the Public Interest, in its petition for rulemaking filed before the FTC, has set out a detailed disclosure model.

Most models require affirmative disclosures of costs, health risks and staff credentials untriggered by specific claims or the need for consumers’ first to request the information. The exceptions is the New York City Consumer Bill of Rights where, except for an affirmatively disclosed warning about the risk of rapid weight loss, the consumer is informed of his/her right to receive certain information upon request. The Federal Trade Commission orders require outcome disclosures only when triggered by express or implied success or efficacy claims. The Connecticut statute is based in part upon the FTC model, requiring triggered outcome disclosures but also requiring that the diet program contract affirmatively disclose information about costs, staffing and program duration. The only in-place model that calls for any sort of untriggered outcome data disclosure is Michigan’s that requires that consumers receive, through informed consent, information about the likely long term success of the program.

Full Disclosure Through Informed Consent

  • potential physical and psychological risks from weight loss and regain
  • likely long-term success of program
  • full costs
  • credentials of weight loss care providers

"Consumer Bill of Rights"

  • must be posted
  • consumers also get palm sized copy
  • all costs and program duration disclosed
  • warning about rapid weight loss
  • only permanent lifestyle changes = long term weight maintenance
  • staff qualifications available
  • client has right to:
    • ask about health risks, nutritional content, psychological support, educational components
    • know price of treatment plus additional costs
    • know recommended program duration New York City Department Of Consumer Affairs

Claims:

  • Safety claim for <1000 kcal okay only for programs with physician monitoring
  • cannot misrepresent likelihood of weight regain
  • success claims for weight loss or maintenance must be representative of clients using program for > 2 weeks
  • permanent weight loss claim must be based on data for a reasonable time period
  • testimonials must also disclose:
    • percent of weight loss by representative sample
    • average duration of maintenance
    • disclaimer: "For many dieters weight loss is temporary"

State of Connecticut
Bill of Rights (in Contracts):

  • three day cooling-off period
  • time needed to lose desired weight loss
  • costs of program
  • staff credentials
  • relocation or letter from physician = right to cancel and pro-rata refund

Case-by-Case Approach: Deceptive Advertising

Any statements made about "success" of participants of any weight loss program in achieving or maintaining weight loss or weight control must be based upon data that are representative of either all participants or a clearly-defined subset of participants.

Example

"Participants maintain an average of 60% of weight lost 22 months after active weight loss (includes 18 mos. on maintenance program). For many dieters, weight loss is temporary."

Federal Trade Commission
National Institutes of Health Technology Assessment Conference

Weight Loss Programs Should Provide:

  • safe diet that includes RDAs (vitamins, minerals, protein)
  • slow and steady weight loss unless rapid weight loss medically indicated
  • health status evaluated by physician
  • costs including fees and additional items
  • percent of all participants who complete program
  • percent of completers reaching various degrees of weight loss
  • proportion of weight loss maintained at 1, 3 and 5 years
  • percent of dieters who experienced adverse medical or psychological consequences

Weighing the Options (1995)

"Any weight management program has a responsibility to provide truthful and unambiguous information that is not misleading or subject to misinterpretation. This includes a written (and for non-clinical and clinical programs, oral) description of the risks and benefits of treatments and the opportunity to ask questions. . .. Information should include. . ."

  • "success" redefined
  • approaches and goals
  • credentials of staff
  • client population and 9 month results
  • costs
  • recommended procedures

Data that Programs Should Collect:

  • potential and actual participants (first meeting)
  • participants beginning program (1st two meetings)
  • those in program after 1, 3, 6, 12 months
  • weight, height, BMI, WHR at 1, 3, 6, 12 months
  • percent of clients completing each treatment stage
  • percent of clients who re-enroll

Institute of Medicine
Mandatory Disclosure:

  • total cost
  • duration based upon evaluation of client
  • staff credentials -- education and training
  • program effectiveness

- weight loss and maintenance after 1 and 2 years

  • permanent lifestyle changes
  • plans for maintenance
  • safety
  • rapid weight loss
  • when to consult physician
  • exclusions

Center for Science in the Public Interest

V. Areas Where Research is Needed

Through the medium of an open forum, panelists and attendees identified several areas where research is needed and discussed means of funding such research. Topics for further research fell into one of two areas: (1) consumer motivation and understanding, and (2) overweight/obesity treatment modalities, their safety and effectiveness.

A. Consumer Behavior Research

  • What messages about weight loss do consumers respond to?
  • Why do many overweight/obese consumers continue to make poor treatment choices?
  • What has been the impact on consumer choice by various state information models in place? Do dieters in those jurisdictions do better in terms of achieving weight loss and weight loss maintenance?
  • What is the most effective means to convey the message that 5-10 percent weight loss is realistic and will result in significant reduction in several critical risk factors?
  • How does discrimination against obese persons influence their weight loss choices and decisions? How can discrimination best be addressed.

B. Weight Loss Efficacy Research

  • How does long-term weight loss affect quality of life issues such as job retention, self-care, etc.?
  • Does sustained weight loss increase (improve) longevity? What is the appropriate treatment intervention to measure this?
  • How safe and effective are various drug combinations, herbal supplements, herb and drug combinations?
  • To what extent has free-living (incidental) physical activity diminished in the workplace and the home, and how has this affected overweight/obesity levels, ability to lose weight and keep it off?
  • How should weight loss outcomes be interpreted?
  • Does the increase in overweight/obesity in particular subsets of the general population result in a corresponding increases in the level of co-morbidities associated with overweight/obesity?
  • What are the factors that produce relapse in obese patients who have lost weight?

VI. Plan of Action -- Where Do We Go From Here?

The final session consisted of a round table discussion by all panelists and attendees. During this session, conference participants reached general agreement to a follow-up plan of action along the following lines:

A. Voluntary Disclosures: Within three months, complete work on the development of voluntary disclosure guidelines covering total program costs, staff credentials, and health risks and side effects, and explore the feasibility of additional voluntary industry guidelines or standards for providing certain core information (to be defined by the coalition) to consumers about outcomes of weight loss products, programs and treatments.(18)

B. Consumer Education: Convene a broad based coalition of scientists, academicians, providers, consumer advocates, and other interested parties to work with the FTC, FDA, NIH, and CDC to plan and develop a coordinated consumer education program stressing:

  1. The significant health benefits of modest weight loss (5%-10% of total weight);
  2. The options available to dieters and what they can expect to achieve from, and the risks associated with, various forms of weight loss;
  3. That consumers should expect weight loss programs to provide them with the information necessary to evaluate the program, including, at a minimum, total program costs, staff credentials and associated risks and side effects (as coordinated with the coalition to develop information disclosure standards); and
  4. That there are no magic bullets. Weight loss requires a lifetime commitment to modified diet and increased physical activity.

C. Research: Continue discussions to:

  1. Identify new areas of research in consumer motivation and response and weight loss outcomes and risks, and
  2. Explore sources for funding such research.

    The National Institutes of Health
    (for Obesity Information)

    SHAPE UP AMERICA!

    www.consumer.gov

Endnotes:

(1)For purposes of the NHANES survey, “overweight” is defined as equal to or greater than a BMI of 27.3 for women and 27.8 for men. BMI, or “body mass index” is determined by dividing weight in kilograms by height in meters squared (BMI = kg/m2) (2.2 lbs. = 1 kg.; 39.6 ins. = 1 m). The cut points for “obesity” are not as clearly delineated; however, most authorities use a BMI of 30 to define where obesity begins.

(2)As previously noted (see n. 1, supra), these prevalence figures are based upon defining overweight as exceeding BMI 27 (approximately). New evidence on the risks of overweight is causing scientists to recommend lowering the cut point where overweight begins to BMI 25. Such a reduction would result in classifying approximately half of the U.S. population as overweight.

(3)In type II (insulin-independent) diabetes, which usually affects persons over 40, the pancreas produces insulin, but the amount produced is inadequate to regulate blood sugar levels.

(4)This figure represents consumer dollars spent on all efforts at weight loss or weight maintenance including low calorie foods, artificially sweetened products, as well as books and other publications on dieting. Current dollars spent on weight loss programs were estimated by various conference panelists to range from one to two billion dollars annually.

(5)The FTC’s involvement with deceptive advertising is longstanding. Over the years, the Commission has brought 150 such cases against purveyors of diet pills, potions, and devices, and against commercial diet clinics.

(6)See nn. 1 and 2, supra.

(7)Trade regulation rules, authorized by Section 18 of the Federal Trade Commission Act (15 U.S.C. § 58), are generally applicable to defined unfair or deceptive practices prevalent throughout a particular industry. Violations of trade regulation rules are punishable by civil penalties of up to $11,000 per violation.

(8)It has been estimated that 10 million Americans used fen/phen, and that prescriptions for both drugs totaled some 18 million in 1996 (Boston Globe, May 6. 1997). Fen/phen sales reached $400 million in 1996 (Wall Street Journal, March 31, 1997).

(9) “Diet-Drug Mystery Grows as New Data Emerge,” Wall Street Journal, October 31, 1997.

(10)See Appendix A for biographical sketches of panelists.

(11)Moderator: Thomas A. Wadden, Ph.D.; Panelists: Leslie Byrne, Director, U.S. Office of Consumer Affairs; Morgan Downey, J.D., Executive Director, American Obesity Association; Leila Farzan, J.D., Center for Science in the Public Interest; Linda Golodner, President, National Consumers League; Alan Heaton, Ph.D., Division of Market Studies, U. S. Food and Drug Administration; Idamarie Laquatra, Ph.D., Shape Up America; Lynn McAfee, Council on Size and Weight Discrimination; Nancy Pappas, Consumers Union; David Schlundt, Ph.D., Associate Professor, Psychology, Vanderbilt University; Megan O’Neill, J.D., Assistant Attorney General, State of Connecticut; Gail Montgomery, President, Diet Workshop, Inc.

(12)Moderator: Roland Weinsier, M.D., Dr. P.H.; Panelists: Denise Bruner, M.D., American Society of Bariatric Physicians; Sue Drawert, M.Ed., R.D., Manager, Sales and Marketing, Novartis Nutrition; Harry Green, M.D., Medical Officer, Slim Fast Foods Co.; C. William Klansman, Senior Vice President, General Counsel and Secretary, Diet Center Worldwide, Inc.; Karen Miller-Kovach, MBA, MS, RD, Weight Watchers International, Inc.; Gail Montgomery, President, Diet Workshop, Inc.; Lawrence Stifler, Ph.D., President, Health Management Resources, Inc.; Robert Reyna, Assistant Attorney General, State of Texas; Nancy Pappas, Consumers Union.

(13) Moderator: Van S. Hubbard, M.D., Ph.D., NIDDK. Panelists: Richard L. Atkinson, M.D., Professor of Medicine and Nutritional Sciences, University of Wisconsin; Robert Kushner, M.D., Associate Professor of Clinical Medicine, Pritzker School of Medicine, University of Chicago; Walter Pories, M.D., Professor of Surgery and Biochemistry, School of Medicine, East Carolina University; Rebecca Reeves, Dr. P.H., R.D., Assistant Professor, Baylor College of Medicine, American Dietetic Association; Peter Vash, M.D., private practice; Idamarie Laquatra, Ph.D., Shape Up America; Myron Winnick, M.D., Weight Watchers International; Thomas A. Wadden, Ph.D., University of Pennsylvania, School of Medicine; Roland Weinsier, M.D., Dr. P.H., Department of Nutritional Sciences, University of Alabama-Birmingham.

(14)The two principal surgical procedures are vertical banded gastroplasty and Roux- en-Y gastric by-pass.

(15)Moderator: Susan Yanovski, M.D., NIDDK. Panelists: A. Joel Aronson, Team Leader, Non-Traditional Drug Team, U.S. Food and Drug Administration; George L. Blackburn, M.D., Ph.D., President, American Society for Clinical Nutrition, Chairman, Massachusetts Medical Society Committee on Nutrition; Justin Dingfelder, J.D., Assistant Director, Division of Enforcement, Federal Trade Commission; Norman Drezin, J.D., Deputy Director, Division of Drug Marketing, Advertising and Communications, U.S. Food and Drug Administration; Richard Kelly, J.D., Division of Advertising Practices, Federal Trade Commission,; Laura Koss, J.D., Division of Enforcement, Federal Trade Commission; Robert Moore, Senior Regulatory Scientist, Office of Special Nutrition, U.S. Food and Drug Administration; Megan O’Neill, J.D., Assistant A.G., Office of the Attorney General, Connecticut; Russ Porter, Ph.D., Bureau of Economics, Federal Trade Commission,; Robert Reyna, J.D., Office of the Attorney General, Texas; Laura Kettel Khan, Ph.D. (CDC); Richard Cleland, J.D. (FTC); Leila Farzan, Center for Science in the Public Interest; C. William Klausman, Diet Center Worldwide, Inc., Physicians Weight Loss Centers of America, Inc, Form You 3, Inc.

(16)See the next section for a summary of the requirements of Connecticut’s disclosure law.

(17) Based upon a presentation by Judith S. Stern, Sc. D.

(18)On December 16, 1997, conference attendees and panelists who had expressed an interest in working on disclosure issues, met at the Federal Trade Commission in Washington, D.C. The coalition produced a set of tentative voluntary disclosure principles regarding costs, risks and program staff credentials which is being drafted into a document for further review.