Voluntary Guidelines for Providers of
Weight Loss Products or Services
The Partnership for Healthy Weight Management
The Partnership:
- A coalition composed of representatives
from science, academia, the health care professions, government,
commercial enterprises, and organizations promoting the public interest.
Mission:
- To promote sound guidance to the
general public on strategies for achieving and maintaining a healthy
weight.1
Principles:
- Following sensible and healthy guidelines
for eating and physical activity is important for healthy weight
management.
- Obesity2
is a serious, chronic disease that is known to reduce life span, increase
disability and lead to many serious illnesses including diabetes, heart
disease, and stroke.
- Excess weight is caused by an interaction
of genetic (inherited) and environmental (social and cultural) factors,
which include metabolic (physical and chemical) and behavioral
(psychological and emotional) components. Because of the complexity of
weight loss, gain, and maintenance, promises of quick and effortless
weight loss are worthless.
- A sedentary lifestyle is a significant
barrier to successfully maintaining weight loss and preventing further
weight gain.
- Losing weight requires burning more
calories than the body takes in, by either reducing caloric intake or
increasing caloric expenditure, or preferably, both.
- Achieving and maintaining even a modest
amount of weight loss can reduce the severity of illnesses associated with
obesity.
- Effective weight management involves
behavior modification which is a lifelong commitment and includes at least
two components: b healthful eating in accordance with the Dietary
Guidelines for Americans, emphasizing a reduction in total calories, a
lowered fat consumption, and an increase in vegetables, fruits and whole
grains, and
- increased frequent and regular physical
activity of at least moderate intensity.
- Medical, pharmacological and surgical
interventions may be options for individuals with more serious cases of
overweight and obesity. These interventions, used in conjunction with a
plan for healthy eating and physical activity, should be utilized in
conformance with applicable treatment guidelines.
- The consumer is entitled to accurate,
reliable, and non-deceptive information about methods for weight
management. The Partnership encourages weight loss providers to adopt the
Partnership's Voluntary Disclosure Guidelines for Providers of Weight Loss
Products and Programs.
- The Partnership opposes discrimination,
including discrimination based upon size or weight.
- The Partnership does not endorse any
particular product or program for weight loss or weight management.
- Healthy weight is defined as a
body mass index (BMI) equal to or greater than 19 and less than 25
among all people aged 20 or over. To determine body mass index, divide
weight in kilograms (2.2 lbs. = 1 kg) by height in meters squared (39.4
ins. = 1 m). See the attached table for quick conversion from height and
weight to BMI.
- For the purposes of this
document, "obesity" is defined as a body mass index (BMI) equal to or
greater than 30, which approximates 30 pounds of excess weight. Excess
weight also places people at risk of developing serious health problems.
VOLUNTARY
GUIDELINES FOR PROVIDERS OF WEIGHT LOSS PRODUCTS OR SERVICES
I. Format and Distribution
These Voluntary Guidelines represent a
consensus of voluntary consumer disclosure practices reached by a panel of
weight management companies, weight loss professionals, and consumer
protection groups. They are not binding, do not represent legal standards or
interpretation of any legal requirements, and are not sponsored or issued by
any government agency. Providers1
should only make these disclosures to the extent that they are permissible
under applicable state and federal law.2
Providers that subscribe to these Voluntary Guidelines may be flexible in
tailoring the Guidelines to the structure and needs of their own programs.
Different programs will comply in different ways with various portions of
the Guidelines. However, providers should not represent, directly or
indirectly, in advertising or otherwise, that they subscribe to or comply
with the Voluntary Guidelines unless they make all disclosures that are
applicable to their particular program or product.
The examples set forth in the Voluntary
Guidelines are provided for the purpose of illustration, and are not
intended to represent a required or preferred form or format. Different
providers and types of providers may utilize varying formats for disclosure.
Providers following these guidelines should
make all disclosures clearly and prominently. Providers that obligate
purchasers to make payments in the future or that collect non refundable
payments in advance for products or services to be consumed or provided in
the future, should make all disclosures in a single document that is given
to all prospective clients/patients on their first visit to the center and
prior to purchase.3 Providers that charge for products
and services as they are used by the purchaser -- "pay-as-you-go programs"
-- or that collect refundable payments in advance of delivery of the
services,4 should also include all
disclosures covered by these guidelines in a single document except that
cost information may be provided either as part of the document or on clear
and prominent postings at each center. Providers who post notices of costs
should do so in a manner that renders them consistently viewable by
consumers during their visit and permits consumers to notice and read the
contents upon first entering the area occupied by the provider's customer
representatives or recruiters.
Providers should instruct their staff to
encourage prospective clients/patients to read all disclosures prior to
enrolling in the program.
Services actually provided should not be
inconsistent with the content of these disclosures. (For example, a provider
should not offer advice of a medical nature if the disclosures state that
medical advice is not provided.) In addition, written or oral
representations contained in advertising or any other materials or
presentations should not be inconsistent with or contradict these
disclosures.
II. Information Content
Providers of weight management services
should, at a minimum, voluntarily provide to prospective patients/clients
the following information:5
- Information concerning staff
qualifications and central components of the program. This includes a
description of the program content and goals6
and pertinent information about the weight management training,
experience, certification and education of the customer service personnel
where the service, including distribution of products, is being provided,
and which is appropriate to the program. The disclosure should include
wording that encourages prospective patients/clients to ask additional
questions about the qualifications of the provider and should not be
deceptive or misleading.
Example 1
Our Staff The "Weight Away Diet Center"
program consists of diet, exercise, and behavioral modification. Program
leaders who have successfully used the Weight Away program to lose
weight monitor your weekly progress. Staff is required to have completed
Weight Away program as well as a six-week in-house staff training
program covering nutrition, weight-loss dynamics, customer service, and
presentation. One or more Weight Away counselors will see you on an
individual or group basis at each meeting. Our staff does not offer
medical or psychological counseling. Please feel free to ask for more
details about any particular leader's training or experience. |
Example 2
Our Staff The "Community Hospital
Obesity Clinic" provides a medically supervised weight loss program for
patients with severe disorders related to obesity or whose obesity
places them at risk of developing such disorders. The program consists
of optional low or very low-calorie diet plans, exercise, and lifestyle
education. During this program, patients following a very-low-calorie
diet will receive a protein supplement diet formula to substitute for
regular meals and a multi-vitamin supplement. Our staff is comprised of
one physician who is board-certified in endocrinology, two registered
nurses (RNs), three registered dietitians (RDs), one masters level
exercise physiologist and one clinical psychologist (Ph.D.) Usually,
patients will visit with the dietitians and exercise physiologist. Other
professional staff are available for consultation if professional
intervention is indicated. Prospective patients are encouraged to ask
about staff experience and training and how much time various staff
members spend with individual patients. |
- Information about the risks associated
with overweight and obesity, and the benefits to be derived from modest
weight loss, e.g.: b That obesity and overweight are associated with
increased risk of heart disease, diabetes, some forms of cancer, gall
bladder disease, osteoarthritis, stroke, and sleep apnea, among other
illnesses, and that moderate amounts of weight loss (five to ten percent
of total body weight) can reduce many of the risks.7
- Information about the risks associated
with the provider's product or program. This includes for programs, the
risks associated with any drugs, devices, dietary supplements, or exercise
plans that are provided in the course of the program or treatment. In
addition to program/product-specific risks, the information provided
should indicate:
- That consultation with a medical
professional is advisable for people who are under treatment for specific
medical conditions or taking prescribed medications.
- That unless medically indicated, weight
loss after the first two or three weeks of dieting should not exceed a
rate of three pounds or approximately one and one-half percent of body
weight per week. More rapid weight loss may cause an increased risk of
developing gallbladder disease, risk which is believed to be higher than
the risk of developing gallbladder disease as a result of staying
overweight/obese. People who are considered medically appropriate for more
rapid weight loss should have their progress monitored by a physician.
- That very-low-calorie diets (< 800 kcal
per day) are designed to promote rapid weight loss in people whose obesity
has resulted in, or has put them at medical risk of, developing serious
health complications. Rapid weight loss may also be associated with some
medical problems. This program provides medical supervision to minimize
risks associated with rapid weight loss.8
That people undergoing weight loss can
experience physical changes in the body (dizziness, interruptions in the
menstrual cycle, hair loss, for example) that may indicate more serious
conditions. People noticing such changes should be advised to talk
immediately to their primary care physician.
Example 3
For providers whose programs are designed to
produce weight loss at a rate of approximately two pounds per week.
What You Need To
Know About the Safety
of the "Healthy Weight Loss Clinic" Diet
This diet has been designed to promote
weight loss of no more than two pounds -or one percent of total body
weight - a week. Medical authorities recommend that losing weight at
such a rate reduces risk of health problems that have been associated
with more rapid weight loss (greater than three pounds per week). Some
people may lose weight at a slightly higher rate. However, we will
monitor your progress and modify your diet if your rate of weight loss
after the first two or three weeks exceeds a rate of three pounds -- or
one and one-half percent of body weight -- a week.
Children and adolescents, pregnant or
breast feeding women, and people with significant health problems such
as bulimia, heart disease, kidney disease, diabetes or psychiatric
disorder, should not begin this program without written authorization by
their primary care provider.
People under treatment for other
conditions or taking medications prescribed by their health care
provider should tell their providers that they have begun this diet
because, in some cases, adjustments to medications or modifications to
the weight loss program may be appropriate.
Weight loss can produce physical changes
in the body such as interruptions in the menstrual cycle, temporary hair
loss, and dizziness. Such changes may indicate more serious health
complications. Report any such changes that you notice to your primary
care provider.
Remember, people who are
overweight or obese are at increased risk of developing heart disease,
diabetes, some forms of cancer, gall bladder disease, osteoarthritis and
sleep apnea. Losing even small amounts of weight (five to ten percent of
body weight), may reduce these risks. The side effects and complications
that some people may experience while losing weight by following a
healthy eating plan and exercise program are usually minor compared to
the risks of overweight and obesity. |
- Information about program costs. This
includes (1) total program costs, including all fixed costs
(administrative fees, entry fees, renewal fees, as appropriate), (2)
periodic costs such as weekly attendance fees or mandatory food purchases
(expressed for food purchases at the option of the provider as either
average approximate costs or a high/low range of costs per scheduled
payment unit or per week), (3) optional costs (such as fees charged for
re-entering the program or for any optional maintenance program), and (4)
discretionary costs (medical tests, for example). Providers should also
identify, clearly and prominently, any non-refundable costs. If
practicable, providers should disclose total approximate program costs
averaged across all dieters.
Example 4
"BYE-BYE BMI Weight Loss Centers" Cost
Schedule:
Mandatory Charges: |
|
One-Time Entry Fee |
$xx.xx |
Each Weekly Meeting
(attended) |
$xx.xx |
Average (approximate)
cost of food per week |
$xx.xx |
Nutritional Supplements
(30 day supply) |
$xx.xx |
|
|
Discretionary
Additional Charges (if Center deems necessary) |
|
Blood tests, Physician
Exam, EKG |
$xx.xx |
Optional Additional
Charges (if client chooses) |
$xx.xx |
Re-entry fee (after
absence of at least __ consecutive visits) |
$xx.xx |
Optional Maintenance
Program |
$xx.xx |
ALL COSTS
NON-REFUNDABLE |
- Consumers of weight loss products and
services are entitled to receive outcome information that would allow
people to make informed choices among weight loss products and services.
Providers are encouraged to collect data, e.g., how much weight consumers
of a particular product or program have lost and how long they kept off
all or part of their weight loss, and disclose weight loss and maintenance
information to prospective clients/patients before they enroll.9
Providers subscribing to these guidelines
should include within the document containing the other disclosures:
- the statement, "Most people who lose
weight are likely to find it difficult to keep the weight off. They can
improve their chances by adopting a lifelong commitment that includes:
- increased frequent and regular physical
activity of at least moderate intensity, and
- healthy eating in accordance with the
Dietary Guidelines for Americans, emphasizing a reduction in total
calories, a lowered fat consumption, and an increase in vegetables,
fruits and whole grains," and
- information about the health benefits of
modest amounts of weight loss (5 - 10 percent of body weight, 10 - 20
pounds).
Example 5
For providers that make specific disclosures
Patients under Dr. Doe's weight loss
treatment lost, on average, 17.5 pounds, and after 18 months, they kept
off 55 percent of their weight loss. This measurement includes all
patients who remained in active weight loss for at least three weeks.
Most people who lose weight are
likely to find it difficult to keep the weight off. They can improve
their chances by adopting a lifelong commitment that includes:
- increased frequent and regular
physical activity of at least moderate intensity, and
- healthy eating in accordance with the
Dietary Guidelines for Americans, emphasizing a reduction in total
calories, a lowered fat consumption, and an increase in vegetables,
fruits and whole grains.
Moreover, maintaining a modest amount of
weight loss over time has been shown to have health benefits. |
Example 6
For providers that choose not to make
specific disclosures.
Most people who lose weight are likely
to find it difficult to keep the weight off. They can improve their
chances by adopting a lifelong commitment that includes:
- increased frequent and regular
physical activity of at least moderate intensity, and
- healthy eating in accordance with the
Dietary Guidelines for Americans, emphasizing a reduction in total
calories, a lowered fat consumption, and an increase in vegetables,
fruits and whole grains.
Moreover, even weight loss of as little
as ten percent of body weight, if maintained over time, has been shown
to be beneficial. |
Endnotes
- "Providers" includes any
individual or organization involved in providing weight loss services
or products to the public, including, but not limited to, physicians,
clinical psychologists, dieticians, nutritionists, and commercial
programs, as well as any one else selling products or publications
designed to cause weight loss or result in weight maintenance.
- Providers of a weight loss
product should note that use of statements about the risks associated
with overweight and obesity, the risks associated with the product, or
about outcomes may render the product adulterated, misbranded, or
unapproved under the Federal Food, Drug, and Cosmetic Act and relevant
regulations promulgated by the Food and Drug Administration.
- In the case of telephone sales,
inasmuch as providers cannot give written disclosures to prospective
patients/clients until they visit a center, sales should not be considered
final until the prospective patient/client has received the disclosures
and had a chance to read them. Alternatively, providers may include with
the disclosures, a clear and conspicuous notice of their right to rescind
such a sale within at least five days.
- A single, non refundable entry
fee or registration fee that does not exceed 150 percent of the fee
charged for a single visit or session in an otherwise pay-as-you-go
program does not remove the program from pay-as-you-go status.
- In order to assure compliance,
these guidelines should be placed in the program/procedures policy
manual or such other written guidance provided to program staff.
- The description of the program
should include information about any products (drugs, devices, dietary
supplements, herbals products, food substitutes, foods, etc.), whether
required or optional, that are provided in the course of the program.
- While most providers will
likely want to include information about the risks of obesity and the
benefits of weight loss, any such disclosure is optional, and the failure
to provide such a statement will not be considered inconsistent with the
guidelines.
- This guideline is only
applicable to providers who offer very-low-calorie diet plans.
- These guidelines encourage but
do not mandate outcome disclosures in terms of weight loss and weight
maintenance. Weight loss programs differ, and at the current time, there
is no consensus on what the content and the format of such disclosures
should be. Research is lacking as to what consumers need and how they
interpret or use such information. The Partnership for Healthy Weight
Management has resolved to pursue means to develop such research and to
encourage the development of consumer education materials that provide
guidance on outcome information and how consumers can use it.
|