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.
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.
1.
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.
2.
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 Guidlines 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
1.
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 " |
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. |
1.
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
1.
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. |
1.
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:
ALL COSTS NON-REFUNDABLE |
1.
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:
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:
Moreover, even
weight loss of as little as ten percent of body weight, if maintained over
time, has been shown to be beneficial. |
Endnotes
1.
"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.
2.
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.
3.
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.
4.
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.
5.
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.
6.
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.
7.
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.
8.
This guideline is only applicable to providers
who offer very-low-calorie diet plans.
9.
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.
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