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Voluntary
Guidelines for Providers
of Weight Loss Products or Services
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PDF version)
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.
Principles
- Following sensible and healthy guidelines
for eating and physical activity is
important for healthy weight management.
- Obesity 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:
- 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.
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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
A.
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.
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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.
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B.
Information about the risks associated with
overweight and obesity, and the benefits to be
derived from modest weight loss, e.g.:
- 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
C.
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.
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D.
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: |
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One-Time Entry Fee
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$xx.xx |
Each Weekly Meeting (attended)
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$xx.xx |
Average (approximate) cost of
food per week
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$xx.xx |
Nutritional Supplements (30
day supply)
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$xx.xx |
Discretionary
Additional Charges (if Center deems
necessary) |
Blood tests, Physician Exam,
EKG
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$xx.xx |
Optional
Additional Charges (if client
chooses) |
Re-entry fee (after absence of
at least __ consecutive visits)
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$xx.xx |
Optional Maintenance Program
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$xx.xx |
ALL COSTS
NON-REFUNDABLE
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E.
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.
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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.
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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.
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