9323282
B222505
UNITED STATES OF
AMERICA
FEDERAL TRADE
COMMISSION
In the Matter of
NUTRITION 21,
a limited partnership,
SELENE SYSTEMS, INC.,
a corporation and
DOCKET NO. C-3758
general partner of Nutrition 21,
and
HERBERT H. BOYNTON,
individually and as President
of Selene Systems, Inc., a
corporation.
COMPLAINT
The Federal Trade Commission, having reason to believe
that Nutrition 21, a limited partnership; Selene Systems,
Inc., a corporation and general partner of Nutrition 21;
and Herbert H. Boynton, individually and as President of
Selene Systems, Inc., a corporation
("respondents"), have violated the provisions
of the Federal Trade Commission Act, and it appearing to
the Commission that this proceeding is in the public
interest, alleges:
1. Respondent Nutrition 21 is a California limited
partnership with its principal office or place of
business at 1010 Turquoise St., Suite 335, San Diego, CA
92109.
2. Respondent Selene Systems, Inc. is a California
corporation and a general partner of Nutrition 21. Its
principal office or place of business is the same as that
of Nutrition 21.
3. Respondent Herbert H. Boynton is President of
Selene Systems, Inc., a corporation. Individually or in
concert with others, he formulates, directs, and controls
the acts and practices of Nutrition 21 and Selene
Systems, Inc., including the acts or practices alleged in
this complaint. His principal office or place of business
is the same as that of Nutrition 21.
4. Respondents have manufactured, advertised, offered
for sale, sold, and distributed Chromium Picolinate for
use in dietary supplements. Chromium Picolinate is a
product subject to the provisions of Sections 12 and 15
of the Federal Trade Commission Act. The United States
Department of Agriculture holds the patent on Chromium
Picolinate, and Nutrition 21 holds the exclusive license
to manufacture and sell Chromium Picolinate.
5. The acts and practices of respondents alleged in
this complaint have been in or affecting commerce, as
"commerce" is defined in Section 4 of the
Federal Trade Commission Act.
6. Respondents have disseminated or have caused to be
disseminated advertisements and promotional materials for
Chromium Picolinate, including but not necessarily
limited to the attached Exhibits A-G. These
advertisements and promotional materials contain the
following statements:
A. Lose the Fat but Keep the Muscle . . .
Chromium Picolinate
At last there is a safe
nutritional supplement that helps you lose unwanted
fat more easily and quickly, while retaining vital
muscle tissue. Now you can have a trimmer, firmer,
leaner body.
LOSE THE FAT BUT KEEP THE MUSCLE
Most dieters who achieve significant weight loss
lose far too much lean body mass (muscle and organ
tissue). . . . Even worse, this lessened lean body
mass lowers your metabolic rate, making it that much
harder to keep the fat off permanently -- the yo-yo
syndrome!
There is now excellent scientific evidence that
Chromium Picolinate can accelerate fat loss while
helping to preserve or even increase muscle.
CONVINCING NEW EVIDENCE
Overweight adults were recruited by a prominent
San Antonio weight loss clinic to participate in a
weight loss study. About half of the volunteers
received supplemental Chromium Picolinate (200 or 400
micrograms chromium daily), while the others received
placebos. Neither the participants nor the doctors
evaluating them knew who was getting the chromium (a
"double- blind" study). The volunteers were
not placed on any specific diet or exercise regimen,
although most of them were motivated to lose weight.
After only 60 days, these were the impressive
results:
The changes in the placebo group were negligible.
But the Chromium Picolinate group, on average, lost
over 4 pounds of fat while gaining nearly a pound and
a half of lean muscle for a Net Physique Enhancement
of 5.6 pounds.
Another double blind-study was conducted in young
off- season football players participating in a
six-week weight-training program. The results were
much the same: more muscle, less fat with
Chromium Picolinate. Chromium Picolinate more than
doubled the net benefits of exercise alone.
LEANER AND FIRMER
Because many people gain muscle with
Chromium Picolinate, their weight loss in pounds
doesn't accurately reflect the benefits of chromium.
Most users report that event [sic] a modest weight
loss as shown on the bathroom scale is accompanied by
lost inches and smaller clothing sizes. They
look and are leaner and firmer. Chromium Picolinate
promotes fat loss, while enhancing the muscle
that assures a trim athletic physique.
HOW DOES CHROMIUM PICOLINATE WORK?
Controls Hunger Many people report that
Chromium Picolinate helps to control appetite,
especially sugar cravings. It is believed that
chromium sensitizes the "glucostat" in the
brain that monitors blood sugar availability and
"tells" you when you're hungry or not
hungry.
"Spares" Protein . . . By
"sensitizing" muscle to insulin, Chromium
Picolinate helps to preserve muscle in dieters so
that they "burn" more fat and less muscle.
Preservation of lean body mass has an important
long-term positive effect on metabolic rate, helping
dieters keep off the fat they've lost.
Stimulates Metabolism It promotes efficient
metabolism by aiding the thermogenic (heat producing)
effects of insulin. Insulin levels serve as a rough
index of the availability of food calories, so it's
not at all surprising that insulin stimulates
metabolism.
HOW MUCH CHROMIUM PICOLINATE SHOULD I TAKE FOR
OPTIMAL WEIGHT LOSS?
Clinical trials with 200 to 400 micrograms of
chromium daily produced significant benefits. Larger
individuals and those engaged in strenuous work or
exercise may see better results with higher levels --
up to a maximum of 400 micrograms daily.
PUTTING IT ALL TOGETHER
The best thing about Chromium Picolinate is that
it makes other sensible weight control efforts more
effective. Many people report that they have tried
diet and exercise before, but say that they didn't
get good results until they added Chromium
Picolinate. . . .
Chromium Picolinate, all by itself, isn't likely
to make a fat person thin. But it can be the decisive
component of an overall strategy for long-term weight
control and, in the bargain, make an important
contribution to good health.
(Exhibit A) (references omitted)
B. WEIGHT LOSS, FAT LOSS AND MUSCLE LOSS
or
"How to Break the String of Yo-Yo
Diets"
CLEARLY, THE KEY TO BREAKING THIS DISCOURAGING
CYCLE OF EVER MORE FAT, EVER LESS MUSCLE, IS LOSING
FAT WHILE PRESERVING--OR EVEN INCREASING--MUSCLE. . .
.
This is precisely what Dr. Gilbert Kaats and his
colleagues achieved in a recently completed study . .
. .
One hundred fifty men and women were asked to join
in a weight loss study. Roughly half were given
supplemental Chromium Picolinate (200 or 400
micrograms chromium daily), while the others got a
placebo. They were not placed on any specific diet or
exercise regimen, although most were trying to lose
weight. . . . After 72 days, these were the
impressive results:
The changes in the placebo group were
insignificant. However the Chromium Picolinate
group, on average, lost over 4 pounds of fat
while gaining nearly a pound and a half of lean
muscle!
The review of clinical trials reported that
supplementation with Chromium Picolinate:
- reduced total serum cholesterol and LDL, the
"bad" cholesterol
- reduced elevated blood sugar levels and
glycosylated hemoglobin in diabetics
- significantly reduced body fat and increased
muscle in exercising individuals.
Chromium is an essential nutrient that is in short
supply in 90% of typical U.S. diets. . . .
CHROMIUM PICOLINATE: Take daily, 200 to 400
micrograms to preserve muscle while you lose weight
Chromium Picolinate has other important
attributes:
- preserving or enhancing muscle; it maintains
or increases the metabolic rate making weight
loss easier.
- significantly lowering elevated serum
cholesterol
- significantly lowering elevated blood sugar
- helping to control appetite. A great many
people report reduced appetite, especially
sugar cravings.
(Exhibit B)
C. CHROMIUM PICOLINATE:
The yeast-free BioActive Chromium with
Important Clinically Proven Benefits
Chromium is vitally important to good health
because it is essential to the efficient function of
the hormone insulin. Poor responsiveness to insulin
is very common and is linked with increased risk for
overweight, heart disease, elevated blood fat, high
blood pressure, and diabetes.
Yet chromium's nutritional status in the U.S. is
very poor: 90% of American diets provide less than
the minimal amount recommended by the National
Academy of Sciences, and most nutritional forms of
chromium are poorly absorbed.
Chromium Picolinate is well absorbed and highly
bioactive. In clinical trials at major hospitals and
universities it has been shown to:
- significantly reduce body fat
- help build lean, strong muscles
- lower elevated cholesterol
- reduce elevated blood sugar in diabetics
By mechanisms that are not yet fully understood
nutritional (trivalent) chromium is absolutely
essential to the function of insulin.
A great many U.S. adults have poor insulin
function. They produce normal or even elevated
amounts of insulin, but their body's tissues are
relatively insensitive to it. Indeed, recent studies
show that at least one in four adults has reduced
sensitivity to insulin.
The majority of these people don't become overtly
diabetic because their pancreas compensates by
secreting increased amounts of insulin. In these
people, insulin insensitivity is a "silent"
problem that can be diagnosed only by observing
increased blood insulin levels and/or modest
impairments of glucose tolerance.
There is increasing evidence that this
"silent" insulin insensitivity is in fact a
serious medical problem.
But there is now evidence that insulin
insensitivity may itself lead to weight gain, owing
to an impairment of "dietary thermogenesis. . .
."
Insulin insensitivity almost certainly also
impairs the development of muscle.
Diabetes As noted, most people can
compensate for modest impairments of insulin
sensitivity by producing more insulin. But in some
people, as insulin sensitivity continues to decline,
the pancreas is unable to keep up with the increased
need for insulin, and "adult-onset" (Type
II) diabetes results. In this syndrome, there is a
significant net reduction in insulin activity,
resulting in persistent elevations of blood sugar
even after an overnight fast. Adult-onset diabetes .
. . is responsible for a tremendous toll in premature
death and disability. Long-term diabetes can lead to
heart disease, arterial disease (often requiring leg
amputation), blindness, kidney failure, and nerve
damage.
POOR CHROMIUM NUTRITION AND
METABOLISM
Diets that are too high in fats and too low in
fiber-rich unrefined foods, inadequate exercise, as
well as overweight, are all major factors
contributing to poor insulin responsiveness. Poor
chromium nutrition also plays a vitally important
role.
Refined American diets are very poor sources of
chromium. The National Academy of Sciences has
recommended a daily chromium intake of 50 to 200
micrograms. Yet studies by the U.S. Department of
Agriculture indicate that 90% of Americans receive
less than 50 micrograms daily--and 25% receive less
than 20 micrograms!
This problem is compounded because most sources of
chromium are not efficiently absorbed. . . .
In addition, there is evidence that many people
may have defective chromium metabolism. . . .
Diabetics also tend to have lower chromium levels.
In brief, impaired insulin sensitivity is very
prevalent and is associated with increased risk for
overweight, heart disease, diabetes, and high blood
pressure.
Chromium, which is crucial for proper insulin
function, is in short supply in most American diets,
is often inefficiently absorbed, and may not be
efficiently metabolized by many people.
THE SOLUTION: BIOACTIVE CHROMIUM
These considerations emphatically suggest the
desirability of dietary chromium supplementation. But
not all chromium supplements are equally effective.
In clinical studies, inorganic chromium (e.g. chromic
chloride) has been beneficial for mild impairments of
glucose tolerance, but has not proven useful in overt
diabetes or for lowering elevated cholesterol. In
contrast, large intakes of brewer's yeast, a rich
source of organically bound chromium, have been found
useful for treating diabetes and high cholesterol. .
. .
The most likely explanation is that some organic
chromium complexes are more readily taken up by cells
than is inorganic chromium.
CHROMIUM PICOLINATE
Scientists at the U.S. Department of Agriculture
have developed an excellent, perhaps an ideal organic
complex of chromium. . . . Chromium Picolinate thus
proves exceptionally effective for achieving
intestinal absorption and intracellular uptake of
chromium.
(Exhibit C) (references omitted)
D. CHROMIUM PICOLINATE -- THE CLINICAL PROOF
. . .
The initial studies with Chromium Picolinate have
yielded exciting results:
Physique Enhancement for
Athletes
Young male athletes engaged in an exercise
program at Bemidji State University (Minnesota)
received daily doses of Chromium Picolinate (200
micrograms chromium) or a matching placebo. After
6 weeks, the chromium group gained 44% more lean
body mass than the placebo group. Even more
striking, the chromium group lost 23% of its body
fat as compared to only 7% in the placebo group.
These differences were highly statistically
significant.
A similar study has been conducted at
Louisiana State University with men and women
beginning weight-training students. A preliminary
report indicates that Chromium Picolinate
accelerated the increase in muscle size in both
men and women, and, in the women, nearly doubled
the increase in lean body mass.
Cholesterol Reduction In a double-blind
crossover study conducted by the medical staff of
San Diego's Mercy Hospital, people with elevated
cholesterol received a daily dose of Chromium
Picolinate providing 200 micrograms chromium,
alternating with a matching placebo. After 6
weeks of chromium, LDL cholesterol . . . had
dropped 10% . . . . Inorganic chromium has not
been reported to lower elevated cholesterol.
Adult-Onset Diabetes A similar
double-blind crossover trial was conducted at
Mercy Hospital with Type II (adult-onset)
diabetics. After 6 weeks of Chromium Picolinate
(200 micrograms of chromium), fasting blood sugar
was lowered by 18% . . .
This is the first time that a nutritional intake
of chromium per se has been reported to improve
glucose metabolism in overt diabetes.
(Exhibit D) (references omitted)
E. Chromium Picolinate --The Results Speak For Themselves
Two well designed, well executed studies prove
that Chromium Picolinate accelerates muscle growth
and reduces body fat. Such a statement cannot be made
for any other chromium compound.
A recent issue of MUSCLE & FITNESS presented
an article calling attention to the newly proven
anabolic role of chromium. Body builders have
believed for a long time that chromium helps build
muscle. What is new is that scientists now have
measured, during a clinical study, the actual
gains that chromium produces.
It no longer makes any difference what people
"think" about chromium or about the
different forms of chromium because the facts
are in -- facts determined by clinical tests
conducted according to acceptable scientific
standards. And they have shown that one form of
chromium --Chromium Picolinate--does accelerate
muscle growth.
(Exhibit E)
F. Lose The Fat; Keep The Muscle With Chromium Picolinate.
Here's Why You Need Chromium Picolinate.
Like iron, calcium, and zinc, chromium is a
nutritionally essential mineral. Its most
biologically available form, Chromium Picolinate, can
have nutritionally helpful effects on your health and
fitness. Combining it with a lifestyle of low-fat
eating and everyday exercise can improve both health
and fitness.
Lose Fat and Keep Muscle with Chromium
Picolinate.
Nine confirming scientific studies with humans and
animals demonstrate a significant reduction in body
fat when Chromium Picolinate is added to the diet.
These studies also show a consistent trend toward
increased lean muscle. Muscle burns calories, fat
merely stores calories.
Chromium Picolinate Helps Maintain A Normal
Healthy Metabolism.
Insulin has very important functions: It maintains
the normal nutritional metabolism of protein (muscle
building), carbohydrate (major energy source), and
fat (energy storage). It also influences appetite
control and calorie-burning. Insulin simply can't
perform normally without an adequate supply of
chromium.
Chromium is Undersupplied in 90% of Adult
Diets.
The National Academy of Sciences recommends 50 to
200 micrograms of chromium daily. U.S. Department of
Agriculture studies show that men get only 33
micrograms and women get only 25 micrograms, on
average, from their food. So, help yourself stay lean
and healthy. Choose low-fat meals; choose exercise
that you enjoy; and choose Chromium Picolinate to
supplement your daily diet. Do it for the healthy
edge. Do it for life!
(Exhibit F)
G. "Lose the Fat; Keep the Muscle"
with Chromium
Picolinate
Millions of Americans are trying to lose weight
and many succeed -- but only temporarily.
Typically, up to 30% of lost weight is muscle.
This lowers your metabolic rate and slows calorie
burning. Muscles burn calories even while you sleep;
fat merely stores calories. This lowered metabolic
rate makes it hard to keep lost pounds from creeping
back. Result: the "yo-yo" syndrome in which
weight is repeatedly lost and then regained. After
each lose-gain cycle the proportion of fat increases.
This can result in a permanently depressed metabolic
rate, persistent overweight. . . and utter
frustration.
To break this vicious cycle it is important to lose
only fat while maintaining, or even increasing
muscle.
Most diet plans not only don't work, they're
counterproductive. Permanent weight loss requires a
permanent commitment. Steps 1, 2, and 3 in the box
[below] are endorsed by nearly all weight loss
experts. Studies show that optimal chromium
nutrition, Step 4, is also an effective part of
long-term fat loss programs. Chromium is in short
supply in 9 out of 10 American diets and it's
absolutely essential for normal insulin function.
Normal insulin activity is crucial for hunger control
and calorie-burning. Studies show that 200-400
micrograms of chromium daily, as Chromium Picolinate,
results in significant fat loss while muscle tissue
is maintained or even increased. Dr. Gil Kaats of San
Antonio reports, "During six weeks on Chromium
Picolinate, overweight volunteers lost more than four
pounds of fat, while muscle increased by nearly a
pound and a half."
FOUR STEPS TO A LEANER FIRMER BODY
1. Reduce Dietary Fat Consumption to No More
Than 20% of Calories--Eating Fat Makes You Fat
2. Increase Dietary Fiber--Low in Calories;
High in Nutrients
3. Get Regular Aerobic Exercise--and Burn Fat
Calories!
4. Take Chromium Picolinate Daily--Lose the
Fat; Keep the Muscle
(Exhibit G)
7. Through the means described in Paragraph 6,
respondents have represented, expressly or by
implication, that:
A. Chromium Picolinate significantly reduces body
fat.
B. Chromium Picolinate causes significant weight
loss.
C. Chromium Picolinate causes significant weight
loss without dieting or exercise.
D. Chromium Picolinate causes long-term or
permanent weight loss.
E. Chromium Picolinate increases lean body mass
and builds muscle.
F. Chromium Picolinate significantly increases
human metabolism.
G. Chromium Picolinate controls appetite and
craving for sugar.
H. Chromium Picolinate significantly reduces total
and LDL serum cholesterol.
I. Chromium Picolinate significantly lowers
elevated blood sugar levels.
J. Chromium Picolinate is effective in the
treatment and prevention of diabetes.
K. Ninety percent of U.S. adults do not consume
diets with sufficient chromium to support normal
insulin function, resulting in increased risk of
overweight, heart disease, elevated blood fat, high
blood pressure, and diabetes.
8. Through the means described in Paragraph 6,
respondents have represented, expressly or by
implication, that they possessed and relied upon a
reasonable basis that substantiated the representations
set forth in Paragraph 7, at the time the representations
were made.
9. In truth and in fact, respondents did not possess
and rely upon a reasonable basis that substantiated the
representations set forth in Paragraph 7, at the time the
representations were made. Therefore, the representation
set forth in Paragraph 8 was, and is, false and
misleading.
10. Through the means described in Paragraph 6,
respondents have represented, expressly or by
implication, that scientific studies demonstrate that
Chromium Picolinate:
A. Significantly reduces body fat.
B. Causes significant weight loss.
C. Causes significant weight loss without dieting
or exercise.
D. Causes long-term or permanent weight loss.
E. Increases lean body mass and builds muscle.
F. Significantly reduces total and LDL serum
cholesterol.
G. Significantly lowers elevated blood sugar
levels.
H. Is effective in the treatment and prevention of
diabetes.
11. In truth and in fact, scientific studies do not
demonstrate that Chromium Picolinate:
A. Significantly reduces body fat.
B. Causes significant weight loss.
C. Causes significant weight loss without dieting
or exercise.
D. Causes long-term or permanent weight loss.
E. Increases lean body mass and builds muscle.
F. Significantly reduces total and LDL serum
cholesterol.
G. Significantly lowers elevated blood sugar
levels.
H. Is effective in the treatment and prevention of
diabetes.
Therefore, the representations set forth in Paragraph
10 were, and are, false or misleading.
12. The acts and practices of respondents as alleged
in this complaint constitute unfair or deceptive acts or
practices, and the making of false advertisements, in or
affecting commerce in violation of Sections 5(a) and 12
of the Federal Trade Commission Act.
THEREFORE, the Federal Trade
Commission on this eleventh day of July, 1997, has issued
this complaint against respondents.
By the Commission.
Donald S. Clark
Secretary
SEAL:
[Exhibits A-G attached to paper copies of complaint, but
not available in electronic form.]
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