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                          Weekly Health Bulletin
             Courtesy of Black Bag Medical Information Services
             America's Online Health Information Connection(tm)
                               302-994-3772

       This document is provided for educational purposes only. The
information provided is NOT to be considered as diagnostic or
individual advice. No specific medical quidance or treatment can be
recommended without consultation with a physician. You  should consult
your personal physician prior to utilizing any medical information
discussed in this document. Those contributing to this informational
bulletin, disclaim all responsibility for any actions taken by persons
in reliance upon information stated in this program. Should you choose to
disregard this warning, you assume the risk and responsibility for your
actions.


    The following information is provided thanks to the FDA Consumer

                      Cystic Fibrosis:
             Tests, Treatments Improve Survival
                    by Ricki Lewis, Ph.D.
     Alex Deford had been ill almost from the moment of her
birth on Oct. 30, 1971. Her frequent colds and ear infections
coupled with her small size, despite a healthy appetite,
prompted doctors to vaguely diagnose "failure to thrive." When
Alex developed double pneumonia at 4 months, it was clear that
something was very wrong.
     That something turned out to be cystic fibrosis, the most
common inherited illness among white people of Northern and
Western European ancestry, although it is seen in all ethnic
groups. Symptoms include thick, sticky mucus clogging the
lungs, impairing breathing and attracting infection; a blocked
pancreas that cannot release digestive enzymes, causing pain
after eating; stubbed fingers from poor circulation;
infertility; salty sweat; and other problems. Patients may
have any or all of these symptoms--Alex had quite a list.
     When she was diagnosed at Boston Children's Hospital
early in 1972, Alex was so ill that she was expected to live
only days. She survived eight years, but not easily.
     Alex began each day by inhaling a decongestant. Then her
parents took turns providing "postural drainage," a 30- to 60-
minute pounding and pressing on each of 11 segments of the
lungs, to loosen the mucus, which she coughed up. Alex would
then take drugs--antibiotics to prevent lung infection and
powdered digestive enzymes mixed into applesauce.
     Despite this daily regimen, Alex died in January 1980.
Her father, sportswriter and commentator Frank Deford, tells
her story in his book, Alex, the Life of a Child.
     Cystic fibrosis (CF) is inherited and affects 30,000
Americans. In 1989, scientists discovered the gene that causes
cystic fibrosis (see accompanying article.) This discovery is
enabling researchers to develop new diagnostic tests that will
help identify those who can benefit from traditional as well
as several new treatment approaches being evaluated by FDA.
How CF Is Inherited
     CF is typically passed from parents who each carry the
gene, to children of either sex. Carriers have one faulty copy
of the gene, which is responsible for the illness, plus one
normal copy, which prevents symptoms. Each child of carrier
parents has a 1 in 4 chance of inheriting CF; a 1 in 4 chance
of being completely free of the mutant gene; and a chance of
1 in 2 of being a carrier, like the parents.
     Couples usually learn that they carry CF when they have
an affected child. By 1985, individuals who had a sibling with
CF could find out if they carried the gene by taking a
"genetic marker" (linkage analysis) test that spots a
particular family's CF-carrying chromosome, but not the gene
itself. Finding the CF gene makes it possible to detect most
carriers, even if there are no affected relatives.
     The Office of Technology Assessment estimates that 100
million to 200 million people in the United States might want
to take a CF carrier test. About 8 million people in the
United  States, or 1 in 25 whites, may be carriers.

Diagnosing CF
     The same gene discovery that has led to development of
carrier tests is expected to help to more quickly diagnose CF,
whose symptoms resemble those of other illnesses.
     The most widely used and best-known CF test is the
electrolyte sweat test. It detects the excess sodium,
potassium and chloride (charged chemicals called electrolytes)
found on the skin of many people with CF. A physician would
perform a sweat test in a child with unexplained failure to
gain weight, or with very frequent respiratory infections.
     The sweat test evolved from the observations made by a
physician, Dr. Paul di Sant'Agnese, during a 1953 heat wave in
New York City. He was curious why so many children with CF
were being brought to Babies and Children's Hospital, where he
worked, with heat prostration. The youngsters were unable to
cope with the heat because too much salt exited their bodies
in sweat. The fact that the sweat of a person with CF contains
two to six times as much salt as normal sweat gave him the
idea for the sweat test.
     The sweat test became widely used by the mid-1950s, and
is the only CF test cleared by FDA for marketing. (A
forerunner of the sweat test was the observation that a
child's brow was salty when kissed. At the turn of the
century, this is how midwives identified babies with cystic
fibrosis.)
     Although the sweat test is a critical part of a CF
diagnostic work-up, salty sweat can indicate any of several
disorders. Other tests help focus the diagnosis. Some of these
tests are based on methodologies developed by reference
laboratories, which perform medical tests and send the results
to physicians. According to Freda Yoder of FDA's Center for
Devices and Radiological Health, methodologies developed in-
house have not traditionally been regulated by the agency.
     Explains Tom Tsakeris, director of the division of
clinical laboratory devices at FDA, "FDA regulates products,
not laboratories. As long as they are not marketing the test
itself, we do not regulate the lab." However, he adds, the
Clinical Laboratory Improvement Act, signed into law in 1988
but not yet fully implemented, will regulate reference
laboratories.
     One test developed by reference labs measures the amount
of the protein trypsinogen in a newborn's blood. Trypsinogen
is manufactured by the pancreas and sent to the intestine,
where it is snipped to a shorter form, trypsin, which helps
digest proteins. If the pancreas is clogged by the sticky
mucus of CF, trypsinogen levels are elevated, because the
longer protein cannot be cut down to size.
     In one study conducted by researchers at the University
of Colorado School of Medicine and Children's Hospital in
Denver, the trypsinogen test identified 95.2 percent of
infants with CF who did not have the earliest sign, a greenish
discharge called meconium ileus indicating intestinal
blockage. But in the study there were many false positives--of
96 infants who tested high for trypsinogen on two tests, only
31 had CF. So, although the trypsinogen test alone is not
perfect, combined with a sweat  test and observing symptoms,
it can begin to paint a portrait of CF.
     Another test detects the level of certain fetal
intestinal enzymes in the amniotic fluid (the liquid
surrounding the fetus). Amniotic fluid is collected for
testing by a procedure called amniocentesis (see "Genetic
Screening: Fetal Signposts on a Journey of Discovery" in the
December 1990 FDA Consumer). In a fetus with CF, these enzymes
are decreased. Again, however, other disorders besides CF can
produce this finding, and therefore it is not a specific
disease marker. Researchers have turned to the genetic
material to develop a definitive CF test.

Enter Genetic Testing
     Developing a test to detect the gene that causes CF would
provide a definitive diagnosis, because this mutant gene is
the only cause of the disorder. The first step was to find out
where the gene behind CF lies among the 23 pairs of
chromosomes.
     By 1985, several research teams had narrowed the search
to a part of chromosome 7 (the seventh largest chromosome).
Until the CF gene itself was isolated and characterized in
1989, relatives of patients could take an indirect test that
uses linkage analysis. Because of the complexity of test
interpretation, these tests are primarily performed at
academic centers.
     A genetic linkage test tracks a known DNA sequence (a
genetic marker) that, within a family, always occurs in people
with CF, and never in those who do not have the illness. A
genetic marker and the gene responsible for the disorder
behave like two inseparable friends. If you see one at a
party, you know the other is nearby. Genetic linkage testing
is based on the observation that genes carried close together
on the same chromosome tend to be inherited together.
     Ray White at the Howard Hughes Medical Institute at the
University of Utah in Salt Lake City and Robert Williamson of
St. Mary's Hospital Medical School in London each found a
marker, one on either side of the CF gene. Using these two
markers, a couple who already had a child with CF could have
fetal chromosomes tested in a subsequent pregnancy. If the two
markers on the two chromosome 7's in the fetus matched those
of the affected child, then it, too, has likely inherited the
disease.
     A major limitation of linkage tests is that they only
work on families known to have CF. Because people can carry CF
without having symptoms, a disease-causing gene can be in a
family without anyone in recent memory being ill. Finding the
CF gene itself, however, may make possible a test useful on
anyone, so that carriers could be detected in families where
no one has CF.
     Like other genetic tests, CF tests can be performed on
any type of tissue, because all human cells (except red blood
cells) contain two copies of all of the genes, and sperm and
egg have one copy of each. The first CF tests used white blood
cells. Then Williamson's group in London came up with a
pleasanter alternative--a mouthwash! After swishing a
saltwater solution in the mouth, the person spits into a
bottle. The CF gene can be  spotted in cells dislodged from
the inside of the cheek.
     Taking a cue from London, Genzyme Corp. (Cambridge,
Mass.) developed a cheekbrush test for CF, which is
investigational. A patient swabs cheek cells onto a brush, and
the physician sends the sample to Genzyme. The presence of
both normal and mutant CF genes indicates carrier status. If
only mutant genes are there, CF is indicated.

To Test or Not To Test?
     A carrier test provides information to couples who are
not ill but whose children are at high risk of inheriting the
condition.
     Many experts predict that the day of universal CF
screening is approaching, with several companies developing CF
tests that simultaneously screen for several CF mutations.
     Two factors contribute to the sensitivity of a CF carrier
test. The first is the number of mutations that can be
detected. The more mutations tested for, the more carriers
will be spotted.
     Ethnic background is the other important factor, says
Marisa Ladoulis, a genetic counselor at Collaborative
Diagnostic Services in Waltham, Mass. For example, a 12-
mutation test that spots 84 percent of whites with a Northern
or Western European background will detect 92 to 95 percent of
Ashkenazi Jews, and the 16-mutation test finds 96 to 98
percent of them.

All CF Mutations Are Not Equal
     Checking for an errant CF gene may be easy, but
interpreting the results may not be. Researchers are finding
that different CF mutations cause different degrees of
sickness. Alex Deford probably had two copies of delta F508,
the most common and one of the more serious mutations that can
cause CF. But a researcher in the laboratory of Francis
Collins, the co-discoverer of the CF gene, has a milder case
of CF because he inherited the delta F508 mutation as well as
a different one.
     This young man must perform postural drainage on himself
and take antibiotics and digestive enzymes, but he also plays
the trumpet, bikes, and sings. Still, a respiratory infection
can send him to the hospital for a week or longer. Clinicians
are finding that some people who have frequent bouts of
pneumonia and other respiratory infections actually have CF.
     Some people with CF may not even have lung or digestive
symptoms. Aubrey Milunsky, D.Sc., Director of the Center for
Human Genetics at the Boston University School of Medicine,
found that some men who were referred to him because they were
having difficulty fathering a child actually had CF. In
examining x-rays that had been taken as part of a standard
fertility work-up, Milunsky noticed the men lacked the vas
deferens, the paired tubes that deliver sperm from the body.
Knowing this is a symptom in 90 percent of men with CF,
Milunsky tested their genes and found they had inherited CF.
     "Cystic fibrosis is not a simple single mutation to look
for," says Margaret Wallace, Ph.D., assistant professor in the
division of genetics in the department of pediatrics at the
University of Florida in Gainesville. "There will be a lot of
problems in doing the diagnosis and giving an idea of what it
means," she adds.

Treating CF
     CF symptoms are controlled with a number of drugs.
Antibiotic drugs combat infections to which CF patients are
prone, including Pseudomonas aeruginosa bacteria, a type of
microbe that is attracted to the sticky mucus in the lungs.
The combination of animal enzymes, called Viokase, that Alex
Deford took regularly is still used today by CF patients. It
is approved as a prescription digestive aid for CF patients
and others with pancreatic insufficiencies. Combined with a
high-calorie diet, this enzyme preparation aids digestion,
helping the patient to maintain weight.
     Many patients also take anti-inflammatory prescription
drugs, such as ibuprofen (Motrin and others), prednisone
(Deltasone, Winpred, Orason, and others), and naproxen
(Anaprox, Naprosyn and others).
     The drug amiloride (Midamor, Moduretic), introduced in
1967 and approved as an adjunct to treatment with some
diuretic drugs, is now being tested as a treatment for CF.
Scientists believe amiloride thins lung secretions by blocking
sodium uptake by lung cells. Clinical studies are under way to
assess amiloride as a CF treatment alone, and in combination
with the biological products adenosine triphosphate (ATP) and
uridine triphosphate (UTP). (ATP and UTP are components of the
nucleic acids DNA and RNA.)
     Other investigational products are aimed at tempering the
body's immune response to lung infection, which can be
excessive. One such product is deoxyribonuclease. The March
19, 1992, New England Journal of Medicine reported that in a
pilot study, this protein biologic given in an aerosol helped
clear the lungs of 16 adult CF patients. It is being tested in
900 CF patients at 50 medical centers in the United States.

Gene Therapy
     FDA has designated recombinant cystic fibrosis
transmembrane conductance regulator (the gene's protein
product, abbreviated CFTR) as well as gene therapy as orphan
products. This gives their sponsors special incentives because
they are developing products for a condition affecting
relatively few people.
     The first human gene therapy study of CF got under way
last April 17 at the National Heart, Lung, and Blood Institute
after FDA gave the go-ahead the previous day. An engineered
cold virus (adenovirus) was introduced into the cells lining
the nose and airways of a 23-year-old man with CF. The virus
was altered to carry the normal CFTR gene and lacks the genes
to cause a cold and to replicate.
     The research was the first use of gene therapy for a
common genetic disorder and the first use of a cold virus to
transport genes. The study includes 10 patients age 21 or
older who have mild to moderate CF symptoms.
     Previous experiments in rats indicated that replacing the
CF genes in just 10 percent of the lung lining cells improves
lung function. However, because the genes go to the patients'
lungs but not their sex cells, CF can still be passed to the
patients' children.
     New knowledge of CF is coming so fast that the goals of
carrier screening may change even before the tests are cleared
for marketing.
     Soon, detecting the gene for CF may be a way of finding
who needs treatment, as early as possible, just as is
presently done for high blood pressure and elevated blood
cholesterol. Says Wallace, "CF research is moving so quickly,
with a lot of hope for treatment in the near future. It will
be treatable, and possibly easily."

Ricki Lewis is a genetic counselor and is the author of
textbooks on biology and human genetics.

Box:
For more information, contact The Cystic Fibrosis Foundation,
6000 Executive Blvd., Suite 510, Rockville, MD 20852;
telephone (1-800) FIGHTCS.
Advances and Stumbling Blocks
     The symptoms of CF were first described in medical
journals in 1938. The malady was attributed to a defect in the
channels leading from certain glands--a remarkably accurate
description, it would turn out. But the disorder was
recognized before it was given a name, as illustrated by the
17th century English saying, "A child that is salty to taste
will die shortly after birth."
     In 1960, a CF patient rarely lived past the age of 12. By
1970, only half lived to see their 18th birthdays. In the
1970s, when postural drainage began to be implemented and FDA
approved enzyme replacement and antibiotic therapy, the
average lifespan began to creep upwards. Today, it is 29
years, according to the Cystic Fibrosis Foundation. New, more
targeted therapies may raise survival age higher.
     Cystic fibrosis researchers marked a medical milestone on
Oct. 8, 1989, when Science magazine published a report by
Francis Collins and his co-workers at the University of
Michigan at Ann Arbor and Lap-chee Tsui at the Hospital for
Sick Children in Toronto on precisely how a specific gene
disrupts a certain protein to cause CF.
     The researchers named the protein the "cystic fibrosis
transmembrane conductance regulator," or CFTR for short. CFTR
is normally manufactured inside cells lining glands in the
respiratory passages, small intestine, pancreas, and sweat
glands. The protein travels to the cell's surface, where it
controls the flow of salt in and out of the cell like a
gateway in the cell membrane.
     In the disorder, CFTR protein is abnormal in a way that
prevents it from reaching the cell's surface. Without the
gateway in the membrane, salt is trapped inside cells.
Following a natural chemical tendency to try to dilute the
salty interiors of cells, moisture is drawn inside them
through other gateways. This dries out the surrounding
secretions, causing symptoms. In most people with CF, the
protein is missing just one amino acid building block out of
1,480--a tiny, but devastating, glitch.
     Almost as soon as Collins and Tsui described the mutation
that causes CF, dubbed delta F508, a difficulty arose. Delta
F508 was not the only way that the gene could be altered. (A
gene consists of sequences of four types of building blocks.
Just as a sentence can have an error in any of its letters, a
gene can be altered in many ways. A person with CF inherits
two abnormal forms.)
     But within days of the publication of the Science report,
several biotechnology firms were already devising carrier
tests for delta F508. A test for the disease-causing gene
variant became available on an investigational basis by
November 1989. But on Feb. 1, 1990, Collins, Tsui, and several
others reported in The New England Journal of Medicine that
only 75.9 percent of white CF patients of Northern and Western
European backgrounds had the delta F508 variant. How useful
would a test for delta F508 be, researchers worried, if this
wasn't the only variant responsible for CF? At current count,
more than 200 variants of the gene are known.
     The multiple guises of the CF gene meant that a test to
spot delta F508 would miss about 24 percent of Northern or
Western  European descended whites in the United States who do
carry a CF gene. This, in turn, meant that the test would find
only about half the couples in the United States who risk
passing CF to a child (this figure is derived by multiplying
the chances of each parent having delta F508). But it would be
too costly to develop a test for more than 200 different
mutations, when only a few of them are common.
     Adding to the complexity is that different populations
have different proportions of the CF gene variants. For
example, delta F508 occurs in only 35 percent of African-
Americans and Jews of Central and Eastern European ancestry
(called Ashkenazi) who carry CF, making the test for this
mutation even less valuable than it is for non-Jewish whites.
For Hispanics and Italians, the frequency of delta F508 is 50
percent.
     The potential powder keg of a carrier test for a common
genetic disease that would, at best, only work three-quarters
of the time set off a flurry of statements by professional
medical organizations. On Nov. 13, 1989, the American Society
of Human Genetics urged caution in carrier testing until a
greater percentage of the CF-carrying population could be
identified, calling for pilot programs to test the tests.
Meanwhile, they suggested the test only for those with a close
affected relative.
     In early March 1990, a panel of physicians, geneticists,
genetic counselors, and attorneys met at the National
Institutes of Health in Bethesda, Md., to develop guidelines
for CF carrier testing. This group echoed the earlier call for
pilot programs, adding that widespread testing should wait
until tests could detect 90 to 95 percent of carriers.
     In December 1992, the American Society of Human Genetics
reevaluated their 1989 statement, in light of the ability to
detect many CF mutations. Their advice remains unchanged--for
now, CF testing should be offered only to those with a
relative who has the disorder. The organization also calls for
informed consent and genetic counseling, confidentiality of
results, and quality control of the laboratory performing the
test.
--R.L.

Part II

                   A Little 'Lite' Reading
                       by Dori Stehlin
     "Low fat." "No cholesterol." "High in oat bran." "Light."
And don't forget "lite."
     Until now, many of these claims have been nothing more
than advertising hype. The public has been misled with
products like the "light" vegetable oil that was just light in
color and the "lite" cheesecake that was just light in
texture.
     But with the publication of new food labeling regulations
in January 1993, the Food and Drug Administration and the U.S.
Department of Agriculture's Food Safety and Inspection Service
(FSIS) address the problem of misleading nutrition claims and
help reestablish the credibility of the food label. The
regulations spell out which nutrient content claims are
allowed and under what circumstances they can be used.
     There are 11 core terms:
~    free
~    low
~    lean
~    extra lean
~    high
~    good source
~    reduced
~    less
~    light
~    fewer
~    more

Free
     The new regulations allow manufacturers the option to use
the following synonyms for the term "free":
~    without
~    trivial source of
~    negligible source of
~    dietarily insignificant source of
~    no
~    zero
     Whatever term the manufacturer chooses, the product must
either be absolutely free of the nutrient in question or, if
the nutrient is in the food, the amount must be dietetically
trivial or physiologically inconsequential.
     For example, zero fat cannot be required because it is
impossible to measure below a certain amount. So, the
regulation will allow a fat-free claim on foods with less than
0.5 grams (g) of fat per serving, an amount that is
physiologically insignificant even if a person eats several
servings.
     Foods that don't contain a certain nutrient naturally
must be labeled to indicate that all foods of that type meet
the claim. For example, a fat-free claim on applesauce would
have to read "applesauce, a fat-free food."
     "Free" also can be used in reference to saturated fat,
cholesterol, sodium, sugars, and calories.

Low
     A food meets the definition for "low" if a person can eat
a large amount of the food without exceeding the Daily Value
for the nutrient. (See "'Daily Values' Encourage Healthy Diet"
on page xx.)
     The synonyms allowed for "low" are:
~    little
~    few
~    contains a small amount of
~    low source of
     "Low" claims can be made in reference to total fat,
saturated fat, cholesterol, sodium, and calories.
     A claim of "very low" can be made only about sodium.

Lean and Extra Lean
     "Lean" and "extra lean" can be used to describe the fat
content of meat, poultry, seafood, and game meats. (FSIS
regulates meat and poultry products; FDA oversees seafood and
game meats.)
     "Lean" means the food has less than 10 g of fat, less
than 4 g of saturated fat, and less than 95 milligrams (mg) of
cholesterol per serving and per 100 g. An example of a serving
is 55 g (2 oz.) for fish, shellfish or game meat. Some "lean"
foods are Spanish mackerel, bluefin tuna, and domesticated
rabbit.
     "Extra lean" means the food has less than 5 g of fat,
less than 2 g of saturated fat, and less than 95 mg of
cholesterol per serving and per 100 g. Examples of "extra
lean" foods are haddock, swordfish, clams, and deer.

Percent Fat Free
     FDA and FSIS believe that this claim implies, and
consumers expect, that products bearing "percent fat free"
claims contain relatively small amounts of fat and are useful
in maintaining a low-fat diet. Therefore, products with these
claims must meet the definitions for low fat.
     In addition, the claim must accurately reflect the amount
of fat present in 100 g of the food. For example, if a food
contains 2.5 g of fat per 50 g, the claim must be "95 percent
fat free."

Good Source and High
     "High" and "good source" focus on nutrients for which
higher levels are desirable. To qualify for the "high" claim,
the food must contain 20 percent or more of the Daily Value
for that nutrient in a serving. Approved synonyms for high are
"rich in" or "excellent source."
     "Good source" means a serving contains 10 to 19 percent
of the Daily Value for the nutrient.

Comparison Claims
     Manufacturers who want to compare a nutritionally altered
product with the regular product may make a relative claim--
that is, "reduced," "less," "fewer," "more," or "light." The
regular products, or reference foods, may be either an
individual food or a group of foods representative of the type
of food--for example, an average of three market leaders.
     Restrictions on these claims and the reference foods
include:
~    A relative claim must include the percent difference and
the  identity of the reference food
~    "Reduced," "less" and "light" claims can't be made on
products whose nutrient level in the reference food already
meets the requirement for a "low" claim.
~    Reference foods for "light" and "reduced" claims must be
similar to the product bearing the claim--for example, reduced
fat potato chips compared with regular potato chips.
~    Reference foods for "less" and, in the case of calories,
"fewer" may use dissimilar products within a product category-
-for example, pretzels with 25 percent less fat than potato
chips.
     At the other end of the spectrum, a serving of a food
carrying a "more" claim (or claims of fortified, enriched or
added) must have at least 10 percent more of the Daily Value
for a particular nutrient (that is, dietary fiber, potassium,
protein, or an essential vitamin or mineral) than the
reference food that it resembles.

Light/Lite
     "Light" or "lite" can mean one of two things:
     First, that a nutritionally altered product contains one-
third fewer calories or half the fat of the reference food. If
the food derives 50 percent or more of its calories from fat,
the reduction must be 50 percent of the fat.
     Second, that the sodium content of a low-calorie, low-fat
food has been reduced by 50 percent.
     The term "light in sodium" is allowed if the food has at
least 50 percent less sodium than a reference food. If the
food still does not meet the definition for "low sodium," the
label must include the disclaimer "not a low-sodium food."
     "Light" will be allowed to describe color or texture,
provided qualifying information is included. However, names
that have a long history of use, such as "light brown sugar,"
can still be used without qualifying information.

Meals and Main Dishes
     Any product represented as or in a form commonly
understood to be breakfast, lunch or dinner is subject to the
special rules for meal products. Examples include frozen
dinners, some pizzas, and shelf-stable items.
     Under FDA rules, a main dish must weigh at least 6 ounces
and contain at least two different foods from at least two of
four specified food groups. (While FDA endorses the five food
groups recommended in current dietary guidelines, the agency
believes treating fruits and vegetables as separate groups in
this situation would allow the inappropriate classification of
a fruit and a vegetable product as a main dish.)
     FDA requires a "meal" to weigh at least 10 ounces and
have at least three different foods from at least two of the
four specified food groups.
     USDA defines a meal-type product as one weighing between
6 and 12 ounces per serving and containing ingredients from
two or more of four specified food groups.
     Claims that a meal or main dish is "free" of a nutrient,
such as sodium or cholesterol, must meet the same requirements
as those for individual foods.
     "Low" claims can be made if the main dish or meal has:
~    120 calories or less per 100 g
~    140 mg sodium or less per 100 g
~    3 g fat or less and no more than 30 percent of calories
from fat per 100 g
~    1 g saturated fat or less and no more than 10 percent
calories from saturated fat per 100 g or
~    20 mg cholesterol or less per 100 g and no more than 2 g
of saturated fat per 100 g.

Implied Claims
     "Made with oat bran" and "no tropical oils" are examples
of statements that may be implied nutrient content claims.
Such claims are prohibited when they wrongfully imply that a
food contains or does not contain a meaningful level of a
nutrient. They are allowed if the food's nutrient content
meets the definition for appropriate nutrient content
descriptors that are implied by the claim.
     For example, FDA considers statements about some types of
oil as an ingredient, such as "made with canola oil" or
"contains corn oil," to imply that the oil in the product is
low in saturated fat. Therefore, to carry that claim, a food
would have to meet the definition of "low saturated fat."
     The statement "made only with vegetable oil" implies that
because vegetable oil is used instead of animal fat, the oil
component contributes no cholesterol and is low in saturated
fat. In this case, the claim could be used only if the food
meets the definition of "cholesterol free" and "low saturated
fat."
     And the statement "contains no oil" implies that the
product contains no fat and thus is fat free. Such a claim on
a product that contained another source of fat, such as animal
fat, would be misleading. Therefore, this statement would be
allowed only if the food is truly fat free.
     Claims that imply a product contains a particular amount
of fiber, such as "high in oat bran," can be made only if the
food actually meets the definition for "high" fiber or "good
source" of fiber, whichever is appropriate.
     Statements that don't fall under the rules for nutrient
content implied claims and therefore are still allowed are:
~    those that help consumers avoid certain foods because of
religious beliefs or dietary practices--for example, a "milk-
free" claim
~    those about nonnutritive ingredients, such as "no
preservatives" or "no artificial colors"
~    those about ingredients that provide added value, such as
"contains real fruit"
~    statements of identity, such as "Colombian coffee" and
"100 percent corn oil"

Fresh
     Although not mandated by the Nutrition Labeling and
Education Act of 1990, as regulations for the other nutrient
content claims are, FDA has issued a regulation for the term
"fresh." Under this regulation, "fresh" can be used only on a
food that is raw, has never been frozen or heated, and
contains no preservatives. (Irradiation at low levels is
allowed.) "Fresh frozen," "frozen fresh," and "freshly
frozen" can be used for foods that are quickly frozen while
still fresh. Blanching (brief scalding before freezing to
prevent nutrient breakdown) is allowed.
     Other uses of the tern "fresh," such as in "fresh milk"
or "freshly baked bread," are not affected.

Healthy
     Along with the final rule on nutrient content claims
published last January, FDA and FSIS published proposed rules
that would allow manufacturers to make a "healthy" claim on
the label. Under FDA's proposal, "healthy" could be used if
the food is low in fat and saturated fat and a serving does
not contain more than 480 mg of sodium or more than 60 mg of
cholesterol. USDA's proposal would allow the term if the food
meets the definition for "lean" and contains no more than 480
mg of sodium per serving.
     Final rules are expected in 1993. n

Special Situations
     "Standards of identity" define a food's composition and
specify the ingredients it must contain. The government
originally developed these standards to protect consumers from
economic deception.
     But some standards of identity require high amounts of
nutrients that many consumers would like to avoid. For
example, the standard for sour cream requires that the food
contain 18 percent fat and the standard for mozzarella cheese
requires it to be 45 percent fat. Before the new regulations,
"reduced-fat" sour cream or mozzarella cheese were required to
have their own standards of identity or be called "imitation"
or "substitute," names that consumers may perceive as
negative.
     The new regulations allow manufacturers to reduce the fat
content of such products and call them "low fat" or "light,"
as appropriate, as long as the food is still nutritionally
equivalent to the regular version. For example, sour cream can
be called "light" as long as its fat content is reduced to 9
percent and has vitamin A added to replace the amount lost
when the fat was removed. If the company decides not to add
the vitamin A, it must call the product "imitation light sour
cream."
     FDA is not allowing nutrient content claims on foods for
infants and children under 2, unless explicit permission has
been given.
     FDA allows manufacturers to use the terms "unsweetened"
and "unsalted" on these foods because these claims are
considered to be about taste rather than nutrient content.
However, current dietary guidelines do not call for limiting
salt or sugar in the diets of children under 2. Therefore, FDA
will not allow phrases that imply low or reduced amounts of
sodium and calories, such as "no salt added" and "no sugar
added," on these types of foods. n
--D.S.

Getting Specific

Here are examples of the meanings of some descriptive words
for specific nutrients:

Sugar
Sugar free: less than 0.5 grams (g) per serving

No added sugar, Without added sugar, No sugar added:
~    No sugars added during processing or packing, including ingredients that
contain sugars (for example, fruit juices, applesauce, or dried fruit).
~    Processing does not increase the sugar content above the amount naturally
present in the ingredients. (A functionally insignificant increase in sugars is
acceptable from processes used for purposes other than increasing sugar content.
)
~    The food that it resembles and for which it substitutes normally contains
added sugars.
~    If the food doesn't meet the requirements for a low- or reduced-calorie foo
d,
the product bears a statement that the food is not low-calorie or calorie-reduce
d and
directs consumers' attention to the nutrition panel for further information on s
ugars
and calorie content.

Reduced sugar: at least 25 percent less sugar per serving than reference food

Calories
Calorie free: fewer than 5 calories per serving

Low calorie: 40 calories or less per serving and if the serving is 30 g or less
or 2
tablespoons or less, per 50 g of the food

Reduced or Fewer calories: at least 25 percent fewer calories per serving than
reference food

Fat
Fat free: less than 0.5 g of fat per serving

Saturated fat free: less than 0.5 g per serving and the level of trans fatty aci
ds does
not exceed 1 percent of total fat

Low fat: 3 g or less per serving, and if the serving is 30 g or less or 2 tables
poons or
less, per 50 g of the food
Low saturated fat: 1 g or less per serving and not more than 15 percent of calor
ies
from saturated fatty acids

Reduced or Less fat: at least 25 percent less per serving than reference food

Reduced or Less saturated fat: at least 25 percent less per serving than referen
ce
food

Cholesterol
Cholesterol free: less than 2 milligrams (mg) of cholesterol and 2 g or less of
saturated fat per serving

Low cholesterol: 20 mg or less and 2 g or less of saturated fat per serving and,
 if the
serving is 30 g or less or 2 tablespoons or less, per 50 g of the food

Reduced or Less cholesterol: at least 25 percent less and 2 g or less of saturat
ed fat
per serving than reference food

Sodium
Sodium free: less than 5 mg per serving

Low sodium: 140 mg or less per serving and, if the serving is 30 g or less or 2
tablespoons or less, per 50 g of the food

Very low sodium: 35 mg or less per serving and, if the serving is 30 g or less o
r 2
tablespoons or less, per 50 g of the food

Reduced or Less sodium: at least 25 percent less per serving than reference food


Fiber
High fiber: 5 g or more per serving. (Foods making high-fiber claims must meet t
he
definition for low fat, or the level of total fat must appear next to the high-f
iber
claim.)

Good source of fiber: 2.5 g to 4.9 g per serving

More or Added fiber: at least 2.5 g more per serving than reference food

--D.S.

("lite")
A fat-free claim on applesauce would have to read "applesauce, a fat-free food."


A serving of a food carrying a "more" claim (or claims of fortified, enriched or

added) must have at least 10 percent more of the Daily Value for a particular
nutrient (that is, dietary fiber, potassium, protein, or an essential vitamin or
 mineral)
than the reference food that it resembles.

"Fresh" can be used only on a food that is raw, has never been frozen or heated,
 and
contains no preservatives.
Part III


On the Teen Scene: Preventing STDs
by Judith Levine Willis
     This article is part of a series with important health
information for teenagers. Unlike previous articles, however,
it contains sexually explicit material in an effort to reduce
the incidence of STDs among teens. Parents and teachers may
want to review the article before giving it to teenagers.
     You don't have to be a genius to figure out that the only
sure way to avoid getting sexually transmitted diseases (STDs)
is to not have sex.
     But in today's age of AIDS, it's smart to also know ways
to lower the risk of getting STDs, including HIV, the virus
that causes AIDS.
     Infection with HIV, which stands for human
immunodeficiency virus, is spreading among teenagers. From
1990 to 1992, the number of teens diagnosed with AIDS nearly
doubled, according to the national Centers for Disease Control
and Prevention. Today, people in their 20s account for one out
of every five AIDS cases in the United States. Because HIV
infection can take many years to develop into AIDS, many of
these people were infected when they were teenagers.
     You may have heard that birth control can also help
prevent AIDS and other STDs. This is only partly true. The
whole story is that only one form of birth control--latex
condoms (thin rubber sheaths used to cover the penis)--reduces
the transmission (spread) of HIV and many other STDs.
     (When this FDA Consumer went to press, the Food and Drug
Administration was preparing to approve Reality Female Condom,
a form of birth control made of polyurethane. It may give
limited protection against STDs, but it is not as effective as
male latex condoms.)
     So people who use other kinds of birth control, such as
the pill, sponge, diaphragm, Norplant, Depo-Provera, cervical
cap, or IUD, also need to use condoms to help prevent STDs,
including HIV infection.
     Here's why: Latex condoms work against STDs by keeping
blood, a man's semen, and a woman's vaginal fluids--all of
which can carry bacteria and viruses--from passing from one
person to another. For many years, scientists have known that
male condoms (also called safes, rubbers, or prophylactics)
can help prevent STDs transmitted by bacteria, such as
syphilis and gonorrhea, because the bacteria can't get through
the condom. More recently, researchers discovered that latex
condoms can also reduce the risk of getting STDs caused by
viruses, such as HIV, herpes, and hepatitis B, even though
viruses are much smaller than bacteria or sperm.
     After this discovery, FDA, which regulates condoms as
medical devices, worked with manufacturers to develop labeling
for latex condoms. The labeling tells consumers that although
latex condoms cannot entirely eliminate the risk of STDs, when
used properly and consistently they are highly effective in
preventing STDs. FDA also provided a sample set of
instructions and requested that all condoms include adequate
instructions for use.

Make Sure It's Latex
     Male condoms sold in the United States are made either of
latex (rubber) or natural membrane, commonly called "lambskin"
(but actually made of sheep intestine). Scientists found that
natural skin condoms are not as effective as latex condoms in
reducing the risk of STDs because natural skin condoms have
naturally occurring tiny holes or pores that viruses may be
able to get through. Only latex condoms labeled for protection
against STDs should be used for disease protection.
     Some condoms have lubricants added and some have
spermicide (a chemical that kills sperm) added. The package
labeling tells whether either of these has been added to the
condom.
     Lubricants may help prevent condoms from breaking and may
help prevent irritation. But lubricants do not give any added
disease protection. If an unlubricated condom is used, a
water-based lubricant (such as K-Y Jelly), available over-the-
counter (without prescription) in drugstores, can be used but
is not required for the proper use of the condom. Do not use
petroleum-based jelly (such as Vaseline), baby oil, lotions,
cooking oils, or cold creams because these products can weaken
latex and cause the condom to tear easily.
     Condoms with added spermicide give added birth control
protection. An active chemical in spermicides, nonoxynol-9,
kills sperm. Although it has not been scientifically proven,
it's possible that spermicides may reduce the transmission of
HIV and other STDs. But spermicides alone (as sold in creams
and jellies over-the-counter in drugstores) and spermicides
used with the diaphragm or cervical cap do not give adequate
protection against AIDS and other STDs. For the best disease
protection, a latex condom should be used from start to finish
every time a person has sex.
     FDA requires condoms with spermicide to be labeled with
an expiration date. Some condoms have an expiration date even
though they don't contain spermicide. Condoms should not be
used after the expiration date, usually abbreviated EXP and
followed by the date.
     Condoms are available in almost all drugstores, many
supermarkets, and other stores. They are also available from
vending machines. When purchasing condoms from vending
machines, as from any source, be sure they are latex, labeled
for disease prevention, and are not past their expiration
date. Don't buy a condom from a vending machine located where
it may be exposed to extreme heat or cold or to direct
sunlight.
     Condoms should be stored in a cool, dry place out of
direct sunlight. Closets and drawers usually make good storage
places. Because of possible exposure to extreme heat and cold,
glove compartments of cars are not a good place to store
condoms. For the same reason, condoms shouldn't be kept in a
pocket, wallet or purse for more than a few hours at a time.

How to Use a Condom
~    Use a new condom for every act of vaginal, anal and oral
(penis-mouth contact) sex. Do not unroll the condom before
placing it on the penis.
~    Put the condom on after the penis is erect and before any
contact is made between the penis and any part of the
partner's body.
~    If the condom does not have a reservoir top, pinch the
tip enough to leave a half-inch space for semen to collect.
Always make sure to eliminate any air in the tip to help keep
the condom from breaking.
~    Holding the condom rim (and pinching a half inch space if
necessary), place the condom on the top of the penis. Then,
continuing to hold it by the rim, unroll it all the way to the
base of the penis. If you are also using water-based
lubricant, you can put more on the outside of the condom.
~    If you feel the condom break, stop immediately, withdraw,
and put on a new condom.
~    After ejaculation and before the penis gets soft, grip
the rim of the condom and carefully withdraw.
~    To remove the condom, gently pull it off the penis, being
careful that semen doesn't spill out.
~    Wrap the condom in a tissue and throw it in the trash
where others won't handle it. (Don't flush condoms down the
toilet because they may cause sewer problems.) Afterwards,
wash your hands with soap and water.
     Latex condoms are the only form of contraception now
available that human studies have shown to protect against the
transmission of HIV and other STDs. They give good disease
protection for vaginal sex and should also reduce the risk of
disease transmission in oral and anal sex. But latex condoms
may not be 100 percent effective, and a lot depends on knowing
the right way to buy, store and use them. n

Judith Levine Willis is editor of FDA Consumer.
Looking at a Condom Label
     Like other drugs and medical devices, FDA requires condom
packages to contain certain labeling information. When buying
condoms, look on the package label to make sure the condoms
are:
~    made of latex
~    labeled for disease prevention
~    not past their expiration date (EXP followed by the
date). n
STD Facts
~    About 12 million Americans a year become infected with
sexually transmitted diseases. Two-thirds of them are under
25, and one-quarter are teenagers.
~    Using drugs and alcohol increases your chances of getting
STDs because these substances can interfere with your judgment
and your ability to use a condom properly.
~    Intravenous drug use puts a person at higher risk for HIV
and hepatitis B because IV drug users usually share needles.
~    The more partners you have, the higher your chance of
being exposed to HIV or other STDs. This is because it is
difficult to know whether a person is infected, or has had sex
with people who are more likely to be infected due to
intravenous drug use or other risk factors.
~    Sometimes, early in infection, there may be no symptoms,
or symptoms may be confused with other illnesses.
~    You cannot tell by looking at someone whether he or she
is infected with HIV or another STD.

STDs can cause:
~    pelvic inflammatory disease (PID), which can damage a
woman's fallopian tubes and result in pelvic pain and
sterility
~    tubal pregnancies (where the fetus grows in the fallopian
tube instead of the womb), sometimes fatal to the mother and
always fatal to the fetus
~    cancer of the cervix in women
~    sterility--the inability to have children--in both men
and women
~    damage to major organs, such as the heart, kidney and
brain, if STDs go untreated
~    death, especially with HIV infection.

See a doctor if you have any of these STD symptoms:
~    discharge from vagina, penis or rectum
~    pain or burning during urination or intercourse
~    pain in the abdomen (women), testicles (men), or buttocks
and legs (both)
~    blisters, open sores, warts, rash, or swelling in the
genital or anal areas or mouth
~    persistent flu-like symptoms--including fever, headache,
aching muscles, or swollen glands--which may precede STD
symptoms.

New Information on Labels
     Information about whether a birth control product also helps
protect against sexually transmitted diseases (STDs), including HIV
infection, is being given added emphasis on the labeling of these
products.
     "In spite of educational efforts, many adolescents and young
adults, in particular, are continuing to engage in high-risk sexual
behavior," said FDA Commissioner David A. Kessler, M.D., in announcing
the label strengthening last April. "A product that is highly effective
in preventing pregnancy will not necessarily protect against sexually
transmitted diseases."
     Labels on birth control pills, implants such as Norplant,
injectable contraceptives such as Depo Provera, intrauterine devices
(IUDs), and natural skin condoms will state that the products are
intended to prevent pregnancy and do not protect against STDs,
including HIV infection (which leads to AIDS). Labeling of natural skin
condoms will also state that consumers should use a latex condom to
help reduce risk of many STDs, including HIV infection.
     Labeling for latex condoms, the only product currently allowed to
make a claim of effectiveness against STDs, will state that if used
properly, latex condoms help reduce risk of HIV transmission and many
other STDs. This statement, a modification from previous labeling, will
now appear on individual condom wrappers, on the box, and in consumer
information.
     Besides highlighting statements concerning sexually transmitted
diseases and AIDS on the consumer packaging, manufacturers will add a
similar statement to patient and physician leaflets provided with the
products.
     Consumers can expect to see the new labels by next fall. Some
products already include this information in their labeling
voluntarily. FDA may take action against any products that don't carry
the new information.
     FDA is currently reviewing whether similar action is necessary for
the labeling of spermicide, cervical caps, diaphragms, and the Today
brand contraceptive sponge.
                                ####


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             The Food Pyramid-Food Label Connection
                   by Etta Saltos, Ph.D., R.D.
     What foods fit in a healthy diet? How can you compare the
nutritional values of food? Can the new food label help you answer
these questions?
     It can, if you use the label information to follow the Dietary
Guidelines for Americans. (See accompanying article.)

Food Pyramid
     The Food Guide Pyramid can help you put the Dietary Guidelines
into action. The pyramid illustrates the research-based food
guidance developed by U.S. Department of Agriculture and supported
by the Department of Health and Human Services. It is based on
USDA's research on what foods Americans eat, what nutrients are in
these foods, and how to make the best food choices to promote good
health. It outlines what to eat each day, but it is not a rigid
prescription. You can use it as a general guide in choosing a
healthful diet that is right for you. The pyramid calls for eating
a variety of foods to get the nutrients you need, and, at the same
time, the right amount of calories to maintain a healthy weight. It
also focuses on fat because most American diets are too high in
fat, especially saturated fat.
     You don't have to avoid foods that are high in fat, saturated
fat, cholesterol, and sodium completely. It's your average intake
over a few days, not in a single food or even a single meal, that's
important. If you eat a high-fat food or meal, balance your intake
by choosing low-fat foods the rest of the day or the next day. The
new food label can help you "budget" your intake of fat, saturated
fat, cholesterol, and sodium over several days.
     The new food label also can help you identify good sources of
fiber and vitamins and minerals.

Look to the Label
     How does it do this? First, descriptors such as "free," "low"
or "reduced" on the front of the package can signal that a food is
low in a certain dietary component, such as calories, fat,
saturated fat, or sodium. Eating those foods can then help you
moderate your intake of these and other nutrients.
     Descriptors such as "good source" and "high" can help you
identify foods that contain significant amounts of dietary fiber,
vitamins, and minerals. (See "A Little 'Lite' Reading" on page 12.)
     Claims about the relationship between a nutrient or a food and
the risk of a disease or health-related condition also may show up
on the front of the package of FDA-regulated products. These are
called health claims, and FDA has authorized seven of them. They
can help you identify foods with certain nutritional qualities that
are of interest to you. (See "Starting This Month: Look for 'Legit'
Health Claims on Foods" in the May 1993 FDA Consumer.)
     However, you don't have to select only foods with descriptors
or health claims on the label to follow the Dietary Guidelines. In
moderation, all foods can fit into a healthy diet.
     Second, look at the nutrition panel, now titled "Nutrition
Facts." With a few exceptions, the nutrition panel will list
calories, calories from fat, and the amount of nutrients of
greatest  public health concern contained per serving of the food.
(See "'Nutrition Facts' to Help Consumers Eat Smart" in the May
1993 FDA Consumer.) Similar information also will be available
voluntarily for some raw foods. (See "Nutrition Info Available for
Raw Fruits, Vegetables, Fish" in the January~February 1993 FDA
Consumer.)
     On the nutrition panel, nutrient content will be expressed not
only as an amount by weight but also as a percent of the Daily
Value, or DV--a new label reference value. (See "'Daily Values'
Encourage Healthy Diet" in the May 1993 FDA Consumer.)
     These percentages can help you decide whether a food
contributes a lot or a little of a particular nutrient. Lower
percentages indicate the food contributes less of the nutrient, and
higher percentages indicate that it contributes more of the
nutrient.
     Look to see whether the nutrients you would like to get more
of (such as carbohydrate, dietary fiber, and vitamins and minerals)
have high percentages and the nutrients you may need to limit (such
as fat, cholesterol and sodium) have low percentages. The percent
Daily Values, while based on a 2,000-calorie diet, will indicate in
a relative way the nutritional contributions of a food to your diet
regardless of your calorie intake.
     Also, because serving sizes are now more uniform across
product lines, comparing the nutritional content of foods is
easier.
     However, the amount of food you eat may be different from the
stated serving size. For example, the serving size for ice cream is
a half cup, so if you usually eat one cup of ice cream, you would
have to double the number of calories and the percentages of the
Daily Values listed to learn the nutrient content of the portion
you eat.

Figuring Fat
     While the food label provides a reliable general guide for
most people, you may want to use the information on it to make more
personal choices.
     You may be concerned about fat, for example. The Dietary
Guidelines suggest that you eat a diet that provides 30 percent or
less of calories from fat and less than 10 percent of calories from
saturated fat. Thus, the recommended upper limit on the grams of
fat and saturated fat in your diet depends on the calories you need
(see chart on page 19). The percent DVs for fat and saturated fat
are based on a 2,000-calorie diet, which is about right for
moderately active women, teenage girls, and sedentary men.
     Some people keep a running total of the amount of fat and
saturated fat they eat in a day and compare this to their target
level. If you eat about 2,000 calories a day, you can simply
monitor the percent DV information from the foods you eat so that
the total is close to or less than 100 percent over the day.
     If you eat fewer than or more than 2,000 calories a day, you
can keep a total of the actual amount of fat and saturated fat
contained in the foods you eat. This information is listed
immediately after the nutrient name (for example, "Total Fat 13
g").
     Daily values based on an intake of 2,500 calories a day are
listed in a footnote, at least on the nutrition panels of larger
packages. These values can be used as a target level for many men,
teenage boys, and active women.
     The chart on page 19 lists recommended upper limits of fat and
saturated fat intakes for other calorie levels. Many older adults,
children, and sedentary women need fewer than 2,000 calories a day
and may want to select target levels based on 1,600 calories a day.
Some active men and teenage boys and very active women may want to
select target levels based on 2,800 calories per day.

Sugars and Others
     The percent DV column also can be used to help you moderate
your intake of sodium and cholesterol. The Daily Values for sodium
and cholesterol are the same for everyone, regardless of total
calories consumed, so you do not have to make adjustments based on
your caloric needs.
     Food labels also can be helpful if you're trying to moderate
your sugar intake. The nutrition panel lists the amount of sugars
in grams (4 grams is equivalent to 1 teaspoon) in a serving of the
food.
     Note that this amount includes sugars that are present
naturally in the food (such as lactose in milk and fructose in
fruit), as well as sugars added to the food during processing. If
you're interested in finding out whether a sweetener has been added
to a food, check the ingredient listing. Terms such as "sugar
(sucrose)," "fructose," "maltose," "lactose," "honey," "syrup,"
"corn syrup," "high-fructose corn syrup," "molasses," and "fruit
juice concentrate" are used to describe sweeteners added to foods.
     If one of these terms appears first or second in the list of
ingredients, or if several of them appear, the food is likely to be
high in added sugars. A percent DV is not given for sugars because
there is no target quantity of sugars to aim for each day.
     Labeling of the alcohol content of beverages is regulated by
the Bureau of Alcohol, Tobacco, and Firearms. Alcohol content (in
percentage by volume) appears on the front panel of some alcoholic
beverage labels. Alcohol content of foods and beverages is not
required to be listed on the nutrition panel. However, some
alcoholic beverages, such as light beers and wine coolers, provide
information about the amount of calories, carbohydrate, protein,
and fat they contain. You may find this information useful if
you're counting calories because alcoholic beverages are generally
rich in calories and poor in nutrients.
      You'll find lots of information on food labels. So take the
time to read them. The information can help you plan a healthful
diet that meets the recommendations of the Dietary Guidelines. n

Etta Saltos is a nutritionist with USDA's Human Nutrition
Information Service.
Dietary Guidelines
     The Dietary Guidelines, developed by the Department of Health
and Human Services and the U.S. Department of Agriculture,
represent the best, most current advice for healthy Americans 2
years and older. They reflect recommendations of health and
nutrition experts, who agree that enough is known about the effect
of diet on health to encourage certain eating practices. The seven
Dietary Guidelines are:
~    Eat a variety of foods to get the energy (calories), protein,
vitamins, minerals, and fiber you need for good health.
~    Maintain a healthy weight to reduce your chances of having
high blood pressure, heart disease, a stroke, certain cancers, and
the most common kind of diabetes.
~    Choose a diet low in fat, saturated fat, and cholesterol to
reduce your risk of heart disease and certain types of cancer.
Because fat contains more than twice the calories of an equal
amount of carbohydrates or protein, a diet low in fat can help you
maintain a healthy weight.
~    Choose a diet with plenty of vegetables, fruits, and grain
products that provide needed vitamins, minerals, fiber, and complex
carbohydrates. They are generally lower in fat.
~    Use sugars only in moderation. A diet with lots of sugars has
too many calories and too few nutrients for most people and can
contribute to tooth decay.
~    Use salt and other forms of sodium only in moderation to help
reduce your risk of high blood pressure.
~    If you drink alcoholic beverages, do so in moderation.
Alcoholic beverages supply calories, but little or no nutrients.
Drinking alcohol is also the cause of many health problems and
accidents and can lead to addiction. n
Find Your Fat Limit

(Recommended upper limits of total fat and saturated fat intake at
different calorie levels)

     Calories

1,6002,000 2,500
2,800

Total Fat53  65   80     93
(grams)
Saturated Fat18   20   25     31
(grams)
(dietguide)
You don't have to avoid foods that are high in fat, saturated
fat, cholesterol, and sodium completely. It's your average intake
over a few days, not in a single food or even a single meal,
that's important.

Descriptors such as "free," "low" or "reduced" on the front of
the package can signal that a food is low in a certain dietary
component, such as calories, fat, saturated fat, or sodium.

Descriptors such as "good source" and "high" can help you
identify foods that contain significant amounts of dietary fiber,
vitamins, and minerals.

In moderation, all foods can fit into a healthy diet.

Look to see whether the nutrients you would like to get more of
(such as carbohydrate, dietary fiber, and vitamins and minerals)
have high percentages and the nutrients you may need to limit
(such as fat, cholesterol and sodium) have low percentages.

The serving size for ice cream is a half cup, so if you usually
eat one cup of ice cream, you would have to double the number of
calories and the percentages of the Daily Values listed to learn
the nutrient content of the portion you eat.

The percent DVs for fat and saturated fat are based on a 2,000-
calorie diet, which is about right for moderately active women,
teenage girls, and sedentary men.

If you eat about 2,000 calories a day, you can simply monitor the
percent DV information from the foods you eat so that the total
is close to or less than 100 percent over the day.

Daily values based on an intake of 2,500 calories a day are
listed in a footnote, at least on the nutrition panels of larger
packages. These values can be used as a target level for many
men, teenage boys, and active women.

The Daily Values for sodium and cholesterol are the same for
everyone, regardless of total calories consumed, so you do not
have to make adjustments based on your caloric needs.
                              ####


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            Bottled Water: New Trends, New Rules
                      by Victor Lambert
     It's practically everywhere. In the workplace. Beside
exercise stations in health clubs. At athletic events. In
backpacks hanging from the shoulders of students. Even on
tables at conferences and workshops. Bottled water, once
considered the refreshment of the affluent, has become the
liquid icon of today's active, health-conscious consumer.
     In 1984, Americans consumed an average of 4 gallons of
bottled water per person. By 1991, that number had doubled,
according to data collected by the International Bottled Water
Association (IBWA).
     More than 700 different brands of bottled water are
available in the United States. Seventy-five of those brands
are made from imported waters. The average retail price of a
1-gallon bottle of domestic drinking water is 90 cents, $5.29
for a 5-gallon bottle that is delivered.
     Taste is the number one reason why people say they prefer
bottled water, according to consumer attitude and usage
surveys conducted by IBWA, the trade association for the $2
billion bottled water industry.
     The final disinfectant agent used by most of the nation's
430 bottling facilities is ozone, a form of oxygen. But,
unlike the chlorine used to disinfect tap water, ozone leaves
no chemical residual aftertaste or smell.
     The second reason more people today are choosing bottled
water has to do with the notion that it's purer and healthier.
Because low levels of lead or chlorination byproducts are
sometimes found in tap water, most bottled water drinkers
believe the bottled variety is healthier than water from the
tap. But is it?

Making Bottled Water Safe
     Bottled water quality standards were originally adopted
in 1973 and were based on the 1962 U.S. Public Health Service
standards for drinking water.
     In 1974, the Safe Drinking Water Act made the
Environmental Protection Agency responsible for ensuring the
safety of municipal water systems, which includes setting
maximum limits for chemical, bacteriological and radioactive
contaminants and physical contaminants that affect odor, taste
and color. In 1986, amendments to the Safe Drinking Water Act
required EPA to set additional standards. When EPA adds or
amends a contaminant standard, the Food and Drug
Administration must set an acceptable level for it in bottled
water or publish in the Federal Register its reasons for not
doing so.
     Since 1975, under the "misbranded products" provision of
the Federal Food, Drug, and Cosmetic Act, FDA has been
responsible for ensuring that the quality standards for
bottled water are compatible with EPA standards for quality
and safety of tap water. In 1978, FDA broadened the bottled
water standards to include maximum allowable contaminant
levels for pesticides, mercury and radioactive matter.
     In carrying out its mission to ensure the safety of
bottled  water, FDA also inspects bottled water facilities on
a regular basis. Like other foods, bottled water must be
processed, packaged, shipped, and stored in a safe and
sanitary manner, and be truthfully and accurately labeled.
     According to Terry Troxell, Ph.D., director of FDA's
division of programs and enforcement policy in the Office of
Plant and Dairy Foods and Beverages, "If we [FDA] find a
problem during an inspection, we make that company a priority
and FDA field personnel inspect it more frequently. For
example, after the Perrier 'mineral' water incident in 1990
[when the carcinogen benzene was found in Perrier], we did a
follow-up survey to analyze the water's quality."
     State agencies, some under contract to FDA, and industry
also conduct regular inspections of bottled water facilities
in an effort to ensure that only safe products are
distributed.
     "We're interested in making sure bottled water companies
produce safe products and that they're truthfully labeled,"
Troxell said.
     The terms "spring," "well," "artesian," "distilled,"
"purified" and "mineral" have appeared on bottled water labels
for years. But recently, there have been an increasing number
of companies whose labels didn't match their products.
     At the same time, variations in how states define the
different types of bottled water have been an issue. In North
Carolina, for example, "spring" water refers only to water
that has been collected from the natural orifice in the
earth's surface. In other states, it can be both water that
has been collected from the natural orifice or from a bore
hole that taps the spring and is located near where the spring
emerges.
     As a result, FDA, last Jan. 5, announced proposed
regulations that would establish standard definitions for all
bottled water products, and set new limits for approximately
50 chemical and other contaminants that may be present in
bottled water. FDA has already established quality standards
for 31 contaminants.
     The regulations would also apply the quality standard
requirements for bottled water to mineral water.
     IBWA petitioned FDA to establish stricter guidelines for
bottled water in l988.
     After studying the situation, FDA proposed standard
definitions because the terms provided by the "misbranded
products" provision of the Food, Drug, and Cosmetic Act were
not specific enough for use in identifying components of such
a diverse group of bottled water products.
     "The bottled water industry has grown too much over the
last few years to continue handling violations on a case-by-
case basis," Troxell said. "We need revised bottled water
regulations that are broad based."

Revising the Regulations
     Under the proposed regulations, "artesian" water would be
considered bottled water that is drawn from a well that taps
a confined aquifer (a water-bearing rock, rock formation, or
group of rocks) in which the water level stands above the
natural water table.
     "Distilled" water would be bottled water that has been
produced by a process of distillation--vaporizing water, then
condensing it in a way that leaves it free of dissolved
minerals.
     "Purified" water would be water that is produced by
distillation, deionization (passing water through resins that
remove most of the dissolved minerals), reverse osmosis (the
use of membrane filters to remove dissolved solids), or other
suitable processes, and that meets the U.S. Pharmacopeia's
most recent definition of "purified" water. The U.S.
Pharmacopeia establishes the standard for "purified" water
because it is commonly used in laboratories and for medical
purposes.
     "Spring" water would be bottled water obtained from an
underground formation from which water flows naturally to the
surface, or would if it were not collected underground through
a bore hole where a spring emerges.
     Bottled water that comes from a hole bored, drilled, or
otherwise constructed in the ground to tap an aquifer would be
called "well" water.
     "Mineral" water, which was previously exempt from bottled
water quality standards, would be water that comes from a
source tapped at one or more bore holes or springs originating
from a geologically and physically protected underground water
source. "'Mineral' water was exempt until now because it was
only consumed in very small amounts," Troxell said. "It was
considered a different product."
     In addition to including "mineral" water in the proposed
regulations, the water ingredient in certain types of flavored
bottled waters have to comply with the same maximum allowable
contaminant levels required of other bottled waters.
     The proposed regulations, however, would continue to
exclude products labeled as "carbonated" water, "seltzer"
water, "soda" water, and "tonic" water, because they are
considered soft drinks.
     "We think the proposed regulations are well done and
we're completely supportive," said Ronald Davis, president of
IBWA and chairman of the Greenwich, Conn.-based Perrier Group
of America. "They provide the basis to have bottled water
regulated in an intelligent yet thorough way."
     And what about bottled water that actually comes from
municipal water systems? All products fitting this
description, under the proposed regulations, would have to be
clearly labeled as such. The requirement would be dropped,
however, if the water has been taken from municipal water
supplies and then processed and treated in a way that would
enable it to be labeled "distilled" or "purified."
      Approximately 75 percent of bottled water comes from
protected springs and wells. The other 25 percent is derived
from municipal water systems that meet federal and state
requirements established by the 1974 Safe Drinking Water Act.
     Under the stricter restrictions in the proposed
regulations, the bottled water label would have to state if
the water comes from a municipal source.
     The proposed regulations also require specific labeling
on bottled waters marketed for infants. Labels on this type of
water would have to indicate if the water is not sterile and
that it should  only be used as directed by a physician or
according to infant formula preparation instructions.
     Besides addressing labeling issues, the proposed
regulations would set maximum limits for many contaminants
found in bottled water.

Reducing Contaminants
     Under a final rule published in the Jan. 3, 1993, Federal
Register, the allowable levels for seven synthetic volatile
organic chemicals were amended to comply with maximum
contaminant levels set by EPA. The seven chemicals are:
benzene, carbon tetrachloride, 1,2-dichloroethane, 1,1-
dichloroethylene, 1,1,1-trichloroethane, trichloroethylene,
and vinyl chloride.
     Proposed regulations would also revise or affirm maximum
levels for inorganic substances such as lead, copper, mercury,
barium, and cadmium.
     The proposed regulations would also establish or modify
permitted levels for 28 synthetic organic chemicals, including
10 synthetic volatile organic chemicals, 17 pesticides, and
polychlorinated biphenyls.
     In all, the proposed regulations would establish 27 new
chemical levels and amend the existing allowable levels of
many others.
     "The new regulations mean a lot to us for two reasons,"
IBWA's Davis said. "They'll help ensure that bottled water is
as good as tap water, and they'll make labeling consistent
from state to state. But we're pleased with the new
regulations and look forward to implementing them."

Victor Lambert, now with Howard University, Washington, D.C.,
wrote this article while on the staff of FDA Consumer. Judith
Levine Willis also contributed to this article.
                            ####


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                  FDA Reports on Pesticides in Foods
                        by Judith E. Foulke
     Pesticide residues on infant foods and adult foods that
infants and children eat are almost always well below
tolerances (the highest levels legally allowed) set by the
Environmental Protection Agency. This was the conclusion of a
recent Food and Drug Administration report based on the
agency's monitoring of these types of foods over the last
seven years.
     The FDA report, "Monitoring of Pesticide Residues in
Infant Foods and Adult Foods Eaten by Infants and Children,"
was published in the May-June 1993 issue of the Journal of the
Association of Official Analytical Chemists International.
     The authors, consumer safety officer Norma Yess and
chemists Ellis Gunderson and Ronald Roy of the Center for Food
Safety and Applied Nutrition, based their findings on food
samples from the three approaches FDA uses to monitor
pesticides: regulatory, incidence and level, and Total Diet
Study.
     Through the regulatory approach, FDA checks foods close
to the point of production for levels of residues and, if they
are violative, considers enforcement action. Incidence and
level is a study approach that analyzes selected samples of
certain foods. Total Diet Study is an approach that uses data
from supermarket shopping.
     Of more than 10,000 food samples reported from regulatory
monitoring, fewer than 50 were violative. No residues over EPA
or FDA action levels were found in samples from the incidence
and level studies. In the Total Diet Study, no residues were
found in infant formulas, and no residues over FDA or EPA
allowed levels were found.

Shared Responsibility
     The responsibility for ensuring that residues of
pesticides in foods are not present at levels that will pose
a danger to health is shared by FDA, EPA, and the Food Safety
and Inspection Service of the U.S. Department of Agriculture.
Pesticides of concern include insecticides, fungicides,
herbicides, and other agricultural chemicals.
     EPA reviews the scientific data on all pesticide products
before they can be registered (or licensed) for use. If a
product is intended for use on food crops, EPA also
establishes a tolerance.
     FDA is responsible for enforcing these tolerances on all
foods except meat, poultry, and certain egg products, which
are monitored by USDA. In addition, FDA works with EPA to set
"action levels"--enforcement guidelines for residues of
pesticides, such as DDT, that may remain in the environment
after their use is discontinued. The guidelines are set at
levels that protect public health.

Regulatory Monitoring
     In its regulatory monitoring to enforce EPA-set
tolerances, FDA checks foods for pesticide residues as close
to production of the commodity as possible--at distributors,
at food processors, or, if  imported, at entry into the
country. If illegal residues are found in domestic samples,
FDA can take regulatory action, such as seizure or injunction.
For imports, FDA can stop shipments at ports of entry.
     The FDA report used data from FDA regulatory monitoring
between 1985 and 1991. The authors chose eight foods that
infants and children eat in relatively large quantities--
apples, bananas, oranges, and pears; apple, grape and orange
juices; and milk.
     FDA found 50 violative samples, representing only 0.3
percent of domestic products and 0.6 percent of imports
reported under the regulatory monitoring approach.
     All foods sampled in regulatory monitoring are analyzed
unwashed and unpeeled--even bananas. Yess explains that
because food processors, and most consumers, wash or peel
produce before eating or using it in food products, many of
the violative samples reported in the FDA study showed higher
residues than the actual amount people are exposed to. Studies
have shown that residues of many pesticides can be washed off
fresh produce, a good practice for anyone fixing a salad or
snacking on grapes (see accompanying article).
     Of the 50 violative samples, nearly all were pesticide
residues for which there were no tolerances or EPA "approval
for use" on the specific food sampled. Since pesticides are
registered for specific crops, residues on crops for which the
pesticide has not been registered are illegal.
     A few samples had residues higher than EPA tolerances or
FDA action levels in effect at the time; a number of
tolerances were revised between 1985 and 1991. The revisions
for daminozide (Alar), for example, reflect that it has not
been used in agriculture since 1989.
     Some domestic milk samples showed small amounts of
chlorinated pesticide residues. The registration for food use
for these compounds expired more than 20 years ago, but
because they persist in the environment, residues are still
found at low levels.

Incidence and Level Studies
     When FDA wants to know more about specific pesticides,
commodities, or pesticide-commodity combinations, the agency
supplements its regulatory monitoring by analyzing selected
samples of certain foods in incidence and level monitoring.
     For the pesticide residue report, the authors used the
results of two studies. One study targeted five specific
commodity-pesticide combinations for infant foods and other
foods commonly eaten by infants and children. The analyses for
this study were directed by FDA and completed in 1990 through
a cooperative agreement with a USDA laboratory in Gulfport,
Miss. The other study, also in 1990, analyzed whole
pasteurized milk samples through an FDA-supported contract.
     Both studies included results of analyses of several
pesticides and pesticide-commodity combinations that have been
the focus of public attention within the last five years. No
residues over EPA tolerances or FDA action levels were found
in samples from either of the two studies.
     The first study involved five tasks. In the first, about
900 samples of commercially prepared infant foods and formulas
were  collected and analyzed for residues of the following
pesticides:
~    benomyl-thiabendazole (fungicides)
~    daminozide (sprayed on apple trees to prevent premature
drop, no longer used by growers)
~    ethylenethiourea (ETU, a breakdown product of a
fungicide)
~    aldicarb (an insecticide, acaricide against snails, and
nematocide against worms)
~    the organochlorine group of pesticides (older, more
persistent pesticides, including those no longer used in
foods).
     The other four tasks were analyses of adult foods eaten
by infants and children:
~    apples, bananas, oranges, and pears for benomyl-
thiabendazole
~    apple and grape juices, applesauce, and canned pears for
daminozide
~    grape juice for ETU
~    bananas, oranges, and orange juice for aldicarb.
     Three-quarters of the samples collected for all tasks
were from large retail grocery stores in six states--
Massachusetts, Illinois, Michigan, Wisconsin, Minnesota, and
Washington. The remaining samples were collected in the
Gulfport, Miss., area (the home of USDA's National Monitoring
and Residue Analysis Laboratory, where the FDA-directed study
was done). The prepared infant foods and formula samples were
selected mostly from the major manufacturers.
     The second study showed the results of sampling for
residues of the organochlorine group of pesticides in whole
pasteurized milk. Organochlorine pesticide residues--mostly
DDT, DDE and dieldrin--were found in 398 of the 806 milk
samples, but all were well below EPA tolerances or FDA action
levels.
     Samples for the milk study came from monthly collections
at 63 sampling stations that are a part of EPA's Environmental
Radiation Ambient Monitoring System, located in large
metropolitan areas throughout the United States. At each
sampling station, milk from selected sources was combined to
represent the milk routinely consumed in that area. Portions
of the milk were sent to an FDA contract laboratory for
analysis.

Total Diet Study
     For its report, FDA also used data from the Total Diet
Study, which is used to monitor a number of nutritional
concerns, including pesticides. As part of the Total Diet
Study, FDA staffers shop in supermarkets or grocery stores
four times a year, once in each of four geographical regions
of the country. Shopping in three cities from each region,
they buy the same 234 foods (including meat), selected from
nationwide dietary survey data to typify the American diet.
The purchased foods are called "market baskets."
     Foods from the market baskets are then prepared as a
consumer would prepare them. For example, beef and vegetable
stew is made from the collected ingredients, using a standard
recipe. The prepared foods are analyzed for pesticide
residues, and the results, together with USDA consumption
studies, are used to estimate the dietary intakes of pesticide
residues for eight age-sex groups ranging from  infants to
senior citizens.
     For their report, the FDA researchers included results
from 27 market baskets collected and analyzed between 1985 and
1991. Included were 33 different infant foods (both strained
and junior), 10 adult foods eaten by infants and children, and
four types of milk. The infant foods included cereals,
combination meat and poultry dinners, vegetables, desserts,
fruits and fruit juices, and infant formulas. The adult foods
included apples, oranges, pears, and bananas; apple, grape and
orange juices; applesauce; grape jelly; and peanut butter.
Milks were chocolate, evaporated, low-fat (2 percent), and
whole.
     No residues were found in the infant formulas, and no
residues over EPA tolerances or FDA action levels were found
in any of the Total Diet Study foods. Low levels of malathion
were found in some cereals because malathion is widely used
both before and after harvest on grains. Low levels of
thiabendazole, a post-harvest fungicide used on many fruits,
were found on some of the fruits and fruit products.
     The low levels of pesticide residues found in the Total
Diet Study and incidence-level monitoring samples show how
processing foods or otherwise preparing them for consumption
at the table can reduce residue levels. Washing at home
removes much of the residues. But commercial food processing
steps, such as peeling and blanching, can further reduce
residues. For example, the highest finding of thiabendazole in
raw apples was 2 parts per million (EPA tolerance is 10 ppm),
0.08 in apple juice, and 0.06 in applesauce.
     Also, agricultural specialists from major infant food
manufacturers work with their contract growers to minimize
pesticide applications and to ensure that only those
pesticides specified in the contract are applied. Therefore,
when pesticide residues are found on infant foods, they are
usually well below EPA tolerances. n

Judith E. Foulke is a staff writer for FDA Consumer. Judith
Levine Willis also contributed to this article.

Wash Before Eating
     Washing fresh produce before eating is a healthful habit.
You can reduce and often eliminate residues if they are
present on fresh fruits and vegetables by following these
simple tips:
~    Wash produce with large amounts of cold or warm tap
water, and scrub with a brush when appropriate; do not use
soap.
~    Throw away the outer leaves of leafy vegetables such as
lettuce and cabbage.
~    Trim fat from meat, and fat and skin from poultry and
fish. Residues of some pesticides concentrate in animal fat.
     Supermarkets, as a rule, don't wash produce before
putting it out, but many stores mist it while it's on display.
Misting keeps the produce from drying, but surface residues
drain off also, in much the same way as from a light wash
under the kitchen faucet.
     A 1990 report in the EPA Journal by three chemists from
that agency, Joel Garbus, Susan Hummel, and Stephanie Willet,
summarized four studies of fresh tomatoes treated with a
fungicide, which were tested at harvest, at the packing house,
and at point of sale to the consumer. The studies showed that
more than 99 percent of the residues were washed off at the
packing house by the food processor.
     A 1989 study reported by Edgar Elkins in the Journal of
the Association of Official Analytical Chemists showed the
effects of peeling, blanching and processing on a number of
fruits and vegetables. For example, in the case of benomyl, 83
percent of the residues found on fresh apples were removed
during processing into applesauce, 98 percent of residues from
oranges processed to juice were removed, and 86 percent of
residues from fresh tomatoes processed to juice were removed.
Another study in 1991 by Gary Eilrich, reported in an American
Chemical Society Symposium, showed similar results. n
--J.E.F.
NAS Evaluation Expected
     The National Research Council of the National Academy of
Sciences (NAS) is expected to issue a report this summer on
its evaluation of the methods the government uses to estimate
the health risks to infants and children from dietary
exposures to pesticide residues. At issue is whether federal
pesticide risk assessments, on which Environmental Protection
Agency tolerances are based, adequately protect special
segments of the population, particularly infants and children.
     Tolerance levels reflect both the toxicity of a chemical
and anticipated dietary exposure. Risks are calculated from
two types of exposure estimates:
~    the potential risk from a one-time exposure
~    a composite average lifetime risk, which includes a
proportionately greater exposure in childhood.
     FDA and U.S. Department of Agriculture monitoring for
pesticide residues consistently show that levels rarely exceed
or approach established tolerances. Estimated dietary intakes
of pesticides by children and adults in the United States are
also well below Acceptable Daily Intakes (ADI) established by
the Food and Agriculture Organization and the World Health
Organization, seldom exceeding 1 percent of the ADI.
     In response to a request from Congress in 1988, NAS
convened a 14-person committee representing academia,
medicine, state governments, industry, USDA, and Canada's
health agencies. EPA asked the committee to address:
~    the ways in which children are more or less susceptible
to the toxicity of pesticides in their diets
~    diets of various age groups
~    pesticide use patterns on crops likely to contain
residues that cause concern
~    improvements EPA could make in its toxicological testing
requirements and methods of estimating risk to improve
protection for infants and children.

--J.E.F.

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