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U.S. issues new standards for dietary supplements
By Lisa Richwine Fri Jun 22, 5:20 PM ET

WASHINGTON (Reuters) - Makers of vitamins, herbs and other
dietary supplements taken by millions of Americans must meet
new government standards to show the products are free of
contamination and contain exactly what the label says, U.S.
health officials said on Friday.

Under the long-awaited U.S. Food and Drug Administration rules,
companies in the $18-billion- a-year industry must test the purity,
strength and composition of all of their supplements.

"This rule helps to ensure the quality of dietary supplements so
that consumers can be confident that the products they purchase
contain what is on the label," FDA Commissioner Andrew von
Eschenbach said in a statement.

Congress gave the FDA power to set manufacturing standards
for dietary supplements in a 1994 law. The final requirements
announced on Friday will not apply to all makers until 2010.

In addition to product testing, the new standards address design
and construction of manufacturing plants, record-keeping and
handling of consumer complaints.

Inspectors will check plants for compliance, FDA officials said.
For less serious violations, the agency may ask a company to fix
a problem. Bigger problems could lead to product seizures or
other action, said Robert Brackett, head of the FDA's Center for
Food Safety and Applied Nutrition.

Some supplements have been recalled in the past because they
were contaminated with microbes, pesticides or metal, or
because they did not contain the ingredients listed.

The FDA also has warned companies that sold supplements
with undeclared drug ingredients for impotence, and others with
less-than-advertise d levels of vitamins A and C and folic acid.

Sen. Richard Durbin, an Illinois Democrat, said the
manufacturing rule was "better late than never. But the
requirements do not appear to go as far as they could have."

"The dietary supplement industry will have significant latitude to
determine what quality control measures are appropriate, and
limited resources will limit FDA's ability to follow up on
complaints," Durbin said in a statement.

Supplements do not have to be proven safe and effective before
they can be sold, as medicines do, and the new rules will not
change that.

The new FDA announcement "not only is 13 years late but will not
do anything to ensure that dietary supplements are safe or
effective - a critical necessity," said consumer watchdog Sidney
Wolfe, head of Public Citizen's Health Research Group.

The FDA said the rules take effect August 24, but they will be
phased in so that large companies comply by June 2008, while
companies with fewer than 500 employees have until June 2009.
Firms with fewer than 20 employees have until June 2010.

Some supplement makers have been following industry
manufacturing standards voluntarily while pushing for the
government rules in hopes the requirements would weed out
unscrupulous firms and boost public confidence.

Industry groups said they were pleased the FDA had issued the
final rules but were still reviewing them.

David Seckman, chief executive of the Natural Products
Association, said the requirements appeared "strong but more
reasonable" than an earlier proposal.

"This will help smaller companies control costs - costs that
would have been passed along to the consumer - while still
maintaining quality standards," Seckman said in a statement.

Companies can petition to be exempted from having to test 100
percent of their ingredients. They must provide documents
showing less-frequent testing would still assure quality.

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Lung Illness Linked to Heart, Bone Problems
June 15, 2007 08:40:41 PM PST
By Randy Dotinga
HealthDay Reporter

FRIDAY, June 15 (HealthDay News) -- Chronic obstructive
pulmonary disease (COPD), a common, often fatal lung
disease in smokers, can also stiffen arteries, new British
researcher shows.

The effect was especially strong in COPD patients who
also suffered from osteoporosis, they add.

While COPD remains incurable and very difficult to treat,
"we are learning more about the problems associated with
the disease, and new treatments are likely to follow," said
study co-author Dr. Dennis Shale, a lung specialist at
Cardiff University in the United Kingdom.

COPD, the fourth leading cause of death in the United
States, kills by slowly closing off a person's airways due to
a combination of emphysema and chronic bronchitis. The
disease typically occurs in smokers, and scientists think it
is caused by inflammation stemming from long-term
smoking or other irritants.

In the new study, researchers looked at two groups of
people, 75 with COPD and 42 people -- both smokers or
ex-smokers -- who did not have COPD or heart disease.

The findings are published in the second issue for June of
the American Journal of Respiratory and Critical Care
Medicine.

Tests suggested that the arteries of the lung disease
patients were "stiffer" than those of the other subjects, the
researchers report, and arteries deteriorated more as
patients got sicker. Stiff or "hardened" arteries -- a
condition called atherosclerosis -- can restrict or even cut
off blood flow, increasing risks for heart attack and stroke.

Atherosclerosis appeared to be especially advanced in the
18 lung disease patients in the study who suffered from
the bone-weakening condition known as osteoporosis.

Scientists still don't understand exactly how COPD and
heart disease might be related. But, Shale said, the study,
"adds a piece to the jigsaw puzzle, by showing that there is
a relationship between the severity of lung disease and
stiffness in the aorta, the main artery leading from the heart
to the rest of the body."

The research also suggests that inflammation plays a
major role, he said.

As for osteoporosis, Shale said the research suggests
that COPD may cause premature aging by quickening the
decline of both bones and arteries.

Dr. Peter Calverley, a professor of respiratory medicine at
The University of Liverpool in the United Kingdom, who's
familiar with the study findings, said the research adds to
existing knowledge by linking both heart disease and
osteoporosis to COPD.

He agreed that these conditions could be related to an
inflammatory signal that arises from the lungs. The bottom
line, according to Calverley, is that doctors and patients
should know that this type of lung disease is "a good
marker for other bad stuff." That means that doctors
treating COPD should also look for both heart and bone
disease in patients.

The next step, he said, is to figure out exactly how lung
disease might cause other problems. "If we understood
that, we might be able to change it," he said.

More information

What Is COPD?

Chronic obstructive pulmonary disease (COPD) is a lung
disease in which the lungs are damaged, making it hard to
breathe. In COPD, the airways—the tubes that carry air in
and out of your lungs—are partly obstructed, making it
difficult to get air in and out.

Cigarette smoking is the most common cause of COPD.
Most people with COPD are smokers or former smokers.
Breathing in other kinds of lung irritants, like pollution,
dust, or chemicals, over a long period of time may also
cause or contribute to COPD.

The airways branch out like an upside-down tree, and at
the end of each branch are many small, balloon-like air
sacs. In healthy people, each airway is clear and open.
The air sacs are small and dainty, and both the airways
and air sacs are elastic and springy. When you breathe in,
each air sac fills up with air like a small balloon; when you
breathe out, the balloon deflates and the air goes out. . In
COPD, the airways and air sacs lose their shape and
become floppy. Less air gets in and less air goes out
because:

The airways and air sacs lose their elasticity (like an old
rubber band).
The walls between many of the air sacs are destroyed.
The walls of the airways become thick and inflamed
(swollen).
Cells in the airways make more mucus (sputum) than
usual, which tends to clog the airways.
COPD develops slowly, and it may be many years before
you notice symptoms like feeling short of breath. Most of
the time, COPD is diagnosed in middle-aged or older
people.

COPD is a major cause of death and illness, and it is the
fourth leading cause of death in the United States and
throughout the world.

There is no cure for COPD. The damage to your airways
and lungs cannot be reversed, but there are things you can
do to feel better and slow the damage.

COPD is not contagious—you cannot catch it from
someone else.