Good Morning All,
This item ran in the NYT in Jan. 2002 but is
good reading now with the coQ10 stuff...

cheers ...... murray

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The New York Times - January 2, 2002, Wednesday

EATING WELL; It's on the Label, But in the Tablet?

By Marian Burros

THE dietary supplement industry has always been
the Wild West of health, unregulated and risky.

There has been no way to know whether a bottle
contained what the label said it did and no way
to know whether the supplement was effective.

Now, in the absence of government oversight,
several private companies are getting into the
business of analysis and certification. While
some critics of the supplement industry are
pleased to see any effort at all, others shake
their heads in dismay, certain that consumers
will be more confused than enlightened.

Unlike prescription and over-the-counter drugs,
for which the Food and Drug Administration
has stringent regulations, there is barely any
government oversight of the safety and efficacy
of vitamins, minerals and herbal and nonherbal
supplements. Not even the venerable USP seal
from United States Pharmacopeia, the organization
that sets standards for vitamins and minerals
recognized by the government, means that products
have been certified by an independent source.
Compliance to the standards is voluntary,
and the use of the USP seal is infrequently monitored.
Only the manufacturer knows if the label information
accurately reflects the actual contents
and their strength.

The three companies that will certify supplements
-- United States Pharmacopeia, ConsumerLab.com
and NSF International -- will test to see if the contents
and potency listed on the label of a product
are accurate. But these tests will not provide
the answers the public really needs: Are these
products safe and effective?

What's more, none will reveal which supplements
failed tests, and there are many unsettled issues
about consistent testing methods. Such partial
certification may have unintended consequences,
leading consumers to believe that a seal on the
label of a supplement is also proof that it is safe
and that it works.

Even the certifiers acknowledge the problem.
''In terms of efficacy, I'm sure there are going to be
consumers who will not look carefully at verbiage
around the seal and aren't going to look at the
Web site and may perhaps interpret the seal
as covering more than it actually does,'' said
Ray Jaglowski, the vice president for business
development at NSF, a nonprofit organization
in Michigan known for its certification of drinking
water. Certification of supplements is a new endeavor
for NSF. ''We are doing the best we can to provide
accurate information,'' he said, ''but we recognize
it's not going to be 100 percent.''

Bonnie Liebman, the director of nutrition for the
Center for Science in the Public Interest, said such
programs have more pluses than minuses. ''Clearly
 some people may mistakenly believe that this stamp
of approval guarantees safety and effectiveness,''
she said. ''But it is still better to have the testing
than have consumers buy these products blind,
because we know there are some products that
give you less than what they claim.''

According to ConsumerLab.com, of the 20
top-selling dietary supplements -- 500 products
in all -- it has evaluated, 15 percent of vitamins
and minerals and 40 percent of herbals failed
their tests, principally because they contained less
of the active ingredient than the label claimed.
A few had too much of certain vitamins, and some
failed because they contained pesticides
or heavy metals, such as lead in calcium.
The company would not reveal the brand names
of the supplements tested, only the general category:
calcium, coenzyme Q10, creatine, echinacea,
ginkgo biloba, ginseng, glucosamine, chondroitin,
iron, MSM, multivitamins, omega-3 fatty acids,
SAMe, saw palmetto, St. John's wort, valerian,
isoflavones like soy and red clover, and C, E
and B vitamins.

The push to certify has its roots in the 1994 Dietary
Supplement Health and Education Act, essentially
treating supplements like food, which does not require
premarket approval. The law effectively barred the
F.D.A. from regulating supplements the way it
regulates drugs. Problems with safety and questions
about efficacy have contributed to a decline in
supplement sales that began in 1998 and has
not let up.

''Consumers are interested and concerned
about the quality of products they are hearing
negative things about, and some type of seal
would be helpful,'' said J. B. Cordaro, president
of the Council for Responsible Nutrition, a trade
association for dietary supplement manufacturers.

United States Pharmacopeia is joining
ConsumerLab.com and NSF in offering certification
for a fee, which troubles Jeff Asher, technical director
of Consumer Reports. ''I think money changing hands
makes it impossible to be unbiased,'' he said. Fees
at ConsumerLab range from $2,000 to $7,000.
At NSF, fees range from $5,000 to $75,000.
United States Pharmacopeia refused to reveal its fees.

Consumer Reports and the Good Housekeeping
Institute are the only organizations that undertake
the more costly testing for safety and efficacy.
But they have investigated only a small fraction
of the supplements on the market. Consumer Reports
take no money. Good Housekeeping offers its seal
only to those who agree to purchase an advertisement
in its magazine.

Unlike NSF and United States Pharmacopeia,
ConsumerLab.com, a for- profit business, chooses
the products it wants to test and buys the supplements
off the shelves. If a product passes the test, it may
appear on the approved list on the company's Web site,
http://www.consumerlab.com . Companies are not
charged for this, but can ask to be included for a fee.
Web site subscribers are entitled to a more
comprehensive list of supplements for an annual fee
of $15.95.

Supplements that failed the test are not revealed.
United States Pharmacopeia and NSF do not
disclose the names of supplements that failed tests,
either.

''Originally we did include those that did not pass,''
said Dr. Tod Cooperman, president of ConsumerLab,
''but we got so bombarded by lawyers we could not
do anything else and had to stop.'' Products that
 appear on its Web site list are tested every three
years, but products that carry the company's seal,
for which a fee must be paid, are retested every year.
The company does not test supplements which are
known to be hazardous, like comfrey. In addition
to testing for the principal ingredients, the company
also tests for the presence of heavy metals
and pesticides.

NSF, which began its program in July, is hired
by manufacturers to test supplements provided
by the company. It has already tested a few
products and expects to certify between 25
and 50 shortly after the first of the year.
Working with the companies, NSF evaluates
the formula for the supplement and the conditions
under which it is manufactured. Accredited products
will be audited once or twice a year.

Like ConsumerLab, it will not evaluate a supplement
known to be hazardous. Unlike ConsumerLab,
it does not test for the amount of time it takes
a supplement to dissolve and disintegrate,
important considerations that determine whether
the consumer will actually get the full benefit
of a mineral like calcium.

United States Pharmacopeia is the best known
of the three certifiers, setting standards recognized
by the Food and Drug Administration for 180 years.
Some vitamins and minerals carry the letters USP
on their labels, indicating they meet those standards.

What many consumers don't realize, though,
is that the use of the USP letters is based on
self-certification. Neither United States Pharmacopeia
nor the F.D.A. tests the products to see if they are in
compliance.

Now United States Pharmacopeia is going into
the certification business. It plans to launch
a program similar to the one at NSF. There are
some differences: United States Pharmacopeia,
for example, will test mineral supplements
for dissolution and disintegration. The question
that comes immediately to mind is how consumers
will be able to distinguish the differences between
the USP now on labels and the certification mark
that will begin to appear sometime next year.

Dr. Forouz Ertl, vice president for United States
Pharmacopeia's dietary verification program,
said the USP certification mark will be quite different
from the letters now in use. ''There will be a very
elaborate campaign to educate people about what
the USP mark will mean,'' Dr. Ertl said.

Despite the caveats, Mr. Asher of Consumer Reports
says third-party certification is a step in the right
direction. ''If there is a seal from a reputable
organization, on balance it's a good thing because
purity and potency would be known even if people
think it covers more.''

But he likened it to the Underwriters Laboratory's
UL seal on the electric cords attached to appliances.

Most people assume the seal is a mark of quality
assurance for the entire appliance, when actually
it applies only to the cord.

On the Web:

The United States Pharmacopeial Convention
http://www.usp.org/
http://www.usp-dsvp.org/home.htm

NSF International
http://www.nsf.org/

ConsumerLab
http://www.consumerlab.com

SOURCE: The New York Times - January 2, 2002
http://query.nytimes.com/search/article-
page.html?res=9C01E0D81430F931A35752C0A9649C8B63

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