The American Reporter Vol. 6, No. 1495 - December 29, 2000

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Vol. 6, No. 1495 - The American Reporter - December 29, 2000

FOOD SUPPLEMENTS CHEAT PUBLIC WITH 'SHORT' DOSES

by Lucy Komisar

American Reporter Correspondent

New York, N.Y.

NEW YORK -- As with the watered-down milk and short weights of meat of an

earlier era, millions of Americans now taking nutrition supplements don't always

get what they think they're getting, according to several new lab studies on one

of the most popular arthritis treatments and other drugs.

New studies on one particular supplement, for example -- glucosamine and

chondroitin, used to treat common osteoarthritis -- show that in 25 percent of

cases, the amount in the pills and capsules was far below that listed on the

labels.

Doctors now prescribe such supplements to treat serious diseases, and they

ought to come under the same scrutiny and control as other medications. But the

FDA lacks the staff to enforce even the weaker regulations that apply to food

additives.

Glucosamine-chondroitin, for example, a food supplement made from crab

shells and animal cartilage has in recent years given hope to millions of people

who suffer from osteoarthritis, which afflicts as many as one in eight adults --

23 million Americans, most of whom get it in their 50's and 60's. (Other

estimates give the figure at 16 million.)

As many as 68 percent of women and 58 percent of men over 65 have

radiological evidence of osteoarthritis. In this degenerative disease, the

cartilage between bones wears away and doesn't repair itself, ultimately causing

pain and dysfunction. When knee cartilage is seriously damaged, sufferers find

it hard to navigate steps and even to walk.

This supplement promises to be the nutritional pill of choice for baby

boomers who have no intention of giving up their tennis or jogging. Even Jane

Brody, the syndicated health columnist for the New York Times, says she takes it

for her knees -- and then ice skates and plays tennis.

Reflecting the increased attention doctors are giving to the supplement,

last fall, the U.S. National Institutes of Health began a testing program which

will involve nearly 1000 subjects, over 300 each using glucosamine, glucosamine

and chondroitin combined, and a placebo.

Now a University of land study, an independent testing organization,

and a famous arthritis doctor charge that some of those preparations, some sold

by major U.S. companies, don't have what they promise on the label inside the

bottle. The university study is accompanied by a recommendation that a

government regulatory policy be established to address the issue of label claims

vs. actual dosage amount. It suggests that the government set specifications for

the contents of nutritional supplements. That is a good idea. The report's

findings show why.

The study by Consumerlab.com, a New York-based testing organization, used

three independent labs to examine the pills. On its website, Consumerlab.com

lists the names of seven products that passed the label test. Out of fear of

legal action, it doesn't mention the six that failed. Dr. Theodosakis,

author of the best-seller " The Arthritis Cure, " lists sixteen " bad " products and

four " good " ones. (Two of his recommended products are also among Cosumerlab's

" passes. " ) The university study lists no names, but says 25 percent of products

failed.

This is disturbing news to the people who take that supplement.

Glucosamine and chondroitin, usually taken in a combined pill, have gained

popular support in this country as a nontoxic, noninvasive way of improving

cartilage. Glucosamine is thought to promote the formation and repair of

cartilage. Chondroitin is believed to promote water retention and elasticity in

cartilage and inhibit enzymes that break down cartilage.

The article by the University of land researchers says that " empirical

findings " and " a series of experiments " show that taking chondroitin sulfate and

glucosamine " can restore chondrocytes and the cartilaginous matrix to their

normal metabolic function " and " inhibit degradative enzymes as well as stimulate

the production of new cartilage and protection of previously existing

cartilage. "

The study by professors at the Pharmacokinetics Biopharmaceutics

Laboratory, Department of Pharmaceutical Sciences, School of Pharmacy,

University of land, says that of 13 products tested, 25 percent didn't have

inside what was promised on the label. The greatest inconsistencies were in the

combination products, with a case where the tablet had under 35 percent of

glucosamine and only 32 percent of chondrotin, and another with only 36 percent

of chondroitin. In a glucosamine tablet, one product had only 76 percent of what

was promised.

Dr. Eddington, a co-author of the study, said, " These products

aren't cheap. People are buying them to treat a chronic disease. Depending on

the lot they purchase one month, they might do well with the allotted daily

dose, but the next month if the manufacturer decides, 'We're running low on raw

materials, let's cutback,' treatment of their arthritic condition might be

hampered. There are not the glaring omissions of four years ago. Some

manufacturers are doing a better job to be sure the label claims equal content.

But there are still some that aren't going to do something until federal

regulation mandates them to do it. "

The testing labs commissioned by Consumerlab.com, which seeks to market

its approval of products that pass its tests, found more of a problem with

chondroitin. All ten glucosamine products it tested were fine, but of the 13

combined products, six didn't meet standards, with some having as little of a

quarter of what they should have. The two chondroitin-only products failed. The

good products were from Nutramax, CVS, Nature's Bounty, Schiff, Walmart, Rexall

Sundown and Walgreen, listed at www.consumerlab.com.

Ted man, president of Consumerlab.com, says he suspects economic

reasons for the shortfall: glucosamine costs $30 a kilo and chondroitin $120.

The " good " products were all national or major store brands. He would not

publicly identify the " bad " ones, though he gave me their names. They included

one national brand, one store brand, and four lesser known companies.

Dr. Theodosakis lists four national brands as good products: Nutramax,

Rexall Sundown, and Twinlab. His " bad " sixteen includes five products

by three national companies: Nature's Bounty, Schiff and Twinlab, and the rest

by lesser known firms. Though Theodosakis names the failing products on his

www.drtheo.com website, he says, in an argument that appears illogical, that

though he's willing to name them, for legal reasons he won't provide the lab

results that back his claims.

I contacted several companies given bad marks in the studies, including

Nature's Bounty, Schiff, and Twinlab, and one not mentioned, Rite

Aid/Pharmassure. Only Schiff agreed to supply test results, which were included

in a comparison chart of 25 products from numerous companies. (The names of the

other products were blacked out.) Its tests showed most products passing, but

listed some unnamed competitors with as little as 15 or 24 percent of the

promised glucosamine and 10 or 20 percent of the label dosage of chondroitin.

Nature's Bounty, Twinlab and Pharmassure ignored repeated requests for test

results on their products.

Luke Bucci at Weider Nutrition, manufacturer of Schiff Painfree, which is

given good marks by Consumerlab and a fail by Theodosakis, says of Theodosakis,

" He's hanging on to old data that is not right, probably from 1998. A few years

ago there were many different ways to test for chondroitin. We were using

chondroitin from shark cartilage, which was more difficult to test for -- some

tests couldn't find it. We've switched to bovine. We always had it in there, and

we have it in there now. " He said, " We are working in labs that test for the

industry. The problem is that testing not is validated. A lot of natural

ingredients pick up water from the air when you're weighing them. "

The contradictions in the testing results and the refusal of some major

companies to supply any results underlines the need for governmental regulatory

standards and oversight. The FDA, which considers the matter of dietary

supplement quality " a critical issue, " this year will publish a proposed rule to

bring supplements up to the standards of other substances it regulates,

including those for " good manufacturing processes " and assurance of quantity of

ingredients.

Cardellina, an official of the trade group Council for Responsible

Nutrition, said, " We know and are frustrated ourselves by lack of complete

quality control, " but noted, " The FDA can any time they choose asking people to

analyze products and take regulatory action against those that don't comply. "

Indeed, under existing regulations, products supplements must include 100% of

what is promised on their labels.

" The problem is lack of expertise and enforcement, " says

Obermeyer, a former FDA technical analyst. " People are looking for the cheapest

raw material. The regulations probably won't stop the problem. The real problem

for consumers is lack of enforcement. The FDA needs inspectors. There have been

cutbacks for the last several years in the facility that does the testing; field

labs were closed. People's responsibilities are doubling and tripling, and the

manpower stays the same. " He joked that it was due to " the reinvention of

government. "

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