[MPWG] Fw: Study Finds Supplements Contain Contaminants

[Patricia_DeAngelis at fws.gov]

Study Finds Supplements Contain Contaminants
By GARDINER HARRIS
Published: May 25, 2010


Nearly all of the herbal dietary supplements tested in a Congressional 
investigation contained trace amounts of lead and other contaminants, and 
some supplement sellers made illegal claims that their products can cure 
cancer and other diseases, investigators found.
The levels of heavy metals ? including mercury, cadmium and arsenic ? did 
not exceed thresholds considered dangerous, the investigators found. 
However, 16 of the 40 supplements tested contained pesticide residues that 
appeared to exceed legal limits, the investigators found. In some cases, 
the government has not set allowable levels of thesepesticides because of 
a paucity of scientific research.
Investigators found at least nine products that made apparently illegal 
health claims, including a product containing ginkgo biloba that was 
labeled as a treatment forAlzheimer?s disease and a product containing 
ginseng labeled as a treatment to preventdiabetes and cancer. They also 
described a salesperson at a supplement specialty store who claimed that a 
garlic supplement could be taken instead of blood pressuremedication.
Any product that claims to treat, cure, prevent or mitigate a disease is 
considered a drug and must go through strict regulatory reviews.
The report, which was prepared by the Government Accountability Office, 
was provided to The New York Times and will be made public at a Senate 
hearing on Wednesday. Its release comes two weeks before the Senate is 
scheduled to begin debate on a landmarkfood safety bill that is expected 
to substantially increase the federal government?s authority over food 
manufacturers.
But it is uncertain how tough the bill will be on supplement 
manufacturers, and it has been the subject of fierce lobbying. Capitol 
Hill staff members familiar with the process said the bill was unlikely to 
include provisions opposed by supplement manufacturers.
Dr. Joshua M. Sharfstein, principal deputy commissioner of the Food and 
Drug Administration, said in an interview that he was not concerned about 
the safety of the supplements tested by the G.A.O. investigators. But Dr. 
Sharfstein noted that the agency had recently announced a recall of Vita 
Breath, a dietary supplement that it said might contain hazardous levels 
of lead.
Steve Mister, president of the Council for Responsible Nutrition, a trade 
association representing the dietary supplement industry, said it was not 
surprising that herbal supplements contained trace amounts of heavy 
metals, because these are routinely found in soil and plants. ?I don?t 
think this should be of concern to consumers,? Mr. Mister said.
Senator Herb Kohl, a Wisconsin Democrat who will preside over Wednesday?s 
hearing of the Senate Special Committee on Aging, said that while 
improvements had been made in recent years in the oversight of 
supplements, ?the F.D.A. needs the authority and tools to ensure that 
dietary supplements are as safe and effective as is widely perceived by 
the Americans who take them.?
Among the witnesses at the hearing will be Dr. Tod Cooperman, president of
ConsumerLab.com, a company that has tested over 2,000 dietary supplements 
made by more than 300 manufacturers and has found that one in four have 
quality problems. According to Dr. Cooperman?s written testimony, the most 
common problems are supplements that lack adequate quantities of the 
indicated ingredients and those contaminated with heavy metals.
Travis T. Tygart, chief executive of the United States Anti-Doping Agency, 
wrote a letter to the committee saying that some athletes have been 
rendered ineligible for international competitions because they took 
supplements that contained steroids not listed on the products? labels. 
There are thousands of supplements available for sale that contain 
steroids or other harmful ingredients, he wrote.
?The F.D.A. is operating in a regulatory environment that is simply too 
burdensome to allow for effective post-market regulation of these 
products,? Mr. Tygart wrote.
Half of the nation?s adult population takes vitamin supplements regularly, 
and about a quarter take herbal supplements at least occasionally. Annual 
sales are about $25 billion a year, and the growing popularity has led to 
an increasing number of imported supplements spiked with illegal drugs.
In 1994, Congress passed legislation that allowed supplement makers to 
sell products without first getting approval from the F.D.A. for their 
ingredients or for basic health claims. But scientific organizations have 
warned repeatedly since then that the F.D.A. should do more to ensure that 
the supplements are safe and that their health claims are substantiated.
In recent years, a vast majority of supplement suppliers have located 
overseas ? principally in China. Nearly all of the vitamin C and many 
other supplements consumed in the United States are made from ingredients 
made in Chinese plants. Those plants are almost never inspected by the 
F.D.A. because the agency is not required to do so, has little money to do 
so and does not view the plants as particularly risky.
Mr. Mister said supplement sellers tested ingredients before using them, 
but he agreed that testing could not ensure quality. He called on Congress 
to provide the F.D.A. with more money to inspect foreign and domestic 
supplement plants. ?I think you?ll see more and more inspections,? Mr. 
Mister said.
He said that a few companies made illegal health claims for their 
supplements, but that the industry was trying to police those. ?I 
occasionally see these late-night commercials with health claims that make 
my blood boil,? he said.
Dr. Sharfstein said the F.D.A. had increased enforcement actions against 
supplements spiked with prescription drugs like Viagra. And he said the 
agency had taken action against supplement makers that made broad health 
claims. ?We don?t want people to think they?re treating a disease with 
something that hasn?t been proven to do that,? he said.
The food safety bill expected to be introduced next month in the Senate is 
likely to mandate that supplement makers register annually with the F.D.A. 
and allow the agency to recall supplements suspected of being dangerous.
But a House provision that would require manufacturers to create plans to 
safely manufacture their products and a proposal made in February by 
Senators John McCain, Republican of Arizona, and Byron L. Dorgan, Democrat 
of North Dakota, to restrict supplements to ingredients approved by the 
F.D.A. will not be included, staff members said.
A version of this article appeared in print on May 26, 2010, on page A15 
of the New York edition.
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