Lead in ginkgo pills. Arsenic in herbals. Bugs in a baby's colic and teething syrup. Toxic metals and parasites are part of nature, and all of these have been found in "natural" products and dietary supplements in recent years.
Set aside the issue of whether vitamin and herbal supplements do any good.
Are they safe? Is what's on the label really what's in the bottle? Tests by researchers and private labs suggest the answer sometimes is no.
One quarter of supplements tested by an independent company over the last decade have had some sort of problem. Some contained contaminants. Others had contents that did not match label claims. Some had ingredients that exceeded safe limits. Some contained real drugs masquerading as natural supplements.
"We buy it just as the consumer buys it" from stores, said Dr. Tod Cooperman, president of ConsumerLab.com. The company tests pills for makers that want its seal of approval, and publishes ratings for subscribers, much as Consumer Reports does with household goods.
Other tests, reported in scientific journals, found prenatal vitamins lacking claimed amounts of iodine and supplements short on ginseng and hoodia — an African plant sparking the latest diet craze.
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"There's at least 10 times more hoodia sold in this country than made in the world, so people are not getting hoodia," said Dr. Mehmet Oz, a heart surgeon and frequent Oprah Winfrey guest who occasionally has touted the stuff.
Industry groups say that quality problems are the exception rather than the rule.
"I believe that the problem is narrow, that the well-established and reputable brands deserve their reputations," said Michael McGuffin, president of the American Herbal Products Association.
Of course, prescription drugs have had problems, too. Dozens of deaths were linked last year to tainted heparin, a blood thinner produced in China, for example. However, pharmaceutical drugs must show evidence to the government of safety and effectiveness before they go on sale. Not so for dietary supplements
Fifteen years ago, Congress passed a law that treats supplements like food and allows them to go straight to market without federal Food and Drug Administration approval. The FDA can act only after consumers get sick or a safety issue comes to light.
"We called it 'the body rule,"' said William Obermeyer, a chemist who left the FDA to found ConsumerLab.com with Cooperman. If a supplement was harmful, "we had to have so many adverse events before we could make a move on it. It was really like closing the barn door after all the animals left."
The law said the FDA could write quality control rules for products sold in the U.S. It took the FDA 13 years to adopt these, and they are just now taking effect. But the rules do not say what tests companies must do to prove what is in their products, and some tests can be fooled by subbing other ingredients. The rules also set no limits on toxins such as lead; nor do they change the fundamental way these products are sold to the public.
"It leaves the level of quality up to the manufacturer," Cooperman said.
In a written statement, FDA spokeswoman Susan Cruzan said the new rules contain what is "needed to ensure quality," and that products that contain contaminants or whose labels do not honestly describe their contents, are considered adulterated and subject to further action by the agency. But she conceded that the agency is spread thin.
"In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness," she wrote.
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