WASHINGTON—The $22 billion dietary supplement industry operates with minimal oversight from the U.S. Food and Drug Administration, despite a history of suspect quality and safety—and independent lab tests that have found one in four products to be substandard.
About one in four dietary supplements tested don't meet quality or safety standards, according to former FDA research scientist William Obermeyer, a co-founder of the independent testing firm, ConsumerLab.com, which tests thousands of supplement products.
Some are tainted with pesticides, salmonella, glass, bacteria or heavy metals such as lead and cadmium. Others fail for a variety of reasons, including a lack of ingredients, improper ingredients, failure to disintegrate properly and mislabeling.
Because manufacturers seek low-cost ingredients, Obermeyer said it's a safe bet that some of the tainted products contain ingredients from China, which typically are cheaper.
Under a 1994 federal law, most dietary supplements—vitamins, minerals, herbs, amino acids and other substances such as enzymes and metabolites, which are taken orally and intended to augment the diet—don't need to be registered or approved by the FDA.
FDA inspections have found supplement manufacturing plants with pest infestations, defective equipment and pipes that leak liquid onto products.
"There's no question the vitamin supplement area is as susceptible, if not more, to this type of adulteration," said ConsumerLab President Tod Cooperman.
But after more than 10 years of development, the FDA still hasn't set minimum standards for the safe manufacture of dietary supplements. Instead, manufacturers set their own standards.
Because supplements are classified as food, they aren't regulated by the same strict guidelines that govern drugs. Supplement manufacturers are responsible for ensuring that their products are safe and include all the ingredients listed on the package label.
And like food manufacturers, supplement makers don't have to record, review or provide the FDA with reported injuries or illnesses that result from their products. Reporting is voluntary, although information typically is provided willingly.
If safety, health or mislabeling problems develop, the FDA can restrict or remove a supplement from the market. Drugs, on the other hand, must be deemed safe and effective before they can be prescribed or sold.
China's emergence as a leading ingredient supplier for the supplement industry has raised new fears since a recent pet food scare was traced to adulterated Chinese wheat gluten. Earlier this year, a shipment of bacteria-contaminated vitamin A from China also was flagged before it could be added to infant formula in Europe. And the FDA will start testing toothpaste imported from China after a poisonous ingredient used in antifreeze was found in Chinese-made toothpaste in Panama.
Record requirements allow officials to track ingredients to the country and plant where they were manufactured.
Supplement companies are urged to buy quality ingredients from reputable firms, whatever country they're in, said Judy Blatman, a spokeswoman for the Council for Responsible Nutrition, which represents supplement manufacturers and suppliers.
"Quality has to be the number one priority for ingredient suppliers and manufacturers," Blatman said. "We need to have high-quality products in order to maintain consumer confidence in them."
That confidence was shaken in 2004, when the FDA banned the sale of dietary supplements containing ephedra, which caused tremors and heart palpitations and was cited as a factor in numerous deaths.
In February 1997, the FDA proposed mandatory rules outlining "good manufacturing practices" for the safe production of dietary supplements. But more than 10 years later, those rules still haven't been finalized.
The FDA rulemaking process, concerns by consumers and industry groups and revisions sought by the White House Office of Management and Budget have slowed the process.
The proposed rules, first published in 2003, called for supplements and ingredients to be tested for purity, quality, composition and strength during the manufacturing process and when the final batches are completed.
They'd apply to domestic and foreign firms that make, package or hold dietary supplements and ingredients that are distributed in the U.S. The proposal requires that manufacturers hire qualified employees and supervisors and design plants that protect supplements against adulteration during their manufacture, packaging and storage.
The guidelines also would require manufacturers to keep records of consumer quality complaints for three years beyond the date of manufacture.
In public comments, supplement makers argued that the proposals would cost the industry some $245 million a year, more than 10 times the FDA estimate. FDA spokeswoman Kimberly Rawlings would say only that the guidelines would be issued very soon.
Because the original proposal has gone through several revisions, it's unclear how much of the 2003 draft will be included in the final version. Rawlings, however, said that the new guidelines "should increase consumer confidence in the quality of dietary supplements."
The original proposal questioned the effectiveness of supplier-provided "certificates of analysis" in verifying the purity and safety of supplement ingredients. But the guidelines didn't disallow their use.
The certificates, which are included in shipments of raw materials used by supplement manufacturers, vouch for the authenticity and quality of the ingredients being shipped.
Obermeyer said the documents aren't always genuine. Sometimes the ingredients haven't been tested or the certificates have included forged results for tests that weren't performed, he said.
Blatman, however, said the certificates should suffice if they come from a preferred ingredient supplier with whom the manufacturer has a longstanding relationship. She said implementing the new FDA rules is her organization's top regulatory priority. The group also favors additional FDA funding to enforce the new regulations.
For more information about the safety of dietary supplements, go to ConsumerLab.com.
To find out more about the FDA's proposed guidelines, go to: