Weight loss pills and immune system boosters largely aren't reviewed by the Food and Drug Administration, watchdogs say, leaving consumers vulnerable to misleading claims about what the supplements can do.
The government is failing to aggressively regulate misleading or prohibited claims in the booming dietary supplements marketplace, potentially putting consumers' health at risk, a federal watchdog warns.
In fact, the Food and Drug Administration is so lax in its surveillance that one out every of five weight loss and immune support supplements makes promises about disease prevention and treatment that are prohibited by federal law, but their manufacturers suffer no consequence, the Department of Health and Human Services inspector general reported Wednesday.
Another 7 percent of such products lack the required disclaimer that they weren't approved by the FDA, the watchdog found.
In a pair of reports, the internal watchdog painted a portait of a FDA surveillance system inside the booming dietary sales world that is so laissez faire -- lacking funding, workers and statutory authority -- as to put public health in danger.
"Supplements that make disease claims could mislead consumers into using them as replacements for prescription drugs or other treatments for medical conditions, with potentially dangerous results," the inspector general warned.
Such worries are only magnified by the growing popularity of dietary supplements: 80 percent of American adults use such products in what has become a $20 billion a year market. Weight loss and immune supplements -- which were singled out by the IG -- are among the fastest growing products.
The IG recommended FDA seek legislation to give it more powers to crack down on supplements that make false or prohibited claims to consumers and to expand its oversight of the marketplace. FDA said it would consider the first recommendation and agreed with the IG's other findings.
"FDA welcomes both OIG reports, and recognizes the importance of the concerns they raise about industry compliance with legal requirements for structure/function claims and facility registration," FDA spokeswoman Tamara Ward said. "The agency intends to consider and address the OIG recommendations as its resources and priorities allow."
Currently, FDA can't stop a dietary supplement before it reaches the market and only checks claims on some Internet-sold products, leaving retails stores mostly unmonitored.
The agency primarily relies on reports from medical providers of adverse reactions to identify problems and monitors advertising and product label claims through basic information filed by the dietary supplement companies. Those documents are supposed to identify the claims such products make to consumers.
But 28 percent of the time, the companies selling such products don't even provide contact information, leaving FDA potentially unable to react to a health scare quickly, the inspector general found.
"If a dietary supplement poses a public health threat, FDA should be able to rely on the registry for contact information," investigators said. "In an emergency involving a dietary supplement, it is critical that FDA be able to quickly trace the source of the product."
When the IG looked at 127 dietary supplements, the investigators found that the "scientific evidence" companies produced to back up their product claims often didn't comply with FDA guidelines. Some claimed to treat HIV, diabetes or the common cold -- all pitches prohibited for dietary supplements, the report said.
And of the 127 supplements, the FDA was only able to produce 21 letters notifying the agency of the claims the products would make to consumers, raising "questions about its ability to adequately monitor and enforce manufacturers’ compliance with structure/function claim requirements," investigators said.
Part of the evidence that companies must submit to back up their claims are human studies investigating the supplement's effect on humans during tests. But of the 1,624 documents manufacturers submitted to the inspector general for review, only 557 were human studies and zero met the FDA's expectations for rigorous scientific procedures, investigators said. In fact, only two percent of the human studies were even about the supplements in question, the report said.
"The remaining 98 percent of human studies focused on an active ingredient that may have been in a different form, dose, or potency," the report said. And four percent of the human studies actually contradicted the claims the supplement companies were making.
The increased scrutiny comes on the same day the Justice Department announced that Abbott Laboratories will pay a $500 million fine for promoting non-FDA approved uses of one of its drugs.
The Food and Drug Administration, or FDA, is the government agency responsible for ensuring the safety of anything that goes into a human body, including food, drinks, medicine and orthopedic implants. They are responsible for testing all new drugs for treating diseases.
The Health and Human Services Department, or HHS, is the federal "government’s principal agency for protecting the health of all Americans," according to their website.