With an ongoing national health crisis, the exploding cost of medical care (and anxiety to go with), as well as media-twisted perceptions about beauty and health, it is the “perfect storm” for the $23 billion-a-year supplement industry that has lobbied hard to keep those profits at an enormous cost to the health of consumers.
“We’re talking about very serious risks and injuries that can happen to people—and often young people—who do not understand that they’re taking prescription drugs and steroids,” Joshua M. Sharfstein, M.D., the FDA’s principal deputy commissioner, told the U.S. Senate’s Special Committee on Aging in May 2010.
Between 2007 and mid-April of 2012, the FDA received reports of more than 6,300 serious events associated with dietary supplements (including vitamins and herbs) from supplement companies, consumers, health care providers and others, according to Consumer Reports. The reports described more than 10,300 serious outcomes, including 115 deaths and more than 2,100 hospitalizations, 1,000 serious injuries or illnesses, 900 emergency-room visits and some 4,000 other medical events.
What’s worse, the FDA suspects most supplement problems never come to its attention, according to Daniel Fabricant, Ph.D., and director of the FDA’s Division of Dietary Supplement Programs.
Fabricant said dietary supplements containing prescription drugs are “the largest threat” to consumer safety. Since 2008 there have been recalls of more than 400 such products, mostly those marketed for bodybuilding, sexual enhancement and weight loss, according to the FDA.
So why are these dangerous products on the shelf?
Theodore Roosevelt signed the Pure Food and Drug Act in 1906, an important part of his progressive-era legislation, which was the first in a series of consumer protection laws that led to the creation of the Food and Drug Administration (FDA). The law took 27 years to pass and came about after muckraking journalists disseminated serious health concerns to a finally outraged public. Before that, hard drugs were peddled as children’s medicine, formaldehyde was a standard preservative and no legal recourse protected consumers from dangerous products or deception in advertising. So why isn’t the FDA doing its job?
In 1994, the Dietary Supplement Health and Education Act was passed, allowing supplement manufacturers to regulate their own products, testing only on a voluntary basis. The law blocked the FDA from regulating supplements unless there was evidence of harm, creating legal entanglements that have made it hard for the FDA to interfere with the industry at all.
Bipartisan efforts to pass reform legislation (the Dietary Supplement Labeling Act and the Dietary Supplement Safety Act) have thus far failed against the muscle of the pharmaceutical lobby.
The New York Times reported last month on research conducted in the U.S. and Canada in which DNA tests of 44 bottles of popular herbal supplements revealed the majority were mislabeled or contaminated and one-third had no trace of the advertised supplement whatsoever.
Assistant professor of nutrition Lanae Joubert said scientific evidence to support taking supplements, even those correctly labeled, in lieu of healthy food choices is not convincing.
“I sit on the pro-foods side of the fence because the benefits of foods are so vast,” she said. “The nutrients found in an orange, for example, are diverse, [can be] absorb[ed] at one given time, tend to not compete with each other for absorption and have compounds we cannot mimic and put into a pill.”
But for those that do take supplements, the best thing to do is talk to your doctor, stay informed and stay skeptical. A 2013 Consumer Report revealed 55 percent of American adults think that supplement labels must warn about potential dangers and side effects, 47 percent think the FDA must review products before they’re sold to the public and 45 percent think that claims about safety or effectiveness must be based on solid scientific evidence. None of that is the case.
Joubert recommended looking for USP, NSF and CL on labels, which are third-party non-profit laboratories that test products on purity, quality and strength. The Office of Dietary Supplements is a good online resource, she said.
“In my opinion, the best things you can do for your health are to eat real foods and enjoy them, move more than you sit and thoroughly appreciate your own human body,” Joubert said.
And tell your friends to think twice about a label that has little incentive to tell the truth in an industry without rules.