While drugs in the U.S. must undergo extensive testing and monitoring to ensure their safety and efficacy, supplements come under much weaker regulation. In a perspective article in The New England Journal of Medicine, Dr. Pieter A. Cohen criticizes the current deficiencies in the regulation of the supplement industry. He argues that a new guidance proposal by the FDA makes important steps toward enhancing supplement safety — but it still doesn’t go far enough.
According to the Dietary Supplement Health and Education Act of 1994 (DSHEA), companies can market dietary supplements that contain established ingredients (meaning that the ingredients were sold in the U.S. before 1994) without providing any evidence of safety or efficacy. For newer ingredients, however, producers are mandated by law to provide data demonstrating their safety. But this just isn’t happening — the law is not being enforced. Since 1994, the number of dietary supplements sold in the U.S. has jumped from about 4,000 to a whopping 55,000. And while it isn’t clear how many of these actually contain new substances, the FDA has only received safety evidence for a measly 170 new ingredients over this period — certainly a far cry short of the number that should have been tested. As ACSH's Dr. Gilbert Ross observes, “Millions of people are blindly taking these supplements without any evidence of their safety. And of course no one knows anything about their efficacy, which is just fine with the supplement makers, since they don’t actually work.”
But according to new guidelines proposed by the FDA in July, supplements will be evaluated based on their history of safe use, their daily dosage and formulation, and the length of time they are meant to be used. If a new supplement contains doses greater than what was historically used, a variety of tests would be mandated. Different formulations of ingredients would be considered as new ingredients, also requiring safety data.
While Dr. Cohen believes that these measures will certainly improve the safety of supplements, he says they are still insufficient. He points out that even a history of widespread use cannot ensure that a particular ingredient is safe for consumers, and certain ingredients will still not require testing in humans under the new proposal. Perhaps worst of all, the guidance does not compel producers to send all of their data to the FDA, so these supplement manufacturers could just send in favorable results and omit undesirable data.
Supporters of the supplement industry, of course, are up in arms against the new measures, calling them excessively stringent. But ACSH’s Dr. Josh Bloom points out that even these guidelines are nowhere close to being as strict as the testing process required for drugs. “People are not aware that most of these supplements are drugs or unknown mixtures of several drugs,” he says. “But since these products are disingenuously called ‘supplements,’ they have managed to largely circumvent FDA regulation. Thus, they essentially get a free pass, while legitimate drugs have to go through a 14-year approval process.”
ACSH’s Dr. Elizabeth Whelan agrees that there is a serious irony to the situation. “These supplement makers can market anything they want in any dose and it’s acceptable,” she comments. “But there’s all kinds of outrage about real drugs, even though these have gone through an intensive approval process.”
With 100 million Americans spending $28 billion annually on some type of vitamins, minerals, herbal remedies, or other dietary supplements, it is clear that many people are under the impression that supplements are both safe and effective. “The current situation with supplements in the country would be laughable if it weren’t tragic,” says Dr. Ross. “We don’t know how many people are harmed by these products. And billions of dollars are being wasted on supplements for which there is no evidence of efficacy or safety.”
For more information on how supplements can affect your health, read ACSH’s assessment of drug-supplement interactions, and Dr. Bloom’s discussion of the difference (or lack thereof) between drugs and so-called herbal remedies.
