What’s Really in Your “Dietary Supplements”?
You may not be getting what you pay for—and you need to consider what “supplements” mean to you.
Surveys have shown that a large majority of Americans are confident in the “safety, quality and effectiveness” of products marketed as “dietary supplements” (a term derived from a 1994 law that questionably grouped drug-type herbal and botanical extracts with essential vitamins and minerals). So many were shocked at the recent news that four out of five popular herbal remedies sold at some of the nation’s leading retailers didn’t contain any of the promised ingredients. The investigation by the New York State attorney general’s office charged GNC, Target, Walgreens and Walmart with selling fraudulent and potentially dangerous products and demanded the products be yanked from store shelves.
Instead of the herbal ingredients listed on the label, DNA testing of store-brand products often detected fillers—including wheat and legumes, possible risks for people with intolerances or allergies. For example, pills sold as ginkgo biloba, a Chinese plant touted for memory benefits, actually contained powdered radish, houseplants and wheat. Ginseng pills, which promise to boost “physical endurance and vitality,” were found to be nothing more than powdered rice and garlic.
But the findings aren’t so surprising to experts who have long warned that the Dietary Supplement Health and Education Act (DSHEA), pushed through Congress by the supplement industry in 1994, leaves such products dangerously under-regulated. “Under DSHEA, the manufacturer is responsible for ensuring that so-called ‘dietary supplements’ are safe before they go on the market,” explains Tufts professor Irwin H. Rosenberg, MD, editor of the Health & Nutrition Letter. “Unlike drugs, which must be proven safe and effective before the FDA allows them to be marketed and used, the FDA does not approve ‘dietary supplements’ before they reach consumers.”
In fact, DSHEA requires the FDA to show that such products are unsafe before the agency can take action to restrict their use or remove them from the marketplace. That process can often take years after an initial complaint. The FDA can challenge companies that cross the line to make specific health claims like those for prescription or over-the-counter drugs. But “dietary supplement” makers skirt such rules with carefully crafted promises—“structure-function claims” permitted under DSHEA—that their products, for example, “support immune health” (rather than claiming to cure or prevent colds and flu) or “enhance mental sharpness and support long-term brain health” (not “prevent Alzheimer’s disease”).
Even the most rule-stretching claims are always accompanied by the tiny-print disclaimer, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
WHAT’S INSIDE: But even if such products don’t always deliver their elusive health benefits, most consumers assume that “dietary supplements” at least contain the vitamins, minerals or herbal remedies listed on the label. The FDA has gone after individual supplements found to contain dangerous ingredients, but its enforcement budget is limited. The New York case is the first time a law-enforcement agency has threatened legal action against major retailers for selling “dietary supplements” that don’t match their labeling. In addition to sending the retail chains a cease-and-desist letter, the attorney general asked them to detail the procedures used to verify the ingredients in such products.
This isn’t the first time such products have been found not to deliver what’s on the label. A 2013 study by scientists at the University of Guelph in Canada reported that a third of 44 herbal remedies tested contained no trace of the supposed main ingredient.
The problem isn’t just that consumers may not be getting what they pay for. A 2013 outbreak of hepatitis that affected at least 72 people in 16 states was ultimately traced to a tainted “supplement.” Three victims required liver transplants and one died. Last year, at a Connecticut hospital, a contaminated probiotic treatment was linked to a young patient’s death.
Between 2004 and 2013, the FDA issued 237 recalls of “dietary supplement” products, amounting to more than half of all agency recalls of “Class 1” products, which include drugs and other products with the potential to cause death or serious health problems. Such recalls don’t always stick, however: A study published in JAMA reported that most “supplements” recalled for containing dangerous or banned ingredients were still available to consumers at least six months later; others quickly returned to market under different names or with other minor changes. (For more on safety concerns, see our June 2014 Special Supplement.)