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Of the fifty-one thousand products introduced since 1994, only 170 (0.3 percent) have any documentation of their safety

Herbal And Dietary Supplements-- Buyer Beware



Americans spend more than $32 billion a year on more than 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics, and other supplement ingredients. 1 While it costs millions of dollars to develop and substantiate a pharmaceutical product, selling supplements requires no such investment. And new products are easily sold as supplements. The only common feature among them, as defined by the FDA, is that these are edible things not intended to treat, diagnose, prevent or cure diseases. However, this is why people take them. 2
A majority of consumers believe, wrongly, that the government requires manufacturers to report all adverse effects and that the FDA must approve supplements before they are sold. Few consumers of supplements are aware of the implications of the Dietary Supplements and Health Education Act (DSHEA), which was passed by Congress in 1994 with strong support from the supplements industry and its political allies. By defining herbal supplements and botanicals as 'dietary supplements' DSHEA excluded them from the more rigorous standards used in regulating prescription, and even over-the-counter drugs. Unlike prescription drugs, supplements do not have to undergo pre-market testing before they can be sold to consumers. Rather, they are assumed to be safe based until proven otherwise. The FDA has the unrealistic charge of identifying and recalling dangerous supplements only after they have caused harm. Since DSHEA was enacted, the number of dietary supplements on the market has surged from roughly four thousand to more than fifty-five thousand. 1 However, of the fifty-one thousand products introduced since 1994, only 170 (0.3 percent) have any documentation of their safety. 3 Owing to the lack of a proper surveillance system for reporting adverse effects promptly to the FDA, harm from supplements is seriously under reported, and in a number of cases the FDA has been woefully slow to act. A recent study used nationally representative surveillance data from sixty-three emergency departments from 2004 through 2013 to estimate the number of visits because of adverse events related to dietary supplements. The authors estimated that 23,000 emergency department visits in the United States every year were attributable to adverse events involving dietary supplements. The most common problems were cardiac symptoms from weight loss, or energy products among young adults and swallowing problems, often associated with micronutrients, among old adults. 4

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In 2011 the Department of Defense banned supplements containing the stimulant DMAA from military bases because of safety concerns, but it took the FDA an additional sixteen months to alert consumers about DMAA's risks, and despite the agency's efforts the stimulant is still present in dozens of supplements. 1 Another issue is that many of the products aren't what is advertised on the label. Canadian researchers tested popular supplements from 12 companies in 2013, and found that products from just two of the companies contained 100 percent of the supplement. The rest had been contaminated with other plants, had mislabeled ingredients, or contained mostly fillers like rice, soy or wheat. The New York Attorney General's office did similar DNA tests of herbal supplements in early 2015 and found that most didn't contain any of the actual herb on the label. 5 Researchers at the University of Maryland showed that melatonin tablets don't always release their contents in a timely fashion. Although industry standards for the breakdown of conventional drugs is generally 30 minutes or less, the studies showed that some commercial melatonin supplements didn't disintegrate or release their contents for periods of 4 hours to more than 20 hours, by which time an ingested tablet may have been excreted. 6 Swedish researchers examined 50 ginseng products sold in 11 countries and found that six samples contained no active ingredient and the concentration of gensenosides in the other samples ranged from 2 to 9%. One sample, sold in the United States, contained no ginseng derivatives at all but had undeclared ephedrine, a potentially dangerous stimulant 7 Other researchers reported that the amount of the active ginseng ingredient in each pill varied by as much as a factor a ten among brands that were labeled as containing the same amount. And again, some brands contained none at all. 8 Jane Brody offers this observation: “This is not to say that all these remedies are unsafe, impure, or ineffective. Some are made by reputable companies under near pharmaceutical conditions. Some have been tested in well-designed clinical trials. Still, the consumer has no way know exactly what is in the bottle and what effects the contents may have on health.” 9

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References

  1. P. A. Cohen, “Hazards of hindsight—monitoring the safety of nutritional supplements,” New England Journal of Medicine, 370, 1277, 2014
  2. James Hamblin, “Why vitamins and other dietary supplements can contain anything,” theatlantic.com, June 26, 2016
  3. P. A Offit, Do You Believe In Magic?, (New York, Harper Collins, 2013)
  4. A. I. Geller et al., “Emergency department visits for adverse events related to dietary supplements,” New England Journal of Medicine, 373, 1531, 2015
  5. John Swartzberg, “Dietary supplements: can you separate fact from fiction?”, livescience.com, May 12, 2015
  6. Janet Raloff, “Herbal lottery,” Science News, 163 (23), 359, June 7, 2003
  7. Joe Schwarcz, Radar, Hula Hoops, and Playful Pigs, (Toronto, ECW Press, 1999), 195
  8. J. Cui et al., “What do commercial ginseng preparations contain?”, The Lancet, 344 (8915), 134, 1994
  9. Jane E Brody, “Herbal remedies: natural does not mean safe,” The New York Times, February 6, 2003


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Jack Dini -- Bio and Archives

Jack Dini is author of Challenging Environmental Mythology.  He has also written for American Council on Science and Health, Environment & Climate News, and Hawaii Reporter.


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