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Toxins in Nutrition Supplements Still Escape FDA Oversight

The views expressed are those of the author and are not necessarily those of Scientific American.

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When young and middle-aged adults started showing up at the hospital with liver failure last spring, doctors in Hawaii struggled to find the thread that connected the patients. They found it in the form of a popular sports supplement, OxyElite Pro.

The supplement was linked last May to severe hepatitis, but the U.S. Food and Drug Administration, tasked with removing such dangerous substances from store shelves, did not learn of the cases until four months later. By February, months after the product was voluntarily taken off the market, there were 97 cases linked back to the supplement, including one death and three liver transplants.

These and other statistics from a new report highlight continued weaknesses in the U.S. system’s ability to protect consumers from OxyElite Pro and other untested supplements. Consumers are continually being put at risk of consuming supplements tainted with harmful substances, Pieter Cohen, a professor of medicine at Harvard Medical School, writes in the April 3 New England Journal of Medicine. About half of all U.S. adults take dietary supplements, meaning that literally millions of people could be at risk.

OxyElite Pro was far from the first such problematic incident. Even five years ago the U.S. Government Accountability Office highlighted serious supplement oversight issues, warning that FDA does not have enough authority to ensure the products are safe. That report, like Cohen’s, called for supplement manufacturers to be required to register their dietary supplements. Currently, the FDA relies on voluntary notifications about supplement-related deleterious health events from clinicians and consumers through an online reporting system called MedWatch. It also hears about such events from manufacturers who receive information of serious side effects or learn of health threats from other academic, federal or state public health partners that contact the agency. The manufacturer is supposed to ensure its own product is safe and also notify FDA if its supplement contains a new dietary ingredient at least 75 days prior to marketing the product, but even that requirement is often ignored. “Firms not submitting [new dietary ingredient] notifications remain a significant concern for the agency,” says Theresa Eisenman, an FDA spokesperson.

The threat of potentially toxic nutritional supplements often comes from pharmaceuticals, steroids, stimulants or other substances that are tucked inside the supplements. Just last year, Cohen and his colleagues detected a new cousin of methamphetamine in a different sports supplement. Meanwhile, FDA found a form of an amphetamine in nine supplements.

To address the woeful monitoring of nutritional supplements, Cohen calls for the creation of a supplement response team that would include clinicians, toxicologists, pharmacologists and chemists that could respond to reports of serious supplement-related adverse events in real time. Such a system, Cohen writes, would speed up responses to help protect consumers.

Cohen also backs another proposed fix. FDA officials told GAO in a follow-up report published in 2013 that one hold-up to acting on adverse event reports is that it’s often difficult to establish a causal relationship between a product and the health problem based on the limited information in the report. One solution, FDA has said, would be setting up an adverse event reporting service like a poison control hotline, especially since some consumers already report such incidents to poison control centers. Questions posed during that call could help fill in information gaps that could speed up investigations, but FDA has said that an obstacle there would be cost. A pilot project designed to test the waters with such a system had promising results, but it did not answer questions about if a nationwide system would actually generate information faster than a traditional system, Cohen says.

The prospects for any significant immediate change, however, seem slim, given that past reform efforts have all but flatlined. Sen. Dick Durbin (D–Ill.) has repeatedly tried to pass a bill that would require supplement manufactures to register their products and to provide more safety information, but it languished in 2011. An effort to attach provisions of the bill to other legislation as an amendment last year also proved unsuccessful. The bill was then reintroduced this session with Sen. Richard Blumenthal (D–Conn.) as its cosponsor, although no one expects the legislation to move. There is also no companion legislation in the House.

The FDA Food Safety Modernization Act, signed into law in 2011, gave FDA slightly more power in this arena—providing it with new enforcement authority to order a recall when a product will likely cause serious harm or death. But with OxyElite Pro, its manufacturers ultimately voluntarily took the product off the market after FDA threatened that it would order the company to stop production otherwise. FDA has had to take action in other cases, however. The new recall authority, however, clearly does not go far enough to protect consumers.

Without sweeping legislative changes, even if Cohen’s other plans were enacted, consumers will continue to have a safety net full of holes.


About the Author: Dina Fine Maron is the associate editor for health and medicine at Scientific American. Follow on Twitter @Dina_Maron.

The views expressed are those of the author and are not necessarily those of Scientific American.

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  1. 1. tuned 7:00 pm 04/2/2014

    Trying to artificially “boost” human performance always has its’ consequences.
    GOOD nutrition, exercises, sleep are the answer. In the end you can not beat your own genetics. It will cost you.

    Link to this
  2. 2. carolcarre 11:15 pm 04/2/2014

    I agree that some supplements are problematic, and I agree that they should meet minimum standards for safety but google ‘deaths from acetaminophen’ and ponder the irony of the anti-supplementers’ hyper focus on the very small number of deaths due to ‘supplements’

    Link to this
  3. 3. singing flea 5:28 am 04/3/2014

    This is one industry that the government should butt out. Supplements and herbal medicine are a tradition that works for some better than prescription and non prescription pharmaceuticals. They are not studied for effectiveness and if they were some immoral company like Monsanto would find a way to force farmers to grow only their “patented” varieties.

    The ridiculous marijuana laws we have endured at a horrific cost to society are only because of drug company lobbyists that want to control all mood altering or pain killing herbs so consumers can only buy their regulated brands at a huge markup in price.

    Allowing the FDA to force regulations on the legal sale of supplements and herbs is just another step towards total fascism and the choke hold placed on free enterprise by to big to fail(or compete)corporations.

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  4. 4. jtdwyer 7:36 am 04/3/2014

    Without attempting to regulate dietary supplements as ‘drugs’, are the being monitored for safety as ‘food’? What would would the FDA’s response be to toxins in breakfast cereals causing serous public health problems, for example? This looks to me like a bureaucratic shortcoming – not a shortage of regulations…

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  5. 5. DavidRopeik 10:20 am 04/3/2014

    The underlying problem here is that we are not as worried about ‘natural’ medicines as we are about ‘human-made’ pharmaceuticals, though of course both are biologically active substances we take to modify our health. Natural risks scare us less than human-made ones, so we have not demanded government action of the sort Cohen calls for, and it highly unlikely we will.

    There could not be a clearer example of what in my book I call the Risk Perception Gap, when our fears don’t match the facts and the gap between our worries and the evidence leads to big time risk all by itself. We often get risk right, but we sometimes worry more than the evidence warrants – about pesticides or nuclear power or vaccines – and sometimes we don’t worry as much as the evidence warns – about climate change, floods and storms, or carcinogenic radiation from the sun that is far more dangerous than nuclear radiation from industrial sources. The reason is simple. Our perceptions of risk are not just about the facts, but mostly about how those facts feel, and one of the underlying psychological characteristics that make things feel more or less scary is whether they are human-made or natural.

    Much more on this specific version of the risk perception gap, and other reports and examples of the risk of natural remedies being overlooked, here

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  6. 6. NancyCRN 11:07 am 04/3/2014

    In a statement from the Council for Responsible Nutrition, Steve Mister, president and CEO, says, “While we believe Dr. Cohen is well-meaning, his expertise is in medicine, not dietary supplement regulation, and while he has some legitimate observations, he misses the mark in some of his solutions.” The law (the Dietary Supplement Health & Education Act) gives FDA all the power it needs to take action against these companies engaging in illegal activity. However, the agency has yet to use the full extent of its power. Check out the full statement to learn why Dr. Cohen’s piece (and also the above story) “misses the mark” — We are the trade association for the dietary supplement industry.

    Link to this
  7. 7. villandra 9:37 pm 04/3/2014

    Hepatitis is a contagious disease. How, please, did this supplement allegedly cause it?

    Grow a head, and find out critical facts, before you preach on what the FDA needs to do!

    Link to this
  8. 8. hb 12:12 am 04/4/2014

    I’d like to make several points:
    1. I don’t know how ‘continually’ people are put at risk from products like OxyElite Pro, but this stuff can obviously pose serious health risks. These products also need to be monitored, even though pharmaceuticals are far more dangerous overall.
    2. Ironically, the contaminants in these supposed natural products are often pharmaceuticals, things like steroids or stimulants; amphetamines are specifically mentioned in the article. Of course, these pharmaceuticals didn’t end up in the ‘supplements’ by accident; there are plenty of unscrupulous operators in the natural products industry too.
    3. Products like OxyElite Pro should not be called nutritional supplements. A nutritional supplement contains nutrients – substances that the body needs and can use. Supplements are simply meant to ensure an adequate supply of essential nutrients. Things like OxyElite Pro are performance-enhancing products, an entirely different category.
    Describing products like OxyElite Pro as ‘dangerous supplements’ makes genuine nutritional supplements look dangerous by association. I wonder if that isn’t intentional, given the recent flood of supplement-bashing articles.

    Link to this
  9. 9. MikeyA 11:16 am 04/4/2014

    @ 7)villandra -

    Actually, you are incorrect. “Hepatitis” simply means inflammation of the liver. True, there are viral diseases that can cause the condition, but those aren’t the only “hepatitis’.”

    Pretty sure YOU should “Grow a head, and find out critical facts, before you preach on” about others’ deficiencies.

    Link to this
  10. 10. ssm1959 3:51 pm 04/8/2014

    The supplement industry as such in the US operates as legalized fraud. It was not until 2011 that it here was any requirement that the stated ingredient actually needed to be present. For all the public knew it could have been ingesting grass clippings and it was still legal. Even with the new regs, dosages range from-53% to +180% from the stated value. At least with pharmaceuticals the mandated range is 10% for name brand and 15% for generic. If supplements are to be considered part of medicine then the must be subject to the same purity standards!

    Link to this
  11. 11. xAnonymous 9:32 pm 04/8/2014

    Find the book: ‘’ (#3.1) // All about toxins, gmos explained.

    Link to this
  12. 12. hkraznodar 4:55 pm 04/9/2014

    Here is a simple solution: When any product kills a group of users, round up the executives, board of directors and owners or major stockholders, charge them with mass murder, put them on trial, when convicted sentence them to death and carry out the sentences.

    If they company is based outside the USA we don’t even need trials. Just call them terrorists and kill them.

    Problem solved. After a few thousand murderous greed mongers die people will be much safer. It is called being civilized.

    Link to this
  13. 13. SuoMotu 6:31 pm 04/9/2014

    Considering the fact more Americans die from prescription related drugs than do as a result of car accidents, this article appears to be about something other than natural remedies. Power. Money. Control.

    Link to this

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