Should We Really Stop Taking Our Supplements?
Contributed by Rylen Feeney.
Confused about supplement safety? You are not alone.
Two recent New York Times headlines asserted, “Skip the Supplements” and “Spike in Harm to Liver is Tied to Dietary Aids.” A week later the same paper headlined “Vitamin E Slows Decline of Some Alzheimer’s Patients in Study”. Confused? You are not alone.
The last year has been particularly rough on the supplement industry. It is probably not coincidental that there have been several proposed and (thankfully) failed bills introduced that would ultimately limit consumer access to herbs and supplements. These bills included legislation to allow the FDA to require all supplements introduced later than 1994 to be subject to scientific safety studies equivalent to those required of pharmaceuticals.
Is the United States (US) positioning itself to follow in the footsteps of the European Union’s (EU) ban on all but the most benign vitamins, mineral, supplements and herbs? It took the EU 10 years and several layers of directives to fully adopt laws that have effectively removed vitamins, supplements, and most herbs from public access.
In my opinion the current rash of articles pertaining to supplements and herbs are an unabashed form of fear mongering, and a way to seed distrust and ultimately greater support for future legislation to limit access to herbs, vitamins, and supplements.
The article that appeared as an opinion piece in the New York Times on Dec. 14th, “Skip the Supplements” was written by Paul Offit and Sarah Erush. Paul Offit is a known skeptic and naysayer, he recently published, “Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine.” Dr. Paul Ofitt is hardly an unbiased opinion; he is head of pediatric infectious diseases at The Children’s Hospital in Philadelphia and has been handsomely paid by the immunization industry for the past decade. 
Mark Blumenthal, director of the American Botanical Council responds to Offit’s piece: ”The authors also cite an outdated, erroneous statistic that the FDA ‘estimates 50,000 adverse reactions’ are reported each year for dietary supplements, but that figure is based on a report from 2000 that estimates prescription drug and vaccine-related adverse event data, not dietary supplement data.  In contrast, FDA officials reported that 3,247 serious adverse events were associated with supplements in 2012. 
-  Walker A. The Relation between Voluntary Notification and Material Risk in Dietary Supplement Safety. US Food and Drug Administration Commissioned Paper, March 9, 2000.
-  Fabricant DS. Post-Market Surveillance and Risk Assessment of Dietary Supplements. Presentation at the International Conference on the Science of Botanicals, University of Mississippi, Oxford, MS. April, 2013.
While the argument that herbs and supplements should undergo the same studies as pharmaceuticals to assure safety and efficacy seems reasonable at first glance, with a more careful eye to detail, we realize that this is unreasonable. When we look at the numbers, it’s completely unrealistic. It is nothing more than a means to remove product availability from consumers.
Who should monitor supplement safety?
Furthermore, I would argue that the FDA does a questionable job at best monitoring pharmaceuticals, so I question the validity of adding herbs and supplements as part of their responsibility. It seems to me that a fresh, non-biased organization would be better suited at overseeing the GMP (Good Manufacturing Practices) of Supplements and Herbs. There is often a false assumption that the FDA has rigorous safety checks, tests and hurdles for drugs to pass before they can be approved and available. This just isn’t the case.
The reality is that the onus for drug safety lies squarely on the pharmaceutical companies – the very company that is developing the drug must prove its safety. A New Drug Application pays between $1,841,500 with clinic data or $920,750, if no clinical data is required. This is only one of the fees paid to the FDA and just the mere beginning of the expense to then actually conduct the studies required for approval. It is immediately clear that the vitamin and supplement industry would not be able to foot such a bill.
Properly prescribed medications are responsible for more than 100,000 deaths a year and are currently the 4-6th leading cause of death in the United States, double the deaths caused by car accidents; while prescription opiates are currently killing approximately 15,000 middle aged adults a year, more than heroin and cocaine deaths combined. These numbers are averages for deaths in the United States. If we add in serious adverse reactions it is even scarier. Consider, in 2010 there were 82,724 deaths from FDA approved drugs and 471,291 adverse effects. In many cases drugs are approved and then it is up to consumers that have adverse effects to report to the Center of Poison Control or the FDA. Once the numbers become alarming the FDA will look at the evidence and recall said drugs from the market. Several of the big recalls of the past decade include Rofecoxib (Vioxx),mixed amphetamine salts (Adderall XR), Tegaserod (Zelnorm), and Propoxyphene (Darvocet/Darvon).
In comparison to the above figures, The American Association of Poison Control Centers 2012 Annual report sites two deaths due to Dietary Supplements/Herbs/Homeopathic Remedies and one under the category of Vitamins. In fact, The American Association of Poison Control Centers only reported a total of 230 deaths from dietary supplements between1983 and 2004. Almost all of these were due to “diet and sport athlete” formulas.
Putting the FDA in charge of supplements and herbs will likely push the most useful products into the hands of larger pharmaceutical companies, and make many less popular products unavailable due the inability to get research funding, and as is apparent from the statistics above is unlikely to prevent any deaths.
Questions to ask about studies on supplement safety.
So, what are we do? I am not here to convince you that all Herbs and Supplements are safe in any form and at any dose. They are not. We cannot argue on one hand that herbs and supplements are 100% safe and then claim them to be harmless at the same time. However, it is my opinion and experience that they are tremendously safer than many properly prescribed medications for managing minor to moderate symptoms.
When looking at studies that claim that there is no benefit, or even worse potential harm in taking supplements, think about the following list of questions posed in a recent blog article by Bastyr Center for Natural Health:
- Who is doing the reporting? Is it a press release, a health column describing the study itself, or a journalist relating second- or third-hand news from conference proceedings?
- How strong is the evidence? Some studies lead to convincing conclusions while others are preliminary.
- Are the results published in a well-regarded, peer-reviewed scientific journal?
- Did the researchers use a control group to compare treatment results with the experiences of people who didn’t use the supplement? If not, observed supplement benefits may be due to the placebo effect.
- Was the supplement given in a form and amount, and for a duration, that could be expected to be effective based on previous knowledge?
- Was the study conducted by people who have no vested interest in the outcome?
- Is there a body of research that suggests it may help with a particular health condition?
A few guidelines for supplementation:
In conclusion I offer the following factors for consideration for supplementation:
- Don’t take supplements in place of food. They are not interchangeable.
- Do take a good quality multivitamin/mineral. I recommend food-form multi-vitamins and minerals whenever possible. It is simply not true that we get all we need from our diets. Most of us, even with effort, find it difficult to get all the nutrients needed for vital health. A food-form multi lays a nice substratum so that you are getting at least a little of everything we know the body needs. However, I agree that taking mega doses of expensive vitamins and minerals can lead to vitamin toxicity. Vitamins and minerals in particular are very complex and depend on each other and food for assimilation and effectiveness. Taking vitamins and minerals with their synergists and in a “natural” food sourced origin reduces any possible negative effects and maximizes intended actions. Additionally, you benefit from all of the co-factors that are inherent to that group of vitamins or minerals.
- Know what you are taking and why! Don’t jump on every media nutrient bandwagon. Work with someone or educate yourself and understand why you are taking what you are taking. Take things for a specific period of time and reassess regularly. If you have any side effects or reactions (even minor) consider talking to a professional and stop taking it!
- Avoid dieting supplements and Sports Athlete enhancement products, or at least approach these with the greatest amount of caution and research. Nearly, all the serious side effects and adverse reactions in the area of supplementation and herbs come from these categories. Also, these categories of supplements are the most likely to be adulterated.
- Get your supplements from a trusted health care provider trained in supplements and herbs, or check with www.consumerlabs.com or http://naturaldatabase.therapeuticresearch.com. Yes, there have been cases of products not containing what they claim to contain and/or worse being adulterated. Do your due diligence and buy smart. I advise similarly if given or prescribed a drug. I would hope given the statistics above that we all would perform our due diligence by checking adverse affects, interactions and the like before taking any medication.
- Support continued access to herbs and supplements. Putting medical doctors, hospitals, pharmaceutical, and/or the FDA in charge of our access to supplements, herbs and traditional remedies that have an amazing safety record overall is not an effective or cost friendly solution. Doctor’s by and large are not trained in the safe use of herbs, vitamins, supplements or even nutrition, so assisting the FDA or Pharmaceutical companies in making these products only available by prescription makes no sense. Most of the herb and supplement industry is eager to comply and help find a solution and should be supported. See notice from The American Botanical Council’s recent endorsement .
Asserting our right to fair and reasonable access.
In closing, I encourage us to not let the consistent negative media coverage dissuade us from protecting our right to fair and reasonable access to supplements and herbs. Continued research is important and necessary, as is oversight to ensure good manufacturing practices. But let us insist on this being separate from the Pharmaceutical companies and FDA, or at the very least a newly devised task force of the FDA that does not benefit from huge financial gains via daunting bureaucracy.
For every negative study there are counter studies. Recently a survey (note not study) suggested that taking multivitamins increased risk of mortality by 2%, yet another study published in the same time frame, based on the European Prospective Investigation into Cancer and Nutrition (EPIC) (24,000 participants), found that antioxidant vitamins may reduce cancer mortality by 48% and all-cause mortality by 42%. Let us remember that these broad surveys and studies rarely account for the quality of the supplement and don’t always account for lifestyle and poor eating habits.
When wondering if supplements are safe and pondering how stringent regulations should be, remember that in prescriptions made by pharmaceutical companies, approved by the FDA and prescribed by doctors kill more than 100,000 people annually, while supplements have killed less than 250 people total in 33 years combined. Finally, just ask yourself, what would it look like if you couldn’t reach for your favorite preventative cold formula when you were trying to ward off a cold or couldn’t take additional a Chinese herbal formula that has alleviated your aches and pains? It happened in the European Union in April 2011. Don’t let it happen in the United States!
References and Links
 Walker A. The Relation between Voluntary Notification and Material Risk in Dietary Supplement Safety. US Food and Drug Administration Commissioned Paper, March 9, 2000.
 Fabricant DS. Post-Market Surveillance and Risk Assessment of Dietary Supplements. Presentation at the International Conference on the Science of Botanicals, University of Mississippi, Oxford, MS. April, 2013.
For more information for helping the EU regain access to supplement see: http://www.anh-europe.org/node/3113
Berl, Rachel Pomerance. “Paul Offit Takes On Alternative Medicine.” US News. U.S.News & World Report, 22 July 2013. Web. 17 Jan. 2014.
“CRN Fires Back at Anti-supplement Editorial.” New Hope 360 – Natural Products Industry Business, News & Lifestyle. N.p., n.d. 17 Dec. 2013 Web. Jan. 2014.
Photo by Healing and Eating on Flickr.