ARE YOUR SUPPLEMENTS SPIKED?
Yes! Spiked. In other words, something has been snuck in your supplement that isn’t listed on the ingredient list. Another question may be if the products purchased actually contain what is on the label and quality of the products is an entirely different question.
During a conference I heard a speaker mention that many of the natural supplements on the market don’t contain the actual ingredients they say they do, or they contain additional ingredients that aren’t clearly noted on the labels. I’ve also heard that if you order things on-line, these can sometimes be “fake” brand name supplements made in other countries. As someone who does take supplements, this concerned me and I was inspired me to do a little more investigating as to what, if any, are the regulations on supplements and is there any published research on this topic.
FDA & SUPPLEMENTS
Currently, the FDA depends on MedWatch (https://www.safetyreporting.hhs.gov) to identify any concerning supplements. However, previous issues with supplements were often identified through other sources and took additional months to prove there was a concern before removing supplements. There is no review of supplements prior to distribution and MedWatch is not very reliable, as it requires reporting by individuals. Previous efforts to create more efficient methods of identifying concerning products have been canceled due to funding efforts. (7)
You might notice on the back of any of your supplements the phrase: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease”. Anything nutrition related and not for medical treatment carries this phrase. This emphasizes that supplements are for nutritional supplementation only and do not treat any specific diagnosis. To be clear, this does not mean that the ingredients haven’t been shown effective for individuals with certain illnesses, only the statement cannot be made that it helps with any medical illness. Well, it may be beneficial if the ingredients listed are actually the one’s included or it could cause harm, as I’ll cover later.
Anything considered a dietary supplement does not need FDA approval prior to marketing and the FDA does not regulate products prior, but can remove once found to be harmful.
In an attempt to regulate supplements prior to production the Dietary Supplement Health and Education Act of 1994 (DSHEA) was created. While vitamins and minerals have nutritional value and are generally safe in recommended doses, this act also includes herbals in this category. This complicates regulations on these products and that is for another discussion (5). DSHEA basically states that “manufacturers and distributors are prohibited from marketing products that are adulterated or misbranded” but no one is actually monitoring the product content prior to it being sold to customers.
In other words, those companies that are manufacturing the supplements are responsible for evaluating the safety of their products before marketing to insure they meet the requirements of DSHEA and FDA regulations. They are self-regulating, and we know how well that often works, especially in corporate settings. Products are still going to market and potentially many individuals can be exposed to unknown ingredients.
The FDA will act ‘after the fact’ if any violations are reported, however, this is in retrospect once a concern is raised, not preventative. Companies are self-regulating where supplements are concerned. Even after the FDA makes recalls, not all supplement companies are removing the products with these substances from the markets (2) and when they do it often takes time to show the supplement is harmful in order to remove, potentially leading to further harm (3). It is estimated 50,000 adverse events occur from dietary supplements annually with damage to liver and kidneys primary events, similar to FDA approved medications (5).
Needless to say, there aren’t any “real” regulations on nutritional supplements prior to them being sold.
SPIKED SUPPLEMENTS & RESEARCH
There are a number of smaller studies that looked at nutritional supplements and found they contained other ingredients not listed on their label. These are just a few that I came across from more recent years.
One study in 2013 found that supplements marketed for support of thyroid function actually contained thyroid hormone in the products. This was seen in 9/10 of the supplements evaluated (4).
Another report in 2013 found an over the counter supplement, OxyElite Pro, caused a cluster of severe hepatitis and liver failure cases, leading to at least one known death. This was only identified due to an astute liver transplant surgeon (3).
“Adrenal support” supplements were evaluated in 2018 and purchased by a “well-known online shopping website”. They tested 12 products and found that all the supplements studied contained a small amount of thyroid hormone and most contained at least one steroid hormone, with pregnenolone being the most common. These supplements were not supplements to support the thyroid but rather pharmaceuticals to treat the symptoms (1).
I contacted the author on this last paper to see about getting additional information. It was confirmed Amazon was the source, which I inferred based on the description. However, the author had moved on to other research projects and no longer had the data to provide the names of the supplement brands. When researchers discover this information, does it get reported?
With tens of thousands of nutritional supplements on the market and probably tens of thousands of “counterfeit supplements” being sold this issue is overwhelming. So far, more than 500 nutritional supplements have been shown to contain a variety of pharmaceuticals and these are just of those tested. There is no doubt, in my mind, there are probably thousands of other supplements that would be found to violate their ingredient list and again, quality and sourcing of the ingredients is something that hasn’t even been addressed. Some of these supplements shown to contain other pharmaceuticals included those for other indications, some that were not yet approved and even some that had previously been banned (6).
5 WAYS TO PROTECT YOURSELF:
Given the current state of overall health and the decreasing quality of our soil, many people may benefit from nutritional supplements at various times in his/her life. In fact, it is estimated that more than half of adults currently take a supplement, and likely more than one, in the United States (3) and this number is only expected to increase.
What can you do to ensure your supplements are safe and contain the ingredients on the label? The answer is that it’s actually difficult to know but there are some ways to limit the likelihood that you end up with a product that contains unlisted ingredients and/or doesn’t have what is listed.
Here’s what I do now and what I advise others to do:
- CHECK TO SEE IF THE PRODUCT IS CERTIFIED. The FDA, in 2007, did establish a regulation called the good manufacturing practices (cGMP) for dietary supplements. This was established in an attempt to ensure quality of supplements during manufacturing, packaging, labeling and storing of dietary supplements. These companies are expected to establish quality control procedures, design and construct manufacturing plants and test ingredients in the finished product to meet these requirements. It also requires recordkeeping and handling consumer product complaints appropriately.
You can go to nsf.org/services/by-industry/nutritional-products/ and search for facilities that have met the certified products designation. The NSF International (formerly National Sanitation Foundation, started in 1944) is an independent organization certifying products. Products will carry the NSF mark if they’ve complied with the standard requirements. This at least reassures that the supplement manufacturer has followed designated methods for production and is evaluated in some way prior to end use. It not only evaluates the ingredients but tests that there aren’t any other contaminants (toxins, microbes, etc). Does NOT being listed on here mean that a company does not have a good product? Certainly not, but this is at least another hurdle companies have gone through to self-regulate.
The US Pharmacopeial Convention (USP) is another option to evaluate supplements. It is an independent, non-profit organization that provides analysis of food ingredients, medicines and dietary supplements to improve quality and safety of those products. They may be a reasonable way to assess vitamins and minerals in supplements, however, in general evaluation of herbal products is much more difficult to determine due to the difficulty in evaluating them, again another discussion.
- READ THE RESEARCH. If a product makes a number of claims that sound too good to be true, they probably are. You can search to see what products and ingredients have research to back them. Now that everyone has access to resources via the Internet, you can look for support of the products you are taking by reviewing journal articles. I find now that the difficult part is not finding the information but finding too much and being able to decipher the reliable from unreliable sources. So, that’s where asking providers you work with for help. Even they, however, may not be aware but should be able to help you decipher what is needed and what isn’t in your particular case.
- DO NOT BUY SUPPLEMENTS THROUGH AMAZON. This isn’t to say anything bad about Amazon; we purchase some products on Amazon but supplements are not on that list any longer. Yes, you may find it cheaper but there is too much potential for imposters. Until Amazon starts putting some of it’s funds into testing these supplements to insure they contain the listed ingredients, I’m not going to get any through them and wouldn’t advise friends, family or clients to do so either.
- DISCUSS/PURCHASE THROUGH HEALTHCARE PROVIDERS. You should discuss any supplements you are considering taking or are currently taking with your health care providers. Supplements do not fall under pharmaceuticals as are not directed at treating a particular illness but to support your health, however, you are ingesting these and can have interactions with other medications you may be taking and interact with each other. Discussing the supplements before simply taking and when available purchasing through a reliable, evaluated source. Your provider should’ve also done his/her due diligence in evaluating the products. The products that I have been using now for my family, I have spoken with the companies directly, they are based in the United States and evaluated through one of the above independent organizations.
- EAT YOUR VITAMINS AND MINERALS. Of course, food is really your best medicine and when possible getting your nutrients through foods will provide the most benefits. Some people may have a more difficult time obtaining the vitamins and minerals they need but as much as possible eating a balanced diet will get you the nutrients needed daily but even your foods need to be carefully selected for the best health benefits. Eat organic when possible and see the Environmental Working Group for their list of Clean Fifteen and Dirty Dozen when selecting your produce.
- Akturk HK, Chindris AM, Hines JM, Singh RJ, Bernet VJ. Over-the-Counter “Adrenal Support” supplements contain thyroid and steroid-based adrenal hormones. Mayo Clin Proc 2018:93(3):284-290.
- Cohen PA, Malier G, DeSouza R, Neal-Kababick J. Presence of banned drugs in dietary supplements following FDA recalls. JAMA 2014: 312(16):1691-1693.
- Cohen PA. Hazards of hindsight-monitoring the safety of nutritional supplements. N Engl J Med. 2014: 370(14):1277-1280.
- Kang GY, Parks JR, Fileta B. et al. Thyroxine and triiodothyronine content in commercially available thyroid health supplements. Thyroid. 2013:23(10):1233-1237.
- Marcus DM. Dietary supplements. What’s in a name? What’s in the bottle? Drug Test Anal. 2016:8(3-4):410-412.
- Vander Bijl P, Tutelyan VA. Dietary supplements containing prohibited substances. Vopr Pitan. 2013:82(6):6-13.
- www.fda.gov/safety/medwatch. Accessed 8.17.19.