What’s in Your Medicine Cabinet? Part 3: Vitamins and Supplements
In this last part of our three-part series titled “What’s in Your Medicine Cabinet?” We’re talking about Vitamins and Supplements. Check out the October and November issues in this series: 6 Concerns for Your Prescribed Meds and Over the Counter Medications as well as the companion articles in the Living Well Branch for more information on this important topic.
A week does not go by without one of my clients asking if there is a supplement they can take for their symptoms. Perhaps you have wondered about this too, since it seems there is something for everything. An estimated more than one-third of all Americans take a multivitamin supplement (MVM). This is big business as sales of dietary supplements in 2014 totaled an estimated $36.7 billion ($14.3 billion-MVM containing). Given the increasing popularity and marketing strategies attached to this growing trend let’s have a conversation about common questions surrounding quality, safety and efficacy.
What is a dietary supplement? The Dietary Supplement and Education Act of 1994 considers supplements to include herbals (botanical products), complementary nutritionals (ex. Amino acids) and micronutrients (vitamins and minerals). Homeopathic products or topically administered herbals are often used by consumers for complementary health but do not fall under the regulatory definition of dietary supplements.
Who oversees the quality, safety, and efficacy of these supplements? The Food and Drug Administration (FDA) has oversight of dietary supplements though the regulatory framework differs from that for prescription or over-the-counter drugs. Manufacturers of dietary supplements containing products that were introduced after October 15, 1994, are required to notify the FDA before marketing and to provide a rationale for the safety of the ingredients often historical use. What is often surprising is that neither safety testing nor FDA approval is required before marketing. You may be familiar with the disclaimer present on supplement labels which states “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”. This is consistent with the National Institute of Health fact sheet updated on July 8, 2015, that states that multivitamins do not appear to reduce overall chronic disease risk though several nutrients included might benefit certain population groups.
With no requirement for safety testing or FDA approval, how can I tell if a supplement is safe? If a dietary supplement is found to be unsafe the FDA can have the manufacturer remove the product from the market. There is criticism that the laws governing recall are not strong enough. A study of product recalls published in 2013 in the Journal of the American Medical Association found that 274 supplements recalled by the FDA between 2009 and 2012 contained banned drugs. A 2014 report found that more than two-thirds of the supplements purchased six months after the recall still contained the banned drugs. Post-market reporting of adverse events is required for only the most serious events including those resulting in hospitalization, significant disability or death. Unlike prescription and over the counter medications there are no requirements to identify adverse events on the dietary supplement packaging.
RDAs, AIs and DVs: what do they mean and how do I know what is the right daily amount for each vitamin or mineral? Whole food sources for our vitamins and minerals is ideal given the inability for lab-created supplements to replicate the phytonutrients and synergy of these as found in food. The Institute of Medicine (IOM) of the National Academy of Sciences set the Recommended Daily Allowances (RDAs) for selected nutrients and where no RDA is established the IOM has developed Adequate Intake levels (AIs). The Daily Values (DVs) are set by the FDA and were updated in July of 2016. The DVs may not still reflect the latest intake recommendations by the IOM as the large manufacturers and small manufacturers have been given until January 1 of 2020 and 2021, respectively to update their labels with the new DVs.
Is it possible to get too much of a nutrient? Yes, which is why the Upper Tolerable Intake Levels (ULs) were set by the IOM. This means that there is an increased risk for adverse events when the UL is exceeded. There are times when the UL may be exceeded based on the specific medical treatment needs supervised by a healthcare professional. This is an important area for public education as the “more is better” belief may be applied to vitamins and minerals. Thoughts that “the excess will just be excreted” assumes that kidney function will be sufficient. Recently upon review of my client’s vitamin C intake, we discovered an excess well above the UL of 2000mg. Her dietary intake from food was more than sufficient with an RDA of 75 mg for her age, though food sources of vitamins do not cause the adverse effects experienced with lab created compounds. These side effects can include nausea, vomiting, heartburn, inflammation that might damage the esophagus (esophagitis), a blockage that keeps food or liquid from passing through your small intestine or large intestine (intestinal obstruction), stomach cramps, fatigue, headache, sleepiness, diarrhea, insomnia and skin flushing. In some people, oral use of vitamin C can cause kidney stones. Long-term use of oral vitamin C supplements over the UL can increase the risk of significant side effects. High levels of vitamin C might interfere with the results of certain tests, such as stool tests for occult blood or glucose screening tests.
How big of a problem is this issue? A recent report from a nationally representative sample of emergency departments from 2004 through 2013 revealed that dietary supplements were implicated in an average of 23,000 emergency department visits and 2000 hospitalizations annually. Children, millennials (ages 20-34) and seniors are reportedly most at risk with seniors most likely to be hospitalized. Child-resistant packaging is not required for dietary supplements except for iron, though it was iron supplements that scored second in unsupervised ingestion by children. Weight loss supplements were most implicated in the 20-34 age group. Swallowing issues were implicated in many of the seniors.
What can I do to limit unwanted side effects? Even though this is an unregulated industry you can make safe and effective decisions related to your choices for supplements. As always communicate with healthcare professionals about what you are taking and the need for additional supplements. Here is a partial list of what I teach my clients to consider when adding a supplement to their plan for health:
- Is the product NSF® Certified and/or Certified for Sport™? This voluntary certification assures that there are no undeclared ingredients in the product that are not listed on the label. Is there additional quality assurance testing to assure that there are no contaminants or bacteria? How frequently is that testing done? Know the limitations of the organic labeling. Since contaminants can be introduced at any stage of the growing and manufacturing practice I feel most confident with endpoint testing to assure quality and purity.
- Does it contain substances that have no proven benefit, for example, fillers or dyes?
- Are there mega doses of selected ingredients above the Upper Tolerable Intake Levels (ULs)?
- Does the supplement contain “whole foods” or food concentrates which are the closest to the nutrients from foods in nature? Does it have a food label or a supplement label?
- Does the manufacturer make fantastic claims about their product? If you hear or see the words “miracle,” “cure,” “ancient remedy,” “secret formula,” and testimonials about diseases that were cured take caution. It is one thing for an individual to share their personal experience with a supplement and quite another to make testimonials in direct contradiction to the disclaimer present on the label.
- Ask to see the research. Primary research, conducted on people who are taking the same product that is in the bottle you have purchased, is not required by the FDA or other organizations like is required for prescription pharmaceuticals. I always ask to review this type of research on any vitamins and supplements I recommend. Surprisingly there may be very little if any documentation of quality or efficacy. There may be borrowed research, for example, a product contains vitamin C so the claim is that their product will perform the same as referenced in the research, though none was conducted on their product. Where the research is published is also important. Independent, third party, double-blind placebo control research, published in peer-reviewed medical journals vs private publications, provides the framework to ensure that the data is credible and collected without bias. The Journal of the American College of Cardiology, Journal of Clinical Periodontology, Medicine and Science in Sports and Exercise and the Journal of the American College of Nutrition are some examples.
According to the 2015-2020 Dietary Guidelines for Americans, “nutritional needs should be met primarily from foods. Foods in nutrient-dense forms contain essential vitamins and minerals and also dietary fiber and other naturally occurring substances that may have positive health effects”. Vitamins and mineral supplements can play an important role in meeting nutritional requirements when a medical condition requires more than can be met with food alone. Become an informed and empowered consumer when this is the case to ensure that you are receiving optimal benefit from this investment in your health.
Cheree M. Albert MSN, CRNP, CPNP is the owner of Integrity Health Source LLC. You can contact Cheree by phone: 407-902-8945 or email firstname.lastname@example.org