Over-the-Counter Medications vs. Dietary Supplements: What’s the Difference?
In a recent post we talked about discussing the differences between brand and generic drugs with our patients. Perhaps equally important, but also less appreciated by many patients, is the difference between over-the-counter (OTC) medications and dietary supplements, which make up the majority of items stocked in pharmacies. In addition, they are often found next to each other on the shelves with similar labeling, making things even more confusing for patients.
In this post, we’ll look at the differences between the two and go over ways we can help patients make the best treatment decisions for themselves.
What is an OTC medication?
The Food and Drug Administration (FDA) defines OTC drugs as those that are “safe and effective for use by the general public without seeking treatment by a health professional.” The FDA’s Office of Nonprescription Drugs regulates OTC drugs and provides two pathways for approval:
OTC drug review process: Because of the vast number of OTC products out there, the FDA groups many OTC drugs into therapeutic categories and then issues a monograph for it. Under this process, any drug meeting the standards of this monograph can be marketed without a New Drug Application or premarket approval.
Drug application process: Any drug not meeting these standards must be approved through a New Drug Application (NDA) before it can be marketed as an OTC drug. This is the same process as prescription drug approval.
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It is also common for medications that were previously available by prescription to later be approved for OTC use. This Rx-to-OTC switch is often done by manufacturers right before the patent on their respective medications expires so they can continue to generate revenue from them, assuming they can gain FDA approval.
What is a dietary supplement?
Dietary supplements are a category of products that include amino acid products, enzyme supplements, herbals, and vitamins and minerals. Herbals may include plant materials, algae, and microscopic fungi.
Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, which established a different set of regulations for dietary supplements than for foods and drug products. Under DSHEA, manufacturers of dietary supplements must evaluate the safety and labeling of their products before marketing them, and the FDA must take action against manufacturers of adulterated or misbranded products after they reach the market.
In other words, under DSHEA the FDA’s role is reactive, only being allowed to take action after adulterated or misbranded products make it to the marketplace, as opposed to having a proactive, premarket approval approach like with OTC drugs.
Unfortunately, adulterated or misbranded products reaching patients is not a far-fetched concern. In 2015, the state of New York asked major retailers to stop selling a wide range of supplements after finding evidence of contamination in many of them. They also found that only 21% of herbal products tested had evidence of the plants listed on the label.
How OTCs and supplements differ
Perhaps the biggest distinction to be found between OTC drugs and dietary supplements is in the claims that are allowed. Drugs are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”
Making a product claim that meets this definition could lead the FDA to consider it a drug, which would have to meet the requirements for approval as an OTC, and not a dietary supplement.
Dietary supplements can, however, make the following claims:
Authorized health claims: These are claims reviewed by the FDA, scientifically supported, and allowed on food products or dietary supplements that say a product might prevent a disease or health-related condition.
Structure/function claims: While a structure/function claim might meet the above definition of a drug, DSHEA established rules for legally using structure/function claims for dietary supplements. Dietary supplements can make statements related to general well-being, as well as statements related to a nutrient deficiency disease. Examples given by the FDA include “calcium builds strong bones” and “fiber maintains bowel regularity.”
Caring for your patients
All of these regulations and legal definitions can be very confusing for patients, so I recommend the following tips to help them make sense of supplement use.
Ensure your patients are purchasing quality dietary supplements
As a pharmacist, we can help patients by only recommending supplements that have been independently verified as having what the label says they have and not having contaminants. If there’s not one like that available, I recommend brands that have numerous other supplements verified through independent testing, because it gives me more confidence in their manufacturing process.
The most well-known program that performs this testing is from the U.S. Pharmacopeia. Look for the USP-verified mark on the bottle to ensure it has been tested by the USP; you can also search for USP-verified supplements on its website. Another well-known program is through NSF International, and products passing its testing also have a unique mark on the bottle. You can seach for NSF-verified supplements here.
Ensure your patients are following their provider’s guidance and informing them of their supplement usage
One of our roles, especially considering patients usually see us much more often than their providers, is to ensure they are informing providers of their supplement usage, that their supplements are not interacting with any medications, and that they’re not using any supplements as a replacement for prescribed medications.
Help them understand the risks and benefits
With some dietary supplements, there might not be many risks with taking them, yet others might not only have drug interactions but also have risks associated with their use, even if they do contain what is on the label.
For example, red yeast rice is known to be at risk for contamination and to have the same risk of adverse effects as statins. In addition, there is no way of knowing how much active ingredient is in the supplement, and the FDA actually determined in 1998 that red yeast rice containing more than trace amounts of the active ingredient could not be marketed as a supplement.
Make sure they know why they are taking it
Many patients look for supplements without having a clear reason for them. For example, I’ve had numerous patients ask me for vitamin B12 because “it’s good for energy.” Most of the time I find out they have not had labs, and don’t even know if they have low levels of vitamin B12. Just as we play a vital role in ensuring patients have a clear indication with prescription and OTC drugs, we should also play a role in ensuring there is a clear indication for all dietary supplements.
Clarify what ‘natural’ means
Finally, there is a widespread belief that “natural” means safe. Not only is “natural” a difficult term to define, but even if a patient does believe a product to be completely natural, we should ensure that they understand there could be risks as well as benefits associated with it.
I often like to make these points when discussing this topic with patients:
There are lots of naturally occurring substances found in prescription drugs too. Examples include penicillin, which came from a mold; ACE-inhibitors, which came from the venom of a snake; and GLP1s, which came from the saliva of the Gila monster.
There are a lot of naturally occuring substances that are dangerous. Asbestos, cyanide, opium, and ricin are all naturally occurring substances.
The most important consideration with any treatment — whether it is natural, synthetic, or even a medical procedure — is to fully understand both the risks and benefits so you can decide if it is right for you.
The bottom line
The regulation, marketing, and distribution of OTC and herbal supplements can be confusing for patients. With these tips, you can help patients fully understand the differences and get the most out of both OTC medications and herbal supplements, while ensuring they keep their providers informed of their choices.
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