The critical differences you need to know: Prescription medicine, over-the-counter medicine and dietary supplements
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The critical differences you need to know: Prescription medicine, over-the-counter medicine and dietary supplements

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The critical differences you need to know: Prescription medicine, over-the-counter medicine and dietary supplements

(BPT) - Seventy-five percent of Americans take dietary supplements, according to a 2018 study by the Council for Responsible Nutrition (CRN).i Furthermore, “87 percent [of adults in the United States] have overall confidence in the safety, quality and effectiveness of dietary supplements.”i While the effort to sustain better overall health is commendable, there is skepticism among healthcare experts regarding the medical benefits of dietary supplements.ii Use and promotion of dietary supplements is considerably broader in the United States than other areas of the world.iii

When caring for your health, it’s important to know the critical differences between prescription medicine, over-the-counter medicine and dietary supplements.

Prescription medicine is a pharmaceutical drug that legally requires a medical prescription to be dispensed.iv In the United States, before prescription medicine can be marketed and sold it must be tested rigorously and deemed safe, effective and manufactured to high-quality drug standards by the U.S. Food and Drug Administration (FDA).v The prerequisite of medical practitioner oversight reflects the potential benefits and risks of prescription medicine and the importance of taking it appropriately.iv

Over-the-counter (OTC) drugs are drugs that consumers can use without prescription, based on the assumed ability of the consumer to self-diagnose the condition and then use the OTC drug by themselves without medical monitoring.vi OTC drug candidates are also assessed by the FDA for safety and effectiveness.vi Often drug manufacturers submit data to the FDA showing a drug is appropriate for self-administration accompanied by studies showing that the product's labeling can be read, understood, and followed by the consumer without the guidance of a health care provider. Additionally, concerns about side effects can sometimes be managed by approving OTC drugs at lower doses than their prescription counterparts.vi A notable example is ibuprofen, which launched as a prescription drug in 1969 and became an OTC drug in 1983. Today it is widely used as an OTC pain killer, but it is available by prescription in doses up to four times higher than the OTC dose.vii

Dietary supplements are not prescription drugs. Rather, they are classified by the FDA as food. As such, they are not intended to treat disease and their safety, efficacy and manufacturing quality have not been reviewed or approved by the FDA as required for drugs.viii Dietary supplements are “products taken by mouth that contain a dietary ingredient such as vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.”viii Dietary supplements, unlike prescription drugs or OTC drugs, are not intended to treat, diagnose, mitigate, prevent or cure diseases.ix

Dietary supplements can sound very appealing as they promote hope and possibilities.x In part, this is because advertising of dietary supplements is not subject to the restrictions and disclosures of prescription drug advertising.xi Consumers need to know that when a product label says it “may work,” it hasn’t necessarily proven to the FDA that it is effective. With so many options and perceived “solutions” in front of consumers today, it’s critical that you check with your healthcare professional if you have a condition that requires a “therapy.”xii Only a healthcare practitioner should be providing medical guidance on what you should take given your specific medical needs and history.xiii


[i] “2018 CRN Consumer Survey on Dietary Supplements.” The Council for Responsible Nutrition (CRN), 18 Oct. 2018, www.crnusa.org/CRNConsumerSurvey#targetText=Commissioned%20by%20the%20Council%20for,consumer%20behavior%20and%20product%20demand.

[ii] “Dietary supplements: Do they help or hurt?” Harvard Health Publishing Harvard Medical School, Jan 2013, https://www.health.harvard.edu/staying-healthy/dietary-supplements-do-they-help-or-hurt.

[iii] Teichner, Warren, and Megan Lesko. “Cashing in on the Booming Market for Dietary Supplements.” McKinsey & Company, Dec. 2013, www.mckinsey.com/business-functions/marketing-and-sales/our-insights/cashing-in-on-the-booming-market-for-dietary-supplements.

[iv] “Prescriptions Q&A.” Diversion Control Division, U.S, Department of Justice & Drug Enforcement Administration, www.deadiversion.usdoj.gov/faq/prescriptions.htm.

[v] Center for Drug Evaluation and Research. “The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective.” U.S. Food and Drug Administration, FDA, Nov. 201AD, www.fda.gov/drugs/drug-information-consumers/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective.

[vi] “Now Available Without a Prescription.” U.S. Food and Drug Administration, FDA, May 2016, www.fda.gov/drugs/drug-information-consumers/now-available-without-prescription.

[vii] Bushra, Rabia, and Nousheen Aslam. “An overview of clinical pharmacology of Ibuprofen.” Oman medical journal vol. 25,3 (2010): 155-1661. doi:10.5001/omj.2010.49

[viii] “Questions and Answers on Dietary Supplements.” U.S. Food and Drug Administration, FDA, 22 July 2019, www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements.

[ix] “Dietary Supplements: What You Need to Know.” NIH Office of Dietary Supplements, U.S. Department of Health and Human Services, June 2017, ods.od.nih.gov/HealthInformation/DS_WhatYouNeedToKnow.aspx.

[x] Harvard Health Publishing. “Supplements: A Scorecard.” Harvard Health, Apr. 2012, www.health.harvard.edu/staying-healthy/supplements-a-scorecard.

[xi] “Advertising Dietary Supplements.” Consumer Healthcare Products Association, www.chpa.org/DS_Advertising.aspx.

[xii] “Are You Considering a Complementary Health Approach?” National Center for Complementary and Integrative Health, U.S. Department of Health and Human Services, 6 Sept. 2016, nccih.nih.gov/health/decisions/consideringcam.htm.

[xiii] “Frequently Asked Questions (FAQ).” NIH Office of Dietary Supplements, U.S. Department of Health and Human Services, 1 July 2013, ods.od.nih.gov/Health_Information/ODS_Frequently_Asked_Questions.aspx.

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