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Regulatory bodies define dietary supplements as products that support general human wellness by supplying substances that are known to have beneficial effects on the human body, whether that means topping off nutritional inadequacies or enhancing a normal physiological process that contributes to our health.^† This definition sounds excellent on paper, but how do you measure something that "supports,” “benefits” or “enhances” health? In today’s advanced scientific environment, supplement manufacturers have untold pages of research at their disposal to support the health-related effects of thousands of ingredients, including vitamins, minerals, amino acids and botanical herbs. Combining several ingredients with shared or cooperative actions into a formula sounds like the perfect way to create a powerhouse supplement that addresses your health concern.^† Say you want to support healthy eyesight – does mixing carotenoids and antioxidants in studied amounts promote optimal vision in everyone? Are certain age groups more likely to receive skin and joint support from collagen supplements? How many active probiotic strains provide the best support for gut health?^†

Is there evidence that supplements are effective?

“Effective” is a coveted term that is liberally tagged on products by supplement brands, because that’s what consumers want to hear. Who wants to take something that doesn’t work? But here's where the somewhat blurry line between dietary supplements and pharmaceutical drugs becomes a lot more clear: supplements have no explicit criteria for what is effective. Medications are designed and dosed to perform a specific action that has been proven to elicit a response in a particular age group or other limited demographic. That’s how and why drugs can be prescribed in discrete amounts, in defined applications and also why this must only be done by a licensed physician. This precision is aligned with the clinical data required to prove a medication’s efficacy. While the notion of supplement efficacy is nebulous and subjective, that’s not to say that researchers haven’t sought to provide answers to this common and reasonable question. Scoping surveys, literature reviews and meta-analyses, which pool information and data on a particular topic, have attempted to find associations between self-reported supplement use and risk of chronic illness or early death. Results have been confusing. Favorable evidence can be collected that supports the benefits of consistent supplement use. Then again, a recent widely circulated report echoed the pessimism from most of these types of investigations that try to draw a very blurry line between cause and effect. Randomized clinical trials in humans, the only type of study that can “prove” efficacy, are rare for supplements and often only affordable for major brands. Consumers have high confidence in supplements, but unfortunately, conflating supplement use with disease endpoints is stretching the limited definition of a supplement, an effort even the FDA avoids. The most useful efficacy data available links individual ingredients with common health markers that may point to disease risk. Omega-3 supplements, typically from fish oil, are the golden child of supplement research, consistently producing strong support that they support the cardiovascular system, immune health and the brain.^† CoQ10 also gets high marks for its ability to boost energy and promote heart health.^† Claiming efficacy of multi-ingredient formulas is a greater challenge.

Effectiveness vs. efficacy

Unless you work in clinical health research or the pharmaceutical industry, it’s unlikely that you would naturally distinguish between something that is “effective” and “efficacious.” Although debate has been raised on the ambiguity of these terms, they are regardless defined differently when it comes to building the evidence base for a new drug. The goal in citing efficacy or effectiveness is to establish the objective guidelines that doctors and other healthcare providers use for safe and reliable treatment practices. The argument hinges on whether the clinical data demonstrating a drug’s performance is controlled or observed. So, a therapeutic substance is deemed effective if it carries out its purpose with observable results. Efficacy is more of a built-in concept; a treatment is designed with the ability to achieve a desired result. In controlled clinical trials, efficacy demonstrates the theoretical capacity of a therapy under ideal conditions. Effectiveness, on the other hand, is the actual degree that an intervention has a measurable result in free-living people. Staying within this clinical peculiarity, a supplement manufacturer builds efficacy into a formula, while effectiveness might refer to the degree of customer satisfaction. One could contend that effectiveness is most important, but under its current definition, this is still less than helpful. The indirect benefits of unique, complex formulas to unique, complex individuals are impossible to measure. Yet, regardless of semantic and interpretive differences, a variety of rational ways could be conceived to build a case for a product’s efficacy or effectiveness.

What criteria might define supplement efficacy?

The way that dietary supplements are regulated in the U.S. suggests one of the ways that we can have greater confidence in their effectiveness. Since supplements technically fall under the umbrella of food, the Food and Drug Administration has made efforts to ensure that supplements are carefully manufactured, with checks and balances that mirror the more stringent procedures required for pharmaceuticals.^† Responsible supplement companies, following federal guidelines, seek fresh, pure ingredients, invest in superior manufacturing facilities and equipment, and are vigilant about ensuring that every batch meets its quality specifications: identity, potency, purity and safety. One attribute of an effective supplement is in its consistent and proven conformance to these criteria.^† Industry standards call manufacturers to chemically verify that ingredients match their reference standards, and confirm that the strength of the ingredient will supply the amount a product claims. At several stages in a supplement’s lifecycle, labs make sure that no detectable contaminants have found their way into the mix, potentially hindering the product’s beneficial effects. Advanced test methods also allow brands to ensure that ingredients, particularly botanicals, match the source that has been studied and backed by research.^† Another key characteristic that increases the likelihood of a supplement’s efficacy is its bioavailability. Referring to the degree to which ingredients are easily recognized, absorbed, and assimilated in the body, bioavailability is one of the key targets of supplement research and development today. Ingredients that require the presence of fat for absorption are now commonly found in “liposomal” forms, meaning the substance is carried and delivered in a handy layer of fat molecules that cells welcome. Other ingredients that must be transformed by our body’s enzymes to have any effect are now pre-activated to bioequivalent forms that can skip ahead in line on their way to supporting your body’s needs.^† Finally, by definition, an effective supplement should promote health with minimal to no risk. Since consumers are free to self-select dietary supplements, “efficacious” formulas, often suggesting higher than typical quantities found in competing brands, should regard estimated intake requirements established by health experts for a wide swath of the public. Although supplements can be marketed and labeled for certain age groups, they are accessible to virtually everyone and their use can’t be prescribed. Seeking to stand out from competitors, supplement brands may be tempted to pull dose data from animal research or short-term clinical trials, naïve to the fact that excessive doses are often chosen by researchers to provoke a significant response. Although adverse events are considered rare, safe formulating and labeling encourage optimal results.^† Benefits may be subjective, but minimizing side effects is obligatory.

Are supplement claims meaningful?

While the FDA does not regulate dietary supplements as drugs and therefore claims are generally unproven, efficacy claims on supplements fall under strict scrutiny. Labels and marketing content must be carefully crafted with “structure-function” language, using words clearly inferring that an ingredient or formula supports the body’s normal structures and functions. From a structure-function perspective then, an effective supplement is one that works well with the body’s innate capacities and avoids introducing any harm.^† Health claims for dietary supplements are typically drawn from previously published research on individual ingredients or research trials that have been conducted on comparable formulas. But many successful brands are striving to add substance to their efficacy claims by sponsoring or developing clinical studies with their products. While they still have to choose careful language in promoting the demonstrated effectiveness of their products, citing an exclusive study is an optimal way to gain consumer confidence. Working with third-party research organizations or academic institutions, supplement formulators can mimic the gold-standard criteria that drug companies use to show measurable benefits using their specific formula according to its suggested use and target demographic. Research data also provides critical user feedback and side effect data that brands can evaluate for better labeling or product improvement. Notably, many international markets including Canada and Australia regulate health supplements more like pharmaceutical drugs, requiring pre-approval and registration of every unique product. The ingredient verification process demands robust evidence of efficacy and safety, pushing many companies to invest in clinical trials that expedite approval. Currently, the US is reevaluating the way it monitors supplements, and rumor has it that the FDA may embrace some of the tighter restraints of our global neighbors.

A path forward for supplement efficacy

It may be that U.S. regulators begin adopting stricter oversight of dietary supplements and start requiring clinical data to back structure-function claims. For now, just because supplements don’t have to be backed by clinical evidence doesn’t mean they can’t have a meaningful impact on health. Their existence and staying power suggest that consumers who take supplements find value in adding these products to their diets, whether it’s a subjective reward or measurable health marker.^† For now, an effective supplement is one that is safe and helps you maintain your daily health. Its ingredients are well-substantiated and formulated in suitable amounts. And at the risk of redundancy, supplements are intended to come alongside the human diet and complement the body’s self-sustaining abilities.^† Let’s not place expectations on supplements to behave as medical treatments or encourage brands to take risks at the expense of safety. It’s possible to formulate supplement formulas that are intentional, unique and beneficial. We can maximize the chance that the supplements we buy are effective by monitoring our health, doing our own research and choosing the ingredients and formulas most likely to support our individual needs.^{† †}These statements have not been approved by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent disease.