Table of Contents
Table of Contents
Truth and trust are expensive commodities in todayâs market. Skepticism â for good or ill â is the dominant currency in an age where just about any message can make it to the masses. Plus, proof is a malleable concept that adapts to context and culture. So the first response to âprove itâ is: What sort of proof will you believe?
Science doesnât just prove the world is round â it makes the world go âround! As the basis for education, medicine, agriculture, and economics, the scientific method is an ongoing and circular process of observing, predicting, and testing that helps us prove and trust whatâs true. Since we all approach proof with assumptions and biases, itâs important to establish this common framework for our shared beliefs, ideas, and values.
Proving that something works is important in any sphere, but proof carries much greater weight and consequence when it comes to human health. Thatâs why pharmaceutical drugs go through rigorous research phases before they make it on your doctorâs prescribing pad. With life and limb at stake, drug makers sign up for multiple trips through the scientific method to earn the âclinically provenâ stamp.
In the pharmaceutical world, ideas for new drugs often begin from observing a health symptom or condition for which there isnât yet a remedy. And whatâs the first step in the scientific method? Observation. Then, using a mix of research and deductive reasoning, scientists will propose a formula that may treat or mitigate whatâs been observed.
Split into four phases, clinical trials represent the rest of the scientific method, with each phase involving testing, analyzing, and drawing conclusions. But before drug candidates get a chance to prove that they work, they must prove that theyâre safe. Thatâs phase 1. Phases 2 and 3 involve more numerous and diverse participants to further verify safety and prove efficacy, with phase 4 dedicated to a post-market safety watch.
By the time a drug is approved by the Food and Drug Administration, itâs shown repeatable evidence that its benefits outweigh its risks, taking responsibility for any contrary results once it hits the market. True clinical research is precisely designed and tightly regulated in order to validate whatâs proven.
Does the same hold for âclinically provenâ supplements?
Both drugs and supplements rely on science to benefit our health. But while pharmaceuticals are required by law to prove theyâre effective and safe, supplements demand a greater degree of faith from consumers. High-quality supplements might be formulated with similar expertise and rigor, but since the government deems supplements âfood,â theyâre in a whole different category in terms of scientific proof.
That said, the clinical trial process can be used for more than drug validation. Since supplements mimic the form and consumption patterns of many oral medications, the gold-standard steps for drug research can easily be adopted to test supplements. While supplements are never a replacement for prescribed drugs, the scientific method works just as well to examine the safety and efficacy of a supplement ingredient or formula.
But thereâs a catch. Drugs passing the phase 3 proof-test have the honor of making profound claims about preventing, treating, or curing a disease. And if thereâs anything you should know about supplements, let it be this: supplements cannot claim to prevent, treat, or cure a disease. Supplement makers can run flawless clinical trials, but they canât make the claims that drugs can.
The supplement market is hotter than ever, making the competition fierce. Itâs not coincidental that the rising interest in âclinically provenâ supplements has followed industry pressure for brands to differentiate their products. With customers demanding greater transparency and ownership of their health, marketing supplements is all about building (and buying) reputation and trust.
Any armchair expert can pull up research on the internet refuting the efficacy of supplements. The problem is that many of these studies are using an unfair standard when theyâre designed to prove a claim only a drug can make. When a widely circulated study on whether multivitamins could prevent cancer or chronic disease was published in 2006, it left a black mark on a consumer good that canât make those claims anyhow.
Like drugs, the government regulates how supplements are made and marketed. In 2022, the Federal Trade Commission (which partners with the FDA on surveilling supplement marketing) announced stricter scrutiny on the use of clinical studies for claims substantiation. With vigilant customers left with an overall impression that top-quality brands can deliver top-quality evidence, âclinically provenâ claims have become top for sales.
Does that make all âclinically provenâ claims a marketing ploy? Hardly. Along with consumer and brand interest in seeing supplements backed by clinical trials, research organizations have answered the call to offer robust scientific methods for supporting supplement claims. But hereâs where that widespread skepticism comes in handy. Deciphering the truly proven from the clinically counterfeit requires a bit of scientific know-how.
First of all, thereâs a key difference between scientific evidence and âclinical proofâ. Remember, clinical research is conducted with tight controls over who, what, where, when, and how on whatâs being studied. That means the results and conclusions apply to the specific treatment, population, and conditions used for the trial. And since supplements can only make claims for healthy populations, generalizing these data to everyone, everywhere is almost always a stretch.
Scientific evidence can refer more broadly to existing research on individual ingredients, like vitamin D or berberine, and oftentimes this means studies done in animals or cells (aka âpre-clinicalâ research). Some top ingredient suppliers (such as patented ingredients like MagteinÂŽ) will run clinical trials with their ingredients, passing on the âclinically provenâ tag to supplement manufacturers who stretch the claim to a multi-ingredient formula.
Since clinical proof is more limited in its scope, a truly âclinically provenâ supplement is one whose exact combination and amounts of ingredients are taken by individuals matching the intended customer. A clinical trial showing that 18-22 year-old college students taking 500 mg per day of ashwagandha felt less stressed during final exams carries little significance when that ashwagandha is one ingredient in an 8-ingredient herbal formula taken by 40-55 year-olds during an election year.
Clinical proof can also be strained when brands use data from pilot trials (such as sending a 30-day supply of a new product to a handful of loyal customers) or subjective, unvalidated surveys as the basis for claims. Not only do these weaker sources fail clinical standards, but theyâre inevitably tainted by selection bias and confounders. Supplement-takers are generally healthier overall, and their experiences may not reflect those of first-timers with an acute health need.
Bottom line? âClinically provenâ is a claim, not a fact. So, like all claims, it needs to be substantiated with unbiased, relevant, and significant proof. The FTC calls this âreliable and competentâ evidence that doesnât exaggerate or mislead. Oftentimes, that means that âclinical proofâ claims should disclose the particulars in the fine print. Qualifying every claim with its study details helps customers discern how applicable it is to their case and circumstances.
Any âclinically provenâ supplement worth its salt shouldnât shy away from full disclosure. Regulators expect brands to follow gold-standard research criteria when running clinical trials and publishing data. That means including placebo controls (a âdummyâ treatment for comparison), randomization (participants who receive treatment are randomly picked), and double-blinding (neither the participants nor the investigators know who takes the treatment vs. the placebo).
Following the scientific method, clinical trials in both drugs and supplements should start with a hypothesis, not a conclusion. If the results contradict the initial assumption, researchers should go back to the drawing board, not cherry-pick or manipulate statistics to fit the desired claim. Clinical trials are a definite risk-benefit wager, and supplements are notorious for giving uncertain or unusable data. Sometimes, broader claims backed by solid scientific literature are more trustworthy than a pricey clinical trial with a long list of limitations.
The supplement space is highly reactive to demand. Similar to the food industry, supplement-makers stay on their toes to give customers, marketplaces, and regulators what they want. At the crossroads of science, health, and consumer goods, perhaps no other product has a hotter seat. Constrained by drug claims on one side and customer expectations on the other, supplement brands walk a narrow line of staying within the law and ranking in sales.
When it comes to diets and dietary supplements, the best evidence that they work comes from observing population health over years â even decades. No matter how powerful the results, clinical trials in supplements can only offer an accelerated, simulated version of reality that suggests theoretical, not real-world benefits. Itâs essential to keep this in mind when impressive scientific jargon leads us to hit âbuy nowâ before checking the facts.
Thereâs clearly work to do to clear the existing ambiguity over what defines âclinically provenâ supplements. No matter what the claim means to customers or marketers, regulators want âproofâ to mean proof. Attention-grabbing is easy; earning trust means investing in real-deal research to make and prove that products work.
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DISCLAIMER: These statements have not been approved by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent disease.
