Why Most Supplements Skip Clinical Studies

You’ve probably heard it before: “I only trust supplements with double-blind, published clinical studies.” It sounds reasonable, right? After all, we want to know that what we put in our bodies is safe and effective. But here’s the hard truth: if all supplements were required to go through rigorous clinical studies, 98% of the products on the market would disappear overnight.

Many consumers assume that supplement companies have the resources to conduct large-scale clinical trials similar to those of pharmaceutical companies. However, most people don’t realize that these studies are expensive, time-consuming, and highly complex, and most supplement companies don’t have the means to conduct them.

The Reality Behind Supplement Studies

When a supplement brand claims to have “clinical studies” to support their products, they often refer to small, low-cost studies that barely scratch the surface of actual clinical research. These studies might involve a handful of people over a very short period of time. In fact, many studies conducted for supplements fall under Phase 0 or Phase 1 trials, which, while technically studies, don’t offer the kind of large-scale, robust evidence consumers might expect.

Now, here’s something even more eye-opening: it’s entirely possible for companies to design these small-scale studies in such a way that they’re almost guaranteed to get the results they want. Some companies even go to research facilities, knowing they can tweak the study design to favor their product’s effectiveness. The unfortunate reality is that this often happens in the supplement industry.

What It Really Takes to Conduct a Study

Let’s talk about what goes into a real clinical study—the kind that pharmaceutical companies use to bring drugs to market. If supplement companies were held to the same standard, most wouldn’t get off the ground. Here’s why:

1. Time: Developing a new drug takes at least 5 to 6 years and, in many cases, up to a decade. That’s just to move it from the initial research phase to approval. Supplement companies, conversely, can’t afford to wait this amount of time if they want to stay competitive and launch products frequently.
2. Money: Conducting a proper clinical trial is no small financial feat. Development costs alone can range from $2 million to $6 million. This doesn’t even include the regulatory fees required to submit the product for FDA approval, which can cost millions more. For small- and mid-sized supplement companies, that’s not feasible.
3. Complexity: Real clinical studies involve multiple layers of research, including preclinical testing on cell cultures and animals before any human trials even begin. Each stage is carefully regulated, and teams of scientists and regulatory bodies scrutinize the results. This process is lightyears away from the short-term, small-sample studies most supplements rely on.

The Difference Between Supplement and Pharmaceutical Studies

It’s important to understand that there are different types of studies, and most of the ones you see supporting supplements are on the lower end of the scale in terms of thoroughness.

• Phase 0 trials are basic and often involve fewer than 15 people. These studies only examine how the body processes the substance (pharmacokinetics) and how it reacts (pharmacodynamics). It’s a quick, early test that doesn’t mention long-term effectiveness or safety.
• Phase 1 trials are slightly larger but usually include fewer than 100 people. They’re designed to test safety, not necessarily efficacy. Sometimes, these trials use healthy volunteers, not even people who might benefit from the supplement or drug.

Compare that to the Phase II and III trials that pharmaceuticals must undergo. These involve hundreds, sometimes thousands, of people in tightly controlled, randomized studies that provide precise data on how effective the treatment is compared to a placebo or existing treatment. They’re also costly and require years to complete.

Even after a drug is approved for market, pharmaceutical companies must continue with Phase IV trials, which monitor safety and side effects in the general population. This level of rigor is simply out of reach for most supplement brands.

Why Most Supplement Companies Don’t Invest in Real Studies

It’s not that supplement companies don’t want to prove their products work—they do. However, the cost and time involved in clinical studies make it nearly impossible for most of them to consider it. Imagine running a small supplement company, and your competitor launches new products yearly. Can you spend 5 to 10 years and millions of dollars on just one product? Probably not.

Instead, many companies opt for smaller, quicker studies that can give them a marketing edge without the financial strain. These studies may be valid in their own right, but they lack the depth and scale to offer the conclusive evidence we see with pharmaceuticals.

The Problem with Consumer Expectations

It gets tricky here: consumers often don’t realize the difference between a small, short-term study and a full-scale clinical trial. When a supplement company claims its product is “clinically studied,” many assume it underwent the same rigorous testing as a prescription drug. But in reality, that’s rarely the case.

Most supplement companies are not equipped to run large-scale clinical trials. They don’t have the millions of dollars or years to complete them. Unfortunately, this leads to a gap between what consumers expect and what’s happening behind the scenes.

Conclusion: Understand What’s Really Behind Supplement Studies

Consumers must recognize that real clinical studies are an enormous investment in time and money. While it’s easy to demand “proof” in the form of studies, the truth is that most supplement companies can’t afford the level of research required to produce the kind of data we see in pharmaceuticals.

So the next time you see a supplement boasting a “clinical study,” remember to dig deeper. Ask questions about how the study was conducted, how many people were involved, and whether it truly stands up to the standards of pharmaceutical testing. In most cases, the study will be far less rigorous than you might think.