Physician Scientist: Consumers Beware: Most Supplements Lack Proof

Dietary supplement use is increasingly common among Americans, according to the CDC, but did you know that these products do not require approval from the FDA? In fact, manufacturers are not required to test for safety or prove effectiveness before selling their products. Best-selling supplement products often come from brands that spend their money on marketing — not on generating proof that they work. How did this happen?

The Synthetic History of Clinical Trials

The emergence of modern clinical trials paralleled the birth of the pharmaceutical industry in the last century, when chemists invented synthetic drugs. For the first time in history, medicine could be patented and highly profitable. Expensive, complex clinical trials were created to test the safety of these never-before-seen synthetic chemicals, prove their effects and justify the high price of the new pharmaceuticals.

Before the birth of the pharmaceutical industry, the medicines that humans relied on for thousands of years were all natural products. However, since they couldn't be patented, they were mostly ignored by the emerging pharmaceutical industry. Unfortunately, this trend has subsequently continued. A recent university study estimated that the U.S. National Institute of Health funded over $100 billion of research that contributed to the development of 210 new patented drugs approved by the FDA between 2010 and 2016. In contrast, the NIH has only spent $2.4 billion since 1999 studying unpatentable vitamins and minerals.

Despite this, today 75% of Americans regularly use dietary supplements. Unfortunately, the vast majority of supplements don't have proof of their effectiveness because the companies that develop them can't easily access clinical trials. Traditional clinical trials cost millions of dollars and mostly serve patentable, synthetic chemical compounds that can sell for high prices. As such, traditional clinical trials are not a viable option for supplements and botanical products that are unpatentable and affordable.

Solving the Proof Gap

How do we solve this glaring proof gap? Democratizing access to clinical trials is the key. If non-pharmaceuticals could access affordable and rapid clinical trials, then they could generate the data they need on dosages and effectiveness. Consumers could make informed decisions, rather than relying on guesswork or marketing campaigns. Physicians could finally trust and recommend specific supplement products based on clinical evidence.

Democratizing Clinical Trials

Thankfully, we are at a point in our history where science, research, technology and social connectedness are converging to democratize access to next-generation clinical trials for the first time. Technology now allows us to conduct clinical trials in an unprecedented virtual, crowd-sourced and direct-to-consumer fashion. (Full disclosure: I am the co-founder of a public benefit B-corp conducting some of the first clinical trials for supplements and natural health products, powered by diverse volunteers who participate virtually.)

The Critical Need for Diversity in Clinical Trials

This model of democratized clinical trials also allows for studying significantly larger populations, including women, minorities and rural populations who have been mostly excluded from traditional clinical trials.

Caucasian males represent a vast majority of all study volunteers across all U.S. traditional clinical trials. Thus it is unsurprising that females experience adverse drug reactions at double the rate men do, in addition to other health risks related to medication and medical devices. Having ethnic diversity in clinical trials is also critical, as we know there are significant distinctions in how different ethnicities metabolize drugs and experience clinical effectiveness and side effects.

A Future With Proof

The time is now for all supplements to develop clinical proof for their specific product, especially proof that is relevant for all Americans. With democratized clinical trials, there can be a tremendous shift in the health and wellness industry, as:

• companies formulate innovative products based on real evidence.

• healthcare providers finally trust and recommend nutraceuticals.

• clinical trials become more diverse, making the findings relevant to more people, which improves personalized medicine and health equity.

• consumers confidently buy products that are proven to work for someone like them.

What Consumers Can Do

As a physician, I highly encourage consumers support and choose supplement brands that are investing in clinical trials. This will cause a sea change, as clinical evidence becomes the standard for the supplement industry.

This won't happen overnight. But in the meantime, choose supplements that have been third-party tested for purity and potency, such as ones with a seal of approval from NSF International, ConsumerLab or U.S. Pharmacopeia. These seals indicate proper manufacturing practices and accurate labeling. There's also the Clean Label Project certification, which means the product has been independently tested for industrial and environmental contaminants, including heavy metals, plasticizers, pesticide residues and other high-risk chemicals, and meets its strict standards.

Also, if you are taking any prescription medications, have medical conditions such as liver or kidney disease, or will be having a surgical procedure, be sure to tell your physician about any supplements you are taking, as there may be interactions that require you to discontinue use of the supplement. In addition, children and pregnant and nursing women should consult with their doctors about supplements before taking any, as they are at higher risk of experiencing negative outcomes.

We are at an exciting time where the democratization of access to clinical trials will enable unprecedented proof generation for an entire industry that has yearned for it but been unable to obtain it. This will fundamentally revolutionize how supplements are manufactured, the way retailers sell them and how healthcare providers recommend them, and most importantly, it will empower consumers to confidently choose the right products to maximize the health effects for their specific body.

The information provided here is not intended as medical advice, diagnosis or treatment. Always consult with a qualified healthcare provider for advice concerning your specific situation.