Health Claims vs. Research: Why Dietary Supplements Sound So Weak.

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You reach for your multivitamins and fish oil each morning, a habit ingrained in your routine. You’ve heard the benefits, you’ve read about them, and you believe they’re helping you avoid disease, slowing the impact of aging, and helping you maintain better mental health. But when you squint at the labels, hoping to read about the health benefits that’ll motivate you to keep taking them, you find that the language is indirect. Even weak. Are they tiptoeing around something?

Yes, they are. And that something is a substantial piece of legislation called the Dietary Supplement Health and Education Act (DSHEA). This act determines the dance between the world of scientific research and the health claims that supplement companies can make.

You might not be interested in laws and legislation, but if you’re interested in using products that support optimal health, you should understand what high-quality, professional supplements can and cannot say on labels and marketing materials. That way, you won’t think a great product is subpar, just because it doesn’t claim to impact your health the same way its supporting research says it will.

Stay with me as we demystify the gap between what you hear in the bustling grapevine of supplement research and what you read on the label of your trusty bottle of pills.

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The History and Purpose of the Dietary Supplement Health and Education Act (DSHEA)

Back in 1994, consumers were just starting to realize the potential benefits of nutritional supplements and fought hard to protect their right to access them.¹

This was when the DSHEA was born. Born out of a need to define and regulate the rapidly growing supplement industry, the DSHEA was more than just a new rule in the rule book. It was a landmark law that drew a clear line between foods (and supplements) and drugs.²

The birth of DSHEA wasn’t a simple process, and it wasn’t born in a vacuum. Its creation was a collaboration between lawmakers, supplement companies, consumers, and medical professionals.³ Each had their interest and their voice in crafting this critical piece of legislation.

Some noteworthy figures who played instrumental roles include:

Senator Orrin Hatch: A Republican Senator from Utah, Hatch represented a state where many prominent dietary supplement companies are based. He was a stalwart supporter of the industry, and his influence was pivotal in crafting and pushing the DSHEA through Congress.⁴
Senator Tom Harkin: A Democrat from Iowa, he was influenced by his personal experiences with dietary supplements, which he believed had helped him with his allergies.⁵
Congressman Bill Richardson: A Congressman from New Mexico who introduced the companion bill in the House of Representatives, which eventually became the DSHEA.
Gerald Kessler: Founder of Nature’s Plus supplements. Kessler was a critical industry voice who championed the rights of supplement companies, working closely with Senators Hatch and Harkin in the formulation of DSHEA.

These figures, along with many others, created a law that could strike a balance between the consumer’s right to access dietary supplements and the need for appropriate regulation and safety. The DSHEA remains their enduring legacy in the health and fitness industry.

Supplement vs. Drug Claims

At its core, the DSHEA aimed to maintain balance. It sought to let supplement manufacturers do their job – sell supplements, while also making sure they didn’t cross into the realm of medical claims, which is the territory of drugs.⁶ This act gave birth to two types of claims that a supplement company could make:

structure-function claims
health claims

Under DSHEA, supplement companies could promote or market how their product affects the body’s structure or function. Think of claims like “supports heart health” or “boosts immune function.” However, they couldn’t state that their product diagnoses, treats, cures, or prevents any disease.⁷ That’s a no-no, as those are the promises of drugs, not supplements.

The act shaped the supplement industry, deciding what they can say, how they say it, and where they can say it. It was and continues to be a game-changer, setting the stage for how supplements are sold and understood today.

Now, where was the pharmaceutical industry in all of this? You might imagine them watching from the sidelines with furrowed brows. After all, dietary supplements could be seen as encroaching on their territory. At the time, the pharmaceutical industry primarily viewed dietary supplements as a different beast altogether—less regulated, less standardized, and with less stringent scientific backing than their carefully curated drugs.⁸

Fast forward to today, and that view hasn’t changed much. Dietary supplements are still seen as playing in a different league. However, there’s an increasing recognition from the pharmaceutical industry that dietary supplements have an undeniable foothold in the consumer health market. Many pharmaceutical companies have even diversified their portfolios to include supplement products, acknowledging the consumer demand for these products.⁹

DSHEA Impact on Supplements

With DSHEA as the rules of the game, supplement companies had a clear path to tread. They had the freedom to market their products but with certain restrictions. And those restrictions? They greatly impacted how you read and understand supplement labels today.

Under DSHEA, supplement companies can make what’s known as structure-function claims.¹⁰ These claims talk about the role of a nutrient or ingredient in maintaining the normal structure or function of the human body. So, when you see statements like “supports bone health” or “maintains healthy skin,” you’re looking at a structure-function claim.

But remember, there’s a line these companies can’t cross. They can’t say that their supplements can diagnose, treat, cure, or prevent any diseases.¹¹ So, while a calcium supplement can say that it “supports bone health,” it can’t claim to “prevent osteoporosis.” The former is a structure-function claim, while the latter is a disease claim reserved only for drugs.

Why this distinction? Because drugs and supplements are regulated differently. Drugs must go through rigorous testing and approval before they hit the market. Supplements, on the other hand, are regulated post-market – they’re monitored after they’ve been made available to consumers.¹²

Now, all this means supplement companies must be careful with their language. They must thread the needle, speaking to the benefits of their product without venturing into drug territory. The result? The language on supplement labels can often seem a bit vague, a bit indirect. But it’s not because they’re trying to pull a fast one. It’s simply the dance they must do, courtesy of the DSHEA.

Health Claims for Supplements: The FDA’s Oversight

Despite the restrictions, there’s still room for supplements to make health claims. But how? The answer lies in the Food and Drug Administration’s (FDA) oversight.

The FDA has established a system where certain health claims can be made if a significant scientific agreement (SSA) supports them.¹³ These are often related to reducing the risk of a disease or a health-related condition.

For instance, claims linking calcium and vitamin D to a reduced risk of osteoporosis have been approved under this system.¹⁴ Others include:

Omega-3 Fatty Acids: We often hear about the benefits of Omega-3s for heart health, and for good reason. The FDA allows certain Omega-3 supplements (EPA and DHA) to claim that they may reduce the risk of coronary heart disease.¹⁵
Folic Acid: For pregnant women, folic acid is a must-have. The FDA allows folic acid supplements to claim that they may reduce the risk of neural tube defects in babies when taken by pregnant women.¹⁶ Keep in mind that you should only take methylated folate, and not folic acid, though. A significant portion of the population cannot convert folic acid to methylated folate, so you should take the methylated form when supplementing.
Plant Sterols and Stanols: These compounds, often found in fortified foods and dietary supplements, are allowed to claim that they may reduce the risk of heart disease by lowering blood cholesterol levels.¹⁷ Of course, the evidence showing that cholesterol significantly contributes to cardiovascular disease is much weaker than most people believe it is.

The catch? The evidence needs to be robust. The FDA requires a high level of scientific support, often necessitating multiple, well-conducted studies. The bar is set high, and for a good reason – these are claims that could directly impact consumer health decisions.¹⁸

There’s another type of claim that supplements can make under FDA rules: qualified health claims. These are claims that have some scientific evidence but not enough to meet the rigorous SSA standard.¹⁹ In these cases, the claim must be accompanied by a disclaimer or qualifier to ensure consumers understand the level of evidence behind it.

The FDA’s system aims to ensure the health claims you see on supplement labels aren’t just hot air. They’ve been through a vetting process and have some level of scientific backing. The key, as always, is to read these claims critically and understand the level of evidence supporting them.

The Difference Between Supplement and Drug Claims

Now that we’ve explored how the DSHEA regulates supplements and the FDA’s role in approving health claims, let’s delve deeper into the distinctions between supplement and drug claims.

Technically, drugs and dietary supplements occupy two different spheres in the realm of health and wellness. The key difference? Their intended use.

Drugs are intended to diagnose, cure, treat, or prevent diseases.²⁰ Think of your antibiotics, beta-blockers, or your thyroid medication. They’re all drugs designed to address specific medical conditions.

Dietary supplements, on the other hand, are intended to add further nutritional value to (supplement) the diet.²¹ They can include vitamins, minerals, herbs, amino acids, and enzymes, among others. The goal? To support overall health and wellness, not to treat or prevent diseases. I realize that many dietary supplements have been used to treat diseases for thousands of years, but in our modern-day, regulatory-based society, they’re not considered treatments.

So, when you’re scanning the labels of your favorite supplement, remember – they’re not drugs. They’re not designed to treat, cure, or prevent any disease. They’re there to provide a boost, to supplement your diet, to help you maintain your health and wellness.

That’s not to say they can’t have a profound impact on your health. But any health claims they make need to be grounded in solid scientific evidence. And they need to tread carefully, not venturing into the territory of disease treatment or prevention.

The Crucial Role of Research in Supplement Claims

So, why do the health claims for supplements sometimes seem weak compared to the research supporting them? The answer lies in the careful dance between regulatory guidelines and scientific research.

Scientific research plays a fundamental role in supplement claims. Rigorous, well-designed studies provide the backbone for any health claim. The more solid the research, the stronger the claim can be. And there’s no shortage of research in this field.

There’s a wealth of scientific studies suggesting that certain supplements can have a significant impact on our health. For example, research has indicated that omega-3 fatty acids can support heart health,²² that probiotics can aid in digestion,²³ and that certain vitamins can support immune function.²⁴

Yet, the language on supplement labels often seems watered down, almost as if it’s hedging. This is due to the tight regulations around supplement claims. As we’ve discussed, the Dietary Supplement Health and Education Act (DSHEA) stipulates that supplements cannot claim to diagnose, treat, cure, or prevent any disease.

In other words, despite the evidence supporting the benefits of certain supplements, they can’t make disease-related claims. They must stick to structure-function claims, describing how the supplement can support the normal structure or function of the body.

That’s why a probiotic supplement can claim to “support digestive health” but can’t claim to “treat irritable bowel syndrome.” The former is a structure-function claim, while the latter is a disease claim.

The takeaway? When you’re scanning supplement labels, remember that the language used is a product of regulatory requirements, not a reflection of the research supporting the supplement.

Practical Summary

There are mounds of research supporting the use of dietary supplements for improving health, enhancing performance, and even helping people who’ve developed various diseases. However, you will not find that information on the label, package, or even the website of a brand selling the supplements.

You either need to read the research yourself, or you need to get the summary from someone who does.

I don’t promote or market specific products on my website because I want you, my reader, to learn about what research shows that supplement or essential oil does for your health. Then you can look for the right product to meet your needs. That way, I can keep you informed without running into conflicts with the DSHEA and my content.

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