Dietary Supplements are not regulated for quality, safety, or efficacy

And that's a far bigger problem than many people realize.

In the United States alone, the dietary supplement industry is currently valued at $159 BILLION dollars and projected to grow by 9.1% year over year.

The problem? This unregulated industry exploits consumer’s desire for control over their health.

Dietary supplements are a large umbrella, with many people not realizing what is considered a dietary supplement. For the sake of brevity, after I define them, I’ll refer to them as [supplements].

Dietary supplements are products taken orally that contain one or more of the following ingredients:

Vitamins: Organic compounds essential for normal bodily function. Vitamins are micronutrients, meaning you only require a miniscule amount for their purposes.

Minerals: Inorganic substance with specific chemical composition and a crystalline structure, which participate in physiological processes in the body, like as bone formation, nerve function, and energy production.

Amino acids: Amino acids are organic molecules that are building blocks of proteins.

Enzymes: Enzymes are proteins with catalytic function, meaning they facilitate chemical reactions. Enzymes facilitate a variety of processes in the body involved in digestion, immune function, metabolism, etc.

Herbs or other botanicals: Plant-based materials, including leaves, stems, roots, flowers, seeds, and fruits, that are used for their perceived health benefits.

Organ tissues, glandulars, and metabolites: Extracts from animal tissues or glands, metabolic byproducts, believed to provide nutritional benefits.

Concentrates, metabolites, constituents, extracts, or combinations: Anything derived from food sources or other natural substances and are concentrated forms of specific nutrients or compounds.

A TL;DR would be: dietary supplements are products you consumer that are intended to supplement the diet and are not considered a substitute for food.

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What products on the shelves would be considered supplements?

A lot of stuff. A non-exhaustive list includes:

• Vitamins and minerals, including multivitamins and multiminerals.

• Herbal supplements of all kinds and herbal teas

• Amino acids and protein powders.

• Omega-3 Fatty Acids or other fatty acid/fish oils.

• Probiotics

• Prebiotics (a marketing buzzword for fiber) and fiber supplements

• Joint health supplements including chondroitin sulfate and collagen

• Sports performance supplements (often blends with proteins, caffeine, amino acids, creatine)

• Antioxidants

• Homeopathic supplements

Pretty much any non-food product that you consume that is NOT an FDA-approved medication (whether it be over-the-counter or prescription) is a dietary supplement.

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Supplements are often perceived as benign or even beneficial. Many people take supplements because someone recommended it to them, having reported feeling better after taking them, or a doctor told them to use them. Some are seemingly more benign, like a multivitamin. Some are much more potentially harmful, especially ones which label with "proprietary herb blends" and so on.

Supplements do not have robust clinical evidence to support their use.

Are there exceptions to this? Sure. In specific medical instances, there are certain well-studied supplements that are safe and beneficial (like folic acid during pregnancy).

But because of the lack of regulation on the supplement industry at large, people believe they are taking something safe and effective. Supplement companies use marketing buzzwords like “science-backed” and “supported by data”, a common tactic used by the wellness industry to promote unproven interventions that I discussed in my Slate piece on Andrew Huberman.

Unfortunately, it becomes very difficult for the public to discern what is real and what's not when it comes to supplements. This highly profitable industry invests a lot of money in marketing, so you’ll see things like "research tested" or "clinically proven", which sound very convincing but are usually baseless and not supported by actual evidence.

Technically, an in vitro study or an animal study is “science-backed”, but that does NOT mean there is human evidence. These statements mislead the consumer.

That’s why the quality of evidence matters. You can find a study "supporting" anything on PubMed: PubMed is merely a data repository of published studies - and there are plenty of bad studies on PubMed. But even if it isn’t a bad study, it might not be a relevant study. Science and the studies published are incremental. They build upon each other. A single study looking at one ingredient of a given supplement in isolation (and not in that supplement) is not evidence that the supplement is effective (this is the tactic the notorious Glucose Goddess uses to promote her new “anti-spike” supplement).

If you want to find a “study” to support you claims, you can, and pretty quickly too. That’s especially true if you have a vested interest or a conflict of interest. But that does not mean that the body of evidence support those statements. It is much more time consuming to review everything in the context of the quality of the data.

Credit: thelogicofscience.com

Often, claims made by people or companies hyping/selling supplements are using in vitro or animal studies. Those are not indicative of what happens in a human. They are weak evidence comparatively. Even human studies that are based on survey data or observation are weak; they cannot tell you whether input X CAUSED outcome Y.

That's why you must weigh randomized clinical studies more heavily. They control other variables that could impact outcome, so you can assess a causal relationship. Meta-analyses and reviews can be very strong, but they depend in the studies included in the group analysis. If the studies included are bad, the meta analysis is also bad. Garbage in, garbage out.

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As such, we must reframe our thinking to the reality: Dietary supplements are unregulated pharmaceuticals.

Supplements often use the appeal to nature fallacy to suggest they are benign, natural, superior. Marketing preys on your desire to have unadulterated adjuvants to your diet that are perceived to improve your health. But dietary supplements are not ‘picked off trees’, they are manufactured synthetically in laboratories, just like FDA-approved medications.

But they aren’t FDA approved. Supplements do not have the stringent regulatory oversight to demonstrate QUALITY, SAFETY, or EFFICACY that medications do. Just because something is a chemical that is found in nature does not mean it is inherently and unconditionally safe. We know that is false. There are tons of natural things that can be very dangerous. Similarly, just because a chemical may be found in a food naturally does not mean that chemical added to a supplement is done in a way that is safe or beneficial for you to consume.

Supplements are made in a laboratory and synthesized. That means that they are pharmaceuticals, but they’re not regulated for safety or efficacy by the FDA. This means even if you buy the same supplement from the same company, there is lot-to-lot variability in the quality, the chemical formulation, and how bioavailable it is. It is better, cheaper, and safer to get the small amounts of micronutrients you need in your diet. There is also the issue that many dietary supplements are multi-ingredient proprietary blends, which means you don’t even know what you’re getting.

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Why aren’t supplements regulated for quality, safety, and efficacy? You can thank your lawmakers for that.

The regulation of dietary supplements, including vitamins, minerals, herbs, probiotics, and more is almost nonexistent. Dietary supplements are not proven safe or effective before they are sold. This contrasts with the rigorous testing and approval process for medications, even over the counter ones that are regulated by the FDA.

We can thank the push for “medical freedom” and “limited government interference” for the The Dietary Supplement Health and Education Act of 1994 (DSHEA), which basically gave supplement companies free reign to sell whatever they want to consumers with no evidence.

Before 1994, supplements fell under the Food, Drug, and Cosmetic Act of 1938 (FDCA), which requires that food, drugs, cosmetics, and medical devices are safe and effective for their intended use when used according to labeled instructions or customary conditions of use.

The FDCA was created in the early years of the FDA to crack down on people selling “magic miracle elixirs” that were filled with pretty much anything and everything, including antifreeze. Yes, literally. Massengil's Elixir Sulfanilamide, sold in 1937, contained an untested solvent: diethylene glycol (DEG), which caused 107 deaths.

Starting in the 1950s and the formation of the John Birch society, this push toward less government regulation started to creep into health. It accelerated in the 1970s with growing interest by lawmakers to reduce oversight among the emerging wellness industry and the push for “healthcare autonomy” (and also included the organic agriculture market, created under the guise of ‘wellness’).

This language is the same used for vaccine opposition. That’s why when I say things like wellness behaviors like supplements and medical conspiracism overlap, it’s because they were cut from the same cloth.

Legislators, including Ron Paul and Orrin Hatch, pushed the creation of the DSHEA to remove supplements from oversight by the FDA, which required clinical testing, regulatory oversight of manufacturing, quality control, and safety evidence. This motivation was to drive the market: regulation would slow the release of new products to consumers. This was a bipartisan effort. Rejection of science is irrespective of political ideology, and that includes belief in unproven wellness interventions.

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The 1994 DSHEA allows supplements to be sold with almost zero oversight and regulation.

The DSHEA replaced the regulatory and safety requirements from the 1938 FDCA. Sure, it has some ‘legal provisions’, but since it eliminated the FDA’s authority, supplement companies routinely skirt those. The loopholes of the DSHEA allows for the sale of unproven, potentially unsafe substances.

The 1994 DSHEA:

• Created the new definition of dietary supplements.

• Eliminated the premarket approval requirements by the FDA for safety and efficacy.

• Requires “labels” to include accurate information about ingredients, serving size, and recommended daily intake (but many supplements do not adhere to this).

• Requires the statement that the ‘product is not intended to diagnose, treat, cure, or prevent any disease’ (but this is routinely violated).

• Requires manufacturers to not lie about product safety, but the burden is on the manufacturer, not an outside regulatory body. Unfortunately, the FDA can ONLY intervene once a product has entered the market, so there is opportunity for harm.

• Requires manufacturers to notify the FDA 75 days prior to introducing a new supplement to the market, to give FDA time to conclude “reasonable safety” (but we know the FDA is underfunded and focused on regulated medications, which was a key motivation for the creation of the DSHEA)

• Supplements can make certain health claims as long as they are approved by the FDA (which is definitely not always the case).

• The Office of Dietary Supplements was created to enhance supplement research.

The FDA only has legal authority to take action against unsafe dietary supplements AFTER it is on the market, and this is usually a result of instances of harm.

These legal requirements are routinely ignored by supplement companies. Because the FDA has no enforcement ability on these products PRIOR to a supplement entering the market, the quality, strength, purity, and packaging of dietary supplements can vary greatly, EVEN LOT TO LOT of the same brand.

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There is very little evidence that supplements are beneficial.

People often think, well, I’m just taking a little extra vitamin C, or vitamin D, or a probiotic to help my gut health, right? But because supplement companies can literally throw whatever they want into a supplement without having to demonstrate the product even works, that means that most of the time, the product doesn’t work.

Often, that’s because of lack of bioavailability.

Bioavailability is the degree and rate at which a chemical is absorbed and becomes available by your body. Because supplements don't need to prove they contain what they say they do or that the ingredient is even bioavailable, it is often the case that they aren't. So while you may think you're buying the same vitamin C which is found in foods, it may not be formulated in a way that is useable by your body.

Drug formulation is complex, whether it is for FDA-regulated medications or for supplements (remember, these are unregulated pharmaceuticals). Since supplements don't need data, they can get away with saving time and money by skipping critical steps to actually evaluate these important features of chemical compounding and manufacturing. (And that means you are paying money for something that at best is useless, at most could be seriously harmful).

And indeed, there is limited evidence for most supplements. That’s even true for micronutrients that we DO require, like vitamin D. I wrote extensively about the seedy underbelly of the vitamin D industry previously, but decades of clinical trials trying to find benefits of vitamin D supplementation have failed to do so.

This goes to the next point: often, you don’t have a deficiency you need to supplement.

There is a misconception that if you need a micronutrient (like Vitamin C) in trace levels, then more of it through supplementation is better.

The reality is that there is no robust body of clinical evidence that supplements offer health benefits in those who don’t have clinical indications (like pregnancy). And too much of a good thing can be a bad thing: remember, the dose makes the poison with everything. Even things essential for our health, like water, like micronutrients, can cause harm in excess.

Supplements can cause legitimate harm to people and have no evidence to support them.

Remember this lack of regulation of dietary supplements. This means that supplements can get away with saying falsehoods about benefits omit ingredients that could harm people, have issues with contamination or adulteration due to bad laboratory practices. In addition, the vast majority of supplements have no robust clinical evidence to demonstrate benefits to health.

A recent study found that the majority of “immune boosting” supplements had inaccurate labels. Of those, 76.4% claimed there were ingredients in them that weren’t detectable. More concerning was that 53% of those with inaccurate labels included ingredients that were not disclosed, meaning people are consuming substances they aren’t aware of, which can pose risks.

Just because something is sold as a “dietary supplement” does not mean that it is safe or benign, and that is a dangerous and widely held misconception.

Many ‘herbal extracts’ can have serious adverse effects on people. They can interfere with medications, inhibit absorption of essential nutrients, and cause acute liver and kidney toxicity. Supplement overdosing accounted for 20% of liver damage and hepatotoxicity in the US in 2017 and that number is likely higher now. Over 50,000 adverse events are reported to the FDA every year, and that is likely lower than those which occur, because people don’t know that you can report supplements.

The lack of regulations means that dietary supplements can be contaminated with bacteria, fungi, or other harmful substances. Contaminated supplements can cause infections, gastrointestinal issues, and other health problems, especially in vulnerable populations like the elderly or immunocompromised individuals.

Just last year, there was an FDA warning about probiotics, which are supplements containing live microorganisms. Not only do probiotics have a lack of evidence for benefit, this warning emerged after unproven probiotics caused the death of an infant. Probiotics can be especially risky for individuals with compromised immune function.

Even homeopathic supplements, which should be nothing more than sugar pills, have demonstrated evidence of harm, including deadly contamination. In 2016 and 2017, children died as a result of Hyland’s Teething Rings being contaminated with lethal levels of belladonna, the substance the homeopathic industry claims is beneficial for pain, fever, GI upset, and more. What’s more, the levels of belladonna were highly variably lot-to-lot: because the supplement industry has zero quality control.

Another loophole is that supplements often use “proprietary blends” to avoid disclosing their full ingredient list. While the claims relate to protecting trade secrets, this means they evade scrutiny and can sell adulterated products which can cause immeasurable harm.

Derek Beres

summarizes the issues about proprietary blends as they pertain to AG1 in this great video.

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Supplements can’t make medical claims, but they do anyway.

Intervention by the FDA only comes after a product is on the market, which means many supplement companies take the risk to make unsubstantiated claims about their products. This was rampant during the COVID-19 pandemic, with supplement companies making claims about preventing COVID-19, treating COVID-19, and more.

Balance of Nature is one company that was found guilty of breaking the law on numerous fronts:

• Failing to comply with current Good Manufacturing Practices (cGMPs)

• Failing to develop good operating procedures

• Failing to develop adequate quality controls

• Making their products adulterated under the FDCA 

The FDA has warned this company numerous times because their product labels routinely make statements that their products can diagnose, cure, mitigate, treat, or prevent diseases such as cancer, heart disease, cirrhosis, diabetes, asthma, and COVID-19. And even though Balance of Nature was ordered by the court to stop selling their products in October of last year, they’re still being sold. That tells you how little oversight there is.

Many newer supplement companies usually have some PhD or MD as their figurehead to legitimize their unsubstantiated claims. Take the supplement company 38TERA, founded by the gastroenterologist Will Bulsiewicz. They sell “probiotic” and “prebiotic” supplements claiming to be “backed by science”, and even claim that they’re doing the opposite of what other supplement companies do:

The irony that they use irrelevant studies that don’t actually assess the formulation of the supplement is either an indication that MDs don’t understand formulation chemistry and the importance of robust clinical trials, or a deliberate attempt to mislead you, the public. Either way, these statements are false.

Way on the bottom of the page, you see the little disclaimer. But the website is sleek, looks super convincing, appeals to your emotions and frustrations of being let down by medical professionals. Now, in their FAQ, they state this:

What this means is that they DID NOT TEST THE SUPPLEMENT as a whole product. They did not even do their own testing on the individual ingredients. What they did do (and they don’t even cite it on their website, they may you go to PubMed and type in their ingredients), is use manufacturer’s studies of select ingredients like Solnul to support their claims. This is not evidence of anything.

What’s worse? 38TERA MAKES MEDICAL CLAIMS.

Not just medical claims, but medical claims related to pseudoscience medical conditions. 38TERA claims it can “reverse leaky gut”, which is a pseudoscience medical condition. These companies are further legitimized by sponsoring social media wellness influencers like Simon Hill. While he is similarly popular like Huberman, he is not a scientist, or a clinician, and has never conducted any primary research. He is skilled at presenting himself like an authority, though.

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The supplement industry is a predatory for-profit conglomerate.

Many supplements don’t have clinical data to support their use (and many don’t even disclose their ingredients). While they market themselves as the ‘altruistic alternative’ to actual medical interventions, they are anything but. Taking supplements can cost you a lot of money, do little to improve your health, and can even be dangerous.

If you’ve fallen prey to the falsehoods of the supplement industry, don’t blame yourself. The messaging used exploits your desire to improve your health, and preys on your emotions. It is insidious and harmful, but it is not your fault.

But please don’t operate under the assumption that supplements are no big deal.

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Thanks for joining in the fight for science! 

Thank you for supporting evidence-based science communication. With outbreaks of preventable diseases, refusal of evidence-based medical interventions, propagation of pseudoscience by prominent public “personalities”, it’s needed now more than ever. 

Your local immunologist,

Andrea