Most Supplements Are Totally Unregulated—Here's the #1 Way to Tell If They Are Safe

·7 min read

There are likely over 80,000 different dietary supplements available on the market. We say "likely" because there's really no way to know for sure, since the supplement industry is not regulated the same way food is by the Food and Drug Administration or U.S. Department of Agriculture. While there are certain databases where companies can voluntary register products (like this one by Therapeutic Research Center), the key word there is "voluntary."

Research estimates that 73% of U.S. adults take supplements regularly, for one reason or another. They seem harmless enough, right? Well, not exactly. Here we'll dive into why supplements can be tricky, and share the best strategy for finding options that are safe.

Supplements aren't regulated—so you have to do your own research

The primary problem with dietary supplements in the U.S. is that they are not regulated. The FDA is technically in charge of regulating supplements, but they do not review any products before they go to market. In short, this means that anyone can create a supplement and sell it, without even having to register it or prove its effectiveness. This also means that it is not confirmed whether most supplements are even safe for consumption. In fact, the only time the FDA can take a supplement off the market is if it's deemed unsafe or mislabeled. Since they aren't actively monitoring most supplements, they get this information by consumers reporting adverse effects.

In theory, supplement companies should not be allowed to make unsubstantiated claims on their labels or about their product. But unfortunately, that's not always the reality. For example, if a company inappropriately markets a supplement as their "immune-boosting blend to fight COVID-19", the FDA would take the product off the market as soon as they became aware of its misleading claims (manufacturers are not allowed to claim that their supplements prevent, treat or cure disease). But there's a chance consumers could be harmed before action was taken, as the FDA is not authorized to review claims or safety before a product is available to consumers. Manufacturers are required to have the FDA do a safety review on any new (not previously reviewed) ingredients that are included in a supplement. And if there are reports of any adverse outcomes, the FDA will investigate. But because any action comes after products are available for purchase, there's potential for harm.

You can see where this makes many aggressively marketed supplements not so benign after all. That said, there are plenty of supplements, like vitamins and minerals or multivitamins, that are perfectly safe and might actually improve your health. But how can you know which is which?

Supplement pills on pale yellow background
Supplement pills on pale yellow background


The #1 Way to Tell If a Supplement Is Safe

Luckily for us, the Department of Defense's Operation Supplement Safety program has created a scorecard (or quiz) to help consumers tell if a supplement is in fact safe. The OPSS Scorecard asks seven yes-or-no questions that consumers can ask themselves when evaluating a supplement. The questions are straightforward and easy to answer from reading the label on the supplement container. Each "yes" answer to a question gets the supplement one point. If the product has more than four points, it's likely OK to use. If it has less than four points, the OPSS recommends that you skip it.

The questions are as follows:

1. Is any one of these third-party certification seals on the product label?

If you click through to the website, you'll see four different logos—BSCG, NSF, USP and Informed Sport. These companies offer testing and certifications to confirm that products actually contain what they say they contain and don't contain any banned or harmful substances. Some companies go through this voluntary third-party testing to help reassure consumers that their products do in fact contain what is listed on the label.

2. Are there less than six ingredients on the Supplement Facts label?

Certain nutrients and dietary ingredients can interact with each other. For example, calcium can help with the absorption of vitamin D. Vitamin C can help with the absorption of iron, but caffeine can inhibit the absorption of vitamin C. How nutrients interact with each other can be complicated, so having a laundry list of ingredients on a supplement can lead to some unwanted side effects (or could compromise its effectiveness). If a supplement has more than six ingredients listed, it would score a "No" or zero for this question. Note: If a supplement lists a "proprietary blend" or "complex," count each ingredient in the complex when answering this question.

3. Is the label free of the words proprietary, blend, matrix or complex?

When a product is listed as a "proprietary blend" or "complex," it does not have to specify the amount by weight of each ingredient in the blend on the label. Instead, producers can simply list the weight of the "complex" or "blend" as a whole and list what ingredients are included in it, without specifying amounts. This could be misleading and potentially dangerous since there is no way to tell the quantities of all of the ingredients in the supplement.

4. Can you easily pronounce the name of each ingredient on the Supplement Facts label?

This might be a bit subjective, but it gets at the greater point that certain ingredients in supplements don't meet the definition of a dietary ingredient. To be considered a dietary ingredient, an ingredient should be a vitamin, mineral, herb or botanical, amino acid, concentrate, extract or some combination. A dietary ingredient is not a steroid or pharmaceutical, which often have less-familiar names. While you might not be familiar with every name for every dietary ingredient, this is a good place to start when vetting a product.

5. Is the amount of caffeine listed on the label 200 mg or less per serving? (If caffeine is not listed, mark "Yes")

There are many instances where caffeine can be helpful, like for endurance performance, mental performance or when you have had restricted sleep, so a supplement containing caffeine isn't inherently bad. But as with anything, we should consume caffeine in moderation. The OPSS recommends consuming no more than 200 milligrams of caffeine at a time, and no more than 600 mg per day. This is the equivalent of 16 ounces of coffee, 32 ounces of black tea or three shots of espresso.

6. Is the label free of questionable claims or statements?

Dietary supplements are not technically allowed to make any health claims on their product. However, since products are not reviewed before going to market, this can oftentimes go unchecked. If there is a statement or claim like "prevents the common cold" or "increases muscle mass," this would be a "No" on the scorecard and score a zero for this question.

7. Are all the Percent Daily Values (% DV) on the Supplement Facts label less than 200%? (If the percent DV is not listed, mark "No")

Too much of a good thing, even a vitamin or mineral, can be a bad thing. Some nutrients have what is called an "tolerable upper limit" set by the National Institutes of Health. This refers to "the highest level of nutrient intake that is likely to pose no risk of adverse health effects for almost all individuals in the general population." From this information, a Daily Value is set to a lower amount that will meet needs without posing risk. Exceeding the Daily Value does not provide additional health benefits and could increase risk for exceeding the tolerable upper limit of a nutrient.

Bottom Line

Next time you are considering buying a supplement, use the OPSS scorecard to help you determine if it's worth your money. Supplements can be complicated to navigate, but this quick and easy method can help make sure that what you're buying is safe for you. Additionally, always be sure to consult your health care provider before taking any new supplements.