The Scary Reality of Dietary Supplements

We've all had a rough night's sleep; whether it's related to jet lag, poor choices, or our own biological dispositions – we've been there. And in many cases we've turned to a supplement in order to help our weary mind get the sleep it deserves. For example, melatonin supplements are popular sleep aids. This is probably due to the fact that most people know the importance of melatonin's role in our sleep-wake cycles – but did you know that the concentration of melatonin in a supplement can vary as widely as 83 % less to 478 % more than what is stated on the label?

This is, of course, problematic. Imagine buying a melatonin supplement, but the actual content of melatonin is 83% less than what's advertised – won't be very effective, now will it? On the flip side, taking a product with too much melatonin can actually disrupt your sleep cycle, resulting in poor quality sleep as well. Additionally, you could experience grogginess during the day, nightmares, nausea, dizziness, headaches, and more.

While these symptoms aren't necessarily life threatening, it is a tad bit worrisome and makes you wonder – are all supplements this unregulated?

Let's investigate:

The FDA and DSHEA

Briefly, let's discuss what the Food and Drug Administration (FDA) is and how the Dietary Supplement Health and Education Act of 1994 (DSHEA) influences the FDA's regulatory power.

The FDA regulates several public health factors such as drugs, medical devices, and the safety of the U.S. food supply. For the purpose of this article, we're only going to discuss their role in regulating dietary supplements.

DSHEA establishes that manufactures and distributors can not market products that have been adulterated or mislabeled and holds these manufacturers responsible for evaluating the safety of a product. This act also holds the FDA responsible for taking action against any unsafe product after it reaches the market.

How the FDA regulates dietary supplements

Now that we have a pretty basic understanding of the FDA and the DSHEA, let's quickly talk about how the FDA regulates dietary supplements.

According to the DSHEA, dietary supplements are considered to be a category of food, which means they are regulated differently than say prescription and non-prescription drugs.

Manufacturers are required to provide the FDA with reasonable evidence that a supplement is safe if it contains an ingredient that is considered "new" (meaning the ingredient is not recognized as a food substance).

However, according to an article written by the American Cancer Society (ACN),

"... manufacturers are not required to test new ingredients or supplements in clinical trials... The DSHEA gives the FDA permission to stop a company from making a dietary supplement, but only when the FDA proves that the product poses a significant risk to the health of Americans."

This means that supplements are only found unsafe after they've harmed the public. This is kind of incredible because drugs are, of course, meant to be proven safe before being sent out into the market. Supplements, on the other hand, are simply considered to be safe until they cause harm.

The problematic nature of the FDA's regulation of supplements

Hopefully by now you're starting to see the big flaw in this system and if not, then I'll kindly ask you to read the previous section again (no judgement). But perhaps you don't think there's an issue with the FDA's regulation of supplements. After all, they're just supplements, what damage could they really cause? Let's talk about it:

In the same article mentioned above, the ACN discusses the several problems that have been found with some dietary supplements. These issues include: herbs being tainted with germs, pesticides, or toxic heavy metals; some supplements not containing ingredients listed on the label; other supplements containing more or less than the amount listed on the label.

Clearly this could pose some serious complications for someone taking a supplement with one of these issues. And, unfortunately, because the content of supplements aren't tested by the FDA, the writers continue on to say,

"A more serious trend today is extra ingredients in supplements. Some "herbal" supplements have been found to contain prescription drugs or other compounds that are not listed on their labels."

A major factor to consider when buying supplements is the interaction it may have with any prescription or non prescription drugs you may be taking. But, if you are unaware of all the ingredients in the supplement, then how can you be certain taking it won't have any negative effects on your health?

According to another article, "Too Little, Too Late: Ineffective Regulation of Dietary Supplements in the United States", Ranjani R. Starr explains that supplements could actually be sold at any concentration so long as the daily recommended value is listed on the label. He continues on to use vitamin D3 as an example, saying that the vitamin is often available in 50,000 IU doses which is 12,500% of the daily recommended value. This excess vitamin D3 could be harmful to the body and is generally unnecessary seeing as the recommended value is 1000-4000 IU.

Daily recommended values exist as a guide for consumers to monitor their intake of vitamins and minerals however, we are often bombarded with information that tells us that taking incredibly high doses of nutrients is beneficial to our health. Unfortunately, there are some serious health risks that come with ingesting too much of a vitamin or mineral such as nausea, nerve damage, liver damage and much more.

Starr also discusses health claims:

"Several deficiencies and potentially deceptive practices in supplement labeling have been documented in the literature. A 2003 Office of Inspector General investigation confirmed that most supplement labels are misleading, uninformative, and inconsistent and that consumers experience considerable difficulty interpreting supplement labels correctly."

Should you trust a product if you can't easily understand what it is and what's in it?

We've only discussed a few of the issues that result from the FDA's current dietary supplement regulation process, but there are many more. Please read "Too Little, Too Late: Ineffective Regulation of Dietary Supplements in the United States" if you're interested to learn more.

Take everything with a grain of salt

Well – that was certainly a lot of surprising information! I think it's fairly safe to say that all supplements are as unregulated as our melatonin example and that that lack of regulation is dangerous to the general public.

That being said, I don't believe you should regard all supplements as evil and deadly. Instead I think we should all make a more conscious effort to inform ourselves about the supplements we buy, who makes them, and whether or not we need them. A lot of the issues consumers face with supplements could be solved by simply contacting the manufacturer directly and learning about the product through them. But, before you even think about contacting a manufacturer, get an opinion from your doctor about whether or not you actually need to supplement your diet.

Ultimately, being an informed consumer is the best thing you can do.

Further reading:

"Using Dietary Supplements Wisely." National Center for Complementary and Integrative Health, 2019.

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