I’ve talked a lot on here about different supplements like collagen and melatonin and mentioned briefly that it can be a challenge to figure out whether a supplement actually works or is just a waste of money.
Finding supplements that work is a challenge for many reasons, but the biggest hurdle (in my opinion) is due to the way supplements are regulated. They’re in a different class than food or drugs, and because of this, have very different rules for testing and regulation.
This long-overdue article will explain what supplements actually are, how they differ from over-the-counter and prescription pharmaceuticals, how to find supplements that work, and how to determine whether or not a supplement is safe and effective. If you ever wonder why I have suspicions about testing that’s not clinically validated or supplement trends, hopefully this will clear some of that up!
What are supplements?
Supplements are vitamins, minerals, or herbs that are intended to support the diet. Supplement regulation requires that each supplement contains a ‘Supplement Facts’ label that details the contents, nutrition labeling, active ingredients, and recommended dose, as well as the place of business of the manufacturer, packer, or distributor.
They generally rely on traditional and historical evidence of their safety and efficacy. Many of the compounds that we now use as pharmaceuticals were initially isolated and developed from herbs or plants that were used as supplements with similar purposes.
The supplement market is massive — about 75 percent of Americans use supplements, amounting to a nearly $40 billion dollar industry. While this pales in comparison to the over $400 billion pharmaceutical industry, it’s hardly insignificant. Although many (justifiably) worry about the impact of money and corruption in “big pharma”, the supplement industry is still subject to the same concerns, but it is under far less scrutiny from regulatory agencies than the pharmaceutical industry.
What’s the difference between supplement regulation and drug regulation?
This section could be WAY longer, but in the interest of brevity, I’ve tried to cut it down to the absolute essentials. Basically, what you need to know is this—there are a LOT of steps involved in taking medication to the market from a regulatory standpoint. There are far fewer required to take a supplement to market.
Note: I’m really only talking about the US here. I know I have people all over reading (thank you!) but for now, I can only take these on one country at a time.
How over-the-counter and prescription pharmaceuticals are regulated
This could be an entire post all in itself, but basically, there are 5 main (very long) steps involved in proving the safety and efficacy of a drug (whether OTC or prescription). This whole process takes, on average, 12 years.
- Step 1: Lab research. Researchers find a compound, they determine how it works, and they determine which side effects and interactions it may have. A lot of things get thrown out at this stage.
- Step 2: Preclinical research. Researchers start to test the drug in laboratories and on animals to get an idea of its safety and efficacy. For 5,000 drugs that enter preclinical research, only about five make it to the next step — clinical trials.
- Step 3: Clinical research. There are three pre-approval phases in clinical research. In Phase I, about 100 participants are studied for several months to determine safety. In Phase II, up to a few hundred people are studied for up to two years to determine the efficacy and side effects of a drug. In Phase III, up to a few thousand people are studied for 1 to 4 years.
- Step 4: FDA approval. All the data from research is submitted to the FDA, which determines whether or not the benefits outweigh the risks.
- Step 5: FDA post-market monitoring. This is also somewhat a “Step IV” of the clinical research stages. Here, the FDA continues to monitor several thousand people over a longer period of time to determine the drug’s long-term safety and efficacy.
How supplement regulation works
The main piece of legislation in the US determining how supplements are regulated is the Dietary Supplement Health and Education Act (DSHEA).
This 1994 act created a formal definition of dietary supplements and required that ingredients were listed and labeled. It also required a printed disclaimer that the FDA did not evaluate any of the claims made by the manufacturer.
For supplements brought to the market after 1994, the manufacturer needs to issue a public statement about their product before it goes on the market, but no pre-market testing is required.
The FDA requires that supplement manufacturers use good manufacturing practices and that their supplements do not create a “substantial risk of injury”. This means that the supplement industry is basically run on the honor system — companies can sell what they want so long as they say a product is safe. Some companies will go through the necessary testing, others will not.
If something is sold as a supplement but via the label or advertising is presented as a treatment, prevention, or cure for a disease, then it meets the definition of a drug. It should therefore be subject to regulation as a drug, but this isn’t always the case.
In my last article on lash growth serums, I mentioned a few lawsuits against the makers of different lash serums because of negative side effects that consumers weren’t aware of. While I hope people are able to recover damages for the impact that these have had, this is a major flaw in the regulation of things like cosmetics and supplements. Companies don’t have to warn us about potential side effects or the medications their supplements could interact with.
Why is supplement regulation so challenging?
Three things are (generally) important when evaluating a supplement: quality, safety, and efficacy. All three of these things can be pretty difficult to regulate.
As of 2014, there were nearly 90,000 supplements on the market in the US and nearly 4000 manufacturers of supplements. (I suspect this is much higher now given that every third fitness influencer sells workout supplements, but I couldn’t find solid current data).
Despite the existence of some good manufacturing practice guidelines for quality assurance, these regulations are pretty loosely enforced, as only about 400 of these manufacturers were evaluated to determine compliance with these standards.
In a 2010 analysis of 40 dietary supplements, 93% had traces of lead, arsenic, mercury, cadmium, or pesticides. In 2011, researchers found that 73% of them failed to meet at least one regulation, and 83% of them substituted out an active ingredient. This means that you can’t necessarily be sure that what you are purchasing is what is listed on the label.
Making it even more difficult is the fact that even if we had better regulatory structures, there are still huge challenges in identifying and testing to find supplements that work.
How to find supplements that work
Efficacy is, in theory, why people would take supplements. People want to take supplements that work, and they want to find alternative strategies to supplement their diet and manage their health.
We know that some traditional medicines are highly effective from years of historical understanding of their uses. In some countries like China and India, these traditional medicines are much more highly regulated than they are in the US, and are often prescribed by a practitioner of traditional medicine who understands their use and how they might interact with other medications, rather than purchased over-the-counter.
I would certainly be in favor of adopting this model in the US. We seem to have differentiated between traditional and allopathic medicine in such a way that we regard traditional medicine and supplementation as a harmless way to take health into our own hands, which it is decidedly not.
A review (where researchers compile and analyze previously-completed studies to find trends and more broad data) of 63 different studies in Western countries evaluated the clinical outcomes of nutritional supplements. In 45 of these studies, there were no benefits to the nutritional supplement. 10 had potentially harmful outcomes, and 4 had harmful outcomes with an increased risk of cancer or cancer-related death, as well as an increased risk of fracture.
Some studies showed both beneficial and negative effects like a decreased risk of cancer, but an increased risk of Type II diabetes.
ONLY twelve studies, those on Vitamin D and Omega-3 fatty acids, showed a clear consensus as to their potential to benefit health. While this doesn’t seem like much, this is promising as it shows that some supplements CAN be beneficial, but need to be tested properly.
It’s clear that herbal supplements have the potential to positively impact health, but they also have the capacity to cause harm when not appropriately used. Finding a supplement that works isn’t necessarily something that can be undertaken on an individual basis and requires not only the guidance of healthcare providers but also effective regulatory frameworks.
How to look for supplements that work and are safe
While there is no overarching framework that dictates how supplements should be regulated in the US, there are third-party institutions that test them to ensure that they are following safety standards.
The American National Standards were established by NSF, an organization that tests supplements and food products. While they don’t test for efficacy, they test for label accuracy (to ensure what’s on the label is what’s in the bottle), contaminant review (ensure no contaminants), and toxicology (to verify concentration). NSF certification is visible on a bottle’s logo.
USP (United States Pharmacopeia) has a Dietary Supplement Verification Program that is up to quality standards in over 150 countries. Their standards are science-based, federally recognized, and adhere to FDA good quality guidelines. Their Herbal Medicines Compendium is a good place to check how herbal medicines are classified chemically, and what they contain. USP logos will be published on a bottle if a supplement has received verification.
Which supplements I take
I’m including this because I want to clarify that I’m not taking the stance of “all supplements are bad” but rather that supplements can be beneficial when used correctly.
Per the advice of my doctors, I take:
- Melatonin in a low dose (1-3 mg) as needed, because sleep.
- Psyllium husk (2 tbsp) daily, because fiber.
That’s it. Sometimes I suck at sleeping, and my stomach doesn’t always love me. This is basically it for my supplements.
Even so, I ALWAYS tell my doctors that I take these supplements when I am at an appointment.
The best way to be safe with supplements on a personal level is to tell your doctors which ones you take and check for any potential interactions on RxList when you have a new medication or supplement in the mix.
Supplements can be helpful, but finding supplements that work for you and your body requires a bit more than just trial and error. While I don’t have a ton of hope that any new laws for supplement regulation will be passed in the US anytime soon, there are steps you can take to ensure you’re keeping safe and not wasting your money on ineffective remedies.