Supplements Unveiled: A guide to choosing safely and smartly #106

The safety of the supplements market

Hello all,

Today, we discuss a very important topic: the safety of supplements.

In this article we will discuss the 6 criteria you can use to judge a supplements company and the laws for supplements in UK, US and Canada.

There is no secret that supplements are heavily used in the management of PCOS. In the lack of precise medication, we turn to other forms of pills. However, these types of pills are NOT as regulated as prescribed medication.

The number of supplement companies popping up out of nowhere regularly proves that it’s not a huge endeavour to put a supplement on the market.

Dr. Jen Grater from The Vajenda (a publication I respect and recommend) tried setting up a supplement business to show how easy it is. You can read the article here.

Pharma has to go through numerous clinical studies to prove the efficiency of a drug before putting it on the market. FDA approval is needed for the initial launch and a post-marketing surveillance process that monitors the drug for side effects. All side effects must be reported. For supplements, there is not much. Whilst the pharma world has its challenges, they are beyond the scope of this article.

The argument would be that they are not as powerful as medication, which could hold some truth, but they are not without harm. Unless you take chamomile flower, dry it and drink it, these supplements are still made in a lab with powdered ingredients, capsules and fillers. They don’t hold as much risk as pharmaceuticals, but they are not without risk.

Because what we put into our bodies is incredibly important, we should understand what regulations exist and how to spot those who might have done more homework.

Let’s start with the law. As my readers are primarily from these countries, I will focus on the US, the UK, and Canada.

The PCOS Newsletter is becoming a paid publication. I am running an intro offer for existing subscribers until the end of the year, so don’t miss your chance. The paid version is built for women with PCOS who value high-quality information and want to be science-led in their PCOS journey.

US Regulations on Supplements

Supplements are regulated under the Dietary Supplement Health and Education Act of 1994, which falls under the remit of the FDA and FTC (Federal Trade Commission). However, the FDA regulates dietary supplements as a food category, not as drugs.

Due to this reason, supplements do not require pre-market approval for safety or efficacy. Manufacturers are responsible for ensuring their products are safe. The FDA has the authority to take legal action against supplement manufacturers after they’re on the market. However, the manufacturer is responsible for recording and investigating adverse events, which it must forward to the FDA.

I don't know about you, but this is a significant conflict of interest. I don’t remember buying a supplement and being told how to report adverse effects. I checked ten different supplement websites, and only 1 had a clear space on their website to report adverse reactions 👇🏼

A dear friend of mine vomited blood 4 times after taking Berberine. She didn’t report it. Why? It’s incredibly hard to demonstrate causality, so you need a research setting to spot these adverse effects and why they happen.

UK Regulations on Supplements

Food supplements in the UK are primarily governed by the The Food Supplements (England) Regulations 2003 and equivalent regulations in Scotland, Wales, and Northern Ireland, The Food Safety Act 1990 and some retained EU regulations No 1169/2011 on food information to consumers and Regulation (EC) No 1924/2006 on nutrition and health claims.

Similarly to the US, a new supplement does not need to be registered. The only time you must notify governmental bodies is when you introduce an ingredient that doesn’t form part of a pre-approved list.

What is most shocking about the UK regulations is that there is no law on reporting adverse effects. If in the US, you must report them to the FDA, in the UK, it doesn’t seem to follow any regulation. Manufacturers must ensure their products are safe for consumption.

In addition, health and nutrition claims must be authorised by the UKNHCC. You are not allowed to make any claims about what it can do, so UK-based supplement companies don’t say much about what it’s used for. They rely on practitioners like nutritional therapists to do that job for them in consultations.

Canada Regulations.

Canada seems to be the most reasonable country. Natural health products (NHPs) in Canada require pre-market approval from Health Canada before they can be legally sold. This requires a Site Licence and Product Licence. This is under the Food and Drugs Act and The Natural Health Products Regulations (NHPR). Health Canada conducts post-market surveillance, including monitoring adverse reactions, inspecting manufacturing facilities and reviewing product quality.

How do we choose our supplements?

I am sure that there are levels of control in place, and manufacturers don’t disregard safety, as they would lose their businesses. However, knowing these regulations means that we, the consumers, can take more responsibility for where we buy our supplements. This is challenging because companies will have marketing departments that help them inspire trust.

However, there are clues and things to look out for that might mean they are safer than others. There isn’t a bulletproof way of choosing, but this is how I navigate choosing the brands:

1. Size of the company

Realistically, the bigger the company, the higher the risk of scandals. Supplements companies with an established network of healthcare providers and a substantial market share will be careful when cutting corners in their manufacturing process.

Companies that have their own manufacturing plants might also be safer. Imagine losing billions of dollars because you missed an essential step in your safety procedures. They will have a team and process to ensure it doesn’t happen.

2. Their manufacturing process is described on their website

Companies that describe their manufacturing process in detail give me confidence that they did the homework. Websites that mention nothing on their website are a bit questionable. This means they are white labelling. White labelling happens when companies contract manufacturing to a company that manufactures for hundreds of other companies. You just put the brand label on.

The minimum they need to say is that their ingredients are non-GMO (not genetically modified) and have been tested for allergens.

Examples of explanation:

If someone recommends a supplement company and you are unsure about their standards, email them. I did this exercise just recently to see if companies are willing to share:

I'm still waiting for a reply on this one…

3. The dosages in their formulations and research

Supplements companies wouldn’t be able to create studies on their supplement formulations as it would be a significant conflict of interest. Some companies still do it through independent research, which is a good clue to look out for. I have yet to see a study that disproves the efficacy of a supplement being discussed or publicised. However, this is where we must take things into our own hands. When I write about supplements in this newsletter, I always mention the dosage of the molecule that was proven to work in studies. For example, as far as research tells us, Inositol's most superior formulation is MI alone (2000mg taken twice a day) or MI:DCI (40:1) ratio. Checking whether their formulations have enough of the needed molecule is a way of checking if someone with a scientific background created their formulas.

For example this formula,tion has 4000mg of Myo-Inositol, the dosage tested in studies.

Compared to this formulation which has only 750mg/tablet, and the dosage recommended is one capsule.

4. They have third-party certifications

Certifications such as “NSF” are a sign that the company has invested money in getting its products and manufacturing vetted by a third party. These organisations exist to audit and provide an independent assessment of the quality of supplements.

One of the supplements that is extremely important to be qualitative is Omega-3 fatty acids. They are highly susceptible to oxidation, which can lead to rancidity. In addition, they can contain mercury and other pollutants from water. IFOS (International Fish Oil Standards) is one of the most respected third-party organisations that checks the quality of fish oil supplements.

Some of the other respected certifications are:

NSF Certified → NSF is a World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Medical Device Safety.

USP (United States Pharmacopeia) - USP has developed over 1,000 quality standards – monographs, general chapters, and reference standards - for dietary supplements and dietary ingredients

Nutrasource - This is a Canadian company that performs IFOS certifications and many other types of checks.

5. Their blogs have references

When someone adds references at the end of their writing, it means that they have done their homework and don’t mind someone checking their sources. You will notice that most of my scientific writing has sources at the bottom. When you review supplement companies' websites, do their blog writers use scientific referencing?

For example, this article has the link to the study they are referencing

This contrasts this article, where they make bold claims without any references.

6. Do I need this?

Lastly, before you buy a ton of supplements, ask yourself: Do I really need this supplement? Can I get these things through food? Have I done enough independent research to know if this has enough scientific backing? Is the person recommending it credible?

You will notice that I have not mentioned the names of the supplement’s company. I intend not to promote or denigrate any existing businesses but to empower you as a buyer to make a better choice for your body. I have not recommended any supplement companies throughout the 2 years I have written this newsletter. This is because I would like to keep my writing focused on scientific accuracy rather than marketing. If I ever recommend a brand, it will be because I fully trust the founders and their rigour.

Overall, we should all aim for a food-first approach. However, I understand that supplements can help in different circumstances. Please make sure you vet the things you put in your body.

See you next Sunday,

Francesca

¹

1. Dietary supplements are regulated by FDA and FTC. (n.d.). Crnusa.org. Retrieved 7 December 2024, from https://www.crnusa.org/regulation-legislation/dietary-supplements-are-regulated-fda-and-ftc

Food supplement use and labels. (2011, September 26). Gov.uk. https://www.gov.uk/government/publications/food-supplements-guidance-and-faqs

Food supplements Summary information on legislation relating to the sale of food supplements. (n.d.). Gov.uk. Retrieved 5 December 2024, from https://assets.publishing.service.gov.uk/media/5a7b8297e5274a7318b8f20d/Supplements_Summary__Jan_2012__DH_FINAL.doc.pdf

Nutrition legislation information sheet. (n.d.). Gov.uk. Retrieved 7 December 2024, from https://www.gov.uk/government/publications/nutrition-legislation-information-sources/nutrition-legislation-information-sheet--2