The Ugly Truth About Food Supplements
Egle Pavyde
Business Development @hVIVO world leader in human challenge trials | Infectious & Respiratory Diseases | Entrepreneur | Industry Consultant | Forbes Council Member | Women Leadership | Speaker | Longevity Enthusiast??
?? In this Nexus:
? Medicinal products ≠ food supplements
?? Food supplements market - the wild wild West
?? From animals to human: lost in translation
?? 7 red flags while choosing food supplements
?? 7 tips how to select a high-quality product
Last week I had a great pleasure to speak at one of the biggest innovations and trends conference in the Baltic states - LOGIN . One of the 7 stages was dedicated to longevity and health related topics. I have decided to convert my speech into an article, to spread the word to an even broader audience. In this Nexus, I discuss the difference between the development and the quality of medicinal products and food supplements, why it is important to trust the data coming from clinical research (i.e. human data), what you need to be aware of the food supplements' market and how not to get lost in the jungle of 100M+ products out there, being pushed to your screen on social media everyday.
Disclaimers
Before I start, lets set the scene with couple of very clear statements:
Medicinal Products ≠ Food Supplements
Medicinal products are not equal to dietary supplements from many various aspects, including regulatory, quality and its' health effects. I will discuss those as you continue to read.
Intended use
The difference is clear from the definition itself. According to the European Medicines Agency, medicinal products are any substance or combination of substances having properties for treating or preventing disease in human or which may be used in or administered to human either with a view to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological, or metabolic action, or to making a medical diagnosis. In simple words, medicinal products are substances or preparations used to diagnose, treat, prevent, or alleviate symptoms of diseases and medical conditions.
According to the U.S. Food and Drug Administration (FDA), dietary supplements are defined as products taken by mouth that contain a dietary ingredient intended to supplement the diet. The dietary ingredients in these products may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. When you read it side by side, you understand what effects can be expected from one or another, and the significance to your overall health of such potential effect.
Development process and regulatory requirements
Lets talk about the difference of regulatory environment. If you want to register a new medicinal product, your drug needs to undergo extensive preclinical research in vitro (or in other words in a tube/flask/Petri dish/etc.) and in vivo (in different species of laboratory animals). If you are lucky to prove that it is safe and effective, there are 3 phases of clinical trials (studies in human), with the growing number of subjects tested in each phase, as well as the growing complexity. Only afterwards you can submit your marketing authorization dossier to the regulators and hope for an approval. This might take your company 10 to 15 years to achieve this, and most probably you will run post-marketing surveillance studies in addition, to ensure your drug is safe in a real-world setting, as shown in the visual below.
In the meantime, in most cases of dietary supplements research and development process in non-existent. Only small part of supplement producers perform some R&D and invest in innovation. The majority of products sold these days are white-label supplements, produced via contract manufacturing process and just put in some nice packaging designed by the selling company.
If I would decide to sell my own brand of longevity food supplements, I could achieve that in a few months, just by finding a manufacturer, ordering what I need in the form that I prefer and building a good marketing strategy to achieve sales. If I am decent enough, I would also need to submit a dossier for notification to the relevant authorities to sell those products in the countries of interest. And as shown in the scheme below, if I put the claims on the package, that are allowed by the regulation - I do not need to perform any testing of such product.
Food Supplement Market - The Wild Wild West
Food supplement consumption is on the rise. Increasing prevalence of chronic disorders, including obesity, diabetes, heart disease, and cancer, as well as busy lifestyles and changes in dietary patterns of consumers are among the key factors driving consumption worldwide.
The global dietary supplements market size was valued at USD 177.50 billion in 2023 and is projected to grow at a CAGR of 9.1% from 2024 to 2030.
Market size value in 2024 is projected to be USD 192.65 billion, and revenue forecast for 2030 is USD 327.42 billion, which is almost double comparing to 2023 results (1). Due to such an attractive projected year-on-year growth from the business perspective, insufficient regulation of dietary supplements and the easiness to sell such products online, there are various issues that consumers should be aware of. As the title of this paragraph states, for me food supplement market is the wild wild West, due to the following reasons:
Between 2007 and 2016, the FDA identified 776 adulterated dietary supplements and implicated 146 different companies (2). These products were predominantly marketed for sexual enhancement (353 or 45.5%), weight loss (317 or 40.9%), or muscle building (92 or 11.9%). Notably, 157 of these products (20.2%) contained more than one unapproved ingredient. The most common adulterants included sildenafil in sexual enhancement supplements (166 of 353 or 47.0%), sibutramine in weight loss supplements (269 of 317 or 84.9%), and synthetic steroids or steroid-like ingredients in muscle building supplements (82 of 92 or 89.1%). Additionally, 28 products were cited in two or three warnings issued more than six months apart. Of these, 19 (67.9%) were found to contain new unapproved ingredients in subsequent warnings, suggesting repeated adulteration. From 2014 to 2016, 117 of the 303 adulterated samples (38.6%) were detected through online sampling, and 104 of 303 (34.3%) through the inspection of international mail shipments.
领英推荐
As you might know I am a pharmacist by training and I have another example that is stuck on my mind. One of my professors in the university, who has all the required equipment in his lab (like high performance liquid chromatography), from time to time takes food supplements available on the market of the same ingredient, and checks is it really there. The results he once presented on Omega-3 food supplements were shocking. Only one brand had exactly what was stated on the label, others had much less of the active ingredient and there were also a number of food supplements, where Omega-3 was changed to a similar chemical structure oil, which does no benefit to our health.
From Animals to Human: Lost in Translation
Many dietary supplements' sellers in their marketing claims put a statement "Scientifically proven". Unfortunately, in most of these cases the data is coming from preclinical research, i.e. data from cell cultures, animal studies, etc. Moreover, you have to understand that this data in most cases is generated not using the product you are planning to buy. Clinical trials are there for a reason. A good example for me is the hype around NAD+ Precursors. As I wrote in the previous Nexus edition, while preclinical data has shown some amazing results and promising data, the translation into human is poor and we don't see the same therapeutic/health effects as in yeast or mice. Have this example in mind each time someone wants to convince you on the effects of any product, using publications from preclinical research.
7 Red Flags While Choosing Food Supplements
There are some facts to check or some red flags to avoid when you browse for products online. These include:
?? "Scientifically proven...". As mentioned in the paragraph above, you need to check if this data was produced by researching animals or humans, is it a reliable source of information (scientific and not a social media article), is the active ingredients and their amounts used in that research are the same as the product of interest, etc.
?? "The products created by me...". I see a number of influencers these days, claiming that they were highly involved in the development of the product. Look, if you don't have a research lab or a manufacturing plant and if you haven't invented a new formulation, route of administration or anything else for the product you are selling, let's just make it clear that the only thing you created was the packaging design. Well, that also requires creativity, isn't it?
?? "Can help cancer patients, diabetics, ...". I also see social media ads, which are far from truth and use very misleading and strong claims, which are even illegal to use. Look at the beginning of this article at the definition of a dietary supplement, and think is a substance under such definition can really cure severe diseases or how significantly they can affect your health. For a better illustration here are some examples of impermissible/permissible claims below:
? Impermissible: Helps reduce the effects of osteoporosis
? Permissible: Helps maintain strong bones
? Impermissible: Lowers blood pressure
? Permissible: Helps to maintain heart health
?? "As seen on Cosmopolitan / Forbes / ...". In many online stores you can see statements as seen on some popular website. This is indeed done to increase legitimacy for users and increase sales. First thing you need to do is to follow these links, and check if this is the actual product that was mentioned in one or another article, or just something similar. Also, think if these info sources are really the ones where you want to check anything related to your health. For me - they are not.
?? Pictures of doctors or scientists on the website. I came across one food supplement website, which had a picture of a doctor who is stated to be a consultant of that company. It looked cringe, so what I did first, took the name of that "doctor" and looked him up on LinkedIn - no results. OK. I then downloaded the picture of him and uploaded it to Google search. And guess what? I found him on free stock images website showing a keyword nearby - middle-aged doctor. SCAM ALERT!
?? Pictures of well-known longevity influencers. Many online businesses are also trying to leverage the popularity of such longevity influencers as David A. Sinclair A.O., Ph.D. , Andrew Huberman or Peter Attia . You can see their photos used without any permission, citing their statements, adding their videos to the ads of products, etc. These guys have their own websites and clearly state their relation to the products or companies with which they collaborate with. So once again - check the facts!
?? Logos or badges "proving" the quality of products. Scammers often try to improve their legitimacy by adding different badges to their website. This usually states "Diamond Quality", "Golden Certification" and other kind of bull... Once again, download such badge photo and check if it is really some kind of certification or just a something created with Paint.
7 Tips How to Select a High-Quality Product
Here are some tips from me as a pharmacist on how to pick a high-quality product or at least how to secure yourself from fraud as much as possible:
Information on the FDA labelling requirements can be found here. Some of the quality marks used in the US are shown below:
To end with, I would like to emphasize that food supplements are only add-on to your health, and definitely not a key matter to care about. And as I ended my presentation at the conference:
If you won't care about your longevity "hygiene" (sleep, healthy diet, physical activity, resilience to stress, mental health), any food supplements you take will be like putting a patch on a wound of a dead man, who died from that wound.
Not too much science this time, but a lot of food for thought and tips how to be more sharp online. Hope you enjoyed the read. More on longevity and healthspan is coming in 2 weeks. Make sure to subscribe!
Founder at AmaZest | $100M Amazon Supplement Brands Portfolio | Helping Scale D2C Supplements and Wellness Brands up to 100% in Just 120 Days on the world's largest Marketplace Amazon.
5 个月Great work, Egle! Your Nexus edition is insightful and provides valuable information about the differences between medicinal products and food supplements. Your practical tips will surely help many navigate through the overwhelming market of food supplements. Keep spreading your knowledge to a broader audience - it's truly impactful.
Executive Wellness Coach ?? | Empowering Leaders to Nourish and Thrive in Life and Work | Certified Health and Nutrition Coach | Women's Hormone Health Expert | Board Member
5 个月At the end of the day, Food Is Medicine. I tell my clients, if it has a label on it, read it. It likely has other ingredients, plus some side effects too. Thanks for brining more light to this subject, supplements are there to 'supplement' a healthy lifestyle and nutrition
Professor of Finance at Vilnius University
5 个月????
Psychiatrist | AI Enthusiast I Co-Founder and CEO at Romuvos Klinika | PhD Candidate in Social Science at Lithuanian Sports University
5 个月Egle, thank you for the valuable, well-structured, and clear information. Your newsletter is an exemplary source of quality content. For those who haven't yet subscribed, I highly encourage you to do so!
Life Scientist
5 个月Puikios ??valgos :) Reikia daugiau toki? prane?im? visuomen?s edukacijai!