Supplements 101 — Part 1
Safety & Effectiveness
I’m not pro-supplements. I’m also not anti-supplements. I’m about being well-informed about supplements. Welcome to Part 1 of Supplements 101.
First, let’s define what we are talking about here, since “supplement” is used to refer to a grab bag of things.
For the purposes of this piece, I consider supplements to be any vitamin, mineral, herb, botanical extract, amino acid, enzyme, or microbial used for some supposed health benefit. For example:
Vitamins: Vitamin D, Vitamin B12, biotin, multivitamins (usually more appropriately called multivitamin/multiminerals), etc.
Minerals: Magnesium, calcium, iron, etc.
Herbs: Ashwagandha, turmeric, ginger, etc.
Botanical extracts: Berberine, green tea extract (EGCG), resveratrol, etc.
Amino acids: Creatine, L-carnitine, glycine, etc.
Enzymes: Digestive enzymes, lactase, CoQ10, etc.
Microbial: Probiotics, Prebiotics, Postbiotics1
Supplement Safety
Supplement oversight is essentially nonexistent.
While medications are regulated by the FDA, food products are regulated by the USDA, and a handful of other regulatory bodies keep tabs on consumer and product safety, the supplement industry is like an unsupervised teenager seeing how far they can go.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) established that supplements do not need approval for safety or effectiveness before going to market. It stipulates that the FDA only gets involved to determine if a supplement is unsafe after it's already for sale. Note: the burden of proof is on the FDA…
What’s A Consumer to Do?
The lack of supplement safety oversight results in three main safety concerns:
Supplements may contain ingredients different from those listed on the label2
Supplements may contain contaminants3
Supplements may contain way more or way less of the stated active ingredient4
Looking for products that are third-party tested is currently the best way to choose safe supplements, including USP Verified, NSF, and ConsumerLab.
But, Wait! Claims — Too Good to be True?
While third-party organizations may test for safety and purity of supplements, they do not test to see if the supplement does what the company says it does.
This is important.
The only labeling requirement that DSHEA outlines is a phrase I’m almost certain you’ve seen if you’ve ever shopped for supplements:
This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
While this statement really says it all, it is like the fine print that no one reads, understands, or pays attention to.
Every bottle of supplements tells us that they aren’t regulated.
Every bottle of supplements states that they aren’t meant to prevent or treat disease.
But does that stop us from believing otherwise? No.
And that is because labels can say just about anything other than “diagnose”, “treat”, “cure”, or “prevent.”
A label can’t say “prevents osteoporosis,” but it can say “supports bone health.”
A label can’t say “treats diabetes,” but it can say “helps maintain blood sugar levels.”
A label can’t say “prevents heart disease,” but it can say “supports healthy cholesterol levels.”
The fact that these claims are misleading is not a consumer problem. It is marketing getting at the heart of our hopes, worries, and desire for health. Heck, some sound tempting to me sometimes, and I study this stuff!
Ok, so this wasn’t the most cheerful piece I’ve ever written. Yet, it is important information for me to share so we can all make decisions for ourselves and our families with eyes wide open.
Supplements aren’t a sure thing for better health, nor are they a guarantee that they won’t do any harm.
Not everyone needs supplements.
But some do.
Stay tuned for Part 2 next week, where I share how I think about supplements for myself and the patients I work with.
Thanks for being here,
~Allison
I know. Confusing. A topic for another piece…
Ex: A study published in BMC Medicine tested 44 herbal supplements from 12 companies and found only 48% actually contained the plant species listed on the label; a third contained undisclosed fillers or contaminants, some with known toxicity.
https://nutrola.app/en/blog/can-you-trust-supplement-labels-fda-testing-reality
Ex: Ashwagandha, rhodiola, ginseng, and schisandra supplements were found to have widespread lead and nickel contamination, with lead exceeding safe limits by up to 235% and nickel by up to 321% in some products. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12650394/
Ex: A study testing 55 bottles of over-the-counter vitamin D from 12 manufacturers found potency ranging from just 9% to 146% of the labeled amount. https://www.managedhealthcareexecutive.com/view/vitamin-d-potency-varies-widely-dietary-supplements