Mechanisms of Action: What, Why, and How?
Decoding the cellular and molecular pathways that turn ingredients into measurable health benefits.
By: Leena Pradhan-Nabzdyk, PhD, MBA
In the nutraceutical world, we often talk about "clean labels" and "purity," but there is a deeper layer of transparency that the industry and the consumer is increasingly demanding: The Mechanism of Action (MoA). As a Pharmacologist and a scientist, I use this term almost daily.
However, based on conversations with colleagues and observations from trade publications and industry events, familiarity with this concept varies across the nutraceutical industry.
As we move toward a more science-centric marketplace, simply stating that an ingredient or a formulation "works" is no longer enough. We need to know how it works at the cellular and molecular levels. Today, I want to dive into why MoA is the next frontier for our industry and how we can lead this charge.
What is a Mechanism of Action (MoA)?
In the simplest terms, the MoA is the specific biochemical interaction through which a dietary supplement ingredient produces its effect in the body. It isn’t just the "benefit" (e.g., "supports heart health"); it’s the "how" (e.g., "inhibits the HMG-CoA reductase enzyme to modulate cholesterol synthesis").
For nutraceuticals, MoAs are often complex. Unlike pharmaceutical drugs, which frequently are single small molecules that target a single "lock" (molecules such as enzymes, ion channels, receptors), botanical extracts and multi-ingredient formulas often act on multiple pathways simultaneously, a phenomenon we call polypharmacology.
Why Is Understanding MoA Vital for the Nutraceutical Industry?
Safety & Interaction Prediction: Understanding the MoA allows us to predict potential herb-drug interactions. If we know a supplement uses the cytochrome P450 pathway, we can warn consumers who are taking medications metabolized by the same enzymes.
Substantiation of Claims: The FDA requires that structure/function claims be "truthful and not misleading." A clearly defined MoA provides the biological "receipt" that supports your marketing claims.
Dose Optimization: You can’t determine the "right" dose without knowing when the biological pathway reaches saturation. MoA studies help us move away from using tiny, ineffective amounts toward efficacious, science-backed dosing.
Consumer Trust: In an era of "science-washing," providing the specific biological pathway of your product builds a bridge of trust with the estimated 77 percent of Americans who now use supplements. Science is your way to building trust and mitigating marketing and compliance risks.
How Can You Find the MoA for an Ingredient?
Finding this data requires a blend of traditional research and modern technology:
Peer-Reviewed Databases: Start with PubMed, NIH Office of Dietary Supplements (ODS), and the National Center for Complementary and Integrative Health (NCCIH).
Monographs: Resources like the American Herbal Pharmacopoeia or the USP (United States Pharmacopeia) provide deep dives into the known biological activities of ingredients.
Next-Gen Tech: This is where my heart lies. This is what we do at Canomiks. Using in vitro methods and modern technologies like Genomics, Bioinformatics, and AI we can now test your ingredients and formulations in our labs and map how they affect gene expression across the entire human genome, revealing MoAs that were previously invisible to traditional testing. Once we understand these molecular pathways and gene expression changes and interactions, using bioinformatics, we can identify the potential wellness benefits of these ingredients and products as well as their safety profile.
Is MoA Required by Regulatory Bodies?
This is a nuanced area. Under DSHEA (1994):
For Existing Ingredients: The FDA does not strictly require you to submit a Mechanism of Action to market a supplement. You are responsible for safety and substantiation, but the specific "how" isn't a pre-market filing requirement.
For New Dietary Ingredients (NDIs): If you are introducing a new ingredient, you must provide safety data. While a formal MoA isn't always mandated, the FDA frequently requests biological data to understand the ingredient’s safety profile and potential toxicity.
The Bottom Line: While not always a legal "must," MoA is a commercial and ethical "should." It is the difference between a "commodity" ingredient and a "premium" science-backed product. It is what consumers are now looking for.
The Path Forward
The industry is shifting from "What is in the bottle?" to "What does it do to my cells and thereby my health?" Let’s not wait for regulators to catch up; let’s lead with the science.
Stay curious and stay scientific!