Here’s what formulators say about the challenges and opportunities related to bringing new products to market.
The panel:
Alicia Kasch, Vice President, Ribus Inc., Sparks, NV, https://ribus.com
Asa Waldstein, Principal, Apex Compliance, Boulder, CO, https://apexcomplianceprogram.com
Danny Hofeditz, Director, Quality & Product Innovation, Aquanova, New York, NY, https://aquanova.de
Gene Bruno, DBM, Chief Scientific Officer, Nutraland USA, Knoxville, TN, www.nutralandusa.com
Giuseppe Famà, Global QHSE Director, Gnosis by Lesaffre, Lille, France, www.gnosisbylesaffre.com
Kelly Vu, Application Scientist, IFF Pharma Solutions/Roquette, Lille, France, www.iff.com; www.roquette.com
Maria Stanieich, Senior Marketing Manager, Kyowa Hakko USA, New York, NY, https://kyowa-usa.com
Sebastian Balcombe, Founder and CEO, Specnova LLC, Tysons Corner, VA, https://specnova.com
Terry Coyle, Chief Innovation Officer, Vitaquest, West Caldwell, NJ, https://vitaquest.com
Creating a new product is fraught with challenges. From determining which market you want to target, to formulating the product for maximum safety and efficacy, to determining ingredient ratios and more, bringing new products to market is a resource-intensive process. However, if you’ve done your research, you’ve likely identified a profitable gap in the market for your product, which, ultimately, will justify all of the R&D investment spent on this new product.
But how can you ensure that you end up with a high-quality product that consumers will love? How can you ensure product-market fit, product efficacy and a timely production process—all without being overwhelmed by your many choices, and all while ensuring regulatory compliance? Nutrition Industry Executive (NIE) has convened a panel of experts to give their insights into creating new products and bringing them to market.
NIE: What are the top issues that determine success or failure when bringing new products to market?
Kasch: At RIBUS, we believe success hinges on aligning innovation with real market needs. We actively seek feedback from formulators and manufacturers to understand which synthetic ingredients they want to replace or what functionality is currently missing. From there, we develop plant-based excipients that mimic the performance of their synthetic counterparts.
Once a product is functional and meets certification requirements, we support the launch with studies, proper certification, and a Getting Started Guide. Before going to market, we partner with RIBUS Certified Contract Manufacturers to beta test the product and provide valuable feedback. This approach ensures we’re introducing a clean label ingredient that meets a specific demand, performs as intended, and has real-world validation.
Hofeditz: For supplement manufacturers, product success typically hinges on a handful of critical factors: Bioavailability and efficacy, speed to market and regulatory compliance.
Consumers today are increasingly informed and results-driven—they expect products that deliver tangible health benefits. Even the most innovative formulation will fall short if the active ingredients aren’t effectively absorbed. That’s where bioavailability becomes crucial.
In a competitive and fast-moving industry, being first—or fast—matters. Long development cycles can result in missed market opportunities or allow competitors to establish a foothold. Leveraging a ready-to-use delivery system like NovaSOL can significantly shorten development timelines.
Bruno: From my perspective, the top factors are timing, differentiation, support for claims and value. By timing, I mean are you offering a product concept that will resonate with consumers at this time (i.e., is it a hot topic or at least a timeless topic that will always have appeal). Can you offer differentiation for your product, or is it just a “me-too” formulation?
Vu: In some respects, the success of a product may not necessarily be a result of how efficacious the product is or how high the quality is—although these factors do certainly help in contributing to the success—it can simply be successful because it was packaged attractively and marketed to the right consumer base. Other factors that can contribute to the success or failure of a new product could be associated with perceived value and necessity for cost.
Stanieich: Bringing a product to market successfully requires more than just a good idea. This process requires strategic foresight, supplier collaboration and clinically substantiated innovation. One of the biggest differentiators is having a clear value proposition supported by clinical science and quantifiable data. Consumers are more informed than ever, and they’re looking for products that deliver proven benefits with clinical studies to back up claims.
Balcombe: One of the most overlooked yet critical factors in a product’s success is the credibility and validation of its delivery system, especially when it comes to technologies that improve an ingredients bioavailability, like liposomes. Without a true, scientifically validated delivery mechanism, even the most promising active ingredients can fall short in real-world efficacy.
Coyle: We have found that success in launching a new dietary supplement depends upon achieving three key goals: market relevance, scientific viability and supply chain feasibility. A great idea can fail if it’s out of step with consumer demand, poorly substantiated by science, or impossible to source or manufacture affordably. Clear communication between brand owners and our Innovation and Formulation teams is vital. We lead with discussions around target claims, budget constraints and target launch dates.
NIE: How do formulators determine the market they want to appeal to?
Kasch: Typically, formulators don’t define the market—they’re given product development parameters by marketing or executive teams. Their role is to create a formula that meets those requirements, which often include specific actives and delivery formats.
Hofeditz: Formulators determine their target market by aligning product development with a combination of consumer demand trends, scientific validation and delivery format preferences. The starting point is understanding what consumers are actively seeking. Trends such as immune support, cognitive health or beauty-from-within drive market segmentation. Formulators track these evolving interests through market research, retail data and health and wellness insights to ensure their products are relevant and in demand.
Bruno: Formulators should work in tandem with marketing and sales personnel from their company. Find out from them what’s hot and what’s not. Run ideas past them. It’s not enough for a formulation concept to appeal to the formulator. The rest of the team needs to buy in on it too.
Vu: Formulators working in new product development are often working with marketing and branding counterparts to identify consumer market segments and health categories in which their new formulation should appeal to. Formulators also leverage the insights from industry events into their product formulation design.
Stanieich: It always starts with identifying who’s going to be using the product. Who are we helping, what products are they already using, and what outcome matters to them most? That could be healthy aging, mental energy, memory recall—once you’ve established that particular need set, everything else becomes more focused and intentional. It’s important to align your ingredient choices and delivery formats with the expectations of a defined audience.
Balcombe: Every formulator has their own unique process, there is no one way to choose a market and the appropriate go to strategy. When we were creating LipoVantage Liposomal Technology, we saw that many if not most legacy ingredients bioavailability and efficacy could be improved with the use of liposomes.
NIE: What are some best practices for product formulation?
Kasch: Clear communication is essential. Know your limitations—whether regulatory, certification-related or ingredient-specific—and communicate them early. That allows us to help formulate within those constraints from the start.
Waldstein: When it comes to formulation best practices, it’s vital to combine scientific evidence with historical herbal use. Practical clinical knowledge is also key to making efficacious formulations, as some ingredients may have excellent clinical data but, in practice, don’t work very well.
Hofeditz: Effective product formulation involves a strategic approach that strikes a balance between innovation, efficiency and reliability. Formulators will want to start with proven delivery systems, leveraging established delivery technologies to streamline the formulation process. By starting with a system that’s already validated, formulators can reduce trial-and-error cycles, accelerate product development timelines and improve the likelihood of achieving desired product performance from the outset.
Bruno: Use clinically relevant doses of nutraceuticals shown in human research to be effective for the purpose intended. Make sure you’re procuring the right form of the nutraceutical from a reputable raw material supplier that provide all of the documentation you need for claims and QA (quality assurance). Be ethical. Avoid the use of fairy dusting in inadequate doses of nutraceuticals just so you can claim they are in the product.
Vu: A best practice I follow when formulating new products or reformulating existing products is to understand the health supplementing ingredients’ material characteristics. I run physical tests to understand the powder flow, compressibility and hygroscopicity, and I work with suppliers to understand the composition profile of the material to determine if there are any additional ingredients that are used as a processing aid in the health ingredient that may impact the final dosage form. A specification is then created for the raw material and any new vendors for the raw material will then need to be vetted through the material characteristics outlined on the specification.
Stanieich: After you have identified your target audience, best practices begin with building on a foundation of trusted, clinically backed ingredients. Formulators should prioritize efficacy, stability and consumer usability from day one. At Kyowa Hakko, we encourage our partners to think not just about the functional benefit, but about how the ingredient will behave in the final format. Will it hold up over time? Will the flavor profile be consumer-friendly? Is it supported by human studies at meaningful dosages?
Balcombe: Validation! You can create a million different products but unless you can validate the ingredient and prove that it works, you are tricking the consumer into taking a product that isn’t going to provide the expected benefits. That is bad for the consumer and bad for industry.
Coyle: Successful formulation starts with clear objectives: what is the product meant to do, what are the desired claims, and who is the end user? From there, best practices include ingredient compatibility screening, delivery system optimization, cost modelling early in the process, consideration of product stability, and collaborating with QA/regulatory teams to ensure compliance from the start.
NIE: How do you determine ingredient ratios when formulating a new product?
Waldstein: Ingredient ratios should be based on established research, traditional therapeutic ranges, and, when applicable, synergistic interactions between ingredients.
Hofeditz: Determining the right ingredient ratios is a critical part of successful formulation, ensuring both effectiveness and regulatory compliance. Our approach is based on two key considerations. First, bioavailability-adjusted dosing. With NovaSOL’s enhanced absorption, smaller amounts of the active ingredient are often needed to achieve the desired effect. This allows for more efficient dosing, streamlined formulations and greater flexibility in product design. Second, reference to clinical and regulatory guidelines is critical. Dosing decisions are guided by a combination of published clinical studies and official regulatory guidelines, depending on the target market.
Vu: In dietary supplement formulations, the health supplementing ingredients constitute for much of the formulation, leaving little room for the excipients; therefore, ratios and selection of the excipients are dictated by the material characteristics of the health supplementing ingredient itself.
Stanieich: The most effective starting point is to anchor your formulation in the dosage levels used in published clinical studies. That clinical validation gives brands the ability to make trustworthy label claims that are grounded in data. From there, you have to ensure those ingredient levels are maintained within the delivery format and desired serving size. It’s not just about what looks good on paper, it’s about what can be practically applied in a finished product while still meeting consumer expectations.
Balcombe: This comes down to the individual formulator and what they are trying to accomplish in their formulation, there is no one size fits all.
Coyle: Ingredient ratios are based on a combination of clinical evidence, formulation synergy and delivery form constraints. We look at the research supporting minimum effective doses, while also considering whether the ingredients work additively or synergistically. Space in capsules or powders may limit total actives, so prioritization becomes essential.
NIE: How do you prevent overwhelm when choosing the right ingredients?
Kasch: Ingredient selection can be daunting, especially with so many options. Start by establishing your non-negotiables—such as certification requirements (e.g., Certified Organic, Made With Organic). This will automatically narrow your options.
Waldstein: To avoid feeling overwhelmed, you can start with the product’s intended outcome to make sure it is compliant. For example, making a product-targeted dietary supplement formula designed to lower LDL cholesterol wouldn’t be a good idea, as this is an implied disease claim. Alternatively, a cardio system support formula is broad enough to allow permitted structure-function claims. You also want to match your form factor to the formulation. For example, certain ingredients taste terrible and need to be in capsules or tablets, and some ingredients are not soluble when delivered as dry mix powders.
Hofeditz: With the vast number of ingredients available today, it’s easy to feel overwhelmed during formulation. The key is to take a structured, benefit-driven approach. We start by clearly defining the specific health benefit we want the product to deliver—whether it’s immune support, joint health or beauty-from-within. From there, we identify ingredients that are both clinically supported and aligned with that benefit.
Bruno: Create a checklist with the following: 1) Does a clinically relevant dose of the nutraceutical fit in the desired deliver form along with the other ingredients? 2) Can you afford to include that specific nutraceutical in the formulation? 3) Is the mechanism of action for the nutraceutical redundant to another nutraceutical I the formula? If so, consider using a different nutraceutical.
Famà: Quality finished products begin with selecting the right raw materials to achieve your formulation goals, starting with your ingredient suppliers. There is an inherent level of trust that a supplier must earn and nurture for lasting, sustainable success. The right supplier partner relieves formulators’ pressure by providing clinically proven, efficacious branded ingredients that meet the strictest industry certifications, including kosher and halal.
Vu: I prevent being overwhelmed by choosing the right ingredients by taking a systematic approach in developing a formula. Often in dietary supplement formulation, a formulator is guided by their marketing teams on a specific consumer segment the new product should be intended for.
Stanieich: Focus is everything. Instead of starting with a long list of trending ingredients, we recommend grounding the process in the functional goal: what is the product intended to do? Once that’s defined, you can start to identify which ingredients are best suited to deliver that benefit with the right combination of science, stability and consumer trust.
Balcombe: Go with the ingredients that have the best designed studies with the strongest results. Don’t be fooled by ingredients that have 10-20 studies as many studies are poorly designed—from looking at end points that have no real-world relevance, to using dosing that no formulator can afford to use.
Coyle: It’s easy to be overwhelmed—there are thousands of ingredients with overlapping benefits. The key is to ground formulation in clear priorities: What is the intended benefit? What are must-haves versus nice-to-haves?
NIE: How do you analyze existing products to find market gaps?
Kasch: The Clean Label Alliance is equipped to support both new formulations and reformulations of existing SKUs. The process is the same: complete the project request form, and we’ll coordinate expert input across the Alliance. Within two business days, you’ll receive practical recommendations to test, all from a single point of contact.
Vu: Existing products/competitive products are often reviewed and analyzed against the label claims via analytical methods. In some instances, reports from third party test labs may also be available for purchase to check the validity and quality of the product.
Stanieich: We’re in a constantly evolving landscape, so you have to look at the market through both a scientific and strategic lens. What are competitors offering, and how do their claims, ingredient choices and delivery formats align with the latest research? More importantly, where is there room for differentiation?
Coyle: We often begin with competitive benchmarking—looking at similar products in the market to assess ingredient selection, dose levels, claims and positioning. Tools like SPINS data or Mintel can support that. From a formulation standpoint, we also reverse-engineer ingredient lists to understand structure and feasibility, identify potential gaps or strengths, and look for opportunities to differentiate.
NIE: How do suppliers assist manufacturers with formulation when using their ingredients?
Kasch: RIBUS provides direct formulation assistance for customers using our ingredients. We invite formulators to fill out a brief form on our website, after which our team follows up with customized recommendations to support your development goals.
Waldstein: Suppliers, especially with well-researched branded ingredients, can be valuable partners by providing substantiation and stability documentation for their ingredients.
Hofeditz: Suppliers play a critical role in supporting manufacturers throughout the formulation process by offering more than just raw materials. They provide integrated solutions. Trusted suppliers provide comprehensive support with technical specifications, safety data and regulatory documentation, helping manufacturers meet compliance requirements efficiently and confidently in their target markets. Suppliers also offer practical formulation guidance tailored to various delivery formats—whether it’s liquid capsules, shots or stick packs. This ensures the ingredient performs optimally in the chosen application and aligns with consumer expectations.
Bruno: Suppliers should provide manufacturers with the data they need, including the standard tech/spec sheets and COAs. They should also provide copies of studies and other validated data the will help support product claims. Supplier can also help provide information on testing methodologies and assist with the actual formulation process if needed.
Famà: A core objective of suppliers is to make it effortless to incorporate their ingredients into any finished product brand owners can dream up. Suppliers worth considering understand how their ingredients interact with or are complemented by other ingredients. They know that proven bioavailability, solubility and stability impact an effective finished product.
Vu: Suppliers can assist manufacturers and formulators by ensuring they have up to date documentation and understanding of the regulatory compliance of their material. In addition to this, data in terms of stability and compatibility on how the material functions in a specific dosage form is highly beneficial for a formulator to have when designing a new product. Starting formulations to demonstrate suitability also is highly helpful.
Stanieich: A good supplier is more than a source of raw materials. We support our customers from ideation to commercialization, which means offering technical guidance on formulation, sharing clinical data to support efficacy claims, and providing regulatory documentation to ensure compliance across global markets. We also offer marketing and positioning support to help brands tell the story behind the science.
Balcombe: As the creator of branded ingredients, it is our duty to know the best ways to formulate with them. We work closely with formulation and R&D teams to ensure that our ingredients are compatible with the final products base, matrix and dosage goals, so the end result is not only effective but also scalable and commercially viable.
Coyle: Suppliers play a crucial role—they often provide technical documentation, formulation prototypes, clinical substantiation and regulatory dossiers. The best suppliers act as strategic partners, helping us understand how their ingredients perform in various formats and how to optimize use levels.
NIE: How does one ensure that the finished product meets regulatory compliance standards and is efficacious?
Kasch: Ultimately, it’s the responsibility of the brand and its certifiers to ensure regulatory compliance and efficacy. While the Clean Label Alliance is not a regulatory body, we serve as a resource of experienced professionals who can guide formulation decisions to help achieve your clean label goals. Our expertise helps bridge the gap between clean label intent and functional, market-ready products.
Waldstein: Finished-product labelling is an essential part of compliance, so ensuring the supplement fact panel and other required elements are correct is a good starting point. From there, ensure there are no litigation triggers such as “all-natural” or “clinically-proven” language on the label, and ensure that all structure-function claims can be substantiated. Keeping in mind retailer-specific requirements is another important nuance to label compliance.
Hofeditz: Ensuring both regulatory compliance and efficacy starts with choosing the right ingredients and verifying that every component of the formulation meets established standards. First, you’ll want to use standardized, well-documented ingredients. Comprehensive documentation like technical dossiers, safety data and clinical studies provides a strong foundation for regulatory approval and ensures transparency throughout the supply chain. Next, you’ll want to ensure you use efficacious dosing, delivering the right dose in the final product.
Bruno: Make sure that: 1) all ingredients are NDI (new dietary ingredient), ODI (old dietary ingredient), or GRAS (generally recognized as safe), 2) the label is consistent with regulations and avoids any egregious or unsubstantiated claims, and 3) use clinically relevant doses of nutraceuticals shown in human research to be effective for the purpose intended.
Famà: Brand owners can be more confident in regulatory compliance and ensuring their products are efficacious if they choose the right ingredients from the right supplier. Prominent players in the dietary supplement market rely on their raw material suppliers according to standard quality requirements defined by dietary supplement regulations.
Vu: During the entire formulation process, regulatory compliance should be kept in mind and re-evaluated as new ingredients or processes are being introduced. This is through extensive documentation collection and reassessment. Efficacy should be supported through validated scientific literature or deemed efficacious from regulating bodies such as the FDA (U.S. Food and Drug Administration).
Stanieich: Again, choosing the right ingredients is essential. A clinically studied, branded ingredient that has undergone years of research and development to ensure its safety, quality and efficacy is going to simplify your formulation and regulatory processes.
Coyle: Regulatory compliance is built into our formulation workflow from day one. We review all ingredients against FDA guidelines, DSHEA (Dietary Supplement Health and Education Act of 1994) requirements, and other relevant regulations. Receiving documentation corresponding to the SIDI (Standardized Information on Dietary Ingredients) protocol is non-negotiable. NIE
