If you’re green to the nutraceutical industry, the learning curve can be steep. Many industry newcomers have business brilliance but less familiarity with the scientific, manufacturing, and regulatory pieces of creating dietary supplements. Some players have spoiled the reputation of this unique industry and are the source of a misguided notion that supplements are entirely unregulated. There are certainly ways to bring a product to market that duck and dodge the rules, but the ethical and legal risks are high, and inevitably their windfall expires.
If there’s one word you need to know and love, it’s “Quality”. A simple word with multi-layered meaning, Quality is the guiding principle behind creating a safe, effective, successful product with true health benefits and market staying power. The substance behind this term is fully defined in the Food and Drug Administration’s (FDA) code of federal regulations, chapter 21, part 111. Commonly referred to as “cGMP”, these written instructions outline what practices and procedures qualify as “good” in the “manufacturing, packaging, labeling, and holding” of dietary supplements.
A Quick Primer on cGMP
Who: Suppliers, manufacturers, testing labs, co-packers, even distributors and brand owners are all responsible for knowing, understanding, and following cGMP in formulating, producing, and handling products.
What: cGMP standards cover facilities, equipment, personnel, raw materials, finished products, packaging components, labels, and the procedures and documentation that verify them.
How: The cGMP umbrella represents a consistent framework for industry players and regulators to share common language and understanding of what defines supplement safety and efficacy.
Why: Every detail of these codes is intended to coalesce in a pure, safe, and genuine product that the end consumer can confidently trust.
We started with a glimpse at the regulatory landscape because formulating high-quality supplements starts and ends with cGMPs. And the first ingredient in any formula is research. Skipping this step is tempting for brand-driven entrepreneurs that start with a clear marketing path to success, but the end of the rainbow is typically fool’s gold. While it’s essential to design a product with intention, a formula is only as good as its foundation.
Now that we’ve established a sense of accountability and authority, let’s get to what exactly goes into the research and development of a high-quality supplement formula, and why partnering with a knowledgeable, responsible expert in custom formulation is the way to go.
Step 1: The Idea & the Goal
Rules and regulations don’t have to put a damper on your ideation process. There are thousands of FDA-approved ingredients and a growing base of scientific research on how and why they benefit human health. It can be helpful to start with the big picture: What claims do you want to make that distinguish your product and attract a specific end customer? What does the product do, and what is the final form of the product? Answering these questions can help you narrow down and filter your scope of research.
It’s also important to become familiar with labeling requirements and health claims that are allowed for dietary supplements. You can probably find a piece of research to back any claim you choose, but that doesn’t mean it’s valid or robust enough to satisfy the FDA. Set your sights on a product with realistic effects, and you will be rewarded with loyal customers.
Step 2: Defining the Details
With an informed and practical goal for your finished product, what ingredients are on your A-list, and why? If you’re looking at unusual ingredients, are they on the FDA GRAS (generally recognized as safe) list? For the most part, it’s prudent to stay within the bounds of approved substances unless you’re willing to spend the time and effort to approve a novel ingredient.
After defining a realistic roster, is there sufficient research data to back the purpose of each ingredient and the interaction of the formula as a whole? What amounts have been shown as safe and efficacious in reference to the product’s intended use? It can also be helpful at this stage to identify whether you prefer a product that is free from any allergens, catered for certain dietary restrictions (i.e. vegan, paleo, gluten-free), is non-GMO, etc., in case these claims place limits on your ingredient selection.
Step 3: Will it Work?
Here’s where your early research really comes back to count. Formula ideation and exploration is fun and exciting, but can it actually be manufactured? Are the ingredients you’ve chosen available and affordable? Will the ingredients blend together into a stable form that is consistent and easy to replicate and scale? Sourcing and feasibility are the two primary components of this step and the point at which a manufacturer is brought into the process.
Successful sourcing precedes the pilot run, which is the hinge point at which your idea becomes reality. A solid, research-backed formula has the greatest likelihood of achieving a positive outcome on the first try, expediting your product development timeline. In an ideal case, optimizing the excipient profile is the key task.
This is also the stage at which cGMP Quality returns to the fore. A key predecessor to the pilot run is a product specification, in which standards are set that identify the authenticity and potency of the ingredients and verify the purity of the final blend. These criteria are then tested and confirmed by qualified laboratories through appropriate analytical methods. Specifications allow the production process to be controlled and refined for repeatability and reliability. Pilot runs are also an opportune time to collect nutritional data or other necessary label information.
Step 4: The Finishing Touch
Your formula is solid and feasible. You’ve got a winner, and the hardest work is done! But there are still critical decisions to make that factor into a truly high-quality product. As we mentioned earlier, cGMPs also include instructions and procedures for packaging, labeling, and distributing your product, so Quality matters here too.
We’ve listed this in logical progression, but decisions on packaging typically coincide with creating product specifications and sourcing. Manufacturers typically need to know serving size and bottle counts for testing and pricing purposes. Having a selling plan and ideas on your product’s aesthetics early in the process accelerates the path to production.
The final step is label design, which should begin as soon as the pilot batch is approved and ingredient sources are finalized. And here is where the formulation process comes full-circle, as the intentionality behind your product results in ready-made, research-backed label claims. Just add your branding flair and you’re off to market!
Why Use a Custom Formulation Service?
We’ve set out to give you a straightforward and realistic overview of a process that is certainly fun and rewarding, but that also demands discernment, organization, and patience. Many contract manufacturers and brokers know how to get you in the door and make big promises, but you might be signing away your ownership of the process and the quality of your product.
The Hydroscience team knows the ins and outs, the highs and the lows of formulation and manufacturing. We see ourselves as your partners, adapting to your preferences and goals yet offering educated guidance to protect you from pitfalls and point you towards best practices. Reap the benefits of our scientific knowledge, regulatory expertise, and industry rapport. Our personal attention to your project invests us in your success, and we can’t wait to be your guide!