Dietary supplement creation 101: Why contract manufacturers who provide end-to-end services reduce lead times and cost

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Creating a custom dietary supplement is one great way to stand out and find success in a highly competitive marketplace, especially for those who are not interested in private-label “off-the-shelf” solutions. Turning an initial idea into a custom finished product with great appeal to consumers, however, is a journey that requires a multifaceted team.

Build a Team for an Integrated Approach

There is no shortage of details that need to be taken into consideration when introducing a new product. Initial discussions with a formulation partner can prevent headaches and expenses later. The right partner—one who is highly experienced, knowledgeable, and brings a deep understanding of the industry—will maximize your chances of success. They will listen carefully to your ideas and, if needed, offer ways to improve your product formulation.

An established partner should be able to provide an efficient, cost-effective approach by offering a full suite of integrated services. These types of turnkey services can help to manage the entire process, from formulation design and ingredient sourcing to prototyping, regulatory approval, laboratory testing, contract manufacturing, and packaging.

The responsibility of creating a dietary supplement does not rest purely on the shoulders of the formulator and manufacturer. An analytical laboratory is required for ingredient and product testing, and a regulatory professional is needed to vet label and ingredient compliance and product licenses. Enlisting experts early in the process will help ensure your formulation meets the required safety, efficacy, quality, and regulatory requirements that can help avoid costly compliance matters later while in market.

The major stages involved in the successful launch of a new product are:

• Research and development
• Manufacturing
• Regulatory consulting
• Quality/laboratory testing

This article expands on each of these stages and the steps involved, as shown in Figure 1.

Figure 1: The journey of supplement creation, from concept to finished product. Illustration courtesy of authors.

Concept — Market Analysis, Competitive Analysis, and Positioning

Prior to formulation design, determine your product goals and understand the nature of the intended market. Make sure you understand your consumer and the distribution channel you are targeting. This applies whether launching a new supplement or reformulating an existing one. Taking the time to understand the current market and whether there is an appropriate demand can potentially be the difference between success and failure.

Questions to ask yourself include: Who is my customer? What health goals are they looking to achieve and/or what challenges do they want to solve? Do they have a preference for dosage format or packaging type? How much are they willing to pay in your market? Are there already similar competitor offerings available—and, if so, who are the category leaders?

There is no shortage of details that need to be taken into consideration when evaluating a new product idea. Speaking with a formulation partner early on can help bring clarity.

Development — Specifications, Regulatory Compliance, and Ingredient Sourcing

Specifications

A sound scientific formulation takes into consideration shelf-life stability and compatibility of the formulation with the intended packaging components. This includes specifications development early on through lab creation of samples and testing protocols for purity, strength, and composition.

What you devise in the lab may not necessarily translate well when scaling up to real-world manufacturing. This is especially true when it comes to ingredient selection.

Regulatory Compliance

The first step in selecting an ingredient is to determine if it is approved for use on government databases. If the ingredient is already approved, it is important to know whether there are regulatory limits on its usage, such as the amount of active ingredient that can be contained in a single dose.

If your active ingredient is new, this is where having the support of regulatory professionals is critical. Your regulatory partner will have to notify your respective regulatory body. In Canada, that takes the form of a new ingredient notification with Health Canada—or, in the United States, as a new dietary ingredient (NDI) notification with the FDA.

Health claims that will appear on your label and in your marketing collateral will need to be substantiated by evaluating the scientific evidence data available to support them. In Canada, companies are required to obtain a Natural Product Number (NPN). The NPN is a premarket authorization that allows for the sale of products to consumers. This is extremely important to have in place prior to producing the first prototype sample.

As a brand owner, you want your regulatory partner to assess the acceptability of the formulation from a regulatory point of view. Simply put, what is the point of building a formulation if it is not going to be approved by Health Canada?

Ingredient Sourcing

After you have assessed the feasibility of your product in terms of market and regulatory acceptance, ingredient sourcing comes next. Typically, a well-established formulator will have a vetted supplier network for sourcing and processes in place to qualify new suppliers. Your product is only as good as the consistency and quality of the source material, and your formulator will work diligently on your behalf taking into consideration ingredient availability at an acceptable quality, price, and volume.

Quality concerns and supply challenges can arise from high market demand for an ingredient due to its popularity, or from unforeseen events such as COVID-19, which created a high demand for ingredients targeting immune health. High demand can also affect the integrity of ingredient quality owing to intentional adulteration. Laboratory testing can help verify ingredient integrity in terms of ingredient identity, quality, potency, and purity, and to ensure the absence of potential contaminants such as heavy metals, residue solvents, microbes, and adulterants.

The cost of raw materials is also important but should not be the only factor. Your product has to be competitively priced so that consumers can afford your product. It is important that formulators keep the price point of the product in mind. In short, this becomes a balancing act between what consumers will pay versus the performance characteristics of the product. This is where the experience and knowledge of a seasoned formulator becomes invaluable.

Prototype Development — Formulation, Dosing Formats, and Laboratory Testing

Formulation

Laboratory-scale samples are created at the prototype development stage. Formulation considerations include dosing by setting the limits of the principal ingredients and raw materials. The emphasis at this stage is on safety and how the ingredients may interact with one another after being blended together. In a solid dose, trace minerals may not affect stability, whereas in liquid-based products these same minerals may catalyze decomposition reactions, resulting in off-tastes—or worse, unstable products.

Your manufacturer will need to address potential manufacturing challenges that may arise due to the individual nature of the ingredients both in isolation and in combination. For instance, if the final product is capsules, the manufacturer will evaluate the consistency of the ingredients. Individually, the ingredients may be hygroscopic and attract water that may dehydrate the capsule shell, causing cracking after manufacturing. In combination, ingredients may cause discoloration due to oxidation; this may not affect quality, safety, or efficacy, but it will impact consumer perception. A blend will also be assessed for flowability. If the powder is sticky, this may cause issues in manufacturing or desegregation during the encapsulation process.

Finally, one has to choose the type of capsule and consider the positives and negatives of each. Vegetable capsules have great marketing advantages but are significantly more costly than gelatin capsules. Gelatin capsules are more economical, but since they are animal-derived, exporting your product across international borders is difficult.

Dosing Formats

Consideration should be given to the effectiveness of the delivery form for consumers. Is it user-friendly? Convenient? Consumer preferences need to be considered when deciding on the delivery format such as capsules, liquid, or powder. This analysis is tied into the population you are targeting with your audience. Are you selling to children? Adolescents? Adults? Seniors? Men, or women?

The type of packaging should also be considered during this stage. This right packaging provides structural protection and integrity, but at the same time it must be attractive on retail shelves. Unattractive and unengaging packaging will not sell. You may have the best formulation, but if you have substandard packaging, your product sales will suffer.

Laboratory Testing

At the prototype sample stage, laboratory testing helps determine the lifecycle of the product from chemical and physical changes over time and under varying conditions. It also confirms manufacturing feasibility.

The next steps in prototype development and testing are to ensure proper formulation, stability, and efficacy prior to commercial-scale manufacturing. The goal of evaluating product stability is to create a shelf-stable product that effectively delivers its dose well beyond the manufactured date up, up until the expiry date. Any strategy has to simulate the passage of time. This is achieved in the laboratory by varying temperature and humidity conditions.

Testing starts the moment your raw ingredient enters the manufacturing facility and carries on during manufacturing and before the finished product leaves the facility en route to your customer. A highly reputable testing laboratory will verify the identity, purity, quality, and strength of your raw ingredients, finished products, and packaging material.

Testing also ensures compliance with Health Canada, GMP, and other industry standards and expectations and, finally, insulates your business. You need proof that what is on your label in in the bottle.

Regulatory Compliance — Labeling

If you haven’t done so already, you will be designing your product label or packaging at this point. Your design will display specific information for the benefit of consumers as mandated by your regulatory body. This includes information such as package contents and format, usage information, ingredients (medicinal and non-medicinal), dosage instructions, contradictions, registration information, manufacturer or distributor information, and, if required, presentation in a dual-language format. Your regulatory partner can help ensure that your label conforms to requirements specific to your jurisdiction.

Manufacturing — Pilot-Scale Batches to Large-Vessel Production

A lot of steps take place prior to manufacturing, and for good reason. The last thing anyone wants to experience is spending a lot of time perfecting a product in a laboratory only to find out that it cannot be duplicated in the manufacturing plant.

It is simple to create a small quantity of the sample in a lab, but a seasoned formulator with a deep understanding of manufacturing can anticipate and plan out the manufacturing steps early on to ensure a successful scale-up from the beaker to large vessels.

A good formulator will also create the technology transfer dossier for the purpose of documenting challenges that may occur during manufacturing. Sometimes a pilot-scale batch is required, which takes places between the steps of laboratory-scale sample and large-vessel batches. Pilot-scale batches can be used to assess the stability and organoleptic characteristics of a given formulation, allowing for adjustments to critical parameters prior to larger-scale manufacturing.

In conclusion, a contract manufacturing partner with breadth of industry experience and who can offer end-to-end capabilities beyond product manufacturing is your best bet to achieve a successful product.“One-stop shopping” can shorten lead times and offer cost-efficiencies by keeping all processes under one roof.

Snehal Patel is vice president of regulatory affairs and manufacturing operations at Total Health Centre, a leading Canadian full-service contract formulator and manufacturer supporting small, medium, and multinational regulated health product brands. The company is an affiliate of the Reena Group, which offers an allied services model for regulatory services, analytical testing, and Natural Health Product contract manufacturing. Christian Sood, PhD, is CEO of the Reena Group of Companies